ISO 9001 Clause 9.2 focuses on the internal audit process within the quality management system (QMS). More specifically, Clause 9.2.1 outlines the requirement for an organization to conduct internal audits at planned intervals (checking the QMS) and clause 9.2.2 focuses on the criteria for planning, establishing, implementing, and maintaining an audit program.
Clause 9.2.1 Explained
Purpose of Internal Audits: The primary purpose of internal audits is to provide information about the effectiveness of the Quality Management System (QMS) in meeting certain criteria.
Conformance to Requirements: The internal audits aim to determine whether the QMS conforms to two sets of requirements:
Organization's Requirements: This refers to the internal standards, policies, and procedures set by the organization for its own QMS.
ISO 9001 Requirements: This refers to the requirements outlined in the ISO 9001:2015 standard.
Effective Implementation and Maintenance: The audits are not just about meeting the criteria but also about evaluating whether the QMS is effectively implemented and maintained. This involves assessing how well the documented processes are being followed in practice and whether the processes are achiving the planned, determined, or expected results.
Clause 9.2.2 Explained
General: The organization shall plan, establish, implement, and maintain an audit program. This program should be based on the organization's quality management system and should take into account the importance of the processes concerned, changes affecting the organization, and the results of previous audits.
Audit Criteria, Scope, Frequency, and Methods: The audit program should define the criteria and scope for each audit, as well as the frequency and methods. These methods include techniques for ensuring objectivity and impartiality of the audit process.
Audit Objectives: The objectives of the audits should be established, and they should include the determination of the extent to which the quality management system conforms to planned arrangements, to the requirements of ISO 9001, and to the requirements of the organization.
Selection of Auditors: The organization should select auditors and conduct audits to ensure objectivity and impartiality of the audit process. Auditors should not audit their work.
Audit Criteria: Auditors should consider the process effectiveness mentioned in clause 9.2.1 above and the effectiveness of the quality management system in achieving the organization's quality objectives.
Audit Evidence: Auditors should collect and report objective, verifiable factual information, as audit evidence that is relevant to the audit criteria.
Audit Records: Records of the audit program and the results of audits (audit report of audit findings) should be maintained.
Clause 9.2 Example Manufacturing Company
Audit Program: The company establishes an annual audit program that covers critical processes such as production, quality control, and supplier management. The program specifies the frequency of audits and the methods used.
Audit Objectives: The audit objectives include assessing the conformance of the production process to planned arrangements, ISO 9001 requirements, and the company's quality objectives.
Selection of Auditors: Trained auditors from different departments are selected to ensure objectivity. The auditor responsible for the production process is not allowed to audit their own department.
Audit Criteria: The audit criteria include process effectiveness, adherence to ISO 9001 requirements, and achievement of quality objectives.
Audit Evidence: Auditors collect evidence through interviews, observations, and review of documents to verify conformance.
Audit Records: Comprehensive records of the audit program, including planning, results, and corrective actions, are maintained for review and improvement.
ISO 9001:2015 Clause 9.2 Internal Audit
Internal audits are a crucial element for ensuring the effectiveness of the QMS, identifying areas for improvement, and maintaining compliance with ISO 9001 and organizational requirements. Clause 9.2.1 emphasizes the importance of a systematic and well-planned approach to internal audits, ensuring that they contribute to the continual improvement of the quality management system.