The questions being asked will depend on the nature of the tests being performed.
Iso 9001 certification checklist iso#
Laboratory Processīecause these questions are based on the guidelines of ISO 9001, an auditor can have a set of questions which are based on a laboratory’s specialized functions. The table below gives examples, based on a sequence of laboratory activities, which show how an auditor can use an audit checklist to verify the lab’s different activities. If there is defined criteria for retention of records, then an auditor can check the records based on the criteria in the process documentation. For more information, see the article ISO 9001 Audit Checklist to get more advice which can help with your audit preparation. If there are certain requirements for process operations defined in the laboratory’s documented procedures, then the questions related to those requirements can be asked through audit checklists during an audit. There are a few constituents mentioned below that should be incorporated in an ISO 9001 Laboratory audit checklist:ġ) Risks and opportunities related to laboratory operations (if applicable)Ģ) Objectives and targets of the laboratory and planning to achieve them (if applicable)ģ) Resource requirements and their provision to perform laboratory operations (manpower and machinery)Ĥ) Competence of personnel performing test analysesĥ) Fitness records for testing equipment (Calibration records)Ħ) Documentation maintained for laboratory processesħ) Sample-taking criteria, retained information and classification of samples and their identificationĩ) Control of non-conforming test results They can include documentation of test procedures, competence of personnel performing tests, fitness of testing equipment, environment in which tests are being performed, measurement traceability of test results, and input/output criteria for performing test analysis. In performing these five basic operations, there are several things that need to be taken care of to produce effective test results. Whichever criteria is being followed in any laboratory, certain process flow steps are followed:ģ) Preparation for testing (conditioning, apparatus preparation or other pre-requisites)
Generally, laboratories are based on two working principles: either they work in any organization to perform tests and analysis on certain products, production processes or operations, or the laboratories work independently as a third party to perform tests and analysis on provided samples from clients/customers. Now, when it comes to auditing a laboratory process, there are certain requirements which an auditor should consider while preparing the audit checklist.
Considering the requirements for ISO 9001 standard, an audit checklist is a tool consisting of questions taken from the quality management system requirements, work performance criteria of the process and the documentation generated for the process that is going to be audited. An audit checklist is a key element for conducting or planning for a process audit.
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