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Keshav Ram Singhal

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Sunday, April 13, 2014

Significant Changes in ISO 9001 Committee Draft

ISO/CD 9001 was released for submission of comments in June 2013. Significant changes observed in ISO/CD 9001 are as under:

1. The term 'product' (used in ISO 9001:2008) is replaced by the term 'goods and services (in ISO/CD 9001)

2. Two new clauses are added in ISO/CD 9001
- 4.1 - Understanding the organization and its context
- 4.2 - Understanding the needs and expectations of interested parties

3. 'Process approach' is added as requirement (clause 4.4.2) in ISO/CD 9001 - The requirements to use process approach has been more explicit now.

4. ISO/CD 9001 does not include a specific clause for 'preventive action'. ISO 9001:2008 has clause 8.5.3 as requirements for preventive action.

5.ISO/CD 9001 includes requirements for 'actions to address risks and opportunities' (clause 6.1). Risk management , thus, will be part of the QMS.

6. The structure in ISO/CD 9001 has been changed. There are 10 clauses in ISO/CD 9001 instead of eight clauses in ISO 9001:2008.

Eight clauses in ISO 9001:2008 are:
Clause 1 - Scope
Clause 2 - Normative reference
Clause 3 - Terms and definitions
Clause 4 - Quality management system
Clause 5 - Management responsibility
Clause 6 - Resource management
Clause 7 - Product realization
Clause 8 - Measurement, analysis and improvement

Ten clauses in ISO/CD 9001 are:
Clause 1 - Scope
Clause 2 - Normative reference
Clause 3 - Terms and definitions
Clause 4 - Context of the organization
Clause 5 - Leadership
Clause 6 - Planning
Clause 7 - Support
Clause 8 - Operation
Clause 9 - Performance evaluation
Clause 10 - Improvement

7. The terms 'document' and record' (used in ISO 9001:2008) have been replaced by the term 'documented information' in ISO/CD 9001

8. The term 'continual improvement' (used in ISO 9001:2008) has been replaced by the term 'improvement' in ISO/CD 9001.

9. The existing standard ISO 9001:2008 is based on eight quality management principles, while ISO/CD 9001 is based on seven quality management principles.

ISO 9001:2008 standard is based on following eight quality management principles: (i) Customer focus, (ii) Leadership, (iii) Involvement of people, (iv) Process approach, (v) System approach to management, (vi) Continual improvement, (vii) Factual approach to decision making, and (viii) Mutually beneficial supplier relationship.

One principle 'System approach to management' is dropped in ISO/CD 9001. There are some editorial changes also. Seven quality management principles, on which ISO/CD 9001 is based, are: (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship management.

10. Quality manual is not required in ISO/CD 9001.

11. Management representative is not required in ISO/CD 9001. Role of management representative is assigned to the top management.

12. ISO 9001:2008 requires six mandatory documented procedures. No mandatory documented procedure is required in ISO/CD 9001.

- Keshav Ram Singhal

Please share this article on social media for creating awareness on changes coming in forthcoming ISO 9001:2015 QMS. Thanks.

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