Understanding Section 7.2

Competence


This is an educational article on Section 7.2 of ISO 9001, entitled “Competence.”

The purpose of this article is to give you an understanding of what Section 7.2 requires.

This article is directed towards:

  • Those responsible for compliance to section 7.2.
  • Those responsible for ensuring competence generally.
  • Others interested in understanding section 7.2.

Section 7.2 is entitled “Competence” and it requires you to:

  • Determine the necessary competence of your personnel.
  • Ensure your competence requirements are met.
  • Provide necessary training.
  • Evaluate the effectiveness of your actions to ensure competence.
  • Keep records as evidence of competence.

Let’s discuss each of these one-by-one.

First, determine necessary competence.

What do we mean by competence? Competence means having the knowledge and skills necessary to achieve the desired results. 

When do you need to determine the knowledge and skills necessary to achieve the desired results?

You need to determine the necessary levels of competence for:

  • Those doing work under your control…
  • …who can affect the performance and effectiveness of your quality management system.

Let’s discuss each of these.

As for those who do work under your control, clearly that includes subcontractors and other external providers who can affect your quality performance. These will also need to be controlled for competence. In such cases, determine what competence levels are required for the work to be done, and ensure that they have that level of competence, and keep a record as evidence of their competence. This of course will probably not be the only control that you apply to external providers, but it is a necessary one as required by this section of ISO 9001.

As for those who can affect the performance of your quality management system, this implies that you only need to meet ISO 9001 competence requirements for those who do work within the scope of your QMS. For example, If the scope of your QMS is only one product line, then the standard would not apply to other products lines, including competence requirements for those working in those other product lines. I bring this up in order to warn you to be careful with this line of thought. If the competence of workers in the other product line, can affect the quality performance of the ISO product line, in any way whatsoever, then you must control their competence as per ISO 9001 requirements.

For the most part, organizations are great at applying competence controls, but some might like to find an excuse to avoid the record requirements of ISO 9001. Just be careful.

Moving on — Once you have determined the competence requirements, then you need to ensure that those requirements are met.  

Specifically, the standard mentions that persons should be qualified on the basis of:

  • Education,
  • Training, and
  • Experience.

Examples of ways that organizations often ensure that competence requirements are being met include:

  • A hiring selection process including
    • applications,
    • resumes,
    • references,
    • interviews,
    • screenings,
    • professional certifications,
    • testing,
    • evaluation periods,
    • and so forth.
  • Training Matrices.
  • A regular employee performance evaluation.
  • Career and succession planning.

Not everyone you hire will be qualified from the start, or will remain qualified throughout all the changes that take place in your company.

So you are required to provide the necessary training to ensure that personnel remain qualified.

For example, training is often needed when:

  • New hires are learning company systems, practices, policies, procedures, values, and so forth.
  • Changes occur in position, roles, or responsibilities.
  • Changes occur in systems and processes.
  • Or for career and succession planning purposes.

Ensuring competence is an continual process.

Since it is a continual process, continual evaluation is necessary to ensure competence requirements are still being met.

Not just formal training, but any action taken by your company to acquire additional competence needs to be evaluated for effectiveness. Its about verifying that the desired level of competence was achieved, before it can turn into poor quality results.  

And ISO 9001 wants evidence that desired competence levels were achieved.

This means you need to document:

  • Competence Requirements, (such as in a job description)
  • The Hiring Process, (such as in a procedure or new hire checklist)
  • Employee Qualifications, (such as a resume or professional certifications)
  • Training Provided, (such as in a training attendance sheet or a training certificate) and
  • Training Effectiveness. (such as through a post-training evaluation)

Organizations tend to have a big problem with providing training and maintaining training records when changes occur.  In the chaos of the change, they may forget that they need to provide additional training related to the changes, and keep records of that training. Auditors will look for records of training whenever they see big changes have occurred in your company.

A good example would be the changes you are undergoing as part of your ISO 9001 project. As a result of the changes, the auditor would want to see training records showing that your people have been trained on ISO 9001 generally, on the related changes in your company, and on any new responsibilities it imposes on them. That is one reason why the Evata Consulting Group provides certificates of training for all training provided.

For more information on how to implement these requirements, watch our implementation videos for section 7.2 and review our template library for examples.