The Seven Most Important ISO

9001:2015 Audit Questions

POSTED BY SPATON ON JANUARY 25, 2016 IN AUDITING, ISO 9001 | 16,672 VIEWS | 16
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By Craig Cochran.

If youre preparing to start auditing to ISO 9001:2015, youve probably already asked yourself the timeless question:
What in the heck am I going to ask these people? Theres no worse feeling in the world than being in the middle of a
audit and realizing that youve run out of questions. Preparation and planning can remedy this, of course, but the fact
remains that ISO 9001:2015 includes a lot of new requirements that have never been part of most audits. To help prepa
you for auditing to ISO 9001:2015, Ive prepared a list of what I consider to be the seven most important audit questio
for ISO 9001:2015:

1. What can you tell me about the context of your organization?

This question is the starting point of ISO 9001:2015, appearing in clause 4.1. The standard uses the clunky term conte
but this could easily be substituted by asking about the organizations internal and external success factors. Questions
about context are usually directed at top management or the person leading the quality management system (QMS)
formerly known as the management representative. As an auditor, youre looking for a clear examination of forces at w
within and around the organization. Does this sound broad and a little vague? It is. Thankfully, the standard provides s
guidance, saying that context must include internal and external issues that are relevant to your organizations purpose
strategy, and QMS goals. Many organizations will probably use a SWOT (strengths, weaknesses, opportunities, and
threats) analysis to help get their arms around context, but its not a requirement. What the organization learns with thi
will be a key input to risk analysis. (Note: Not everybody will understand the term context. Be prepared to discuss th
concept and describe what ISO 9001:2015 is asking for.)

2. Who are your interested parties and what are their requirements?
The natural follow-up to context is interested parties, found in clause 4.2. Just like context, interested parties are a key
input to risk. The term interested parties has a bizarre, stalker-like ring to it, so smart auditors might want to replace
with stakeholders. Remember, effective auditors try to translate the arcane language of ISO 9001:2015 into
understandable terms that auditees can grasp. Typical interested parties include employees, customers, suppliers, busin
owners, debt holders, neighbors, and regulators.

As an auditor, youre making sure that a reasonable range of interested parties has been identified, along with their
corresponding requirements. The best way to audit this is an exploratory discussion. Ask questions about the interested
parties, and probe what theyre interested in. If youve done some preparation in advance of the audit, youll know wh
their examination of interested parties is adequate.

This brings up an important planning issue: Youll have to do a bit more preparation before an ISO 9001:2015 audit. W
So youll have a grasp of context and interested parties. How can you evaluate their responses if you dont know what
responses should be?

3. What risks and opportunities have been identified, and what are yo
doing about them?
Risks and opportunities could accurately be called the foundation of ISO 9001:2015. No fewer than 13 other clauses re
directly to risks and opportunities, making them the most connected section of the standard. If an organization does
poor job of identifying risks and opportunities, then the QMS cannot be effective, period.

Auditors should verify that risks and opportunities include issues that focus on desired outcomes, prevent problems, an
drive improvement. Once risks and opportunities are identified, actions must be planned to address them. ISO 9001:20
doesnt specifically mention prioritizing risks and opportunities, though it would be wise for organizations to do this. R
and opportunities are limitless, but resources are not.

4. What plans have been put in place to achieve quality objectives?

Measurable quality objectives have long been a part of ISO 9001. Whats new is the requirement to plan actions to ma
them happen. The plans are intended to be specific and actionable, addressing actions, resources, responsibilities,
timeframes, and evaluation of results. Auditors should closely examine how the plans have been implemented through
the organization and who has knowledge of them. Just as employees should be aware of how they contribute to objecti
they should be familiar with the action plans.

5. How has the QMS been integrated into the organizations business
processes?
In other words, how are you using ISO 9001:2015 to help you run the company? This is asked directly of top managem
(see subclause 5.1.1c) and is a very revealing question. The point is that ISO 9001 is moving away from being a qualit
management system standard and becoming a strategic management system. Its not just about making sure products o
services meet requirements anymore. The standard is about managing every aspect of the business. Remember clauses
and 4.2 of ISO 9001:2015? They examine the key topics of context and interested parties. These concepts touch every
corner of the organization, and this is exactly how ISO 9001:2015 is intended to be used. Top management should be a
to describe how the QMS is used to run the company, not just pass an audit.

6. How do you manage change?

This topic comes up multiple times in ISO 9001:2015. The first and biggest clause on the topic is clause 6.3, Planning
changes. Here we identify changes that we know are coming and develop plans for their implementation. What kind of
changes? Nearly anything, but the following changes come to mind as candidates: new or modified products, processe
equipment, tools, employees, regulations. The list is endless. An auditor should review changes that took place and see
evidence that the changes were identified and planned proactively.
Change that happens in a less planned manner is addressed in subclause 8.5.6. Here the auditor will seek records that t
changes met requirements, the results of reviewing changes, who authorized them, and subsequent actions that were
necessary.

7. How do you capture and use knowledge?

ISO 9001:2015 wants organizations to learn from their experiences, both good and bad. This could be handled by a va
of means: project debriefs, job close-outs, staff meetings, customer reviews, examination of data, and customer feedba
How the organization captures knowledge is up to it, but the process should be clear and functional. The knowledge sh
also be maintained and accessible. This almost sounds like it will be documented in some way, doesnt it? Thats exa
right. One way to audit this would be to inquire about recent failures or successes. How did the organization learn from
these events in a way that will help make it more successful? Its the conversion of raw information to true knowledge
it just happens to be one of the most difficult things an organization can achieve.

These are by no means the only questions youll want to ask. Theyre just the starting point. I didnt even mention
management review, corrective action, or improvementall of which are crucial to an effective QMS. The seven topic
discussed here are the biggest new requirements that auditors need to probe. I would be very interested in hearing from
on this subject. What audit questions do you see as critical in ISO 9001:2015? Please leave your comments below.