ISO 9001:2015 was published in Sept 2015 and it has been developed based on high level structure as per directives. The purpose of HLS….
- Easy alignment with other standards
- Generic terms
- Uniform clause number and title
- Document of context of the organization is additional
- Document of needs and expectation of interested parties is additional
- Process approach has been emphasized with detailing
- Document of quality risk and opportunity for each process/ activity
- Document of environment risk and opportunity for each process/ activity
- Document of environmental life cycle thinking of product/ service
- Detailed action plan for each quality objectives
In addition to above, there are certain cosmetic changes for avoid wrong interpretation of standard requirements.
It is WRONG interpreted by many others since new edition of standard is published.
- MR requirement has been deleted.
- Documentation requirements are reduced.
- Records are no more required.