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- Keshav Ram Singhal
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Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Monday, October 20, 2014

What's New? A Look at the Changes in ISO/DIS 9001




International Organization for Standardization (ISO) had issued ISO/CD 9001 on 03 June 2013 for review and comments as a part of the revision process of ISO 9001 QMS Standard. Now the International Organization for Standardization (ISO) has issued ISO/DIS 9001 on 8 May 2014 for voting to be begin on 10 July 2014 and terminate on 10 October 2014. ISO/DIS 9001 is the formal draft of the forthcoming ISO 9001:2015 that describes the potential requirements of the revised version of ISO 9001 and it should be noted that this is not the final version, however this DIS version provides an idea on what might be included in the forthcoming standard. Further changes are possible in the ISO/DIS 9001 before final publication of ISO 9001:2015 that currently scheduled to be published in the fourth quarter of 2015. Those interested to procure a copy of ISO/DIS 9001 should contact ISO. A copy of ISO/DIS 9001 can be purchased at the ISO website (http://www.iso.org/iso/catalogue_detail?csnumber=62085).


The significant changes proposed in ISO/DIS 9001 relate to:
- Structure and terminology
- Internal and external context of an organization's QMS and risk-based approach (Clause 4 and 6)
- QMS requirements (Clause 5, 7 to 10)
- Incorporation of Annex A, B and C

Annex A provides clarification of new structure, terminology and concepts. Annex B provides details of seven quality management principles on which the ISO QMS Standards portfolio are based. Annex C describes the ISO 10000 portfolio of quality management standards that can provide assistance to organizations in establishing or improving their QMS, processes or activities


ISO/DIS 9001 contains following changes in the terminology:
- The term 'product' used in ISO 9001:2008 standard is changed to 'product and service' in ISO/DIS 9001. ISO 9001:2008 QMS Standard used the term 'product' to include all output categories. ISO/DIS 9001 uses the term 'products and services' that includes all output categories (hardware, services, software and processed materials). The specific inclusion of 'services' is intended to highlight the differences between products and services.
- The terms 'document' and 'record' used in ISO 9001:2008 standard are changed to 'documented information' in ISO/DIS 9001.
- The term 'work environment' used in ISO 9001:2008 standard is changed to 'environment for the operation of processes' in ISO/DIS 9001.
- The term 'supplier' used in ISO 9001:2008 standard is changed to 'external provider' in ISO/DIS 9001.
- The term 'purchased product' used in ISO 9001:2008 standard is changed to 'externally provided products and services' in ISO/DIS 9001

Clause 1.2 of ISO 9001:2008 standard mentions concession to organization for exclusion of any requirement(s). Now this requirement is not included in clause 1, the scope, of ISO/DIS 9001. However, clause 4.3 of ISO/DIS 9001, determining the scope of the quality management system, mentions the requirement for stating the justification for any instance where a ISO/DIS 9001 requirement cannot be applied. ISO/DIS 9001 no longer makes specific reference to 'exclusions' when determining the applicability of its requirements to the organization's quality management system.

ISO/DIS 9001 mentions new requirements with regard to the context of the organization - clause 4.1 - understanding the organization and its context, and clause 4.2 - understanding the needs and expectations of interested parties. Now as per ISO/DIS 9001, an organization establishing a quality management system needs to understand the organization and its context by determining relevant internal and external issues, understand the needs and expectation of interested parties, determine the scope of the quality management system, and determine risks and opportunities.

It is an opinion that ISO 9001:2008 standard has a inward-focusing methodology approach, while ISO/DIS 9001 has a external-focusing methodology approach to develop and implement quality management system. ISO/DIS 9001 now requires organization to determine interested parties and their requirements. ISO/DIS 9001 is closely aligned to the adoption of risk-based approach.

ISO 9001:2008 standard clause 8.5.3 contains requirements for preventive action, however with inclusion of risk-based approach now ISO/DIS 9001 does not mention specific clause on preventive action.

We will post more articles on changes and forthcoming standard to create awareness.

- Keshav Ram Singhal