ISO 9001 Clause 7.2 - Competence
This clause requires the organisation to determine and provide the competence of people whose work affects QMS performance, with documented evidence retained.
What Does ISO 9001 Clause 7.2 Require?
Clause 7.2 of ISO 9001:2015 requires organisations to determine the competence needed by people doing work that affects QMS performance and product or service quality, to ensure that those people are competent based on appropriate education, training or experience, and to retain documented information as evidence of that competence.
Where gaps are identified - people doing work without the necessary competence - the organisation must take action to address those gaps and then evaluate whether the actions taken have been effective.
What Counts as Competence?
Competence under Clause 7.2 means having the ability to do the work to the required standard, based on a combination of education, training and experience. The standard does not require formal qualifications for every role - experience and on-the-job training can satisfy the requirement where they are appropriate and documented.
The clause applies to anyone whose work affects quality - which in most organisations means the majority of the workforce. The practical focus is on ensuring that the competence required for each role has been identified, that the people in those roles meet the requirement, and that the organisation has records to demonstrate this.
How to Document Competence
The most common approach is a training and competency matrix - a record showing the competence requirements for each role and the current status of each person against those requirements. This gives an immediate overview of where gaps exist and provides the documented evidence required by the standard.
Supporting records typically include training certificates, induction records, annual review notes, and records of any training undertaken to address identified gaps. The standard does not require a specific format - the test is whether there is sufficient evidence to demonstrate that people are competent to do their work.
Competence is one of the areas where I'll speak to people directly during an audit rather than just reviewing documents. I'll check that training records are complete and current, but I'll also ask staff about how they were trained for their role, what they would do if they weren't sure how to do something, and whether there are any training needs that haven't been addressed. A competency matrix that is up to date and actively used gives me confidence. A stack of training certificates with no record of who holds what qualification tells me the competence management is there on paper but not in practice.
Managing competence is of course important, as it can impact on the quality of products and services offered by the organisation. Many specialist firms require employees with degrees to work there, other companies require every new employee to complete internal training according to their own handbooks, there are various competency requirements depending on the company and its activities.
Clause 7.2 is essentially asking you to know that your people can do their jobs and have a record to show it. A training matrix showing who has done what, combined with copies of any relevant certificates, covers most of what is needed. Where someone is new to a role, an induction record and a note of when they'll be signed off as competent addresses the gap. Keep the records current and this clause takes care of itself.
Practical Compliance Guidance
To comply with Clause 7.2, the organisation needs defined competence requirements for quality-relevant roles, a system for recording current competence against those requirements, and documented evidence of the training and qualifications held by each person.
The alphaZ documents below provide a complete framework for managing and evidencing competence under Clause 7.2.
| alphaZ document | How it supports Clause 7.2 |
|---|---|
| ISO 9001 Management System Toolkit | The complete toolkit for implementing an ISO 9001 compliant management system. Includes the competency matrix, induction record and all supporting documents. |
| ER2 Staff Training and Competency Matrix | The primary tool for recording and managing workforce competence. Shows required competencies by role and current status for each person, identifying gaps and providing an overview for auditors. |
| F-Q4 Staff Induction Record | Documents the induction process for new starters, providing evidence that they have been introduced to the QMS, the quality policy, their responsibilities and any role-specific requirements. |
| F-Q6 Staff Annual Review Form | Provides a structured annual review that captures competence assessments, identifies development needs, and links to training planning - supporting the ongoing management of competence. |
Note - all the above files can be downloaded with an alphaZ subscription
