According to the standard, all staff that work under your organization’s control are competent, and the evidence of this is documented accordingly. As with much of the ISO language, competence is left for each organization to define. This can become quite a discussion during audits due to a difference in interpretation by the company and the auditor. We try to help out here.
7.2a) Determine Necessary Competence
The organization must decide what specific competencies are necessary for someone to perform his or her job effectively. To define personnel requirements for a given job position, you might ask the following questions:
- What job-specific knowledge area(s) must be well understood by someone in this position?
- What manual, mental, or interpersonal skills must an employee have to do this job well?
- What natural abilities or talents must someone possess to be effective in this area?
A properly defined job description can help with guiding this process. The description should at least give a basic understanding of what is required and how the employee qualifies for the job. After you have collected the answer to those questions, the hiring process and training and development plans can be created. Also, the selection of the right person will be a lot easier when these requirements are clearly defined.
7.2b) Ensure Competence
The requirements mandate that everyone who affects the QMS (i.e., everyone in the organization) must be competent. So, what exactly is ‘’competent”? It’s the condition that enables a person to perform a task in a manner that meets the required performance standard. ISO 9001:2015 clarifies this by separating four different variables relating to competence:
Of course, it is pretty much up to the organization what they define as competent,—but it should be in line with the job description. Remember you don’t have to follow things that you haven’t documented. However, make sure you set these guidelines in line with the job description. Also be cautious for inconsistencies. When someone is hired that doesn’t really fit the profile, make sure the appropriate training is giving.
7.2c) Take Action to Achieve Competence
Once competency has been determined for all personnel affecting product conformity, the organization must compare individuals to its competency needs and identify where gaps exist. Options for dealing with a gap between actual performance and required performance include:
- On-the-job training.
- Coaching and counseling.
- Independent study (traditional, audio, video, and internet-based).
7.2d) Keep Evidence
One more thing that must be in place is records. ISO 9001:2015 specifically requires you to retain documented information (i.e. records) as evidence of competence. This can be accomplished in a single record or multiple records. The fewer individual records, the better—particularly if the records are kept on paper.
Digital training records are the most common approach for organizations. They clearly and quickly show what training has taken place or is planned and make gaps obvious. The long-term costs of digitizing your QMS are usually much less than the cost of administering paper records. Examples of evidence include:
- Job descriptions/postings (evidence of determination of competency).
- Employee resume and certifications (evidence that competency was met).
- Training attendance and agendas ( evidence that competency was met).
- Test results, certifications, performance evaluations (evidence that actions were effective).