What is ISO 9001?
The current version of the ISO 9001 standard is 9001:2015.
ISO 9001 is the international standard for a quality management system (“QMS”). In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
A few details about ISO 9001:
There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. Typically, an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department. The current version is ISO 9001:2015, which was published in September of 2015 (thus the: 2015).
- It does NOT matter what size your organization is: 1 person or 1 million people. See ISO 9001 Implementation for Small Businesses
- It does NOT matter what industry you are in (service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.
- It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
- It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an organization or company becomes certified. Individuals, however, CAN become an ISO 9001 Certified Lead Auditor after a 5 day training course. This then allows them to audit other companies.
- There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only ISO 9001 certification.
- It is NOT a membership group – An organization cannot “join” ISO 9001. To become ISO 9001 certified, your organization must
- Follow the steps to implement an ISO 9001 quality management system.
- Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating that your organization is Registered to ISO 9001 for a three year period. (See Who is able to grant certification)
- Finally, the organization must be re-certified every three years in order to maintain their ISO 9001 certification status.
A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy example of ISO 9001 applied to making cookies.
The Definition of ISO 9001 Certification
“ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements.
Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).
Some Helpful Resources:
- Estimate the Cost of ISO 9001 Certification
- What is a Quality Management System?
- Learn the Steps to ISO 9001:2015 Certification
- Learn about the ISO 9001:2015 Requirements
- Learn about the entire ISO 9000 Family
- ISO 9001:2015 Training reviews all the clauses of ISO
- ISO 9001 is based upon the 7 principles of quality management which form the basic characteristics of quality management
- Learn about the Benefits of ISO 9001:2015
What is the resource impact of ISO 9001 on my company?
As with most business processes, the more you do yourself, the less the cost, but the more time it may require. No matter how many external resources are utilized, there will need to be involvement by your employees and staff to varying degree. While there is no total “do it yourself” solution, you can go a long way on ISO 9001’s basic requirements by using pre-formatted materials for documentation and training. (Check out our materials here!) While the procedures and methods in these must be tailored to your situation, they are typically created with the goal of minimizing the changes required and maximizing the ability for others to use and comprehend them. The goal of any quality management system should not be to add unnecessary paperwork, but to make all references clear and highly usable.
History of ISO 9001 Revisions
What is ISO 9001:2015 (Current Version)?
ISO 9001:2015 is the current version of the ISO 9001 standard which outlines the requirements an organization must maintain in their quality system for ISO 9001:2015 certification. ISO 9001 is explained in detail above. It is the most recent version of the standard which included several changes from ISO 9001:2008 including:
- Adaption/adoption of the new ISO structure (Annex L) to align with other standards including ISO 14001, ISO 45001, etc.
- Enlarging the relationship between organizations and quality management systems
- ISO 9001:2015 promotes a process approach in order to produce the sought after quality outcomes
- Presents requirements for quality performance in the organization’s strategic planning
- Greater emphasis on top level management for ownership of the QMS
- Less prescriptive requirements compared to previous versions
- The main focus is on customer satisfaction
- Straightforward terminology throughout the standard
For more detailed information, please see below:
What is ISO 9001:2008?
ISO 9001:2008 was published on November 14, 2008, replacing ISO 9001:2000. The 2008 version became obsolete effective September of 2018 and was replaced by ISO 9001:2015.
List of significant changes the 2008 version brought to ISO 9001 (from the 2000 version):
Clause 0.2 (Process approach):
- Text added to emphasize the importance of processes being capable of achieving desired outputs
Clause 1.1 (Scope)
- Clarification that “product” also includes intermediate product
- Explanation regarding statutory, regulatory and legal requirements
Clause 4.1 (General requirements)
- Notes added to explain more about outsourcing
- Types of control that may be applied to outsourced processes
- Relationship to clause 7.4 (Purchasing)
- Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system
Clause 4.2.1 (Documentation)
- Clarification that QMS documentation also includes records
- Documents required by the standard may be combined
- ISO 9001 requirements may be covered by more than one documented procedure
Clause 4.2.3 (Document control)
- Clarification that only external documents relevant to the QMS need to be controlled
Clause 4.2.4 (Records control):
- Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management rep)
- Clarifies that this must be a member of the organization’s own management
Clause 6.2.1 (Human resources)
- Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system
Clause 6.3 (Infrastructure):
- Includes information systems as example
Clause 6.4 (Work environment)
- Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather
Clause 7.2.1 (Customer related processes)
- Clarifies that post-delivery activities may include:
- Actions under warranty provisions
- Contractual obligations such as maintenance services
- Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
- Clarifies that design and development review, verification and validation have distinct purposes
- These may be conducted and recorded separately or in any combination as suitable for the product and the organization
Clause 7.3.3(Design & development outputs):
- Clarifies that information needed for production and service provision includes preservation of the product
Clause 7.5.4 (Customer property):
- Explains that both intellectual property and personal data should be considered as customer property
Clause 7.6 (Now retitled Control of Monitoring and Measuringequipment)
- Explanatory notes added regarding the use of computer software: “Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”
Clause 8.2.1 (Customer satisfaction)
- Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
- Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.
In conjunction with the publication of ISO 9001:2008, Quality management systems – Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems, has published a number of guidance modules:
- Guidance on ISO 9001 sub-clause 1.2 “Application”
- Guidance on the documentation requirements of ISO 9001:2008
- Guide to the Terminology used in ISO 9001 and ISO 9004
- Guidance on the concept and use of the process approach for management systems
- Guidance on ‘Outsourced processes’
- Implementation guidance for ISO 9001:2008
- Frequently Asked Questions (FAQ’s)
- Advice for users on implementing ISO 9001:2008
What is ISO 9001:2000?
The ISO 9001:2000 revision allowed exceptions to design and development procedures if a company does in fact NOT engage in the creation of new products, as well as introducing a few concepts:
- Process approach, replacing an inspection mentality.
- A focus on Management Commitment instead of only relying upon quality personnel.
- Performance metrics
- Continual improvement
- Customer satisfaction
Changes from 1994 to 2000
The text has been reworded for easier adaptation to a wider range of organizations. Some definitions have been changed.
- “Subcontractor” was changed to “supplier”.
- “Organization” now refers to the main organization seeking certification.
- “Customer” remains unchanged.
- Compare ISO 9001:1994 to ISO 9001:2000
The standard has a process-oriented structure. It includes a process model based on the Plan-Do-Check-Act cycle, which outlines the product and/or service cycle and the management control cycle.
The 20-point format was replaced. The text of the standard is now organized into four major processes:
- Section 5. Management Responsibility
- Section 6. Resource Management
- Section 7. Product Realization
- Section 8. Measurement, Analysis, and Improvement
Documentation requirements are less-prescriptive, and allow greater flexibility.
What is ISO 9001:1994?
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of final product inspection, requiring evidence of compliance with documented procedures. This version also included ISO 9002 and ISO 9003 as in the 1997 versions.
What is ISO 9001:1987?
ISO 9001:1987 was based on BS 5750, with three quality management systems depending on the activities of the organization:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
- ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
- ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (“MIL SPECS”), and was better suited to manufacturing.