We received these questions:
1. We are initiating to get accreditation for ISO 17025:2017 for our laboratory, we are pharmaceutical company having all the related SOP's for ISO 9001:2015, etc. All the required SOP's related to laboratory working including testing procedure, calibration/qualification of equipment, validation of methods/qualification of personnel working in lab for their competency.etc. what you suggest we can get it done easily ?
Answer: This is a good question, as it is important to structure your documentation correctly, to make the process easier. The ISO/IEC 17025:2017 Documentation Toolkit will help you achieve this. The Diagram of ISO 17025:2017 Implementation Process provides the steps for you to follow for implementation and accreditation. As guided by the Toolkit, you will start by documenting the Quality Policy and Quality Objectives of your laboratory. The Project Plan for Implementation provides clear direction for you to specify individual project objectives, and plan what documents will be written by when. Knowing the ISO 17025 mandatory requirements and evaluating the risks and opportunities for the laboratory’s processes and procedures will help you focus and keep the documentation to the necessary minimum. You can incorporate all the existing ISO 9001:2015 SOP’s into your ISO 17025 quality management system. Make sure these are revised, if necessary, to include all ISO 17025 activities.
2. Is it required to get accreditation for each testing method perform in the lab? or just need to prove that we are working as a competent lab as all the tests performed under the required environment using qualified equipment by competent personnel.
Answer: Unless required by regulators or legislation, you do not need to include all your test methods. In fact, this is an important decision which must be made early on, as indicated in the Diagram of ISO 17025:2017 Implementation Process (Determine the Scope). The choice of tests will be driven by regulator, customer or market need. Many laboratories become accredited initially, with only a few test methods. You can always extend the scope later. It is important to be clear, however, that general claims of technical competency are not allowed. A laboratory can only claim that they are accredited to provide results using those methods or techniques listed on the accreditation certificate.
The following articles will provide more information:
The links to the ISO 17025 Toolkit material are: