8.8 Internal Audits (Option A)
The laboratory shall conduct internal audits at planned intervals to ensure conformance to its management system requirements and the requirements of this document.
8.8.1 Internal Audit Objectives
The laboratory shall conduct internal audits at planned intervals to provide information on whether the management system:
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Conforms to:
- The laboratory’s own requirements for its management system, including laboratory activities.
- The requirements of this document.
- Is effectively implemented and maintained.
8.8.2 Internal Audit Requirements
The laboratory shall:
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Plan, establish, implement, and maintain an audit programme including:
- Frequency of audits.
- Methods used for audits.
- Responsibilities for conducting audits.
- Planning requirements.
- Reporting process.
The audit programme shall take into consideration the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits.
- Define the audit criteria and scope for each audit.
- Ensure that the results of the audits are reported to relevant management.
- Implement appropriate correction and corrective actions without undue delay.
- Retain records as evidence of the implementation of the audit programme and the audit results.
Note:
ISO 19011 provides guidance for internal audits.