7 Keys to a Successful ISO 9001 Audit

A successful quality audit – any kind of audit, for that matter – gives the audited organization something to grow on. As an auditor, I’ve been involved in some successful quality audits, as well as a number of them that were destined to fail. The difference between a successful and a failed audit depends on:

  1. The primary objective of the audit,
  2. Adequate preparation for the audit,
  3. The audited organization’s level of commitment to quality,
  4. The degree and kind of communication between the auditor and auditee,
  5. The desire of both parties to cooperate,
  6. The auditor and auditee having a positive attitude, and
  7. The desire of both parties to improve products, processes, and ultimately, the organization.

The Primary Objective

Why have your organization – or just a small part of the organization – audited? To show compliance? For certification? For quality improvement? The main reason for the audit – your primary objective – has a huge impact on the audit and its outcomes.

I think it’s safe to say most organizations undergo quality audits for reasons related to certification. Organizations want to be certified to ISO 9001 to keep and grow their business. In a global economy, it’s not possible for us to know every intimate detail about our prospects, our clients, or our competitors. It’s a far different world from what our parents, grandparents, and beyond knew.

Offering proof that your business complies with applicable standards and regulations – for example, the phrase “ISO 9001:2008 Certified” displayed prominently on your website, etc. – is one way to gain a prospective buyer’s trust. There’s nothing wrong with that. It’s intelligent marketing.

However, having “compliance” or “certification” as your primary objective misses the point of ISO 9001. In the Introduction to the ISO 9001:2008 quality standard, the authors wrote that:

“This International Standard can be used by internal and external parties,
including certification bodies,
to assess the organization’s ability to meet customer, statutory, and regulatory requirements
applicable to the product, and the organization’s own requirements.”

Note that “customer requirements” comes before all other requirements. The authors of the standard believe the customer’s requirements are the most important. I believe it, too. I believe that if you’re not meeting or exceeding your customers’ requirements – if you’re not making improvements to your products or the way you’re conducting your business – your business will not succeed, in which case all the other requirements become immaterial.

Always make sure your customers come first, and your audits will be more productive.

Preparing for the Audit

A successful quality audit requires adequate preparation on the part of the auditor and the auditee. Neither one can go into a quality audit cold and expect to see meaningful results from that audit.

For both the quality auditor and the auditee to be adequately prepared, each has to give the other something. The auditor needs to prepare and submit an audit schedule and plan in advance, to ensure the auditee’s consent and cooperation. The auditee must likewise comply with reasonable requests from the auditor, like a request to review quality-related documentation in advance (e.g., quality manual, quality policy), or to ensure the availability and participation of certain parties (top management, process owners, etc.)

Of course, the best preparation for any quality audit is the development, implementation, and maintenance of an efficient and effective quality management system.


In my experience, nothing is more important to the success of a quality management system – or a QMS audit – than an organization-wide commitment to quality improvement. Commitment flows from the top of the organization through every aspect (function). Commitment – whether to quality, customer engagement, or other aspect of the business – must be part of the organizational culture. It’s not enough to post a “committed to quality” banner in every department. Everyone in the organization has to believe in and practice that commitment, every day. Without a commitment to quality, an ISO 9001 audit is an exercise in futility.


The quality auditor and the auditee must communicate frankly – in an open, honest, and direct manner, as long-time friends communicate with one another. Neither the auditor nor the auditee can afford to withhold pertinent information from the other, nor can they let personality, opinion, or emotion overrule their duty to deal with the facts of the case. They each have a duty to the other to be objective and fair. In a successful audit, auditors and auditees are not adversaries; they are on the same side.


Auditors and their auditees cannot afford to be uncooperative during an audit for even a moment. They are a team. The benefits of a quality audit – especially the opportunity to improve – cannot be fully realized unless auditor and auditee cooperate totally. That’s not to say that can never argue a point or that they have to completely acquiesce to the other to keep the peace. Auditors and auditees will – should – have differences and they need to acknowledge this fact before beginning the audit. Every audit should include a plan[1] for resolving differences.

Positive Attitude

How many times have you, as a quality auditor, audited an organization in which every employee said and/or acted like the audit was a great opportunity? Where they looked forward to every audit? Where their number one goal was to improve their function or department and by extension, the company as a whole? It’s a great feeling, isn’t it?

As an auditor, you have the ability to improve the quality audit and its results by having a positive attitude. I’d even go so far as to say you have a duty to the auditee to come to the audit with a winning attitude. You’re not there to find fault or harshly criticize – you’re there to help. Help make a bad situation better and make a good situation better than it already is. Recognize opportunities for improvement and share them with the auditee. Help them understand that change and improvement are achievable. Be encouraging.

Desire to Improve

Improvement means change. Change, even in small doses over an extended period, doesn’t sit well with many people. It takes time to learn a skill and considerably more time to learn and execute it well – for it to become “second nature”. As a result, many of us resist change or pretend it isn’t happening.

Change is the one constant, however. If we don’t accept, look forward to, encourage, or promote change, it will force itself on us, often painfully. It’s not enough, and really never has been, to be satisfied. Satisfaction often leads to complacency. We take things and people for granted. “If it isn’t broken, don’t fix it” becomes our mantra. (As if preventive maintenance was a crazy idea, a waste of time.)

Therefore, a successful quality audit happens when the auditor and auditee both have a strong desire to improve the current situation. For the auditee, that means being continually mindful of the need to move forward, to do it a little bit better, to reject the status quo. For the auditor, that means being an ardent agent of change – helping the auditee to realize its potential.

* * * * * * *

Remember – the seven keys to a successful quality audit are:

  1. The primary objective,
  2. Preparation,
  3. Commitment,
  4. Communication,
  5. Cooperation,
  6. Positive attitude, and
  7. The desire to improve.

Also note that while I presented these keys in the context of the ISO 9001 quality standard, they apply equally to ISO 14001 environmental audits, OHSAS 18001 (health and safety) audits, and virtually every other kind of audit.

May your next audit be a success!


[1] It needn’t be a formalized plan, though it certainly wouldn’t hurt to state what you’re going to do when differences of opinion arise.


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Posted in ISO 9001 audit, Quality audits, Quality improvement

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