The ISO 17025 Quality Manual serves to document the overall Lab Quality Management System, providing a way to reference and link all the requirements together in one place. For example, the Internal Auditing process and programme must be reviewed to include technical audits. Evidence must be available to demonstrate the effective implementation and maintenance as relates to the laboratory competency. Unless the ISO 9001 was implemented upfront with ISO 17025 in mind, revision of activities and documentation will be required. This would require a gap evaluation to determine to what extent this is met. This means that ISO 17025 requirements must be met in the way that the processes were established, how they are performed, documented and controlled. To answer your question - No, don’t delete section 8.2 to 8.9.Īs your organisation is ISO 9001:2015 certified when you implement ISO 17025:2017, Option B provides for the following arrangement - Your laboratory can use your already established ISO 9001:2015 quality management system to demonstrate compliance with the requirements for ISO 17025 clauses 8.2 to 8.9 ifit was established to include laboratory activities and ifit has been maintained in a manner that supports and demonstrates the consistent fulfilment of Clauses 4 to 7.
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