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ISO Accreditation Frequently Asked Questions
Choice The range of FQS- I accreditation customers has expanded from environmental and equine/animal drug testing laboratories to include crime laboratories, forensic DNA testing laboratories, and "police science" units in law enforcement agencies. Value Laboratory Accreditation:
The value of accreditation is clear. Contact us to learn about our programs. Find out if they offer you the best value as a way to acquire the recognition provided by accreditation. Flexibility This flexibility also applies if a testing deficiency is discovered - the accreditation for that specific test at that specific site can be suspended without affecting the other parts of the laboratory that are still in full compliance. Flexibility extends to the accreditation cycle as well. We will discuss with each laboratory the accreditation interval that best suits their needs, provided that it is not less than 2 years and not more than 5, and, in the event that it is more than 2 years, there is sufficient surveillance (which will include at least one on-site surveillance visit).
- Is It Worth the Pain? Is It Worth the Pain? There is a myth that accreditation is one of the “no pain, no gain” areas of life for a testing laboratory. However, pain is not a requirement during the accreditation process. FQS-I accreditation program will assist you in creating an effective quality system that focuses on providing a quality service to your clients. The assessment process should be a positive experience at all times, ultimately accomplishing something of which you can be proud. Sure, during the initial review, there may well be several areas of non-conformance. The assessors should have persuasive, objective evidence that you are not in conformance. They should be able to show you where the problem lies and why it is a non-conformance with the standards. The combination of an experienced, well-trained Lead Assessor and a Technical Assessor team with current best practice knowledge in the test area creates the basis for an effective and fair evaluation.
FQS-I program focuses on the effectiveness of your quality system and the quality of your test results. Non-conformances that do not directly affect the quality of your test results are treated as opportunities for improvement. How Does FQS-I Treat a Problem in One Section of a Laboratory? FQS-I treats individual testing areas in each laboratory separately. ISO accreditation programs, run in compliance with national and international standards for the operation of accrediting bodies, require that the laboratory has a detailed scope of accreditation. For example, the assessment would focus on your fire debris testing, without regard for other testing areas that may also be conducted in your facility. Does Accreditation of an Individual Section Have to Wait Until All Areas are in Compliance? No. For example, if the document and firearms examination sections are ready, but drug chemistry and latent prints are not, the accreditation can proceed in any or all compliant sections. Any restrictions will be declared in the scope, and other sections can be added as soon as they are ready. This can be a very effective way to pursue accreditation as the non-conforming sections can build on the experience of the ones that have met the accreditation standards. Are Results Known When the Team Leaves? Yes. FQS-I's Lead Assessor provides the results of the assessment at the close out meeting. What are the Proficiency Testing Requirements of the FQS-I Program? Apart from complying with the requirements of any applicable community consensus standard for proficiency testing, such as the requirements of the National QA Standards for DNA Testing, all you have to show is an effective proficiency testing (PT) program as part of the way that you control your quality. You have the options of internal programs and voluntary inter-laboratory collaborative trials as well as purchasing from external sources. The use of standards and certified reference materials are considered along with your PT program. Is There Any Reason To Be Afraid of This New ISO Stuff? No reason at all. ISO accreditation has been around for decades and is working effectively in countless testing laboratories in all industrialized countries. If you are using an accrediting body that is experienced in running ISO programs and meets the standards of the National Cooperation for Laboratory Accreditation (NACLA) for accrediting bodies, you have nothing to fear. Is ISO Relevant To the Needs of a Forensic Testing Laboratory? Yes, the program consists of three parts: One part deals with your management system, verifying that you have the systems to do the right thing in the right way. The second part deals with technical matters, addressing quality assurance at the testing, evaluation, and reporting levels. The third area utilizes a set of field specific criteria to illustrate compliance factors in the test area. FQS-I's program uses field criteria based on the international consensus guide for forensic science published by the International Laboratory Accreditation Cooperation (ILAC) (www.ilac.org), as well as any relevant national QA criteria (such as those published by the various Scientific Working Groups (SWG). FQS-I also provides a range of guidelines to assist with specific clauses in the standard. Who Accredits the Accreditors? FQS- I has provided accreditation to the International Organization for Standardization / International Electrotechnical Commission (ISO/IEC) Guide 25 and Standard 17025 for over six (6) years. We are the only provider of accreditation in the forensic science field that is recognized by the National Cooperation for Laboratory Accreditation (NACLA). This was a highly demanding process that spanned more than four years working towards completion. FQS- I 's NACLA recognition assures you that we are doing our job correctly in assessing your testing operations to the requirements of ISO 17025. Very few of the numerous accrediting bodies in the United States have achieved this status and NACLA takes its recognition of accrediting bodies very seriously. There are no short cuts and accrediting bodies are required to demonstrate compliance with all aspects of ISO/IEC 17011 and NACLA's own requirements.
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