Frequently Asked Questions

What are the benefits of ISO 9000?

When ISO 9001:2008 is implemented in an organization there are many benefits including:
Well defined and documented procedures improve the consistency of output
Procedures ensure corrective action is taken whenever defects occur
Defect rates decrease
Defects are caught earlier and are corrected at a lower cost
Defining procedures identifies current practices that are obsolete or inefficient
Documented procedures are easier for new employees to follow
Organizations retain or increase market share, increasing sales or revenues
For more on this topic visit our page on the Benefits of ISO 9001:2008 read more about the benefits

We are a small company employing 3 people do you think ISO9001 is still relevant?

Yes, ISO 9001 is relevant to even the smallest companies. You are able to make the system simple, to suit your small organization.

Can a sole proprietor be ISO 9001 certified?

Yes, ISO 9001 is relevant to even the smallest companies. You are able to make the system simple, to suit your small organization.

What is ISO?

ISO is the International Organization for Standardization situated in Geneva Switzerland. Because International Organization for Standardization would have different abbreviations in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek ISO meaning equal. Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO.
ISO is in charge of issuing international standards that different countries can adopt, ranging from quality and environmental management systems to product or material specific standards.
The main purpose is that all of the standards that ISO issues have been approved by its 157 member countries making them truly international.

Why would my company need ISO 9000?

Companies need ISO 9001 Registration for several different reasons.
One reason is Market Pressure, a customer of yours asks you to become ISO 9001 Registered. Customers ask for ISO 9001 to make sure that their suppliers have a good quality management system in place.
Another reason companies register is for the internal benefits. Registered companies experience internal improvements and increased profitability. Click Benefits to read more about this.

What are the drawbacks to ISO 9000?

There are costs associated with the implementation and maintenance of the system. You will need to have a Registrar come every 6 months or year to make sure your system still meets requirements. Most companies find that the improvements within the company pay for these costs.

What is ISO9000 meant to show?

ISO 9001 registration shows that an organization has a comprehensive quality management system in place, and that they comply with that system.

Why ISO 9001?

A better question may be Why not ISO 9001?”
It would be difficult to run a business without addressing the management aspects covered by ISO 9000. If ISO 9000 is not used, you will need to develop something that will end up looking very much like ISO 9000.
ISO 9000 has done this development for you. Experts world wide have worked on this system for years now, determining what a successful business needs to have in place to achieve that success.
You can benefit from this expertise by following the system they have developed: ISO 9001:2008.

Does my company need ISO9000?

Any company can benefit from an ISO 9001 Quality Management System. To answer if you need ISO 9001 Registration, you need to look at your own situation.
Some companies are asked by their customers, or their market puts pressure on them to get registered.
Some companies need ISO 9001 because they need improvement in their operations.

Does my department need ISO9001?

ISO 9001 applies to the organization as a whole, not just a department.

What companies need ISO?

Any organization can benefit from ISO 9001. Many companies are asked by customers or their market demands ISO 9001 certification to be competitive. Some industries require certification, for example the automotive industry, aerospace industry and medical device industries have some requirements for their suppliers to be registered to ISO 9001 or industry specific quality management system standards.

Why do I need ISO?

Any company can benefit from Registration. ISO 9001 can help you improve your internal operations. If you are asking if you must register the answer is if your customers are looking for ISO 9001 registration from their suppliers. You need ISO 9001 Registration if:
1. Your customers ask you to become registered
2. Your market demands it (competitors are registered, customers like to see or are used to seeing registration)
3. You supply the automotive, aerospace, or medical device industries (If you do you want to find out exactly what is required for your company. There are industry specific standards to be aware of. They may apply)

When and where was ISO initiated?

ISO 9001 was developed by technical experts from the member countries of ISO. ISO is an international organization that develops all sorts of international standards. You will find their web site at www.ISO.org

How was ISO developed?

The ISO 9000 Series was developed by an ISO technical committee. TC 176 is responsible for the ISO 9000 series. Technical committees are made up of industry professionals from member countries. They set up working groups to draft the standard. The standards are circulated and reviewed until there is consensus. Members then vote on adoption of the document as an international standard.

Why did they named ISO standards as ISO 9001 and what does 9001 stand for?

ISO has thousands of standards. They number them to keep track, and the 9000 series is all Quality Management. 9001 is the standard with the requirements that you must meet to become registered.

What does ISO do?

ISO is an international group that develops standards of all types. ISO 9001 is the quality management standard that gives the requirements for building and maintaining an effective quality management system. ISO Registration shows your customers and potential customers that you have a good quality management system in place.

What is an ISO firm?

An ISO 9001:2008 registered company has implemented a Quality Management System that meets the requirements of ISO 9001. They have been audited by a 3rd party, called a Registrar, and obtained registration. ISO 9001:2008 Registration shows that the company has an effective quality management system in place.

What does ISO stand for?

International Organization of Standardization Instead of using an acronym (IOS) they used the Greek word for equal, which is ISO.

What is the ISO 9001 logo?

When a company is registered, the registrar will give the company a logo or mark that can be used to show that the company is registered.

Can I get an ISO logo?

When a company is registered, the registrar will give the company a logo or mark that can be used to show that the company is registered.

Who can apply for ISO certification?

Any company can apply for ISO Certification.

Why ISO 9000?

The ISO 9000 management system standards were developed during the 1980s. They were derived from many similar individual national standards around the world which had been developed from about 1970 onwards. Neighbors in Canada had their Z299 standards, the Australians had AS3900, and here in the US, the nuclear industry had the NQA-1 standard. The defense industry had been using similar standards for years – many will be familiar with MIL-Q-9858A.

Probably the best recognized nondefense management system initiative was established in the United Kingdom in 1983 when the British government created the National Accreditation Council for Certification Bodies, now the National Accreditation of Certification Bodies (NACB). This was created to monitor the activities of companies like BSi, Lloyds and BVQi performing third-party audits on management systems implemented by British businesses using the British standard for quality management systems, known as BS5750:1979. BS5750 became one of the strongest models reviewed by the international committees of the International Organization for Standardization as they started to develop the ISO 9000 standards.

The ISO 9000 standards were first issued in 1987, reissued in 1994 and again in 2000 and then in 2008. They rapidly became very popular, and have now been adopted by over 180 nations worldwide, including every major trading partner of the US and the European Community. For any organization seeking an internationally recognized model for management systems, here is the perfect answer. Not only are the standards already written, but thousands of companies have implemented them successfully, achieving third-party certification to prove it. In addition, many customers are starting to look for ISO certification from those with whom they choose to do business.

Who or what is ISO?

Actually, no one. The ISO in ISO 9000 comes from the Greek, and means the same as. It is the same prefix as is found in the word isobar meaning a line on a weather map which connects areas where the air pressure is all the same.

What is the ISO organization, and where are they?

Many people from many countries all over the world. The ISO standards are published by the International Organization for Standardization, which has its offices in Geneva, Switzerland. It is a small office, with very few permanent staff. Its sole function is to coordinate the activities of a whole lot of committees, called Technical Committees (TCs), and publish their work when it is completed. Individual countries then decide whether or not to use the standards that the International Organization for Standardization publishes.
The ISO 9000 standards were written by TC 176, which has a wide representation from many countries including the US, and they have been adopted by the national standards organizations of countries worldwide. When a national standards body adopts an ISO document, it usually gives it a national number – hence, in the UK the ISO 9000 standards are called BS5750, in the European Community they are the EN29000 standards.

Why ISO 9000?

THE HISTORY OF ISO 9000
Developed during the 1980s
Followed on from many similar quality standards around the world
Similar to the highly successful BS5750:1979 management system initiative.
The standard has been around – ISO 9000 standards were first issued in 1987, reissued in 1994.
Now adopted by over 181 nations
Every major trading partner of the US and the EC recognizes and is using ISO 9000
Many customers now prefer ISO 9000 certified suppliers

What is ISO 9003?

There are relatively few companies whose customers will be assured of anything from an ISO 9003 system, although the 1994 version of that standard is much more comprehensive than the original 1987 one. ISO 9003 covers those operations where the assurance given to the customer comes only from the company’s inspection and test activities. This standard applies to relatively few companies, and in many countries it is hardly used.

What are ISO 9000 and ISO 9004 used for?

ISO 9000 has a couple of functions. It starts out with a section which explains what a management system is all about and some of the concepts of management systems. The second part of ISO 9000 consists of a vocabulary used within the quality profession which has certain meanings and interpretations which can be a little different than normal colloquial English. This is a very useful document, as it ensures that the people writing management systems and the people auditing them understand each other. The standard used for the actual management system requirements is ISO 9001. This standard covers everything from initial sales enquiry to post-delivery contractual issues. Companies can exclude certain limited requirements, for example whether or not they perform design activity on that product – in other words their scope of activity includes the design of their products.
The business scope chosen for certification need not embrace all the company’s activities, but it should cover the essential core businesses which are associated with one or more deliverables. It is not uncommon for a large organization to undertake its ISO program in a product- or process-specific manner. Remember that the management system which will be audited for certification must cover all of the essentials of the ISO 9001 standard across all of the activities which impact upon the deliverables included in the scope statement.

What are ISO 9000 management systems?

A management system is a collection of resources comprising capital, people, processes and procedures which ensures that a customer’s requirements for quality are met by the organization supplying the product or service involved. To really make sense of that statement, it is necessary to understand what is meant by quality in the ISO 9000 context.
Quality is not goodness, scale or niceness. Quality is more narrowly perceived as conformance to defined specifications in terms of performance, price and delivery. The technique used to achieve that conformance is called quality assurance or quality management – hence, the term quality management system. The system is a means whereby the organization’s management can plan what they are trying to achieve in terms of delivering a quality product to their customers, plan how they should fulfill that intent, and provide everyone involved with the tools, techniques, training and instruction necessary to fulfill their tasks efficiently and effectively.
Some companies have the luxury of their customers telling them precisely what they want, and then they go about the design and build work. Many other companies start on more difficult ground, and one of the first things that they have to do is to figure out what their customer wants – in other words, they have to develop the specification for the deliverable.
This activity embraces the concept sometimes called the voice of the customer – listening to end-user feedback – as well as addressing the need to comply with today’s regulatory requirements, anticipate what new regulations may be in force when the product is ready for sale, take note of what the competition is doing now and what they may be doing down the road, guess where client taste is likely to be by the time the deliverable hits the streets. For some organizations, all this has to be done on a global scale.
Once the design is determined, the organization then has to create the production process, purchase materials, arrange delivery processes, handle orders and all of the million and one other details which go into the successful development, manufacturing and delivering of a product or service to the customer. A management system is the series of processes and methods whereby all this is done; an ISO 9000 system is one based upon the precepts of the ISO 9000 Series of Standards, and that framework has been found to be extremely effective in improving the operational activities of many companies.

What does ISO do for my operation?

From a marketing point of view, achieving ISO 9001 registration makes it easier to access certain markets to obtain or to bid on contracts. It demonstrates that the company has a structured, formal methodology by which it conducts its business, which has been reviewed by an independent third party and found to meet the needs of ISO 9001. At a very practical level, it will help to ensure that any major customer who prefers to deal with ISO 9001 registered companies will look to your company for the fulfillment of their needs. It will send a powerful message about the organization’s commitment to excellence.
The company benefits in a number of ways. The opportunity which ISO 9001 implementation provides to reexamine and review operational methods and techniques usually results in increased efficiencies.
The formal documentation of methods and practices leads to much greater consistency in the manner in which any company works, and the documentation which will be required will also result in an enhanced training and awareness process for new staff coming into the company.
The process of ISO 9001 implementation causes an organization to not only reexamine its internal workings as they are documented, but also to review and study its linkages – within the company and outside the company. This frequently results in a better definition of interfaces, with improved communications, less errors and smoother functioning.

What does quality management system documentation look like?

The best systems look simple. Clear, concise, well-written documentation is essential if the system is to work properly. Documents should be short – no one reads long ones.
Documents should be accessible – if people can get at them easily, they will be more likely to use them.
Documents should be written to be used by people who have the training, background and experience of the usual person employed to perform the task – they shouldn’t be written for the person on the street.
Documents should reflect reality – write about what actually happens, not what could happen in the ideal world.
Documents should be written by the people who are going to use them, not by an external expert or a professional writer. He or she may know how to write, but will never know the process as well as the people who do it every day. Also, consultants may assist in the preparation of documentation, they should not dictate the control of the process involved.

What is in a quality management system?

The typical system has three tiers of documents and a foundation of records. It is often shown as a triangle, with a quality manual at the top, management operating procedures at the second tier and work instructions on the third. There should be linkage between the tiers to enable readers to navigate their way through the system and find the documents they need and the records associated with those documents. Very large and complex operations will often have more than one layer of system manuals and procedures. The top level may be a corporate quality manual and procedures, with divisional level manuals and procedures below that, and finally, functional plant level documentation. Each has to link to those above and below it, and should support the overall quality policy of the organization. This should be declared at the highest level.

What help or information is there for small companies to adopt ISO9001?

We assist many small companies. There is a lot of information for you on our site. Start by subscribing to our newsletter at: Subscribe and you will receive an Implementation Kit to get you started. Visit our Basics of ISO 9001:2008 free tutorial for an introduction to the standard and the project. Go to our Step-by-step page for Implementation Steps.

What product can have ISO 9001:2008?

Products themselves do not get certified. An organization gets Registration for its Quality Management System. Any type of organization can get registration.

Who is eligible to have ISO 9001?

Any company is eligible. The company must build a Quality Management System to meet the requirements of ISO 9001, and have a Registrar come and audit.

We are not a production company, do we need to be ISO registered?

Any type of company can be registered. There is no requirement to be registered it is always a choice. If you are being asked by customers to be registered, it is a business choice for you to make. Many companies register because of customer demand and market pressures, many register for the internal improvements.

Can a sole proprietor be ISO 9001 certified?

Yes. There are no limits on size.

What role do standard procedures play in strong business performance?

Procedures can play an important role in business performance. If the procedures are developed carefully, approved by management and communicated to employees procedures will help ensure that processes are performed in a correct and consistent manner. This will lead to constant quality product or service. It will also allow you to control changes to lead to improvements. As a change to the process is made, it is approved and documented. You can then measure the affect of the change.

What are the criteria to have a service of high quality?

The ISO 9001:2008 general criteria are to meet customer requirements and continually improve customer satisfaction. The elements that you need to have in place to achieve this are detailed in the Standard.

In what way does ISO 9001 contribute to continuous improvement?

By building an ISO 9001:2008 based quality management system, you will build processes that lead to continuous improvement. Processes driving improvement include: Internal Audits, Corrective and Preventive Action, Management Review, and Measurement, Analysis and Improvement of Processes. You will also drive improvement by setting quality goals and measuring performance against those goals and making changes and improvements as needed to meet those goals.

Does ISO 9001 apply to small business?

ISO 9001 is very applicable to small business; many businesses as small as 2 to 10 people are registered. We can help small businesses register by saving them the expense of using a consultant.

How is ISO 9001 implemented in a R&D centre?

ISO 9001 applies to R&D functions. For the R&D functions you would need to address the requirements under Design and Development We have a process for meeting these requirements documented in our Design and Development procedure. It is available for purchase individually or as part of our Documentation Package.

What does it mean to be ISO 9001 Registered?

It means that you have a quality management system in place that meets the requirements outlined in ISO 9001, and that it has been verified by a Third Party Registrar.

We are a software development company. Is ISO 9001 a good standard for us?

ISO 9001 applies to the software industry, as well as many others. There is a guidance document, ISO 9000-3 to help you apply ISO 9001 to the software industry.

I would like to know what are the difficulties for small business in obtaining ISO 9001-2008 quality management system?

The biggest hurdles are usually having the technical expertise to run the project, and the time to implement the system. We are here to help you overcome both of those hurdles with our All-in-One Documentation and Training Package Follow that link to see how this package can provide you with the technical information you need, and reduce the time required from you and your staff for implementation.

What is ISO 9000?

ISO 9000 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001 is one of the documents in this set; it contains the actual requirements an organization must be in compliance with to become ISO 9001 Registered. We can help you with your ISO Project. I recommend starting with our Free Tools: Free Basics of ISO 9001 Tutorial

What’s the difference between ISO 9000 and 9001?

ISO 9000 is often used to refer to the set of ISO Quality Management System documents. ISO 9001 is the document that contains the requirements for the Quality Management System. You will register to ISO 9001. ISO 9000 is a guidance document on the fundamentals and vocabulary for quality management systems. ISO 9002 and ISO 9003 are no longer in use. All companies register to ISO 9001.

ISO contents

ISO 9001 contains requirements for a Quality Management System. The requirements are broken down into 5 sections covering: Quality Management System, Management Responsibility, Resource Management, Product Realization and Measurement Analysis and Improvement. Try our Basics of ISO Tutorial.

What is the definition of ISO 9002?

ISO 9002 is no longer in use. It was the standard that applied to organizations that did not do design or development. It was made obsolete with the 2000 year revisions. The latest version is 2008 revision. Now companies that do not do design are registered to ISO 9001; they include a Permissible Exclusion in the Quality Manual stating that design and development do not apply and are not included in the Quality System.

Can an organization exclude design from their Quality Management System?

ISO 9002 is no longer in use. It was the standard that applied to organizations that did not do design or development. It was made obsolete with the 2000 year revisions. The latest version is 2008 revision. Now companies that do not do design are registered to ISO 9001; they include a Permissible Exclusion in the Quality Manual stating that design and development do not apply and are not included in the Quality System.

How do I see the standard ISO 9001 2008?

The way to see the text of the standard is to purchase it from www.asq.org , www.techstreet.com or www.ISO.org It is a copyrighted document, so you will not find the text online, however you can get a download version so you can review it right away.

How many elements are present in the ISO 9001 2008 standard?

The elements are:
4 Quality Management System Requirements
5 Management Responsibilities
6 Resource Management
7 Product and Service Realization
8 Measurement Analysis and Improvement

What are the roles of ISO 9000 and 9004?

ISO 9000 and 9004 have further guidance on Quality Management Systems. ISO 9000 has definitions and general guidance, and ISO 9004 provides guidance for performance management. They are not Normative Standards, that is they do not provide requirements for your quality management system, but more information and guidance for you to use to develop your QMS.

What’s the full title of ISO 9001 2008?

ISO 9001 Quality Management Systems- Requirements

What is ISO 9003?

ISO 9003 is an obsolete version of ISO 9001. The current version is ISO 9001:2008, and it does not have a document numbered 9003.

What is ISO 9004

ISO 9004 is a guidance document that gives you more detailed guidance on quality management systems, useful when implementing ISO 9001. It is QMS-Guidelines for performance improvements.

What is Quality Management System Standard?

A Quality Management System Standard has requirements for an effective Quality Management System. If a company implements processes to address all the requirements they will have an effective quality management system in place to achieve quality, continual improvement and customer satisfaction.

Why did they name ISO standards as ISO 9001 and what does 9001 stand for?

ISO has thousands of standards. They number them to keep track, and the 9000 series is all Quality Management. 9001 is the standard with the requirements that you must meet to become registered.

Is 9001 the comprehensive standard?

ISO 9001 is the document that contains the actual requirements for your Quality Management System. There are supporting documents that give you additional information that you can use to improve your quality management system.

How many elements are in the standard?

There are five elements that contain requirements for your quality management system. Elements 4 through 8 contain requirements.

Where can I find the actual ISO 9001 2008 Standard?

You can purchase the standard at: www.Techstreet.com

Do you sell standards?

We have a link to a site that does: Visit Techstreet at www.Techstreet.com

Can an organization exclude design from their Quality Management System?

Yes. If you do not do design and development then you may exclude it. You do this by writing a permissible exclusion in your Quality Manual. This means you would write in the design section of the manual that you do not do design and you are excluding it from your quality management system. You may do this for any requirement in section 7 that is not applicable to your company. You may only exclude things that do not apply to your organization. If you do design, it must be included.

What is the purpose of a quality management system?

A quality management system is a Management System. It covers top level planning, operational performance, quality, service, administrative functions, and measurement analysis and improvement.

What is process management?

Process management is managing your business as a system of interrelated processes. If you design your Quality Management System based on ISO 9001:2008, you will be using a process approach.

What are advantages of Integrated Management Systems?

Integrated Management Systems enable you to have a quality management system and another management system such as environmental, and have them integrated into one management system that will cover both aspects. The integrated management system will work to address both environmental and quality management.

Explain the philosophy of total quality management as applied to a manufacturing organization.

A Quality Management System is used to address customer satisfaction. It does this by focusing on the 8 quality management principals.

What are the 8 quality management principles?

The Quality Management Principles are:
Customer Focus- understand your customer needs, meet requirements and strive to exceed customer expectations.
Leadership- Top management establishes the direction and purpose of the organization. Create an organization where everyone is involved in achieving objectives.
Involvement of People- People at all levels of the organization are important and are fully involved in meeting goals and objectives and customer requirements.
Process Approach- activities are managed as a process
System approach to management- the organization is managed as a system of interrelated processes.
Continual improvement- continual improvement is a permanent objective for the organization
Factual approach to decision making- data is used for effective decisions.
Mutually beneficial supplier relationships- the organization and suppliers are interdependent, beneficial relationships create value.

Could you explain clause 5 of the ISO 9001

Clause 5 details the responsibilities of Management. Management must set a quality policy, identify quality goals and objectives, conduct management review, provide resources for the QMS and make sure that customer requirements are identified and met. There is a procedure at: Procedures For actual requirements see ISO 9001:2008.

ISO 9001clause 5.1

Management must show commitment to development and implementation of ISO 9001. For example: set a quality policy and quality objectives, make sure the QMS is established to meet those objectives, provide resources, decide on actions for continual improvement, and conduct management review. For actual requirements, see ISO 9001:2008.

ISO 9001 clause 5.2

Clause 5.2 covers customer focus. Management must make sure that customer requirements are determined and met. The first step is to make sure that the needs and expectations of the customer are determined; there must be a process for obtaining this information and communicating it throughout the organization. For actual requirements see ISO 9001:2008.

ISO 9001 clause 5.3

Clause 5.3 is about the Quality Policy. The highest level of management is responsible for developing and implementing the Quality Policy. The Quality Policy must address the purpose of the organization, a commitment to comply with requirements, continual improvement of the quality management system, and the framework for quality objectives. The policy must be communicated and understood throughout the organization, and be reviewed for continuing suitability. For actual requirements see ISO 9001:2008.

ISO 9001 clause 5.4

Top management must make sure that quality objectives are established at relevant functions and levels within the organization. Make sure the quality objectives are measurable, attainable and realistic. For actual requirements see ISO 9001:2008.

What is ISO?

ISO is the International Organization for Standardization situated in Geneva Switzerland. Because International Organization for Standardization would have different abbreviations in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning equal. Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO. ISO is in charge of issuing international standards that different countries can adopt, ranging from quality and environmental management systems to product or material specific standards. The main purpose is that all of the standards that ISO issues have been approved by its 157 member countries making them truly international.

What is in a quality management system?

The typical system has three tiers of documents and a foundation of records. It is often shown as a triangle, with a quality manual at the top, management operating procedures at the second tier and work instructions on the third. There should be linkage between the tiers to enable readers to navigate their way through the system and find the documents they need and the records associated with those documents. Very large and complex operations will often have more than one layer of system manuals and procedures. The top level may be a corporate quality manual and procedures, with divisional level manuals and procedures below that, and finally, functional plant level documentation. Each has to link to those above and below it, and should support the overall quality policy of the organization. This should be declared at the highest level.

What is the difference between ISO 9001 2008 and AS 9100?

AS9100 includes all of the requirements of ISO 9001:2008 and some additional requirements specific to the Aerospace Industry.

Do you have to implement ISO 9001 before you implement AS9100?

No, they are separate systems. AS9100 is based on ISO 9001 but is a different standard.

What do I need to get ISO 9000 registration?

You need knowledge of the ISO 9001 requirements, a Good project plan and tools to help you build your Quality Management System. We provide these to you here, giving you the confidence you need to complete your project. Our Quality Manual, Procedures and Forms give you a completely documented Quality Management System that meets the requirements of ISO 9001:2008. Use this as a foundation for your system; edit it easily in Microsoft Word to make it your own. Use our Employee Training to educate your project leader and team and introduce ISO 9001 to your employees. Use our All-in-One Documentation and Training Package to combine all of our tools in one money saving package. Remember all of our products include technical support from our ISO 9001:2008 experts.

How can we implement procedures in our organization?

We have a Free Quick Start Guide that explains how to implement the ISO 9001:2008 procedures in your organization. You can get this by Subscribing or by emailing a request to webmaster@the9000store.com

Does my company need a certified project manager to be ISO9001 certified?

No, there is no requirement for a certified project manager or a certified lead auditor.

Where do I start ISO 9001?

Well, we have some great information to get you started on your ISO 9001 project. If ISO 9001:2008 is new to you, start with Introduction to ISO and our Basics of ISO 9001:2008 Tutorial. For guidance on Implementation of ISO 9001:2008, go to ISO 9001 Step by Step. And for our most complete package of all the tools you will need for your project visit our All-in-One Package information page.

Can we get ISO 9000 registered without consultant?

Yes. We provide tools and knowledge to help you get registered without using a consultant. I recommend our All in one package to provide you with everything that you need.

I want to implement ISO9001 2008 in our organization, what would I have to do?

To implement ISO 9001 2008 in your organization you will need to put quality processes in place to address the requirements of the standard, and then follow those processes, collect records and pass an audit by a registrar.
I recommend a few steps to get started.
Purchase a Copy of the Standard
Visit our free Tutorial
Look at Our All in One Package

What is the shortest time to implement ISO 9001 2008?

The amount of time required to register will depend on the state of your current Quality System. You will need to have processes in place to meet the requirements of the standard, so getting ready to be registered can take anywhere from about 3 months to 18 months depending on the complexity of your organization and the status of your current quality system.

Who can lead the ISO project?

Any one in the organization can lead the ISO project. The management representative is a typical choice. The management representative is a person with responsibility to make sure the Quality Management System is implemented and maintained, report on the performance of the system to Management and to communicate the importance of meeting customer requirements throughout the company. The management representative also coordinates/communicates with the Registrar.

How do I acquire an ISO 9001 certification?

To become ISO 9001:2008 registered, your organization will need to implement a Quality Management System that complies with the requirements of ISO 9001:2008, run that system and collect records, then have a 3rd party auditor, called a Registrar come and audit your system. If they find that you are complying with ISO 9001:2008 requirements, you will become ISO 9001:2008 registered. The registrar will come back every 6 months or year to make sure you stay in compliance.

How do I apply for ISO-9001?

You apply by selecting a Registrar. The Registrar is the company that will come and audit your organization and grant the ISO 9001 Registration. We have a list of Registrars at: Registrars Before the Registrar comes to audit, you will need to put an ISO 9001 Quality Management System in place.

Is it possible to get ISO certification in just 3 months?

That would depend on your situation. The time it takes depends on your current quality system, the size and complexity of your organization and the resources you are able to devote to implementing the system. I have seen companies do it in 3 months if they had a good quality system in place already, and put the people needed on the project to get it completed.

What is the average time to be ready for certification ISO 9001-2008?

Most companies take 6 to 12 months. It will depend on the complexity of your organization and status of your current quality system.

Please give me some examples of measuring the customer satisfaction

Customer satisfaction can be measured in surveys, interviews, focus groups, general phone calls, returns, complaints, compliments and any other feedback that you receive from customers.

Do I need to send a survey to customers to find out if they are satisfied?

You need to get their feedback. A survey is one option. Phone calls and regular communication are also methods. Most organizations will find that several methods are needed to get feedback.

How can we identify requirements not stated by the customer, but necessary?

This requirement is found in Customer Related Processes; these are “implicit” requirements. What do you know about your product that the customer does not need to specify, or may not even know themselves? You know the intended use of your product, and are the expert on the product. If a customer in a luggage shop requests “Carry on Luggage”, they may not know what the acceptable size is to be able to carry on the bag. But the company that sells their bag as “Carry on Luggage” should know what the restrictions are, and meet those restrictions even though the customer did not know the size they needed.

What documents are required to meet ISO 9001?

The ISO 9001:2008 standard requires a Quality Manual, Quality Goals and Objectives, a Quality Policy and specific procedures for Document Control, Control of Quality Records, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits. These are the specific procedures mentioned by the standard, and you must have these procedures, but you must also pay close attention to the clause that requires documents needed by the organization for effective planning and control of processes. This means that even though only six procedures are specifically mentioned, your organization must determine what other procedures are required for your organization. We have used 22 procedures to build our ISO 9001:2008 Quality Management System. Customers may use some, or all of these, depending on the complexity of the organization. We find that our customers typically use all of the procedures that apply to the scope of their business. Documentation is an effective way of controlling processes.

What is the hierarchy of documents for ISO 9001?

Quality Manual
Procedures
Work Instruction
Records

Approximately how many documents are required for a complete set of ISO9001 compliant procedures?

We use a Quality Manual, 22 Procedures with approximately 30 related forms. You will also have work instruction level documents. The number will depend on the number of processes you have.

Standard operating procedure template

We have a package of procedure templates for the ISO 9001 quality management system processes. You can find more details at: Quality Manual and Procedures

What procedures are required?

The ISO 9001:2008 standard requires specific procedures for Document Control, Control of Quality Records, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits. These are the specific procedures mentioned by the standard, and you must have these procedures, but you must also pay close attention to the clause that requires documents needed by the organization for effective planning and control of processes. This means that even though only six procedures are specifically mentioned, your organization must determine what other procedures are required for your organization. We have used 22 procedures to build our ISO 9001:2008 Quality Management System. Customers may use some, or all of these, depending on the complexity of the organization. We find that our customers typically use all of the procedures that apply to the scope of their business. Documentation is an effective way of controlling processes.

Do I have to have hard copies of procedures available?

The people performing the procedure must be able to access it. If they can access it on a computer (conveniently) then you would not need a hard copy. If there is not a computer for easy access, you would need to provide a hard copy.

Define procedures

Procedures describe a process such as Purchasing. They describe an overall process, where as work instructions would describe a more detailed portion of the procedure such as Completing a PO or Ordering supplies. Procedures are used for all of the Quality System Processes. You are required to have a procedure wherever they are necessary to ensure that the process is performed correctly and consistently. We have prepared procedures for all of the Quality System Processes.

Contents of procedures

Our procedures include sections on responsibilities, definitions, a step by step description of the process, and related forms and required records.

Describe the advantages of documented quality procedures

Documented Quality Procedures will help you control your processes, helping to ensure that they are done in a planned manner, consistently, and according to criteria.

Explain purchasing procedures

You will need to evaluate and approve your suppliers, and continually monitor their performance. You need to review and approve purchasing documents before release.

What are the procedures involved in obtaining an ISO 9001 2008 certification?

To obtain ISO 9001 you need to implement a documented quality management system that meets the requirements of ISO 9001, run that system, and then have a Registrar audit the system. If your system complies with the requirements, the Registrar will grant you registration (certification).

What is a quality manual?

A Quality Manual describes your company’s overall Quality Management System. It states, in a general way, how your company meets the requirements of ISO 9001:2008. A Quality Manual is required by the standard and must include a reference to the procedures of the Quality Management System, and identify the interrelation of the Quality Management System Processes (often handled in a flow chart).

How do I write a quality manual?

I recommend starting with our Quality Manual to benefit from our years of ISO 9001 experience and save time and resources. A Quality Manual describes your company’s overall Quality Management System. It states, in a general way, how your company meets the requirements of ISO 9001:2008. A Quality Manual is required by the standard and must include a reference to the procedures of the Quality Management System, and identify the interrelation of the Quality Management System Processes (often handled in a flow chart). The Quality Manual is also where you identify requirements that do not apply to your company. For example, if you do not do design or development you would write a permissible exclusion in your Quality Manual stating that the clause does not apply.

Does the Quality Manual have to be a controlled document?

Yes. The manual must be controlled. For more detail on Document Control, try our Document Control Procedure.

Describe the structure of a quality manual

Quality Manuals are typically structured similar to the ISO 9001 Standard, this is not a requirement, but is a common effective approach. Each section briefly describes how your organization meets the requirements of the standard, and references the quality system procedures related to that section. The quality manual will also describe the interrelation of the quality system processes. This is often done in a flow chart.

How do you develop a quality manual?

I recommend starting with our Template: Quality Manual You will save a tremendous amount of time. To write a quality manual from scratch, outline how your company meets the requirements of the ISO 9001 standard. The information in the Quality Manual is a general summary of your processes. Refer to Quality System procedures throughout your manual.

Establish a quality policy

Implement and maintain a quality management system to meet the quality policy. Support the quality policy with quality goals and objectives

What’s the difference between quality policy and quality objectives?

A quality policy covers the whole organization, has to do with the purpose of the organization, the commitment to comply with requirements and continually improve. Quality objectives are more specific, are set at all levels of the organization, are measurable, and when achieved support the quality policy.

Typical quality objectives

Some typical quality objectives are:
Decrease nonconforming product by X% Increase customer satisfaction by…
Decrease turnaround time/delivery time etc..
Improve corrective action response time…
Increase efficiency of X process…
Remember; make your goals and objectives measurable.

Do employees get enthusiastic when you introduce ISO 9001?

Not usually, at first they are hesitant because another new program must mean more work. But we find that as the system develops and is used they see the advantages, and it helps make their job easier. Then support builds. It is up to Management to see that the program is presented to employees in a way that will get them to support the program and see its benefits.

Communicate the importance of meeting customer requirements throughout the organization

Provide resources for the Quality Management System.

What is the definition of design in ISO 9001 2008?

Design is a process that transforms requirements into characteristics.

How do I measure process performance?

Start by setting goals and objectives for your processes. Then identify a measurement for that goal. Set up a process to collect data on the measurement. Report on the measurement, and take action if you are not meeting your goals.

Management review meeting requirements

You need to schedule management review meetings on a regular basis, quarterly is usually effective. You need to review the performance of the QMS. Review data from corrective action, internal audits, supplier performance, measurement of QMS process, and evaluate how you are doing in meeting quality goals.

Management review schedule

You need to schedule management review meetings on a regular basis, many companies fine that Quarterly meetings are effective. You need to review the performance of the QMS. Review data from corrective action, internal audits, supplier performance, measurement of QMS process, and evaluate how you are doing in meeting quality goals.

How often should we hold management review?

Your organization can determine the appropriate time frame, but quarterly meetings are very common and are effective. Be sure to hold them at regularly scheduled intervals, and often enough to continually improve the quality management system.

Who should attend management review?

Top management, the management representative and management or leadership from the different areas of the company should attend. You want to make sure that you have included people that will be responsible for devoting resources to the quality management system. Management review meetings will result in actions being assigned to correct problems and make improvements to the system. This could include any area of the company, and it is good to have good representation at the meeting.

Is once per year enough for management review?

No. It is not enough to be effective and lead to improvement of the quality management system. We recommend quarterly or monthly management reviews. Quarterly is the interval we see used most often.

What is a management representative?

The management representative is a person with responsibility to make sure the Quality Management System is implemented and maintained, report on the performance of the system to Management and to communicate the importance of meeting customer requirements throughout the company. The management representative also coordinates/communicates with the Registrar.

What are ISO 9001 management responsibilities?

Management must set a quality policy, identify quality goals and objectives, conduct management review, provide resources for the QMS and make sure that customer requirements are identified and met. Would you like a procedure detailing how to meet these requirements?

Who is Top Management?

Think of top management as the function that provides all the resources for the quality management system who will approve spending?

How does Top Management involvement affect QMS?

Top management is critical in providing the resources needed and in making the project a priority for people.

How is 7.5.1 “Control of production and service provision” different from 7.1 “Planning of product realization”?

In 7.5.1 the requirements focus on the processes that actually create your hardware or your service that is delivered to your customers. You are required to follow the plan that you created based on requirements in 7.1A written procedure for this section will be useful in defining how you are meeting these requirements. By clearly documenting the way that you are satisfying the requirements of 7.5.1 you will ensure that the requirement are understood and followed consistently.
Most organizations will also need documentation in the form of work instructions to control these processes. Your planning in 7.1 will determine where these are needed; to meet the requirements of 7.5.1 these must be in place, available to employees performing the process. Instructions can take many different forms: written steps, pictures, drawings, prints, travelers or flow charts are some of the methods used. Specify in your procedure what documents are necessary for the control of your processes.The procedure should also state how you ensure that suitable equipment is used, and how release, delivery and post-delivery activities are controlled.

How can supplier performance be measured?

The most common aspects of performance that are measured are quality, service and price. What can you put goals and numbers to that will tell you how the supplier is performing in each of these areas? Decide what the most critical aspects are to you, is it an item that you can get from a number of different suppliers? Is price, or on-time delivery the deciding factor? Or is it an item or material that can vary in quality and will affect the quality of your product? In this case, the supplier with the most consistent quality may be the best source, regardless of the price. Measure what is most important about what is being supplied.

Customer product

Clause 7.5.4 requires you to have processes in place to handle product or other customer property. You must protect it from damage or loss, and report any damage or loss to the customer.

What training is required as we implement ISO 9001?

There are several types of training that you will need to consider. Your project leader, your employees and your internal auditors will all need specific training. You may also need to train Management on what ISO 9001:2008 is, and what their role is during implementation and after registration. We provide training in two formats. We provide computer based training that people can work through on their own, giving you the convenience of each person being able to choose a convenient time, and avoiding pulling people out of the working environment in groups.
Computer based training courses are: Understanding the Standard, a 2 to 3 hour course for your project leaders

Introduction to ISO 9001:2008, a half-hour course for all employees
We also provide Training Materials to enable you to present training to a group.

Training Materials available are :
* Introduction to ISO 9001:2008 Presentation, a PowerPoint presentation and speaker notes covering each clause of the standard.
* Internal Auditor Training, a day and a half long program to train your audit team

Is an ISO registered company required to conduct on going training in their process and if so how much?

Yes. Ongoing training is required to make sure that employees are trained as required on the processes they are responsible for. If a process is changed, employees must be trained. If an employee changes responsibilities, they must be trained. New hires must be trained on ISO 9001 an on their responsibilities.

Is it better to have training done in-house, or at a public program?

This really depends on your situation. Generally, it is more cost effective to have training performed in-house if you have five or more employees that need the same type of training.

What is the role of the quality manager within ISO 9001?

The role of the Quality Manager can be defined by your Quality Management System. Many companies make the Quality Manager the Management Representative, but there is no requirement for this. Some companies create ownership of the system outside of the Quality Department by making someone else the Management Representative.

How can I be ISO lead auditor

To be a lead auditor, you will need to take a Lead Auditor Training Course, offered by registrars and quality organizations like ASQ . You need to follow up your training with audit experience, observed by a lead auditor. After you get the required amount of experience you can apply to RAB or IRCA to be a Lead Auditor.

I want lead auditor training.

External auditors (3rd party auditors) must be registered lead assessors. That means RAB training, an exam, and a specified number of hours of 3rd party auditing under the observation of another registered lead assessor. The best place to find the Lead Assessor Training is from a Registrar.

Why are training records needed?

You will need to have training records that show each employee has had the training required for their position and responsibilities.

How can we evaluate the effectiveness of training?

You can evaluate the effectiveness of training in any number of ways.
Some examples are: a written test (good for group classroom training), observation of a person performing a task they were trained on (good for on the job training), inspection of product that a person made, having the trainee demonstrate what they learned to an experienced person, certification programs, probationary periods with review of performance.

What are the audit questions for management?

Audit questions will be determined by your processes. You will need to ask questions that will demonstrate if the process is being done in planned consistent manner and meeting requirements. We have a checklist that you can use to start your audits.

If our company does a corrective action, and it prevents the problem from reoccurring, is this considered preventive action?

No, your corrective action is taken to prevent reoccurrence of the problem; it is part of the corrective action process. In order to be considered preventive action you must be preventing a problem from occurring in the first place. One good place to determine preventive action is during management review, when you review data from the QMS. You can look at that data to see what problems might occur in the future, and take action to prevent them from occurring. You might also find opportunities for preventive action by reviewing corrective actions to see if the information shows you other problems that might occur, and take action to prevent them.

What is a Stage 1 audit?

A Stage 1 audit is performed in order to ensure that the design of your system conforms to the requirements of the selected standard. For quality management system audits this review is sometimes known as a Desk Study and is performed at the registrars’ office. For other management system audits (like environmental or health and safety) the review needs to take place on-site.

What is a Stage 2 audit?

A Stage 2 audit is performed only after a successful Stage 1 audit has been completed. This audit focuses on the implementation and on the effectiveness of the management system being audited. It is at the conclusion of this stage that the organization is either recommended for certification or given additional time to correct major issues that resulted from the audit before being recommended for certification.

What is a Surveillance Audit?

A surveillance audit is an audit that takes place usually either every 6 months or on an annual basis. These audits are about 1/3 the time of the initial audit and are conducted in order to ensure that the management system is maintained and operating effectively in accordance to the requirements of the certified standard.

Can I Integrate Audits? (Certified to more than one standard at a time?)

This depends on the registrar but most registrars that are accredited to certify companies to more than one standard do offer the possibility of having integrated audits.

What sort of things do audits usually find?

The typical audit findings tend to center around issues of documentation, calibration, training records, closeout of corrective actions and audit findings, the use of unapproved subcontractors, an absence of work instructions, inadequate planning, poor training records and a lack of management review.

How do I get ISO registered?

To become ISO 9001:2008 registered, your organization will need to implement a Quality Management System that complies with the requirements of ISO 9001:2008, run that system and collect records, then have a 3rd party auditor, called a Registrar come and audit your system.
If they find that you are complying with ISO 9001:2008 requirements, you will become ISO 9001:2008 registered. The registrar will come back every 6 months or year to make sure you stay in compliance.
I recommend looking at our All-in-one Package for a complete solution to preparing for registration.

What is the difference between ISO registered vs. certified?

The words are used interchangeably, but a company registers for ISO 9001.

How do I find out if a company is ISO certified?

The best way to find out if a company is ISO Certified is to ask them. If they are certified they will be able to provide you a copy of their certificate.

Can clients demand copies of my ISO 9001 documents?

It is up to you what you release. It is typical to give the Quality Manual out on request. It is your business decision to release any documentation.

Is ISO 9001 certification for a company or a facility?

That is flexible. You will work with your registrar to determine if you apply it to more than one facility. You can do one facility or many facilities.

What happens to your ISO 9001 registration if you are acquired by a company that does not have registration?

It is possible that the certified portion of the company may still maintain the certificate. You would have to meet with the registrar to discuss it with them.

Will my ISO registration be recognized in other countries?

Yes. Registration is recognized internationally. Be sure to discuss specific accreditations with your registrar.

How much does it cost to get registered ?

There are three types of costs that you need to consider.
Cost of Tools: Documentation and Training Tools (This is what we provide on this site)

Cost of the Registrar: The cost of the Registrar will depend on how big and how complex your organization is. The Registrar will charge you depending on how many audit days they spend at your organization. There will be travel costs if the Registrar is not local, and there are administrative and accreditation fees as well. Contact a few Registrars in your area to discuss registration and get quotes for their services.
The other costs depend on if you decide to use a consultant, or if you will be doing this on your own. You can save quite a bit of money if you do not need a consultant. Many companies use tools such as prepared Documentation and Training Tools to enable them to do it on their own.

Internal costs: employee time
The last cost to consider is the time your employees will need to spend building and implementing the system. Our free Implementation Kit guide can help you estimate the time needed from employees throughout the project.

What is an accreditation fee?

Accreditation fees are the fees that registrars have to pay to the Accreditation Body in order to issue a certificate with their name on it. This is a common practice if you require to be certified by more than one accreditation (i.e. the American and the German accreditations) but more and more registrars are waiving this fee if you only need one accreditation.

What is an Accreditation Body?

Each country has an accreditation body that represents and enforces the interpretation and implementation of the ISO standards in that country (or countries). The Accreditation Body accredits the Registrars or Certifiers in order to certify companies to the international standards. The accreditation body gives credibility to the Registrar since the registrar needs to comply with certain rules that are verified by the accreditation body. The accreditation body is in most cases (although this is not the case in the United States) a government entity. The US accreditation body is ANAB. It is important to select an accreditation body that has recognition internationally. The American as well as most of the European accreditations are members of the International Accreditation Forum, therefore, any of those accreditation bodies ensure that your certificate will be recognized nationally and internationally.

How long is the certification good for?

The certification is usually good for three years from the initial certification audit. At the end of the three year period, if your organization still wants to be certified, it is necessary to perform a recertification audit which is usually 2/3 the time of the initial audit. But that does not mean that you wont see the auditors for three years; registrars will perform surveillance audits.

What is the Scope of Certification?

The Scope of Certification is the description of the activities that the company performs that will be covered under the certification. In other words, it is the description of what you do. Examples are: Distribiution of Circuit Breakers, Manufacture of Widgets, Transportation of Hazardous Materials, etc.

What is third-party registration?

The registration (or certification) process involves an external organization auditing your company’s activities and processes against the requirements of ISO 9001 and your documented management system. The audit process is limited to the scope of the business activities being audited, as agreed in advance with the registrar.

How long does it take to get Registered?

This depends on your commitment, your company size, standard, and number of locations. Generally, registrars want to have a functioning system for 3 months before the certification audit. The average time for small companies is about 12 months, 18 months for medium sized companies and 24+ months for larger companies.

Why do I need to become Registered?

Unless your customers are requiring registration, you do not have to become registered. There are thousands of companies that use ISO as a base management system and are compliant to ISO, but choose not to obtain registration. You may then ask yourself; if that is the case, why use ISO at all?

Can I get an ISO logo?

When you become registered, your Registrar will tell you how you can use the logo.

Are travel costs included in the registrars’ quotes?

Most registrars offer their services on a plus expenses basis. Some do offer an all inclusive bid but this does not necessarily mean that it is a better deal for you since the registrar has to include their travel expenses on their bid, and they usually err on the side of caution, making this choice more expensive in the long run for you.

How do registrars determine the number of days for my audit?

Respected registrars follow the International Accreditation Forum Guide 62 as their main rule for assigning the number of days to a particular job. This has been done in order to ensure that registrars are on site a minimum number of days to do an appropriate audit. You should be weary of registrars that give you too few days or too many days compared to others. This is another reason why it is important to always compare quotes.

What is a Registrar / Certifier?

The companies that certify or register companies to the different standards (i.e. ISO 9001, ISO 14001, etc) are known as Certifiers or Registrars since they in fact keep a registry of all the companies that have achieved the certification. Independence is key for these companies, so they act as third parties meaning that they do not represent any interested party (you or your client) except themselves and the accreditation body that they represent.

I received a major non conformance from my registrar and I would like to change. Can I do this?

This depends on the registrar but more often than not, this will NOT be possible. One of the common requirements when changing registrars is that the certified company does not have any major non conformances open with their current registrar. Still, this does not mean that you will not be able to change registrars but it does mean that the new registrar might want to do a full audit rather than accept the previous registrars certificate.

I like my auditor but I don’t like my registrar. Can I change?

This will depend if your auditor is a full time employee with your registrar. Many registrars hire contractors or independent experts to perform audits for them. This works well for the registrars since they only have to pay their contractors if they have work for them. In the case that your auditor is NOT a full time employee, it is very common for auditors to work for more than one registrar, so it is entirely possible that you could change registrars and still keep your same auditor.

I concluded my Stage 1 audit but I would like to change registrars. Can I do this?

Yes! Most accredited registrars will accept the Stage 1 audit from another accredited registrar if you provide them with the Stage 1 report issued by the previous registrar and actions items to address the issues raised during the Stage 1 audit.

Can I change registrars in the middle of my certification cycle?

Yes! Most registrars accept the certificates of other accredited registrars. The requirements vary from registrar to registrar but most require you to submit a copy of your current certificate, copy of last audit report and assurance that you do not have any outstanding major non conformances with your current registrar.

I received only minor non conformances from my registrar and I would like to change. Can I do this?

Yes! Most registrars do not have a problem with the transfer of certificates if you have only minor non conformances, provided that you can provide a copy of your current valid certificate, a copy of the last audit report and action plans to close out the minor non conformities.

Where can I find information on Registrars?

Simply go to www.ISORegistered.com for a list of registrars as well as other important information regarding ISO and related standards.

Help me with ISO

Ok, let’s get you started. First of all, if you are new to ISO 9001:2008 I recommend you go through our Basics of ISO 9001:2008 Tutorial. That will give you an overview of what ISO 9001:2008 is, and what it means to your organization. Next, subscribe to our newsletter and receive a Quick Start Guide Print your guide and review the steps to Implementation. To get your project off to a great start, order our All in One Documentation and Training Package

Do you have internal auditor training?

Yes. We have an Internal Auditor Training Materials package. This is a set of materials for conducting a day and a half long group training session. It includes a Trainer’s Guide, PowerPoint presentations, exercises and a set of Documentation for your students to audit. There is a Quality Manual, Procedures, Forms and Records, all with hidden non conformances for your auditors to find. They will plan the audit, hold opening and closing meeting, document non conformances and write a final audit report. Everything you need to conduct an engaging, effective Internal Auditor Training course.

Will your products assist in developing and implementing ISO 9000 to meet requirements gain certification?

Yes, our products have helped thousands of companies all over the world successfully implement and register to ISO 9001:2008. Using our products gives you the information, training and confidence you need to lead your company to registration. I recommend our All-in-One package; it is our most comprehensive package, giving you everything you need to implement ISO 9001:2008. It is the best value package on the site.

What procedures do you use in your ISO 9001 2008 quality management system?

Here are the procedures that make up our QMS. They are all available for purchase, either individually or as a package.
Document Control,
Control of Quality Records,
Management Responsibility,
Competence, Awareness and Training,
Infrastructure Planning of Product Realization Processes,
Customer Related Processes,
Design and Development,
Purchasing,
Control of Production and Service Provision,
Identification and Traceability,
Customer Property,
Preservation of Product,
Control of Measuring and Monitoring Devices,
Monitoring,
Measuring and Analysis of Customer Satisfaction,
Internal Audits,
Monitoring, Measuring and Analysis of Product and Realization Processes,
Control of Nonconforming Product,
Corrective Action,
Preventive Action

How can your procedures help develop my system?

Our procedures are all written in Microsoft Word and Excel, so they are easily edited to make them your own. We have developed these documents based on a decade of consulting experience, working with a wide variety of industries. Our system evolved as we used it in more and more types of companies over the years, resulting in an effective and efficient Quality Management System. We found that when we went in to a company as consultants, we worked most effectively and efficiently when we started with this proven Quality Management System and tailored it to the individual company. You can do the same thing. Start with this proven system, and make it your own. We are here to answer your questions as you implement the system in your company. I recommend looking at our two Packages; these give you the best value on our products.

Will this program help me write better procedures?

Yes. By using our procedures as a foundation, you will be writing effective, efficient procedures for your Quality Management System.

What are the contents of procedures?

We offer the procedures as templates that make up the QMS for purchase, either individually or as a package. By using our procedures as a foundation, you will be writing effective, efficient procedures for your Quality Management System. The content of these procedures will be coming from your own system which you practice or are yet to start practicing.

How does the quality manual help us?

ISO 9001:2008 requires a Quality Manual. Our manual meets the requirements of the standard, and simplifies the task of writing a Quality Manual for your company. Instead of starting from scratch, you will use our fully written manual as your starting point. The manual describes what your company must do to meet the requirements of the standard. You edit the manual so it describes your organization. The information in the manual helps you determine how to structure your ISO 9001:2008 Quality Management System.

How many pages is the quality manual?

The Quality Manual is 35 pages long. Our manual meets the requirements of the standard, and simplifies the task of writing a Quality Manual for your company. Instead of starting from scratch, you will use our fully written manual as your starting point. The manual describes what your company must do to meet the requirements of the standard. You edit the manual so it describes your organization. The information in the manual helps you determine how to structure your ISO 9001:2008 Quality Management System.

Is the quality manual hard copy or on disk?

That is an electronic file. You can download it immediately after purchasing it. You may also request that a back up CD be shipped to you. The manual does not come in Hardcopy, because you will need to edit it to make it your own.

I need a quality manual

We can help you out with that. We have a fully written Quality Manual that you can use. You will edit this manual in Microsoft word to make it your own. Quality Manual This manual is easy to use, and has guidance on how to tailor it for your company. The manual is 35 pages long, and is in Microsoft Word. It will save you much time compared to starting on your own; it will also make sure you are starting off on the right track with your quality management system.

Does the ISO 9001:2008 Quality Manual and Procedure package includes a hard copy manual and a back up CD?

The package is electronic. You can download it immediately after you purchase. When you order you will see a Back up CD in your cart. If you leave that in you will be sent a CD by mail. We do not send a hard copy. You will need to edit these documents so a hard copy will not be useful to you. You will print your manual and procedures after you edit them for your organization.

What software is used to generate the Quality Manual and Procedures?

The Quality Manual and Procedures are all in Microsoft Word and Excel so they are easily edited for your organization.

Do you have employee training?

Yes, we offer a Computer Based Training Program to train your employees. It is a general introduction to ISO 9001:2008 and the employee’s responsibilities. It is a half hour long course, with quizzes after each section to measure effectiveness of the training. The employee must pass the quiz to proceed in the training. At the end of the training they are able to print a Training Certificate.

Tell me about your employee training.

We offer a Computer Based Training Program to train your employees. It is a general introduction to ISO 9001:2008 and the employee’s responsibilities. It is a half hour long course, with quizzes after each section to measure effectiveness of the training. The employee must pass the quiz to proceed in the training. At the end of the training they are able to print a Training Certificate.

How do your training products help?

Our training products help you learn about ISO 9001:2008, and train others in your organization. Understanding the Standard is a computer based course for those who will be closely involved in the ISO 9001:2008 implementation project. Introduction to ISO 9001:2008 is a computer based course for all employees to get a basic introduction to the standard.

Training for management and project leaders

I recommend using one of the following : ISO 9001:2008 Presentation Materials.
This is a PowerPoint presentation with speaker notes that prepares you to present ISO 9001 Training to a group. This presentation can be 1 to 2 hours long, and covers the details of the standard.
Understanding ISO 9001:2008 is a computer based training that people work through independently. It runs 2 to 3 hours long, includes audio explanations, exercises, quizzes and examples. It covers the details of the standard and how to implement it in your organization.

On going training

You will need to train new employees on ISO 9001 as and when they are hired. You will also need to continue to train employees on the processes they are performing. If an employee is asked to perform a process that is new to them, you must ensure that they will be trained first. If processes are changed, employees will need to be informed of or trained on the changes.

What is included in the Internal Auditor Training Package?

That package includes materials to conduct group training. The training is designed to be one and a half days long. The material includes a trainer’s guide, presentations (PowerPoint), student manuals and exercises, and documentation for the students to audit (Quality Manual, Procedures, Records and Forms) Internal Auditor Training Details

Does a company with ISO 9001 need to renew its accreditation every year?

The certificate is valid for a three year period. The registrar will continue to audit your company throughout that three year period, and then you will need to renew it at the end of the three years.

What is a Surveillance Audit?

A surveillance audit is an audit that takes place usually either every 6 months or on an annual basis. These audits are about 1/3 the time of the initial audit and are conducted in order to ensure that the management system is maintained and operating effectively in accordance to the requirements of the certified standard.

What is an accreditation fee?

Accreditation fees are the fees that registrars have to pay to the Accreditation Body in order to issue a certificate with their name on it. This is a common practice if you require to be certified by more than one accreditation (i.e. the American and the German accreditations) but more and more registrars are waiving this fee if you only need one accreditation.

How do registrars determine the number of days for my audit?

Respected registrars follow the International Accreditation Forum Guide 62 as their main rule for assigning the number of days to a particular job. This has been done in order to ensure that registrars are on site a minimum number of days to do an appropriate audit. You should be weary of registrars that give you too few days or too many days compared to others. This is another reason why it is important to always compare quotes.

How long is the certification good for?

The certification is usually good for three years from the initial certification audit. At the end of the three year period, if your organization still wants to be certified, it is necessary to perform a recertification audit which is usually 2/3 the time of the initial audit. But that does not mean that you wont see the auditors for three years; registrars will perform surveillance audits.

What is a Registrar / Certifier?

The companies that certify or register companies to the different standards (i.e. ISO 9001, ISO 14001, etc) are known as Certifiers or Registrars since they in fact keep a registry of all the companies that have achieved the certification. Independence is key for these companies, so they act as third parties meaning that they do not represent any interested party (you or your client) except themselves and the accreditation body that they represent.

What is the Scope of Certification?

The Scope of Certification is the description of the activities that the company performs that will be covered under the certification. In other words, it is the description of what you do. Examples are: Distribiution of Circuit Breakers, Manufacture of Widgets, Transportation of Hazardous Materials, etc.

How many standards are out there?

There are several standards out there. The most famous and proliferate is ISO 9001 which is the standard for a Quality Management System. Some standards are not issued by ISO but by other organizations (for example OHSAS 18001) but are still recognized by many countries as valid standards.

I received a major non conformance from my registrar and I would like to change. Can I do this?

This depends on the registrar but more often than not, this will NOT be possible. One of the common requirements when changing registrars is that the certified company does not have any major non conformances open with their current registrar. Still, this does not mean that you will not be able to change registrars but it does mean that the new registrar might want to do a full audit rather than accept the previous registrars certificate.

Can I Integrate Audits? (Certified to more than one standard at a time?)

This depends on the registrar but most registrars that are accredited to certify companies to more than one standard do offer the possibility of having integrated audits.

I like my auditor but I don’t like my registrar. Can I change?

This will depend if your auditor is a full time employee with your registrar. Many registrars hire contractors or independent experts to perform audits for them. This works well for the registrars since they only have to pay their contractors if they have work for them. In the case that your auditor is NOT a full time employee, it is very common for auditors to work for more than one registrar, so it is entirely possible that you could change registrars and still keep your same auditor.

I concluded my Stage 1 audit but I would like to change registrars. Can I do this?

Yes! Most accredited registrars will accept the Stage 1 audit from another accredited registrar if you provide them with the Stage 1 report issued by the previous registrar and actions items to address the issues raised during the Stage 1 audit.

Can I change registrars in the middle of my certification cycle?

Yes! Most registrars accept the certificates of other accredited registrars. The requirements vary from registrar to registrar but most require you to submit a copy of your current certificate, copy of last audit report and assurance that you do not have any outstanding major non conformances with your current registrar.

I received only minor non conformances from my registrar and I would like to change. Can I do this?

Yes! Most registrars do not have a problem with the transfer of certificates if you have only minor non conformances, provided that you can provide a copy of your current valid certificate, a copy of the last audit report and action plans to close out the minor non conformities.

What happens during an audit?

The audit process is divided into two major activities. The first being the adequacy or desk audit, the second is the compliance audit. During the desk audit, auditors compare the company’s documented system with the requirements of the standard. They are looking for the system to meet the fundamentals of the requirements. This initial audit produces an audit report, and as a result of this audit report – assuming all is well – the decision is made to proceed with the second part of the audit.
During the compliance audit, auditors are on site talking to staff, asking questions about what they do and how they do it, what documents they have to use, what records they maintain, and who has all this stuff.
During the course of the audit, questions are asked of staff at all levels in the organization. The auditors will be following a predetermined plan, an advance copy of which will be given to the area’s management representative. Each auditor is accompanied by a guide whose job is to escort the individual from place to place, and to help the auditor identify to whom they need to speak about the issues they want to examine. Answer questions honestly, but only answer what is asked.
Lots of notes are taken during the audit – these are the audit findings. Most of what the auditor writes down will be about activities that they have found to be conforming with the standard and the documented system. Some will be things that are not right, and these may become audit nonconformities by the end of the process. Everything that is reported as a nonconformity will be supported by objective evidence – in other words, the auditor has to be able to reference a clear requirement of either the standard or the management system which is not being followed in order to write a nonconformance. Findings are witnessed by the guide signing off on them.
At the end of the audit, the audit team will decide what they want to report and what they do not. This results in the audit report and findings which are issued to the company, together with the decision as to whether the system is regarded as acceptable or not.
Every area of the company can expect to receive nonconformities. The site being audited may contain many hundreds, even thousands, of people, documents, instruments needing to be calibrated, stock items and materials and so on. The auditors are likely to find a few things out of place in every facility – and it doesn’t matter if they do. A number of minor nonconformities will not impact the ability of any company to achieve certification.

The auditors will assess the overall effectiveness of the system. The key issues which the auditors will be reviewing and seeking objective evidence of comformance for are these:
Are all the required elements of ISO 9001 in place?
Is there clear evidence that staff know their role in operating the system?
Are records generated as required and stored properly?
Is the internal audit process robust and effective?
Is there an adequately resourced and effective corrective and preventive action program in place?
Is the management review process solid and operating effectively?
During the internal audit training, which all companies implementing ISO will need at some stage, the trainee auditors will learn more about what to look for and how to evaluate the significance of an individual finding. That information will be utilized in the operation of the internal audit program and should help resolve a lot of these issues for the staff. The audit is nothing to fear – it is a collaborative, cooperative process… and you are the customer.
Once the main audit is successfully completed, you will encounter surveillance audits on a regular basis – probably about every six months. On a sample basis, auditors will revisit various parts of the company for short follow-up audits to ensure that the system remains fully operational. These surveillance audits will usually encompass a sample of activities, typically one or two elements of the ISO 9001 standard will be addressed in addition to the mainstream elements. There are three subjects which typically get audited every time the auditors come around. These are:
5.6 Management Review
The records of this process demonstrate that the system is being properly and effectively maintained;
8.2.1 Customer Satisfaction
This element demonstrates that the organization is taking steps to understand how it is seen by its customers.
8.2.2 Internal Audit
This shows that the system is continually under review by the organization and its’ management.
8.5.1 Continual Improvement
Provides evidence that the management system is providing the organization with measureable improvements in products or services, processes and systems.
8.5.2 and 8.5.3 Corrective and Preventive Action
Demonstrates that the organization is reacting to problems and identifies through either product, process or system review activities.
A good corrective and preventive action process means that the system is being highly reactive and proactive to continuously improve.
The internal audit activity, and the records it generates, tells the registrar if the system is operating successfully in between surveillance audits and is driving continuous improvement.
Probably the biggest change which occurs as a result of the ISO 9001 implementation is the initiation of the internal management system audit process. This is one of the most powerful tools a company can use for driving continuous improvement – it also happens to be the one which costs the least. An effective internal audit process also enables management to measure its own effectiveness in controlling the operation of the company in the manner intended.
Constant review of the workings of the management system reveal opportunities for improvement in the system, in the training of personnel, and in overall process control. Along with management review, the effective maintenance of the internal audit program is a vital part of the system. Both activities should take place at regular intervals if management seriously intends to maintain the system.
The internal audit process will be an ongoing activity, continually auditing different parts of the system and covering all areas of the organization on an established basis. Areas of the company where the audit findings are adverse should receive more frequent audits until such time as the audit results stabilize; particularly important activities should also be audited more frequently.

What sort of things do audits usually find?

The typical audit findings tend to center around issues of documentation, calibration, training records, closeout of corrective actions and audit findings, the use of unapproved subcontractors, an absence of work instructions, inadequate planning, poor training records and a lack of management review.
Like all other areas of the company, control of documentation is an important issue, as is ensuring that personnel do not have obsolete documents or controlled documents which are marked up in an inappropriate manner. Document control issues typically account for 70 percent of the findings reported by auditors during certification audits.

How much does it cost to become Registered?

This depends on several factors including:
How much of the work a company is willing to do itself;
How large the company is;
How many sites the company has and where they are located;
How quickly the company wants to get registered; and Which standard is the company getting registered to.
All these factors come into play when a company begins its registration process.
The best avenue for a company to take is to have a Gap Analysis performed. All companies have systems in place. A Gap Analysis is a method to determine how your current system matches up with a new ISO-based system.
When properly performed, a Gap Analysis and the Gap Analysis report will provide you with the necessary information to determine costs, and timeframe for registration.
The cost of a Gap Analysis will range from $1,250 – $1,500 per day. When researching a provider for a Gap Analysis, it is important to find someone that will supply you with a detailed report telling you not only that you are deficient in some respect, but how to fix the problem. For a free sample copy of a Gap Analysis report from The Victoria Group, send an e-mail to Rd Goult at rod.goult@Victoriagroup.com.
Regarding cost, ISO can range anywhere from $2,500 to millions of dollars.

How long does it take to get Registered?

This depends on your commitment, your company size, standard, and number of locations. Generally, registrars want to have a functioning system for 3 months before the certification audit. The average time for small companies is about 12 months, 18 months for medium sized companies and 24+ months for larger companies.

Why do I need to become Registered?

Unless your customers are requiring registration, you do not have to become registered. There are thousands of companies that use ISO as a base management system and are compliant to ISO, but choose not to obtain registration. You may then ask yourself; if that is the case, why use ISO at all?
ISO is an internationally recognized management system. There are currently over 800,000 companies registered to ISO worldwide. In the United States alone, over 600 new companies each month achieve registration. ISO based systems have been proven to save money by reducing costs, increasing efficiency, reducing wastes, and providing employees a well structured, and organized process to follow.

Is it better to have training done in-house, or at a public program?

This really depends on your situation. Generally, it is more cost effective to have training performed in-house if you have five or more employees that need the same type of training.

Where can I find information on Registrars?

Simply go to www.ISORegistered.com for a list of registrars as well as other important information regarding ISO and related standards.

Do I have to have hard copies of procedures available?

We do not send a hard copy. You will need to edit these documents so a hard copy will not be useful to you. You will print your manual and procedures after you edit them for your organization.

Do you have internal auditor training?

Yes.The training is designed to be one and a half days long. The material includes a trainer’s guide, presentations (PowerPoint), student manuals and exercises, and documentation for the students to audit (Quality Manual, Procedures, Records and Forms) Internal Auditor Training Details

How do we ensure the goal of ISO 9000 registration?

Say what you do (Quality System Documentation).Do what you say (Implementation) .Prove it (Audit /Registration) .Improve it (Continuous Improvement)

How does my company go about getting ISO 9000 certification?

Your company’s steps to ISO 9000:Create a plan and establish a timeline (When planning, take into consideration employee time, availability, and expertise, and whether to use an outside resource.)Educate management, then all employees Develop the quality system documentation based on what your company does and what ISO 9000 requires.Implement the system,Begin the Internal Audit function,Registrar’s review of quality system documentation ,Pre-assessment of the system , Audit and registration by the Registrar.

What are ISO series of standards?

The ISO 9000 series of standards

ISO 9001 is one of a series of quality management system standards. It can help bring out the best in your organization by enabling you to understand your processes for delivering your products/services to your customers. The ISO 9001 series of standards consist of:

ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.

ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.

ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.

Do I need to buy the standard to certify my organization?

You will need a copy of ISO 9001 in order to get registered, ISO 9004 is not required, but highly recommended and ISO 9000 is quite useful. These can be ordered from our website.

Who is ISO 9001:2008 applicable to?

Any organization can benefit from implementing ISO 9001:2008 as its requirements are based upon eight management principles:
a customer focused organization
leadership
the involvement of people
ensuring a process approach
a systematic approach to management
a factual approach to decision making
mutually beneficial supplier relations
continuous improvement

How many companies worldwide have registered for ISO 9001?

There are nearly one million companies worldwide registered to ISO 9001 and nearly that many registered to one of the industry specific variants (i.e., AS9100 in aerospace, TS16949 in automotive, etc) or compliant but not registered.

There are companies with one or two employees that are registered to ISO 9001, and there are companies with thousands of employees, and everything in between

How do I know if ISO is suitable for my organization?

ISO 9001 is suitable for any organization looking to improve the way it is operated and managed, regardless of size or sector. However, the best returns on investment come from those companies that are prepared to implement it throughout their organization rather than at particular sites, departments or divisions.

In addition, ISO 9001 is designed to be compatible with other management systems standards and specifications, such as the OHSAS 18001 Occupational Health and Safety standard and the ISO 14001 Environmental standard. They can be integrated seamlessly through Integrated Management. They share many principles so choosing an integrated management system can offer excellent value for money.

What are ISO surveillance ausits or assessments?

Surveillance assessments are the heart of the post-certification process for ISO 9001 certification. The ISO 9001 surveillance audits assure ongoing conformity, determine whether your management system remains effective, and encourage continual improvement, thereby helping enhance your profitability. The last ISO 9001 surveillance audit is always a recertification audit to ensure accreditation conformity and full assessment of the requirements.
There can be semi annual or annual surveillance audits.

How does your ISO certification get renewed?

Once every three years (the third year of each 3-year ISO 9001 certificate period), your QMS needs assessment in its entirety. The duration of this ISO 9001 re-assessment is typically equal to about 2/3 of the audit days required for the initial assessment. By assessing the entire quality management system during one ISO 9001 assessment activity, the relationship of all the processes comprising it can be fully evaluated for effectiveness.

How do you start with ISO implementation planning?

The Steps at a high level are
1. Purchase a copy of the standard (our site has a link to purchase)
2. Establish management commitment
3. Conduct gap analysis
4. Develop a project plan and execute it

What is a QMS manual?

Your management system manual briefly describes how you meet the requirements of the standard using the system you implemented. Write this document last. It will be hard to write it before you implement your system, and it will have to be rewritten as you fine-tune your system. If you write the manual at the end of your project it will be a simple summary of what you have implemented for each clause. Your manual must include or reference your procedures.

What are procedures?

Procedures describe how to perform a task in general, outlining the key steps and their order. A purchasing procedure may describe who is responsible for approving purchases, and what records need to be kept, for example. Procedures can be described as looking at “what” you do (not necessarily how you do it). Procedures should reference related work instructions.

What are work instructions?

Work instructions provide detailed step-by-step descriptions of a task, not just an outline. They should describe “how” you perform a task. A purchase order work instruction would tell you how to fill out a purchase order, for example. Work instructions should reference related records

What are records?

Records are the documents you keep to show that you follow your quality system. Your completed purchase order would be a record. Records are a history of what has occurred and as such should not change.

What are the various types of audits?

Gap Analysis
The foundation of your implementation program should be a thorough Gap Analysis. This is an audit of what systems you already have in place. This gives you a starting point in your planning process.
Supplier Audit
Often you will want to conduct an audit of your suppliers, especially if they are not ISO registered.
Internal Audits
Regularly scheduled internal audits of your quality system are required by the ISO standards. These audits are a measure of how your quality system is working.
re-assessment or System Audit
When your system is fully implemented you may want to have internal auditors from another location within your company, a consultant, or the registrar come in and evaluate your entire quality system to see that everything is in reasonable shape for your registration audit
Registration Audit
Once your management system has been implemented (including internal audits) for three to six months, you will be ready for your Registration Audit. The Registrar you have chosen will conduct a thorough audit of your management system and decide whether it is ready for Registration.
Surveillance Audit
Once you have achieved your ISO registration, your registrar will conduct periodic surveillance audits to see whether your system is still meeting the ISO standard. This is required in order to maintain your registered status.

What records are required by the standard?

he standard specifically requires records for the following items:

Management reviews
Education, training, skills and experience
Evidence that processes and product or service meets the requirement
Review of customer requirements and any related actions
Design and development including: inputs, reviews, verification, validation and changes
Results of supplier evaluations
Traceability where it is an industry requirement
Notification to customer of damaged or lost property
Calibration
Internal audit
Product testing results
Nonconforming product and actions taken
Corrective action
Preventive action
Records you need to provide evidence of following your processes.

What is process auditing?

Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your quality management system by area or department and then auditing all the applicable ISO elements while in that department, you are doing process auditing. If you are auditing your quality system by ISO elements throughout the organization you are not set up currently for process auditing. Process Auditing

How does having an ISO 9000 / ISO 9001 system benefit us from an internal standpoint?

1. Transforms your operation from detection mode to prevention mode
2. Creates consistency throughout the organization
3. Improves business performance
4. Lessens dependency on key individuals.
5. Provides blueprint for controlled, disciplined growth.
6. Ensures consistent training
7. Improves management oversight

Must quality / environmental / health-safety management systems be separate?

No. The related Standards have parallel construction and many significant elements in common. You can implement an integrated business management system — either all at once or on an incremental basis — that addresses quality as well as environmental management and even health/safety management — without redundancy or duplication of effort.

Can you implement ISO only one department of the organization and still see results?

Yes; however results would be limited to that department. We recommend an approach that prioritizes based on high risk departments.

What is the biggest pitfall to success of acheicing an ISO certification?

Lack of top management support. All initiatives fail due to lack of top management support. Without top management support resources will not be allocated for success.

What are the levels of a Quality Management System (QMS)?

Strategic level: The quality manual of your firm.
Tactical level: The requirements required of the standard, defining a company’s procedures.
Operational level: The working instructions focused on the more detailed operating procedures of a company.
Historical level: The data and records of a company’s quality manual.

What is the cycle of a Quality Management System (QMS)?

There are six phases to the cycle of a QMS. They are:
Assessment: A company evaluates the need for a QMS.
Planning: A company plans out how to construct its QMS.
Upgrading or Redesigning: A company determines what needs to change in an already existing QMS.
Implementation: The actual introduction of a QMS to a company.
Auditing: checking to ensure the company is adhering to the QMS.
Continuous Improvement: The on-going process of monitoring and amending a QMS.

What are some reasons a registration audit would fail?

There are a number of reasons that could result in a company not passing its registration audit. Some of those reasons include:
Lack of proper documentation
Failure to follow the documentation
Poor employee training
Bad product
Improper storage of data or product

What if I have nonconformances during my pre-assessment audit?

If nonconformances are discovered during a pre-assessment audit, it is recommended that a company postpone any final registration audit already scheduled, examine the nonconformances discovered during the pre-assessment process and focus on conducting a second pre-assessment after the nonconformances have been addressed.

It is not recommended that companies with a number of nonconformances discovered in the pre-assessment audit move forward with a final registration audit without first confirming that the nonconformances have been addressed and resolved. Going into a final registration audit without being fully prepared is poor use of the registrar’s time and a company’s money.

Can my company still get certified with nonconformances?

Most registrars will award a company with ISO certification if there are fewer than three nonconformances and the company maintains an active role in assuring the registrar that the nonconformances will be addressed immediately.

Why the need of the International Quality Management System (QMS)?

Acceptance of QMS ISO 9001 is through a confederation of countries comprised within the International Organization for Standardization (the ISO 9000 series first published in 1987 with its roots going back to post – WW II). Implementing and registering a management system to the criteria and requirements set by the International (or a variants) has become common practice for industry (including government entities). Your customer may impose or otherwise expects in their effort that yourself control process and activities and improve linking within the customer’s supply-chain

What are the External Benefits of ISO 9000?

Increased business competitive edge and market share
Improved customer confidence and satisfaction
Improved conformity to customer and regulatory quality requirements

What are the Internal Benefits of ISO 9000?

Improved operational efficiency and productivity
Improved process consistency and stability
Facilitated continual improvement
Improved focus and effectiveness of training programs
Improved employee motivation and participation
Led to improved supplier performance
Increased business profitability

How should the documentation be structured?

A typical Document structure is like a Pyramid, driven by the Policies & objectives
Level 1: Quality Manual – approach and responsibility
Level 2: Procedures – methods (Who, What, Where and When)
Level 3: Work Instructions – description of processes (How)
Level 4: Forms, Data and Records – providing auditable evidence

Document numbering

Auditors prefer if the quality manual follows the same numbering convention as ISO 9001. ISO 9001 does not dictate a numbering format, but it is much easier. All ISO 9001 quality manuals have a similar structure because theyapply to the same ISO 9001 requirements. However, the procedures and work instructions which will vary based upon your organization. You should decide what format is the most useful to your organisation and whether it meets your business’s unique needs.

How detailed should an ISO 9001 Quality Manual be?

It depends on how much control you need in your processes. ISO 9001 Clause 4.2.2 says:
The organization shall establish and maintain a quality manual that includes: a) the scope of the QMS, including details of and justification for any exclusions b) documented procedures established for the QMS, or reference to them c) a description of the interaction between the processes of the QMS

Is a larger quality manual better?

No. The number of processes as well as their complexity will determine the size of your quality manual. It just needs to clearly outline what you do to meet the requirements.

Why are the Quality Manual, Procedures and Forms all separate documents?

Separate documents allow you to revise a single procedure without having to update an entire manual. Revising the entire manual each time an operating procedure is amended can be very . This approach also allows for tailored distribution of documents relevant to the need of the recipient.

Are procedures referenced in the QM?

Yes without the revision to save you from revising the QM each time a procedure is revised. We recommend a separate list to identify the procedures. This is easier to manage.

Where do I show the interaction of processes?

The QM should include a simple flowchart showing all the process interactions. It needs to show the interaction of the individual processes as well as how customer processes interact with organizational processes.

What information is in a procedure?

Procedures should describe how the process works: define who does what and when they do it. Responsiblities, definitions and other details are included.

Does every employee need a copy of the Quality Manual?

No, distribution to all employees is not required.

We recommend you publish a PDF version on your company Intranet and email employes a link to access it.

ISO 9001 All in One Package

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