SOME OBVIOUS THINGS
- The updated ISO 9001:2015 standard was published in September 2015
- Hence you have until September 2018 to implement the new version
- Your certification body will provide a Gap Analysis document and general assistance, they want you to succeed!
- The clause numbering has been completely changed as the standard is now written as defined by the Annex SL template for management system standards.
- The need for a Quality Manual and the six “mandatory” procedures of the ISO 9001:2008 standard have been removed. (i.e. Documents, records, non-conformance, internal audit, corrective action, preventive action)
- The standard is no longer one size fits all. Your quality system should now be defined by the context of your organisation i.e. internal/external considerations and interested parties. The needs and expectations of interested parties and the risks/opportunities from this analysis need to be defined.
SOME NOT SO OBVIOUS THINGS
- The old 2008 version of the standard covers at least 80% of the 2015 standard but the section numbers are different
- Keep your Quality Manual and your mandatory procedures if they are useful
- You do not need to restructure your present system around the new ISO 9001:2015 clause numbers
- If you MD used to be on just nodding terms with both the assessor and the old standard system, sit him down and tell it to him straight that with the new standard he has to be involved and the assessor will expect to discuss the system WITH HIM at the assessment visit.
- The new standard should be embraced as a good way of taking a balanced view of your present system, reviewing and simplifying your present system where required and thinking about integration of the quality system with your environmental and OHS systems.
HOW TO IMPLEMENT THE STANDARD
- Have a session with the top management team to define the context of the organisation by defining internal/external considerations, the needs and expectations of interested parties and the risks/opportunities from this analysis. .
- From the above define the scope of the organisation. Define measurable quality objectives. Confirm the operating processes are still applicable with the above thinking.
- If these operating processes do not include flow chart then define flow charts. If these procedures are more than four A4 pages then think again. Review these processes with the process owners and do not forget the process workers.
- Decide what support (mandatory procedures) are still applicable and useful to the organisation. The certification body will be less interested in these procedures.
- Double check your thinking with the Gap Analysis produced by your certification body.
- Ensure you communicate with all personnel regarding any new systems
- Have a robust management review system at least quarterly to review objectives, non-conformances, internal audits and define improvements. Review the context document annually.
- Work with your certification body
