The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
On June 1, 2022, the group revised its guidance for auditing competence and published the revised document on its site. Ensuring competency is a critical part of any QMS, but also one of the aspects that organizations struggle the most to understand or truly capture, presenting a continual struggle for all parties during audits, and highlighting a widespread management deficiency.
“Competence is part of the backbone of any organization. The APG paper giving guidelines on auditing “Competence” has been revised to provide an expanded view in relation to competence requirements throughout the entire body of ISO 9001 requirements.”
Of note from the document:
The competence of persons is one of several factors cited that may influence the extent and need for documented information of the quality management system. Not every activity needs to be supported by documented information, because people may be capable of performing their tasks due to a combination of their experience, education, and on-the-job training and the complexity and impact of the activities itself. Therefore, when evaluating “documented information determined by the organization as being necessary for the effectiveness of the quality management system” (ISO 9001:2015, 7.5.1 b)) the auditors need to evaluate the balance between the documented information determined by the organization, the competences of personnel as well as the risks to the intended outcomes of the QMS.
Auditors should keep in mind the definition of competence, which calls for the ability to apply knowledge and skills for an intended result. Therefore, auditors should be careful when raising the findings that documented information is needed, without first considering the influence of the existing competencies of personnel. The need for documented information on required competencies will also vary across different organizations, depending on their complexity, size, the products and services provided, the statutory and regulatory context of their activity (including those related to qualifications) and type of personnel already employed by the organization, as well as the importance of competences for the achievement of objectives.