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ISO 9001 Audit Checklist

Free guidance and a useful example of an ISO 9001 audit checklist used by a modern, progressive Quality auditor; suitable for internal, supplier and certification audits.

As an auditor of ISO standards, and one who trains fledgling auditors, I am well aware of the appeal of an audit checklist; it is the comfort blanket of auditors, but is it useful?

If you look up the definition of checklist, and I use Merriam Webster, to check such things, it tells me that a checklist is “a list of things to be checked or done”. Wow! I can live with that.  My problem is that so many checklists that I have seen being used are the master rather than the servant of the auditor.

One of the many things I love about auditing is that ability to change the objective, the criteria and/or the scope. It’s like having a child’s kaleidoscope – you get different pictures of what is actually happening, and it’s a new adventure each time it changes.

"I love to find added value, to find efficiencies and how to make processes more effective, how to reduce alienation in functional areas, to identify training needs, to increase customer satisfaction – who wouldn’t? I need a special kind of checklist for that, one that allows me to fully explore a process or processes and identify all the areas of conformance I can and all the areas of improvement I can."

If you use a prescribed checklist, you pretty much ask the same thing every time and get the same answer… every time! Sure, it allows you to check on all the things you need to and ensures you don’t forget, and, in the beginning, it gives you confidence; but what do you want to achieve as a professional auditor? I love to find added value, to find efficiencies and how to make processes more effective, how to reduce alienation in functional areas, to identify training needs, to increase customer satisfaction – who wouldn’t? I need a special kind of checklist for that, one that allows me to fully explore a process or processes and identify all the areas of conformance I can and all the areas of improvement I can. If there are nonconformities, then I’ll record them, as well as investigating the root cause – how, why, when and where are they coming from?  What kind of correction do they need? Obviously, it has to prevent recurrence or it’s just a sticking plaster job, and as soon as the sticking plaster falls off, the nonconformity will recur. Maybe it’s because someone found a better way of doing something in which case changes will need to be made to procedures, work instructions, forms, activities, etc.  That might include training, or changes to the whole management system; but people will be recognised for their involvement and engagement in the processes for their efforts to make things better. How great is that?

"Excellent observation and note-taking, skillful questioning, accurate recording of responses, and the ability to evaluate, are all crucial in determining the worth of documentation within the management system. They need to be trained to do this and then they need to practice and gain confidence."

Whichever you use, never forget that a management system is a living thing – it is designed, created, resourced, populated, driven by strategic goals and quality objectives, with cascading Key Performance Indicators for departments and processes. They all need to work together like a well-oiled machine. Auditors are well-trained and competent professionals who can bring to the table the most up-to-date and useful information on the effectiveness of the management system and its processes.  However, to do this, their tools have to be the finest available. Excellent observation and note-taking, skilful questioning, accurate recording of responses, and the ability to evaluate, are all crucial in determining the worth of documentation within the management system. They need to be trained to do this and then they need to practice and gain confidence. Auditors need to be real. They need to provide accurate, precise data which allows for effective decision-making, therefore, while checklists can help achieve this, they need flexibility and adaptability to follow the lines of evidence.

So, why did I say, “I can live with that”, when I saw the Merriam Webster definition of a checklist? Because it said, “a list of things to be checked or done”. I’m OK with a list of things to be checked, but I really need a list of things to be done as an auditor.

My preparation includes roughing out process maps and identifying who does what, and with what documentation guiding them to do their activity, as well as what they produce out of their activity. Here’s an example:

 

PERSON IN THE PROCESS

THE ACTIVITIES WITHIN THE PROCESS

DOCUMENTATION THAT GUIDES SOMEONE TO UNDERTAKE ACTIVITIES IN THE PROCESS

DOCUMENTS PRODUCED FROM EACH STEP IN THE PROCESS (IF ANY)

NOTES FOR THE AUDITOR

Receptionist.

(Observe the process in action with agreement.)

Finding out what the customer wants through discussion and questioning.

Procedure for dealing with enquiries.

Form with a note of customer requirements.

Questions for the receptionist:

1.   What happens if...?

2.   How would you deal with…?

3.   Does the procedure help or hinder…?

(Examine the procedure and the form produced for fitness for purpose against the objective of the process. Examine customer feedback.)

 

And, there you have it, my checklist for auditing which allows me to achieve my client’s and my own objectives for the audit!

 

About the author: Karen MacKenzie is a highly-respected business and quality consultant, having the vision and adept ability to discern the key processes and personal development issues that are of paramount importance in any organisation. Karen is an ISO 9001 Lead Auditor, Internal Auditor and implementer of ISOs 9001, 45001 & 14001 systems in diverse industries from construction to fabrication; and from environmental landscaping to Health & Safety consultancies. She is also an advisor to Scottish Enterprise National on the quality assuring of vocational education and training programmes, having responsibility for rolling out the programme of self-assessment, quality development planning and continual improvement for education and training providers within Scotland.

 

Photography credit: Glenn Carstens-Peters