Issue 34 – Clause 9.2: Internal Audit
Clause 9.2: Internal audit
What’s new in Clause 9.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 33) we discussed the topic of “monitoring, measurement, analysis and evaluation”, and now here in Clause 9.2 we address “internally auditing your QMS”.
Note A: This Clause DOES include requirements for “documented information”.
Note B: In case you were curious, the content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies. I gain a lot of hands-on experience from conducting training workshops and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. Combining an on-site Gap Audit with ISO 9001:2015 Essentials Training, has become our most popular request for proposal from our Newsletter readers. Another popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 (…more details on these training sessions, as well as other training that we offer, can be found below).
The new numbering format…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Clause 9.2 Internal audit consists of two (2) Sub-Clauses as listed below:
9.2.1 The organization shall conduct internal audits at planned intervals…
9.2.2 The organization shall…
Let me begin by saying that the requirements for “internal audits” have had essentially no changes made to it from the 2008 version of this Standard. Based on this fact, some people have then assumed that there is no need to train their internal auditors, however keep in mind that although the requirements of the auditing process have not changed, the scope of the QMS requirements have indeed expanded. Internal Auditors should be educated on how the QMS has been revised to reflect these new 2015 requirements so that they can properly assess/audit it. In addition most ISO Registrars will expect to see that a complete system audit to new requirements has been conducted by auditors trained on the new 2015 Standard.
Let me repeat that statement one more time… organizations will need to show documented evidence that their entire QMS has been internally audited to the new requirements PRIOR to their upgrade to this new ISO 9001:2015 Standard AND that the auditors who conducted this activity were trained on the ISO 9001:2015 Standard.
One very effective way to accomplish both of the above activities is to conduct a combination training/auditing event. I’ve been involved in a number of these sessions and besides the obvious benefit of getting training and auditing done at the same time, the other big advantage is that each auditor gets to immediately apply the training in the field. There is nothing better than hands-on experience in conducting audit interviews in a live setting vs classroom role playing. This type of event can be accomplished in a 3 day or a 4 day or a 5 day time frame, depending on the scope of the audit.
Here are a few suggestions I have for internal auditors: a) Try to look at auditing as a way to learn about an area you are not familiar with… being curious and wanting to learn more has kept auditing interesting for me (…at least for the past few decades that I have been doing it); b) Wear the hat of a typical Customer when conducting an audit… what I mean by that is, think like a Customer would… if you were spending your hard earned dollars buying the product/service that your company provides, what questions would you want answered?; and c) Pick just one sample of an outbound product (or service) that your company provides and take it to each and every department… set it down on the bench or table or desk and ask the person you are interviewing what THEY specifically do to make that product happen… and if a sample of your product is too large or can’t be carried around (or if you sell services), then find a way to represent it using possibly a picture/graphic of that final product or service… the idea is to get the discussion laser focused on how your interviewee contributes to making that product or service a reality… I use this approach myself (and have watched others do it as well) and it is a great way to get from just “general” audit discussions into a more specific process dialogue… and by the way, it works equally well with top management, with front line employees, as well as with every supporting function.
On a final note, if you are one of a number of organizations that outsource their internal audits to an outside firm (and nothing within the ISO Standard prevents you from doing that), keep in mind that you still need to “audit the audit process”. In these situations I recommend that my Clients retain objective evidence that they directed, observed, monitored, and were actively involved in, the conduct of the outsourced audit. This is how they ensure that their audit process is being carried out as planned/outlined within the QMS. The ISO Registrars that I have worked with have accepted this as evidence of “auditing the audit process”.
Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
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For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements in the ISO Standards.
This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator. This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame. If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part). Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it. A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant. As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed. PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event. This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.
Q: How do you perform a gap audit for Clause 9.2 of ISO 9001:2015?
A: For Clause 9.2, a Gap Audit checklist should cover these areas:
– There are essentially no new requirements within this Clause therefore no gap should exist in your QMS
Until next time…
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