New ISO 9001:2015 structure
9001:2015 standard is on the basis of the new high level structure (HLS) that brings to us the framework which is universal to all standards of management systems which keeps consistency of all standards.
The key changes of the standard are:
- Risk management more focused
- Leadership more emphasized
- Awareness and effective communication
- Objectives to be measurement and changed
| ISO 9001: 2008 | ISO 9001: 2015 |
| Products | Products and Services |
| Exclusions | It’s not being used (See Chapter A.5 for
clarification of implementation and exclusions ) |
| Management Representative | It’s not being used (Assigned similar
responsibilities and authorities, but there is no requirement for a single representative of the Top Management) |
| Documentation, Quality Manual, Documented Procedures, Records | Documented information |
| Working environment | Environment for the operation
of processes |
| Monitoring and measurement equipment | Monitoring and measurement resources |
| Purchased product | Products and Services provided by the external provider |
| Purchaser | External provider |
Auditor courses ISO 9001/13485/3834,CWI,API in INDIA & ABROAD 