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ISO 9001:2008 section 4
4. Quality management system ISO 9001:2008 section 4.1, ISO 9001:2008 section 4.1a and ISO 9001:2008 section 4.1b
Section 4 splits into two management requirements;
ISO 9001:2008 section 4.1 Quality Management Systems, and
ISO 9001:2008 section 4.2 Documentation
Looking firstly at ISO 9001:2008 section 4.1 Quality Management System.
The standard specifies the requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements
In my view ISO 9001:2008 section 4.1. is the single most important section of ISO 9001:2008 in regards to the concept of quality and continual improvement. This is where an organisation sets out its intention, desire and road map to meeting effective quality management. It is within this section that the concept of businesses being viewed as an interrelationship of entwined processes is introduced. Businesses are encouraged to lay out the way they operate in a manner that shows a clear map of internal and external functions and how continual improvement is an inherent part of these related processes working together. As with any motor, all parts must function for the engine to continue to turn, and thus produce drive and momentum in the required direction.
Put more simply, if this was an essay it would be the subject, if it was a thesis or dissertation the introduction. Its' purpose is to introduce the organization in the broader sense rather than jumping into the substantive detail.
By understanding the importance of the interrelationship of processes and defining these in a manner that communicates a clear vision of the structure of the organisation, will allow a fundamental awareness of why the organisation exists for its customers to be drawn.
The clause itself is sub divided into six requirements a) to f)
- identify the processes needed for the quality management system and their application throughout the organization,
- determine the sequence and interaction of these processes,
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
- ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
- monitor, measure and analyse these processes, and
- implement actions necessary to achieve planned results and continual improvement of these processes.
It is within these six requirements that the intent of ISO 9001:2008 is mapped out for us, including guidance on how the requirements of your quality management system should be applied, this in regard to how you plan to achieve, and not how you actually accomplish the products or services you supply. Section 4.1, is about identifying how to develop, implement, monitor and maintain your quality management system such that continual improvement is built-in. Whilst developing your system it is an effective system that is important, not necessarily a documented one, although six mandatory documented procedures are defined within the standard. With documentation, it should be remembered that policies, procedures and instructions should have one thing in common, they should all seek to achieve their goal, it is important to remember that this goal should add value to the quality management system and not merely meet regulatory compliance or even worse just be black ink on paper only to be produce at the time of audit..
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