The Most Important Audit Questions for ISO 9001:2015

If you’re preparing to start auditing against ISO 9001:2015, you’ve probably
already asked yourself the timeless question:

What the heck am I going to ask these people?

There’s no worse feeling in the world than being in the middle of an audit and realizing that you don’t have anything to say in the way 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. In order to expedite your thinking, these are what is believed to be the most important audit questions for ISO 9001:2015:

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

This question is the starting point of ISO 9001:2015, appearing in section 4.1. The standard uses the clunky term “context,” but this could easily be substituted by asking about the organization’s internal and external success factors. Questions about context are usually directed at top management or the person leading the QMS (formerly known as the management representative).

As an auditor, you’re looking for a clear examination of forces at work within and around the organization. Does this sound broad and a little vague? It is.

Thankfully the standard provides some guidance, saying that context must include internal and external issues that are relevant to your organizations’ purpose, strategy, and goals of the QMS. Many organizations will probably use SWOT analysis (strengths, weaknesses, opportunities, and threats) to help get their arms around context, but it’s not a requirement. What the organization learns with this will be a key input to risk analysis.

NOTE: Not everybody will understand the term ‘context.’ Be prepared to discuss the concept and describe what ISO 9001:2015 is asking for.

  • Who are your interested parties and what are their requirements?

The natural follow‐up to context is interested parties, found in section 4.2. The term “interested parties” has a bizarre, stalker‐like ring to it, so smart auditors might want to replace it 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 are employees, customers, suppliers, business owners, debt holders, neighbors, and regulators. As an auditor you’re
making sure that a reasonable range of interested parties has been identified,
along with their corresponding requirements. The best way to audit this is as an exploratory discussion. Ask questions about the interested parties, and probe what they’re interested in. If you’ve done some preparation in advance of the audit, then you’ll know whether their examination of interested parties is adequate.

That brings up an important planning issue: You will have to do a bit more preparation before an ISO 9001:2015 audit. Why? So you’ll have a grasp of
context and interested parties. How can you evaluate their responses if you don’t know what the responses should be?

  • What risks and opportunities have been identified, and what are you doing
    about them?

Risks and opportunities could accurately be called the foundation of
ISO 9001:2015. No fewer than 13 other clauses refer directly to risks and
opportunities, making them the most “connected” section of the standard. If an organization does a 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, and drive improvement. Once risks and opportunities are identified, actions must be planned to address them. ISO 9001:2015 does not specifically mention prioritizing risks and opportunities, though it would be wise for organizations to do this. Risks and opportunities are limitless, but resources are not.

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

Measurable quality objectives have long been a part of ISO 9001. What is new is the requirement to plan actions to make 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 throughout the organization, and who has knowledge of them. Just as employees should be aware of how they contribute to objectives, they should be familiar with the action plans.

  • How has the QMS been integrated into the organization’s business processes?

In other words, how are you using ISO 9001:2015 to help you run the company? This is asked directly of top management (see section 5.1.1c) and is a very revealing question. The point is that ISO 9001 is moving away from being a quality management system standard and becoming a strategic management system. It’s not just about making sure products or services meet requirements anymore. The standard is about managing every aspect of the business.

Remember sections 4.1 and 4.2 of ISO 9001:2015? There we examined 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 able to describe how the QMS is used to run the company, not just pass an audit.


  • How do you manage change?

This topic comes up multiple times in ISO 9001:2015. The first and biggest clause on the topic comes up in section 6.3. Here we identify changes that we know are coming, and develop a plan for their implementation.

What kind of changes? Nearly anything, but the following changes come to mind as candidates: new or modified products, processes, equipment, tools, employees, regulations. The list is endless.

An auditor should review changes that took place, and seek evidence that the change was identified and planned proactively. Change that happens in a less planned manner is addressed in section 8.5.6. Here the auditor will seek records that the changes met requirements, the results of reviewing changes, who authorized them, and subsequent actions that were necessary.

  • 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 variety of means: project debriefs, job close‐outs, staff meetings, customer reviews, examination of data, customer feedback. How the organization captures knowledge is up to them, but the process should be clear and functional.

The knowledge should also be maintained and accessible. This almost sounds like it will be “documented” in some way, doesn’t it? That’s exactly 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 them more successful? It’s the conversion of raw information to true knowledge, and it just happens to be one of the most difficult things an organization can achieve.

These are by no means the only questions you’ll want to ask. They’re just the
starting point. We didn’t even mention management review, corrective action, or improvement—all of which are crucial to an effective QMS. The seven topics
discussed here are the biggest new requirements that auditors will need to probe.

By Craig Cochran

Quality in Schools

Quiet children can be outstanding leaders

Schools have different ways of choosing their leaders. Some schools choose leaders on the basis of those who excelled at leadership camps. Then there are schools that use a voting system where staff members and children choose by secret ballot.

Sadly, there are those schools – and it applies also to many businesses and governments – that have a voting bias in favour of the extroverts. The loudest and most eloquent children with ‘larger-than-life’ personalities seem to get preference over their quieter classmates. Yet those very quiet ones could be just as suitable and sometimes even better to take on leadership roles.

Too often leaders are unwisely chosen on their sound quality rather than their sound qualities.


There have been exceptional leaders who’ve given so much to the world in their quiet, unassuming ways. In the 20th century we’ve had introverts such as Madame Curie, Albert Einstein, Mahatma Gandhi and Rosa Parks of American civil-rights fame. Think of the many positive contributions that introverts of today such as Bill Gates, the Dalai Lama and Angela Merkel give our world.

Extroverts need to guard against a common negative characteristic. Their egos and forceful personalities can relentlessly (and recklessly?!) drive their personal agendas. Think of the present-day leadership found in both the United States and North Korea. Too often, extroverts aren’t good listeners. They hear but they don’t listen to the voices of quiet reasoning from introverts.

Fascinating research from Adam Grant at the University of Pennsylvania has identified a common strength of introverts. Quiet leaders usually give others greater freedom to run with their own ideas. They’re less concerned with their own egos. Quiet leaders give great attention to their thoughts before moving in to action. A core question that they often humbly ask is:

What is the best that we can do for others?

However, challenges face the quiet child when wanting to take on a leadership role. A leader is often expected to be a confident public speaker; the quiet leader prefers the one-on-one interaction with others rather than the big-group gatherings. The preferred stance of staying silent when all around them people are blabbing endlessly, is incorrectly interpreted as a weakness.

Yet the quiet child can be nurtured to gain confidence to speak in public; can be given the skills to interact comfortably in a crowd. As others get to know and understand such a child, there can be growing acceptance and respect for the innate quiet leadership. If you have a quiet child in the family, gently discourage ‘putdown’ comments such as, “I’m too quiet to be a leader. Nobody listens to my ideas,” or “Nobody notices me because I’m not a superstar in such-and-such a sports team.”

Yes, there was a time in so many schools that the extroverts and dominant personalities were viewed as the best to take up leadership positions. Fortunately, such flawed thinking is diminishing. There’s a growing realisation that quiet children can also be outstanding leaders.

Sue Cain is an internationally acclaimed writer on the issue of the introverted quiet person. In one of her books she writes a manifesto for the introverted child.

Four statements included in the manifesto are:

  1. A quiet temperament is a hidden superpower.
  2. Most great ideas spring from solitude.
  3. You don’t need to be a cheerleader to lead. Just ask Mahatma Gandhi.
  4. Speaking of Gandhi, he said: “In a gentle way, you can shake the world.”

Affirm and nurture the quiet child’s self-worth. Encourage the child to strive to take on leadership roles at school. The quality school welcomes the various leadership talents amongst the children. Quiet children deserve and need to be part of such leadership.

  • By Richard Hayward

Cain, S 2016. Growing up as introvert in a world that can’t stop talking. London: Penguin.
http:/ quiet-please-unleashing the-power-of-introverts