ISO 9001:2015—Establishing the Context of the Organization

Organizations may need to broaden their traditional concepts of themselves

Context. What the heck is that and how do you apply the term to your organization?
Credit: Takako Tominaga

One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?

What the standard says

When making sense of Clause 4.1—“Understanding the organization and its context” and Clause 4.2—“Understanding the needs and expectations of interested parties,” we first want to look at what the standard actually says:

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Comments

Interested Parties and External Auditors

Pam,

This is a great article on the new ISO standard.

Question: TO what extent will our external auditors audit who our organization's interested parties are ? If we potentially have interested parties that are not mentioned in our organizations Quality Manual, could that constitute a finding ?

Thank you !

Extent of auditing interested parties

Hi,

This is an excellent question and one that is still being trialed.

The standard does not specify that this be retained as documented information but it is a requirement, so I advise our auditors to ask: "what is your process?". The audit of the process starts with your response and we will be looking for the effectiveness of your choice. We will be looking for obvious missing pieces and obvious missing parties will almost certainly result in an NC or at least an opportunity. For example, if your QM refers to an interested party (IP), but your process does not include them, that would in my opinion be an NC if the IP is significant. In another example, if you supply a market with a regulatory body and your IP does not include them, that would be an NC. In this example, if you supply automotive and ignore NHTSA, that would be possibly be an NC, depending on your product of course.

I suspect this will be a bone of contention between auditor and auditee.

Pam

ISO 9001:2015

A very informative piece on the why & what of ISO 9001:2015 certification.. Good read!

Hi, Although the standard

Hi,
Although the standard keep clause 4.1 and 4.2 separate but I think that in reality it is the interested parties that create or set the context of organization.