DAVID TREW CONSULTING LIMITED
Clause 8.8 requires:
Laboratories to have and follow a predetermined schedule for performing internal audits. These internal audits intended to confirm:
- The laboratory’s quality systems are appropriate and suitable for the laboratory’s business functions
- The laboratory’s quality systems are compliant with current regulatory requirements and expectations
- The laboratory’s operations are carried out according to its quality systems and standard operating procedures
We can perform internal audits of your laboratory to provide assurance that your laboratory is complying with requirements of you quality management program.
In addition, we can also perform audits of your vendors to confirm they meet your requirements.
However, irrespective of the type, the number of weaknesses or deficiencies that will be discovered during an audit will depend on its comprehensiveness and the time spent on the inspection. In addition, as audits are based on an examination of a sample of documents and activities there can be no guarantee that all non-conformances will be identified and the absence of non-conformances is no evidence that no non-conformances exist.
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