I thought it would be a good idea to talk about the upcoming changes to ISO9001. For the next few blogs, I will discuss things that I noticed when reviewing the DIS level of the revision. Please comment on things that you noticed and also what you think is going to change in the 3rd party auditing. Let me know if you agree or disagree with my thoughts.
The 2009 requirements for a QMS were contained in sections 4, 5, 6, 7 and 8; they are now contained in sections 4, 5, 6, 7, 8, 9, and 10. I will highlight below thing things that caught my eye as being new requirements or terminology.
Section Context of the Organization:
- Understanding the context of the organization is required
- Understanding the needs and expectations of the interested parties is required
Section 5 Leadership:
- Leadership – New Term
- Requires Top management shall demonstrate leadership and commitment with respect to the quality management system
Section 6 Planning for the Quality Management System
- More definition for setting and monitoring objectives
- Tighter controls required when changes are made to the QMS
Section 7 Support
- New section for The Environment for the Operation of the Processes
- Requirement to monitor and measure resources and having organizational knowledge
Section 8 Operation
- Very similar to section 7 of the 2009 revision
- Seems to be more emphasis on post-delivery activities
Section 9 Performance Evaluation
- This section is similar to section 8 of the 2009 revision
- Allows the organization to determine the aspects that need to be monitored to ensure structure, control and accountability
Section 10 Improvement
- Covers non conformity and corrective action
- Preventive action has been removed but the activity is covered in the new subsection in section 6 on Risk.
Next blog, I am going talk specifically about section 4. There are some pretty significant things that need to be discussed and understood. Can’t wait to share and hear what you think.