Quality systems accreditation

Accreditation to ISO/IEC 17025 or GLP is becoming a standard approach to creating a quality system (chapter 9). Note that accreditation, as such, is not part of the VAM principles, but it is one of alternative quality systems (see chapter 1). Like any quality system, accreditation only fulfills its purpose if implemented properly. Some laboratories have done the minimum to achieve accreditation, and then take the view that having paid for their accreditation payment of the annual fee will then suffice. This practice is evidenced when accredited laboratories perform no better in testing rounds than experienced laboratories without accreditation (see chapter 5). 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

This would check the certification status of the quality system, verifying that any certification was properly accredited. For non-ISO 9000 registered subcontractors, a quality system assessment may be carried out at this stage either to ISO 9000 or the customer s standards. 

Laboratory Accreditation and Quality Systems" Together these make laboratory managers look for added security in assuring data quality and thus invoke a desire in them to fall back on the best available standard. The result is that a CRM is often used instead of a working standard. This is a tendency that is supported and encouraged by some RM providers but discouraged by others. 

In large laboratories, where dozens or even hundreds of different types of analyses are carried out, an additional internal process to test the quality system is particularly important. An external assessment team can only hope to observe and assess in detail a relatively small number of the analyses during each visit, so there may be years between any one of a laboratory s externally assessed analyses being re-examined in detail. Laboratories may not have entered all of the analyses that they carry out in their scope of external accreditation. If they wish to ensure quality is maintained in these other areas of their work, an internal... 

Section 1 Formal quality system in the laboratory if third party assessed (i.e. if UKAS accredited or GLP compliant)... 

The AALA accreditation is also based on the ISO/IEC Guide 25. This accreditation indicates that a laboratory has demonstrated that it is competent to perform specific tests or specific types of tests that its quality system addresses and conforms to all elements of the Guide 25 and is fully operational and that it conforms to any additional requirements of AALA or specific fields of testing or programs necessary to meet particular user needs. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

Figure 9.1. Relationships between the international conformity in trade system and quality systems including accreditation. (Adapted from a document of European Accreditation, accessed from www.european-accreditation.org, October 2004.)...

A specification agreed with a supplier is not a guarantee that all deliveries will fully comply with it and arrive in full and on time. A Certificate of Analysis adds confidence and if the supplier is accredited to the ISO 9000 series or a national equivalent it shows that the quality systems have been independently audited and found to be acceptable. However, there is no substitute for regular performance reviews, backed up as appropriate by audits of the manufacturing facilities and quality systems (including incoming raw materials). This is a very onerous and time-consuming exercise, well beyond the resources of most soft drink manufacturers. 

Laboratories accredited by the DOD branches usually have better quality systems than the laboratories that work for private industry clients only. 

Because the NELAC standards are general, they require interpretation or clarification in certain areas of application. That is why the US DOD undertook a task of specifying some of these broad areas in definite terms in a manual that unifies laboratory requirements of the Navy, Air Force, and United States Army Corps of Engineers (DOD, 2000). This manual, titled Department of Defense Quality Systems Manual for Environmental Laboratories, is offered to the DOD representatives and contractors who design, implement, and oversee contracts with environmental laboratories. Currently, the three DOD branches implement their own laboratory accreditation programs with some reciprocity between the three a task force has been created to combine these programs into a single DOD accreditation process. 

O Malley C. 1997. Quality measurement for health systems Accreditation and report cards. Am J Health-Syst Pharm 54 1528. 

Traceability and uncertainty of measurement results are basic technical elements of quality systems in analytical laboratories whose competence is recognized by accreditation according to ISO/IEC 17025 [24]. However, GLP and GMP standards widely used since the 1960s for the... 

The initial procedures for the conduct of official OPCW proficiency tests have been developed by the Special Task Force on Analytical Issues in the period 1994 to 1996, and subsequently recommended for adoption through Working Group B to the Conference of States Parties the respective procedures were adopted by the First Conference of States Parties in May 1997 (5). The evaluation criteria have been further developed since, through consultation with participants in the proficiency-testing scheme. These consultations were often initiated by practical problems posed during individual proficiency tests. The numerous amended documents have recently been compiled into three comprehensive quality system documents that describe the process of the OPCW proficiency test, which has been accredited by the Dutch accreditation body in 2001 ... 

The evaluation is performed in accordance with the evaluation criteria specified in the quality system document QDOC/LAB/WI/PRO003 (8) Reported spiking chemicals that meet the criteria are accredited with +1 points, whereas spiking chemicals that do not (fully) meet the criteria, for any reason, are penalized with — 1 points. The latter penalty is also used for false negative results. 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

Before the designation, the laboratories developed their laboratory methods for testing, constructed and made operational their laboratory quality system and obtained its accreditation, and continued the participation and successful performance in the OPCW proficiency tests (PT). Analytical methods in particular and a certain level of quality assurance systems have existed in the laboratories, involved often in research, well before their designation. Participation in the international interlaboratory... 

Operating accredited quality system is beneficial to the laboratory in the following ways ... 

The Quality System is under continuous development because of regular internal audits, annual audits made by the accreditation body, and other improvement actions... 

Agency, 2006). The scheme provides a framework within which environmental measurements can be made in accordance with the Agency s quality requirements and this includes documentation of the sampling and analytical procedures. Internationally, laboratories use the ISO/IEC 17025 Standard (British Standards, 2005) to implement a quality system aimed at improving their ability to produce valid results consistently. As the Standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. 

In early days IMEP became internationally known because it was one of the few ILCs that was not based on consensus values derived from participants results. Contrary to common belief, the results of the various IMEP comparisons showed an unexpected large spread of participants results even for simple measurements, far from the laboratories own quoted standards of accuracy. To learn more about the origin of this spread, participants in IMEP were also asked to bll in a questionnaire. The questions gather information on the methodological approach, the establishment of traceability via the use of CRMs and the evaluation of uncertainty, the experience of the analyst, the self-declared status of accreditation, and the quality system. Based on general information about the laboratory (e.g., country of origin) and the answers given in the questionnaire, the results obtained... 

An assessment is always an external examination carried out by a laboratory accreditation body such as UKAS (see Section 5.2). It includes all of the elements of an audit, i.e. an in depth check that the quality system as documented is implemented and in operation. In addition, it involves a technical assessment of the laboratory to confirm that staff are qualified and competent and that the procedures being used for testing are fit for the intended purpose and able to achieve the level of performance claimed by the laboratory. 

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