Many laboratories have little or no exposure to ISO 17025 and are not able to generate a logical and robust approach to achieving accreditation. There are basically two ways to go. First, you can try to do this on your own. You may think attending a training course for ISO 17025 will enable you to understand the requirements. However, the knowledge gained during a typical training course is not usually sufficient for generating and implementing a compliant quality system. This is not the trainers fault; most training courses are excellent but it is hard for you to learn all you need to know in a few days. It is advantageous for everyone to have some type of formal training in ISO 17025, but it would be hard for a laboratory to distill sufficient understanding from a few days training to develop and implement a compliant quality system. If this is your chosen route, it is strongly recommended that you have, at a minimum, your management system documents, including your Quality Assurance (QA) manual, reviewed by a person experienced in ISO 17025 compliant systems before the on-site accreditation visit.
Second, you can engage an experienced and knowledgeable consultant who will be able to provide many services, all directed toward successful accreditation for your laboratory. The consultant will assist you in developing a clear, complete, and concise proposed scope of accreditation. The accreditation scope will influence the type of management system developed by the laboratory and so must be developed before system documents are written. I know you may think you are now ready to go but, before you do start generating management system documents, it is recommended that you have your consultant perform a gap analysis. This will determine the compliance status of the laboratory and identify what systems and documents need to be developed. It is only after this stage that you should start to generate management system documents, processes, and procedures.
The first document to generate is the laboratory’s Quality Assurance (QA) manual. The manual contains the laboratory policies from which management system Standard Operating Procedures (SOP) are developed. For a technical laboratory, section 4 of ISO 17025 often presents the main challenge to achieving compliance. Every staff member in the laboratory will eventually have to work within the management system so it is never too early to get them involved in, at a minimum, training in ISO 17025 requirements. Generation of compliant documents takes time; do not try to rush through this. You will be repaid for the time spent during this phase of the process; it is always easier and quicker to do something correctly the first time than try to fix problems that you may have created.
It may be self-evident to most of you but you must write your QA manual and implementing SOPs so that they are compliant with ISO 17025, regulatory/statutory and your chosen AB’s requirements. There are many ways to achieve this but what you write must be reviewed, revised, and then re-reviewed. It is unlikely that you will get everything correct the first time around so keep going until you are confident that you have correctly translated QA policy requirements into SOPs and that SOPs contain sufficient operational detail for successful implementation. Your AB will provide you with review comments for, at a minimum, your QA manual so that these issues may also be resolved before the on-site accreditation assessment. A word of caution, it is possible that non-conformances (NCR) identified during the accreditation assessment will require revision of your QA manual and/or SOPs. It is often wise not to issue a new revision of a document based on review comments; waiting until you are in the corrective phase of the accreditation process will ensure that you only have to do one revision to the document. Having revisions in draft form to show the auditors is always a good thing.