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Laboratory accreditation process for internal audit

Jul 28, 2018

Laboratory accreditation generally requires internal audit before conducting management review and on-site review. Are many small partners not aware of it? Then let Xiaobian explain it to you. The general order of internal audits can be divided into several phases, namely:


1. Internal audit investigation

The audit team shall arrive at the audit site on time and convene a formal first meeting to explain the purpose, scope, basis and method of the audit. If it is an additional review and only one department or a clause is reviewed, this first meeting can be simplified as appropriate.

On-site audits should be based on facts, based on criteria or system documents, collect objective evidence, and record audit findings in detail.

2. Internal audit planning:

a) The quality person in charge shall formulate the annual internal audit plan for the current year at the beginning of each year or the internal audit plan for the next year at the end of the year; if it is a routine review, it shall be carried out according to the annual internal audit plan; if it is an additional review, it shall Clear purpose and subject or terms of the trial. Each review must also clearly identify the basis for the review and the status, terms, or related testing activities for the review.

b) The head of the audit will be designated by the person in charge of quality, and the team leader and the person in charge of quality will select and determine the members of the audit team and form an audit team.

c) The audit team leader should prepare a specific audit plan schedule and assign audit tasks to each audit team member.

d) Each auditor shall prepare a checklist and implement it after approval by the team leader. At the same time, the whole group should focus on relevant documents (such as standards, manuals, relevant procedures, work instructions, etc.) for review.

e) The audit department should be notified as soon as possible after the audit plan schedule is determined.

f) Conduct communication before the audit, communicate with the audited department, and obtain the consent of the audited department; the internal communication of the audit team, including review preparation, discussion of difficult problems, and matters needing attention.

3. Internal audit report

The audit team leader prepares an audit report according to the specified format based on the internal audit results and findings. This report is officially issued to the department under review after being examined and approved by the quality person in charge.

4 Before the management review meeting, the quality responsible person shall compile a comprehensive quality summary report based on the audit report, and analyze and evaluate the effectiveness of the entire system; and compare the results with the last internal audit to evaluate its progress; At the same time, a summary analysis of the implementation of corrective measures throughout the year. The quality summary report should be reported to the top management of the laboratory as one of the inputs to the management review.

5. Internal audit analysis

Internal auditors should analyze the findings and identify non-conformities. The non-conformance report should be filled in according to the regulations, and the department/person of the trial is required to recognize the facts (signature).

If necessary, convene an internal audit team meeting at the end of the day's review.

The on-site audit ends with the last meeting. At the last meeting, the audit team shall report the results of the audit, read out the non-conformance report, and clarify the rectification requirements.

The form of internal audit may include reviewing the system documentation of the laboratory, checking whether it meets the requirements, arranging on-site experiments, and checking whether the operation of the inspector meets the requirements of the testing standards and corresponding work instructions.

6. A comprehensive analysis of the preparation of the audit report and a summary analysis of the completion of the corrective action plan.

7. Tracking of corrective actions

The audit team tracks and validates the implementation of the corrective action plan.

Each of the above steps should be clearly defined in the internal audit procedures. The internal audit process should be based on the actual situation of each organization, but the content of these main steps is not missing.