ISO 9001 - Understanding ISO 9001 Requirements

CONTINUOUS IMPROVEMENT PROCESS MODEL

FIGURE 1
Key Explanation Points and Tips:

ÞFigure 4 - shows the macro level application of the PDCA model to an entire organization. The organization’s QMS (as depicted by the processes within the circle) is used to PLAN the controls over all inputs, resources, value-adding activities and outputs. We DO - implement our plan by using various resources to convert customer inputs (requirements) into outputs (product) that meet customer requirements. We CHECK - by monitoring and measuring QMS performance and through customer feedback. We ACT - by using this information to continually improve QMS effectiveness. At the micro level, this same model can be applied to each QMS process.

ÞControls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail.

0.3 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards, which have been designed to complement each other, but can also be used independently. Although the two standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.

ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization’s overall efficiency, as well as effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.

Key Explanation Points and Tips:

ÞThe difference between ISO 9001 and ISO 9004 are as follows:

ÞThe ISO 9001 standard provides requirements for your QMS that can be certified by an accredited Registrar; whereas ISO 9004 provides guidance to improve your QMS and is not subject to Registrar certification.

ÞISO 9001 focuses on improving QMS effectiveness alone; whereas ISO 9004 focuses on improving an organizations overall performance and efficiency as well as its effectiveness.

ÞISO 9001 provides the initial stepping stone for quality management; whereas ISO 9004 takes you further down the road towards total quality management.

ÞThe scope of ISO 9001 focuses on requirements intended for certification and contractual purposes; whereas ISO 9001 provides guidance that addresses a broader range of stakeholders such as owners, community, personnel, suppliers, investors, etc.

ÞThe layout, structure and numbering sequence of the requirements in the two documents are similar. ISO 9004 includes the requirements of the ISO 9001 standard in boxed tables and further discusses concepts, principles, issues and ideas for QMS development and implementation, for each clause.

ÞKeep in mind that ISO 9004 goes far beyond what may be required for initial ISO 9001 certification. Use it to gain knowledge and ideas, but be careful about trying to implement all that it covers, as it may be quite overwhelming if you are developing a QMS for the first time. Use ISO 9004 to continually improve the effectiveness and efficiency of your organization beyond certification.

0.4 Compatibility with other management systems
This Standard ha been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.
This Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements.
It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this Standard.

Key Explanation Points and Tips:
ÞThe ISO 9001 standard has been aligned with ISO 14000 EMS (environmental management systems) requirements for compatibility. The technical requirements are obviously different, but many of the management (MOP’s), support (SOP’s) and quality management (QMP’s) are very similar, (e.g., control of documents; control of records, management responsibility, etc.). There is a longer term objective of integrating the audit of QMS and EMS systems.

ÞISO 9001 does not include requirements for - environmental management; occupational health and safety management; financial management; risk management. There are separate ISO standards for most of these business sectors.

ÞYou have the flexibility to develop or use your existing QMS in any way that facilitates ease of use and understanding by users and effective application of QMS controls within your organization. This includes integrating other business sector standards such as EMS or health and safety. However, for certification to ISO 9001, you must show evidence that you have addressed all applicable requirements of the ISO 9001 standard in your QMS.


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