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Laboratory Accreditation: Making Conformance Count

  • What is Accreditation?
  • Who makes it work?
  • How is it controlled?
  • Why do it?
  • Where do I get more information?

What is laboratory accreditation?
The international standard for competence in laboratories is ISO 17025.

Accreditation to this standard allows for mutual recognition of data generated by laboratories worldwide. For such a holistic approach to work, all laboratories must operate within the same set of guidelines.

ISO 17025 is written in such a way as to allow this to happen without undue proscription on business practice within the organizations to which the individual laboratories belong. It is, in essence, an over-arching statement of intent implemented by documented processes through validated methodology supported by record-keeping and audit.

This process driven approach is a move away from previous compliance based systems.

Who makes it work?
It is the responsibility of each laboratory to write and implement a quality system according to the principles detailed in ISO 17025.

To avoid divergence as a result of over flexibility in the inter-laboratory interpretation of the standard, external inspections are required. These inspections take the form an initial assessment and award, followed by surveillance assessments to monitor on-going conformance and the cycle is closed by a further certification assessment on a rotating basis.

The assessments are rigorous documentation reviews coupled to witnessed reviews of work taking place but can only be a snap-shot of the entire laboratory operation at the time of the visit. It is essential therefore that there is a commitment at the highest level within the applicant organization to adhere to the spirit of the standard at all other times.

The recommendation for award of accreditation to the standard will require the satisfactory resolution of any non-conformances raised at any and all of the visits. The scope and timescale of resolution will be discussed, recorded and agreed at the time of the assessment visits.

How is it controlled?
The standard ISO 17025 is controlled by the International Organization for Standards (ISO).

At a national level, awards of accreditation to this standard are controlled by various certification bodies, e.g. L.A.B and NVLAP in the USA, in Europe, UKAS and RvP.

Certification bodies are empowered by national accreditation bodies, usually government agencies, (who may also be certification bodies). Mutual recognition agreements exist to allow for international co-operation.

In the USA, NACLA assess and recognizes certification bodies. In the UK, UKAS performs the same task. Most national accreditation bodies are signatories to the ILAC (International Laboratory Accreditation Co-operation). Which leads us neatly back to ISO.

Why do it?
Valid analytical measurement is the goal of all laboratories large or small.

The competent operation and confident reporting indicated by accreditation to ISO 17025 allows client relationships to flourish without doubt and uncertainty to muddy the waters.

The standard almost demands communication both within the laboratory and outside of it. The resultant clarity facilitates operations and, properly harnessed, will improve the development of the laboratory as a business with the concomitant budgetary advantages.

At the beginning of the last century, the UK government linked the value of the Sterling currency to the price of gold. The so called 'gold-standard' was eventually adopted by all the major currencies around the world. With the eventual inclusion of the US dollar, this precipitated previously unimagined economic growth through stable international trade.

ISO 17025 allows the mutual recognition of data between accredited laboratories worldwide. The certificates of analysis generated by these laboratories and the goods they support will facilitate international trade. As the world wakes up to emerging economies ISO 17025 is the system that will allow the world to sleep easier at night.


Where do I get more information?
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