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Monday, December 8, 2008

Understanding ISO 9001:2008 Quality Management System

Chapter 2


Author – K. R. Singhal

Clause 1 (Scope) – Sub clause 1.1 (General) and Sub Clause 1.2(Application) – It is mentioned in ISO 9001:2008 that product also includes intermediate product. The phrase ‘regulatory requirements’ of ISO 9001:2000 Standard has been replaced by the phrase ‘statutory and regulatory requirements’ in ISO 9001:2008, thus making the requirement of this clause more clearly in meaning.

The note, the term ‘product’ applies to the product intended for a customer or required by a customer, of ISO 9001:2000 QMS Standard has been expanded in ISO 9001:2008 and now according to ISO 9001:2008, the term ‘product’ in ISO 9001:2008 means the following:
product intended for a customer, or product required by a customer,
any intended output resulting from the product realization processes

An additional note (Note 2) has been added in ISO 9001:2008 that states statutory and regulatory requirements may be expressed as legal requirements. Accordingly, Legal requirements = Statutory requirements + Regulatory requirements

ISO 9001:2008 QMS Standard mentions requirements for a quality management system, where an organization needs to demonstrate its ability to consistently provide product, and aims to enhance customer satisfaction. Here the product that meets customer requirements, and applicable legal requirements (= applicable statutory and regulatory requirements). The customer satisfaction can be enhanced by
the effective application of the ISO 9001:2008 QMS, including processes for continual improvement of the system, and
the assurance of conformity to customer requirements and applicable legal requirements (= applicable statutory and regulatory requirements).

All requirements of ISO 9001:2008 Standard are generic. All requirements of this standard can be applied to all organizations, regardless of their type, their size and product they provide.

Where any requirement / requirements of ISO 9001:2000 QMS Standard (within clause 7) can not be applied due to the nature of an organization and its product, the same can be considered for exclusion, however such exclusion must not affect the organization’s ability, or responsibility, to provide product/service that meets customers requirements and applicable legal requirements.

Clause 2 (Normative reference) – There has been editorial changes in this clause. Now ISO 9001:2008 refers to ISO 9000:2005 Standard as normative reference document, instead of ISO 9000:2000 Standard as mentioned in ISO 9001:2000 QMS Standard. It has been mentioned in ISO 9001:2008 that the reference documents are indispensable for the application of ISO 9001:2008 QMS Standard and for dated references only the edition cited applies and for undated references the latest edition of the referenced document (including any amendments) applies.

Accordingly, on going through the requirements of ISO 9001:2008 QMS Standard, we notice that following reference documents have been mentioned in the Standard:
ISO 9000:2005, Quality management systems – Fundamental and vocabulary
ISO 19011 – Latest edition – Guidelines for quality and/or environmental management systems auditing

Clause 3 (Terms and definitions) – The explanation of who the ‘customer’, ‘organization’ and ‘supplier’ are (as mentioned in ISO 9001:2000 QMS Standard), has been removed in the ISO 9001:2008 QMS Standard.

It is stated that the terms and definitions mentioned in ISO 9000 are applicable for the requirements of ISO 9001:2008 QMS Standard. It is also mentioned that the product also mean ‘service’. Accordingly, the term ‘product’ in ISO 9001:2008 means the following:
Product/service intended for a customer, or product/service required by a customer,
any intended output resulting from the product realization processes


What are the key changes in clause 1 (Scope) of ISO 9001?
What does the product mean in ISO 9001:2008?
What are the key changes in clause 2 (Normative reference) of ISO 9001?
Which version of ISO 9000 Standard is referred as normative reference document in ISO 9001:2008?
What are the key changes in clause 3 (Terms and definitions) of ISO 9001?
What are reference-documents mentioned in ISO 9001:2008 QMS Standard?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.

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