ISO 9001:2015 Human Factors

Most people that know anything about management systems understand that human factors have to be accounted for. You can’t simply write a procedure or implement a control and then assume that it will be adhered to. People are not like that. People can be lazy, selfish, tired, distracted, hacked off … all of which can reduce the chance that a procedure, no matter how correct and communicated, may not be followed all of the time.

In general terms that means that a system manager should try so far as is possible to make the RIGHT thing to do also the EASIEST thing to do, as this dramatically increases the chances of conformance. Things that can’t be made easy (some things just are complicated) probably need a high level of monitoring (to account for the medium/high risk of nonconformance through poor understanding, laziness, short cuts or whatever).

At the time of writing, most of us are at the “theoretical” stage of understanding how ISO 9001:2015 will work. That is, we can see how it looks, but we don’t really know the levels that the certification bodies will operate at in terms of what they will and won’t accept. That process (which tends to work by custom and practice, osmosis even) will take some time to reveal itself. That said, I’ve noticed a couple of curious things that have not previously appeared in the standard that COULD have a significant impact – and the things I’m going to write about are very much hidden in the detail …

Controls to Prevent “Human Error”

How often is “human error” used as the Corrective Action Get Out Of Jail Free Card? Quite often, in my experience. Well, given the specific reference in Clause 8.5.1g, the options for organisations to use that excuse should be limited. Controls should seek to include actions to PREVENT HUMAN ERROR. Therefore, if human error is the cause of the nonconformity, then that Process Control requirement is not met. It will be interesting to see how that is audited (if it gets audited at all). At this stage I can’t help thinking that the standard might have been better if the aim to prevent human error was also included in the Nonconformity and corrective action clause too. It is very easy to overlook …

The “Social” and “Psychological” Work Environment

Good Lord! The requirements of clause 7.1.4 require that the organisation in terms of its work environment considers the following issues … (and I must to quote)

“Social (e.g non-discriminatory, calm and non-confrontational; and

Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)”

Are they desirable attributes of an effective workplace? Well, yes they are, with the concept I have no problem. What I am looking forward to with a mixture of anticipation, trepidation and amusement is how they will be applied. Let’s think this through. How on earth will a QMS auditor interpret that? Quite aside from the fact that you are highly unlikely to witness highly charged and stressful events actually DURING the audit (because people are told to bite their tongues for a day) this could have significant legal implications for the company in countries where the employment laws deem stress, bullying, discrimination and so on to be unlawful. Are QMS sufficiently well versed in Employment Law so as to be legally correct in the call they make? In my experience they aren’t. Certification Bodies had better get their lawyers on standby.

I think this requirement, no matter how noble in its intent, is practically unenforceable. My guess is that this will actually be ignored.

Let’s see how these things move on. Time to get out the popcorn and plump up a cushion …

Shaun Sayers

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6 Responses to ISO 9001:2015 Human Factors

  1. Luiz Mello says:

    Interesting points on clause 7.1.4. I also wonder how these requirements may be interpreted in connection organization context and risk management aspects.

    I have a customer who fosters a very aggressive and stressful work environment. It’s part of their company culture by design (which I don’t like or agree with, but that’s beside the point). When we were discussing these practices he made it very clear that this culture is something integral to their business model, and therefore not negotiable. He also was very adamant that any potential legal liability was acceptable to him.

    We decided that it was well within ISO 9001:2015 requirements to operate according to his company’s core principles, as long as these principles are well established and communicated (they are) and that any potential negative effects from these practices are systematically managed as risks (with the risks retained as an informed decision).

  2. Shaun says:

    Thanks for taking the time to read and comment, Luiz

    I agree with you that this new requirement will pose curious questions. Who is to say what is “right” and “wrong”?


  3. Ashok Deobhakta says:

    Interesting point. I am sure auditors will turn around while auditing this aspect.
    In any case, the training bodies have to appropriately (I am sure IRCA and others) must have included
    learning objectives for these issues.

  4. eddy says:

    That is simpy wrong. There is no problem with clause 7.1.4. It is written: “The organization shall determine, provide and maintain the environment necessary for the operation of its processes. A suitable environment can be a combination of human and physical factors, such as: Social, Psychological, Physical”.
    It is up to organization to determine those conditions. It is not even necessary to relate to psychological factors at all. The key words are: “Can be” instead of “shall be”. Pay attention, please.

  5. Shaun says:

    I expressed an opinion on the likely interpretation of the clause and potential issues with it. You may disagree, but to say it is “wrong”, I think is hard to say. I don’t think anyone can argue with the actual spirit of the requirements of clause 7.1.4, my concern, and with the benefit of having seen a few auditors flounder with it already, is about auditor competence. Few are HR specialists and, in order to keep clear of potential litigation when it comes to matters of bullying, harassment and stress in the workplace, my view is that before you put pen to paper, you’d best make damned sure you are technically correct on all points of detail.

    Thanks for taking the time to read this article and to comment. Despite the fact I disagree with you, I do appreciate your time and interest in the post.


  6. Pingback: Carnival of Quality Management Articles and Blogs – October, 2016 – The world is too small? or Is it?

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