ISO9001 2008

ISO9001 2008 is the most recent revision of the ISO9001 series of quality management system requirements published by the ISO organization. (Although people often say ISO 9000 2000 or ISO 9000:2008, the ISO 9001 standard is the one that people are registered to.) While it is mostly a compatibility type revision (allowing it to harmonize and thus facilitate easier implementation of ISO 14001:2004), it is still the standard which a company must comply with in order to be considered "ISO certified". This means that any type of organization can certify to ISO9001 2008, even though more specific standards exist for certain industries (such as automotive, medical, aerospace, laboratories, etc.). Changes in over 30 clauses have been noted including areas such as documentation (requirements and control), work environments, tracking (mainly through product development cycles) and process monitoring. While no major changes have resulted, this invalidates ISO 9001:2000. Any certifications under that standard expire on November 15, 2010. See the 2008 changes to the ISO 9001 standard.

ISO 9000/ISO 9001 standards

ISO 9000 standards describe a body of quality management guidelines managed by the International Standards Organization. While most recent attention has been given to the differences between the ISO 9001:2000 and ISO 9001:2008 versions, the quality management series actually reflects four versions since the first was created in 1987. Subsequent versions reflect a major change which resulted in ISO 9001-2000. Less changes were made in the 9001:2008 revision which focuses mostly on compatibility within/among other ISO standards. Some interesting changes did include extending control to those items that are not just used for either product production or final service provision, but also to control of outsourced products and services.

ISO procedures as part of a quality management system

ISO Procedures outline the steps an organization takes to deliver consistent services or goods output and are part of the ISO 9001 documentation requirements. For example, ISO 9000 procedures may include document and records control, in effect ensuring that the entire organization is using the same version in the application of the key processes. Other critical ISO procedures in this area include controlling non-conformances that may occur through product/service creation design and development procedures to help ensure that products meet desired specifications, procedures for measuring and testing product output and procedures for purchasing raw material and sub assemblies or processes such as supplier qualification. There are even procedures for such areas as how managers must review the quality process and how to setup and maintain machinery

ISO 9001 quality manual and required iso documentation

The ISO 9001 quality manual outlines the quality management methods used to meet the ISO 9001 standard. While there are many forms and approaches to building an ISO 9001 quality manual under the ISO 9001 standards, the quality manual is the portion of the ISO documentation package that that relates the requirements to the referenced procedures. It is required to be both detailed and authoritative, in effect providing the rules and regulation of the quality system within the organization. It outlines the current (and it must be kept current to be valid) approaches to quality delivery including how these processes interact (i.e. how they impact each other). The standard recognizes the need for flexibility and tailoring each ISO 9001 quality manual publication to the type, size and mission of that group. The 9000 store provides an efficient and thorough quality manual template.

what is ISO 9000, what is iso 9001, and what are the differences?

What is ISO 9000? (and similarly what is ISO 9001) is usually asked by organizations who have been pushed towards iso 9000 certification by their customers. The question what is ISO 9000 immediately focuses on the requirements to iso 9001 certification and both internal and external organizational benefits. However, at its heart, ISO 9000 really constitutes a system for creating and regulating a process to deliver consistent results, resulting in higher customer satisfaction. This is a distinction from in effect producing an end product or service that is of higher quality, even though the result is often a product or service that more consistently meets a specified requirement(s). There are many companies (manufacturing and service) that would see the benefits of ISO 9000 in their work, since many companies have no comparable quality systems, even though their competitors do.

Like other ISO 9000 quality standards, ISO 9004 expands the idea that a well run quality management system benefits the organization as a whole. However, rather than focusing on strictly production-aligned quality conformance, ISO 9004 focuses on driving improvement after the iso certification. It seeks to plan, implement, measure and continuously correct and improve the process according to these varied inputs and the requirements they create. Still based on maintaining a quality standard, ISO 9004 has through its four revisions evolved from being more of a broader scope, continuously improving aspect of the ISO 9000 standards into a more strategic incarnation of a quality management system. It seeks to become a more integrated, and ultimately more successful, means of maintaining quality by ensuring the overall health and stability of the organization including finances, supply chain, customer satisfaction among other influences.

ISO 9000 certification

Many companies seeking ISO 9000 certification learn that they can only certify to ISO 9001. despite the fact that their customers are requiring that they receive iso 9000 certification. The ISO 9000 family of quality management standards has become a sort of de facto reliance, particularly when dealing with global trade. Yet, there are more basic reasons to seek ISO 9000 certification. These include:

• The ability to better assess and ultimately respond to various challenges or risks within the business environment. This is because of the robust and active quality management culture that ISO 9000 brings to an organization. In effect, you will be ready for just about anything if your products and processes are at the top of their game.
• You can raise more capital and enhance demand for your product as your reputation improves based on your ability to deliver consistently, what the market wants and what you can profitably produce. ISO is no panacea for all business problems, but the commitment to work its requirements into every aspect of your business always produces positive results.
• It shows all stakeholders (employees, suppliers, customers, investors, regulators, directors) that your company means business in the areas of consistent improvement and the ability to respond to changing market conditions.

ISO 9000 training

ISO 9000 training often becomes a requirement when embarking on any ISO 9000 series certification process. There are needs for training at just about every stage of the process and for each function, and the ISO 9001 Training Requirements do not stipulate specifics such as:

• Overall quality system management, teaching employees the overall need and functioning of the system Documentation of methods and processes, instructing how this is done and the value and approach taken for keeping documentation up to date and when, how and were to reference and employ it
• The importance of oversight and continued interest in the process, particularly by top management, plus the priorities of time and other resources that must be provided
• In product design and realization, making sure the products meet not only specifications but can aid the delivery and application of a consistent, enduring quality system
• Supplier requirements and expectations including some level of oversight and pre-emptive monitoring and corrective actions A means for assessing, satisfying and communicating with customers to maintain ongoing quality expectations
• How to properly collect and utilize measurement data as a means to identify and respond to inconsistencies and other undesired events before they become problems that affect revenue, reputation or profitability
• Correct execution of the processes and work instructions to deliver consistent results, as well as record keeping of those results.