The latest in our series of FAQs on compliance and risk management.
What evidence should we provide for compliance to ISO 9001:2015 clause 4.2 Interested parties?
This is a clause that was essentially new with the release of the 2015 version of the standard. In summary, it requires your organization to:
(a) determine who is an interested party that is relevant to your QMS
(b) determine their requirements that are relevant to the QMS
(c) monitor and review the above (e.g. to consider any changes)
Note the use of the word 'relevant' above.
The standard doesn't actually specify any requirements for documented information. However, you need to consider how would you provide evidence if it wasn't documented? One option is to create an 'Interested parties table' that is a standalone document or forms part of a Quality Manual or QMS Overview. One useful model would be a 4-column table.
- The 1st column is to list the interested parties.
- The 2nd column is to list their relevant needs and expectations.
- The 3rd column identifies whether the item is a 'compliance obligation' e.g. a legal, contractual requirement or other requirement that you choose to comply with.
- The 4th column references what you do to meet the identified needs / expectations.
Evidence of monitoring and review can perhaps be provided by including the subject as an agenda item in your management review. Its worth noting that although ISO 9001 requires monitoring and review, some of the other standards do not. We still think it's good business practice to do this.