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!