A bitesize guide to ISO 17025

An international standard for testing and calibration laboratories, ISO 17025 is a set of requirements that laboratories need to show so that their quality management system is of a high standard. Essentially, this ISO showcases a laboratory’s technical competence when it comes to the work that they deliver. But what is involved in ISO 17025?

 

 

The 5 clauses of ISO 17025

ISO 17025 is set out over five clauses, the first of which concerns scope. This section contains a clear, concise statement on everything that your laboratory delivers in terms of its services and for which of these it seeks certification. For example, a testing laboratory will set out its specific methods for testing and so on.

Secondly is normative values and third is a list of terms and definitions that will be used in the two main clauses which are management requirements and technical requirements.

Management requirements

This section is split into 15 sub-clauses all of which will need completing before the certification can be successfully awarded.

As an example, you will need to collate policies and procedures that relate to correction actions and preventative actions. Likewise, you will need to show procedures and policies for controlling records, how internal audits are completed and how complaints are dealt with.

The clause begins by listing your legal status, what facilities you have and how confidential information is handled. You’ll also need to supply a clear visual management structure, effectively showing how staff are appointed and managed.

This clause covers, as you would expect, all the documents that relate to how you not only run your organisation but specifically how the integrity of your laboratory is also run. Showing your commitment to continual improvement of testing, technology and your staff also underpins this clause.

Technical requirements

As a laboratory, you will understand the need for every test and calibration to be done with integrity – and that means being clear on the processes being used (and why), and what factors could affect the results.

This clause is split into ten sub-sections and covers general factors, as well as personnel and how laboratory staff are properly skilled and qualified. It also examines policies and procedures for accommodation and environmental conditions, testing and calibration methods, equipment used and measurement traceability.

Policies and procedures for sampling and handling tests are also included in this clause, along with ensuring test results are reported clearly and objectively.

An important certification for any laboratory testing facility

Every laboratory rises and falls on the integrity of the work and results it produces. Your clients rely on you ‘getting it right’. They need to have the confidence that you are aware and proactive in working towards objective, unbiased testing that produces results on which they can make solid decisions.

It’s a competitive field, and that means you want to stand out from your competitors but also showcase just how trustworthy your testing facility is. ISO 17025 goes a long way in doing just that.

How can we help you?

If you’re in need of assistance with any aspect of ISO certification, here at Synergos we’d be delighted to help. Whether you have questions about the path to certification or are looking for advice and support to maintain an existing standard call 01484 666160 or email info@synergosconsultancy.co.uk and we’ll be happy to talk it over with you

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