Auditing ISO 9001:2015 Clause 7.2 – Competence requires assessing how an
organization determines, manages, and maintains the necessary competence of
personnel performing work that affects the quality management system (QMS). The
competence clause is crucial because it ensures that individuals have the skills,
knowledge, and experience required to fulfill their roles effectively and contribute to the
achievement of product and service quality.
1. Audit Objective
The objective of auditing ISO 9001:2015 Clause 7.2 is to ensure that:
The organization identifies the necessary competence for roles affecting the QMS.
Competence requirements are met through appropriate training, education, skills,
and experience.
The organization has implemented processes to evaluate, maintain, and improve
competence.
2. Audit Scope
The audit will cover:
How the organization identifies required competencies for different roles.
Methods for acquiring and maintaining competence (e.g., training, education,
experience).
Procedures for evaluating the effectiveness of competence-building activities.
Records of competence and training, as well as evidence of meeting competency
requirements.
3. Audit Criteria
The audit will assess compliance with the following:
ISO 9001:2015 Clause 7.2 – Competence
The organization’s internal policies and procedures related to competence,
training, and employee development.
Any customer-specific or regulatory requirements related to personnel
competence.
4. Audit Checklist for Clause 7.2: Competence
4.1 Identification of Required Competence
Q: Has the organization identified the necessary competence for personnel
performing tasks that affect product or service quality?
Evidence: Review job descriptions, competence matrices, or skills
assessments.
o Key Points:
Verify that job descriptions clearly define required qualifications,
skills, and experience.
Check if the organization maintains a competence matrix linking
roles with required competencies.
4.2 Determining Competence
Q: How does the organization determine the current competence level of
employees?
Evidence: Review skills assessments, evaluations, and performance
appraisals.
Key Points:
Determine how the organization assesses new hires to ensure they
meet competency requirements.
Evaluate whether employees undergo periodic performance
reviews to assess their competence for their current roles.
4.3 Competence Development (Training, Education, and Experience)
Q: What methods does the organization use to develop competence (e.g.,
training programs, education, on-the-job training)?
Evidence: Review training records, schedules, and competency
development plans.
Key Points:
Check if the organization offers training that is directly relevant to the identified competence gaps.
Evaluate the use of internal/external training programs, on-the-job
training, mentoring, or professional certifications.
4.4 Evaluation of Training Effectiveness
Q: How does the organization evaluate the effectiveness of training and other
competence-building activities?
Evidence: Review post-training evaluations, feedback forms, and results of competence assessments.
Key Points:
Ensure that the organization collects feedback from employees
after training sessions.
Verify that there are follow-up actions or assessments to measure how training has improved competence (e.g., on-the-job
performance, certification tests).
4.5 Competence Records
Q: Are there adequate records to demonstrate the competence of employees, and are these records maintained and up to date?
Evidence: Review personnel files, competence matrices, training records, certifications.
Key Points:
Check if the organization retains training and competence records
for all relevant employees.
Verify that certifications, licenses, and qualifications are current and
valid.
4.6 Addressing Competence Gaps
Q: What actions are taken if an employee is found to lack the necessary competence?
Evidence: Review records of corrective actions, additional training, or reassignments.
Key Points:
Confirm that the organization has a process in place to identify
competence gaps (through appraisals, performance reviews, or nonconformity records).
Evaluate how the organization responds to competence gaps,
including additional training, reassignment, or recruitment.
4.7 Competence for Specialized Roles
Q: How does the organization ensure the competence of personnel in specialized
roles (e.g., auditors, inspectors, welders)?
Evidence: Review records of certifications, qualifications, and training
specific to specialized functions.
Key Points:
Check that the organization has a clear definition of required
certifications and experience for specialized roles.
Verify that employees in specialized roles have current
qualifications and meet industry-specific or regulatory requirements.
5. Audit Execution Steps
5.1 Opening Meeting
Meet with HR, department heads, and the quality management team to clarify the
audit objectives and scope.
Explain the importance of competence in achieving quality objectives.
5.2 Document Review
Competence Matrices: Review competence matrices to ensure each role has clearly defined skills and qualifications.
Job Descriptions: Review job descriptions for clarity in specifying required
competence for key roles.
Training Records: Examine records of training provided, including attendance,
completion, and assessment results.
Performance Reviews: Check how employee performance is evaluated and
linked to competence requirements.
Training Plans: Review training schedules and plans to verify that training needs
have been identified and addressed.
5.3 Interviews
HR Department: Ask how competence requirements are identified and
managed, and how training needs are assessed.
Department Managers: Discuss how they ensure that their team members are
competent and how they assess this competence regularly.
Employees: Interview a few employees to verify if they understand their required
competencies and how they have been developed through training or
experience.
5.4 Process Walkthrough
Observe any training activities or on-the-job coaching to ensure they align with
the organization’s methods of competence development.
Assess how competency gaps are addressed in practice, and if any corrective
actions are being applied when gaps are identified.
5.5 Verification of Competence
Review a sample of competence records for key personnel to verify compliance.
Check for evidence that the organization evaluates training effectiveness (e.g.,
post-training tests, job performance improvement).
6. Reporting Audit Findings
Nonconformities
Identify nonconformances where competence requirements are not defined,
competence evaluations are not performed, or training records are incomplete.
Example: A critical employee was performing tasks without the necessary
qualifications or training records to support competence.
Opportunities for Improvement
Highlight areas where the competence evaluation process could be enhanced.
Example: The organization could implement a more structured post-training evaluation process to ensure training effectiveness is assessed.
Positive Findings
Document strengths in the organization’s competence management.
Example: The organization has a comprehensive training program that includes regular updates on industry regulations.
Corrective Actions
Recommend corrective actions for any competence gaps or inadequacies identified.
Example: If training records are outdated, recommend the implementation of an automated system to ensure records are updated and accessible.
Closing Meeting
Present the audit findings to management and HR, discussing any nonconformances, opportunities for improvement, and positive observations.
Agree on timelines for corrective actions and any necessary follow-up audits.
7. Follow-Up
Ensure that any nonconformances related to competence are addressed through
corrective actions.
Schedule a follow-up audit or review to verify the effectiveness of corrective
actions, especially if competence gaps were identified during the audit.
Key Records to Examine During Competence Audits
1. Competence Matrices
2. Job Descriptions
3. Training Plans and Schedules
4. Training Attendance and Completion Records
5. Skills Assessments
6. Post-Training Evaluations
7. Certification and Licensing Records