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When exactly was "competence" added to the ISO-9001 standard?


Involved In Discussions
I just got beaten up in an audit when I tried to put forth evidence of training when the auditor asked me about competence.


Involved In Discussions
Yep! I got hit on that one too. That was added in the 2015 language. You can train someone all you want, it doesn't prove that their 'competent' at their job. This is done through evaluations, testing (applicable standards may apply like IPC) and documented information regarding performance. Since the company I worked for had not performed employee evaluations for a few years, this was something we had to put together relatively quickly.

I guess saying "the employee is competent because they still are working here and in their position" doesn't fulfill the standard haha ;)

Ed Panek

VP QA RA Small Med Dev Company
I wrote several open book quizzes trainees were required to take and make 75% or greater on. When asked by my auditor why it was an open book I responded "The SOPs are all available 100% of the time online. If they can look up an SOP to find the answer to the quiz they can also look up the SOP to do their job competently."


Quite Involved in Discussions
I think also one can use nonconformance issues related to a person's role to also be an indicator of competence. If there is a lack of n/c's as a result of that person's work, it at least implies competence, even if its not a formal evaluation.


Captain Nice
Staff member
I think also one can use nonconformance issues related to a person's role to also be an indicator of competence.
I dealt with this back in 1998 in QS-9000 (and again soon after in TS 16949) audits. Data is what I used way back then to beat off some 'difficult' auditors with, and never lost. Internal and external nonconformance data, mainly.

Actually, there are many things you can shut down a 'difficult' auditor with using data.


Captain Nice
Staff member
The only 'failure mode' with NC data is in companies which do not have effective / robust / comprehensive nonconformance systems (Both Internal and External) which is... Many companies... An example is a company I worked with some years ago which believed their NC system was very good, which in general it was. But as I pointed out, problems identified in their routine service visits were not going into their nonconformance system. Sort of a " missed a spot..." moment.
" Exactly. What would an incompetent employee do to our metrics? If you can show that there is little to argue with. "

[Ed], to play devils advocate to the question you posed, let me posit that any root cause analysis in an organization's records that relied on that old saw "operator error", with training as the correction, might lead in that direction.

John Broomfield

Staff member
Super Moderator
Usually, newcomers are under close supervision until they have demonstrated their competence. You’ll also have evidence that supervisors are competent to evaluate the competence of the employees for which they are responsible.

You may find the supervisor defines the required abilities, skills and knowledge (for the recruiting and training process).

Process Owner or department manager could maintain a matrix for each process or department to show who is competent to complete jobs well without close supervision, who is still under evaluation and who plans to acquire the necessary competencies.

Start by working closely with supervisors to analyze how it works right now. You’ll find on health and safety grounds alone they will not knowingly allow an incompetent worker to work alone.
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