Many types of laboratories gain accreditation to ISO 17025, some examples of these being: Forensic (DNA, scene-of-crime, fingerprints, fire-arms, toxicology, blood alcohol, etc.); environmental laboratories (water, solid matrices, organic, inorganic, and classical chemistry); pharmaceutical laboratories; food laboratories; material testing laboratories; and health services laboratories.
Regardless of the arena the laboratory works in, the same prerequisites must be established and implemented before accreditation may be obtained. The purpose of this article is to provide laboratories with an overview of a logical sequence towards, and identify the prerequisites required for, accreditation. It is hoped that the “road map” concept will provide a logical journey through the accreditation process.
ISO 17025 (“the Standard”) replaces a number of older standards and guides including ISO/IEC Guide 25 and EN45001. ISO 17025 requires laboratories to address issues that directly affect data quality and technical competence. Section 4 of the Standard addresses the laboratory’s quality system with requirements for activities such as document control, corrective action, and management review. Section 5 of the Standard addresses requirements for activities such as test method validation, personnel competence, traceability of measurement, and measurement uncertainty. Accreditation to this Standard will help enhance your laboratory’s reputation, verify and support data quality, and demonstrate technical capability and expertise.
You are at a cross roads and it is decision time for your laboratory. Whether you want, need, or are required to be accredited, now is the time for action. Business development, survival in a challenging economy, and/or regulatory initiatives may be the driving forces behind your decision. Whatever has brought your laboratory to this point, it is time for the laboratory to move forward on the road to accreditation. Your management has agreed that the accreditation process will go forward but what should you do next?
The path you take will depend, in part, on which Accrediting Body (AB) you choose. It is highly recommended that you research the available ABs to ensure you select one that has a strong program for your proposed scope of accreditation and offers value for money. The AB will provide you with documents, policies, and general requirements, and also details regarding their accreditation process. Needless to say, these documents are critical to ensuring the laboratory develops and implements an ISO 17025 and AB compliant management system. The laboratory will not be accredited unless it meets all requirements, whether they are from the Standard itself or from the ABs policies. One of the sometimes forgotten things the laboratory must do is obtain a copy of the ISO 17025:2005 Standard. There are many on-line sources for purchasing the Standard which are easily identified on the Web. You are now on the road to accreditation!
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.
Two other important activities that must be completed before your on-site assessment are Proficiency Testing (PT) and an internal audit. ABs may have slightly different requirements for what PTs must be performed as well as for reporting. This information is available on your AB’s Web site or talk to them in person if you are not sure what your obligations are. The AB can provide you with a list of approved PT providers and advise what you need to do if commercial PT schemes are not available for tests on your scope. The PTs will challenge the analytical method and analyst and demonstrates that the laboratory can do what it says it can do. An internal audit of the entire management system helps you to identify potential problems in the management system and give you the opportunity to correct the issues before the on-site assessment takes place.
Your on-site assessment is over and you now have non-conformances (NCR) to resolve. Some laboratory managers are concerned about the number of NCRs written during the on-site assessment. It is not true that “good” laboratories get few NCRs and “bad” laboratories get many. Do not play the numbers game, just approach the NCRs logically and calmly and process them through your corrective action process. What is significant is how you react to the NCRs. It is sometimes hard to accept what is perceived as criticism for a system that you have labored long and hard over. Remember, the aim of the entire process you have embarked upon is to implement a compliant management system. Your AB will also review the root cause analysis performed as well as the corrective actions implemented. The laboratory must, therefore, ensure that in-depth root cause analysis is performed, asking “why” until you cannot ask this question anymore for each NCR.
Congratulations, you have successfully attained accreditation! You have done the hard work and deserve your success. Now all that remains is for the laboratory to continue to use and improve the management system and move on to bigger and better things.
Dorothy E. Gill BS, BA, MS, is an experienced chemist and quality assurance professional. She has experience in forensic science, toxicology, drug analysis, environmental chemistry, and disposal of radioactive hazardous waste. Ms. Gill has performed many ISO 17025 audits and has, as a consultant, assisted laboratories prepare for accreditation. Generation of QA manuals and SOPs and performing internal audits and gap analyses are also examples of Ms Gill’s consulting services. As an independent consultant Ms. Gill can help you prepare for a successful accreditation process. Ms. Gill is an American Society for Quality Certified Quality Auditor (ASQ CQA) and a Registrar Accreditation Board Quality Management System Auditor (RAB QMSA). firstname.lastname@example.org; www.lcvcompany.com