To accreditate or certificate?

It has been a little over a year since the revised laboratory accreditation standard ISO/IEC 17025:2005 came into effect. However, confusion still exists over the differences between accreditation and certification

Both Laboratory accreditation and certification address the issue of quality management systems. The recent publication of a UKAS Guide to Calibration Services emphasises the fact that this continues to be an issue for many laboratories.

If you don’t know the difference between an accredited laboratory and a certified laboratory, you are not alone. Confusion is widespread throughout the UK and abroad and even exists within laboratories themselves.

As the sole national accreditation body recognised by the Government, UKAS (the United Kingdom Accreditation Service) can count some 1500 laboratories and over 120 certification bodies amongst its customers. As UKAS also represents the UK Government on accreditation in the international arena it is in a fairly unique position to witnesses the sort of business decision that can arise from the confusion about accreditation versus certification.

Nevertheless, the distinctions between the two types of recognition of laboratories by either accreditation bodies or certification bodies are easily explained. Knowing what these distinctions are will mean laboratories and their customers can make more informed choices, which can bring a range of business benefits.

When considering the relevance to your business of either certification or accreditation it is important to be clear what the definitions of these terms are.  Certification represents a written assurance by a third party of the conformity of a product, process or service to specified requirements. Accreditation, on the other hand, is the formal recognition by an authoritative body of competence to work to specified standards.

When it comes to testing, calibration or measurement services in particular, one of the most important considerations must surely be that the services in question should give accurate and reliable results. In this case, a key point to appreciate when weighing up the relative merits of a laboratory accredited to the international standard ISO/IEC 17025:2005  or certified to ISO 9001:2000 , is that there are differences between the emphasis and the processes used to determine compliance with the standards for each.

For accreditation against ISO/IEC 17025:2005 the emphasis is to establish the technical competence of a laboratory for a defined set of tests, measurements or calibrations. This standard actually incorporates two major components, namely the technical requirements and also the management requirements. The management requirements meet the principles of ISO 9001:2000 and are written in language relevant to laboratory operations.   Assessments of laboratories are conducted by teams comprising relevant technical experts and assessors able to evaluate compliance with these management requirements. However, the major emphasis is on determining the specific technical competence of personnel and the availability of all the technical resources needed to produce reliable data and results for specific test methods.

ISO 9001:2000 is a generic standard for quality management systems applicable to all organisations irrespective of type, size or product or service provided. It can, therefore, be applicable to laboratories but in this case the emphasis is on establishing a laboratory’s compliance with requirements for a quality management system. Unlike ISO/IEC 17025:2005, it does not contain technical requirements for laboratory personnel and operations. As such, certification against ISO 9001:2000 should not be interpreted to mean that it demonstrates the technical competence of a laboratory to produce valid data and results.

For certification of a laboratory against ISO 9001:2000, the assessment team will consist of auditors with detailed experience in assessment of quality management systems. Whilst they may have the technical expertise to enable them to apply the generic requirements of the standard to operations of laboratory services, their emphasis is on determining compliance with the quality management system requirements.

All laboratories want to distinguish themselves from their competitors. Good marketing will get a company’s message across, but it is accreditation that provides customers with a formal recognition of the competence, impartiality performance and capability of a particular laboratory. This can be especially important in new business where there is the absence of proven track record with that customer. Gaining accreditation to an internationally-recognised standard such as ISO/IEC 17025:2005 also provides a laboratory with access to the impartial technical expertise of the assessors. The benefits of this experience can, in turn, be passed on to a laboratory’s customers, offering a potential competitive advantage.

Customers of laboratories accredited to IOS/IEC 17025:2005 also benefit from the reliable accuracy of measurements and tests carried out by the laboratory in compliance with best practice. These can help to limit product failure and downtime and control manufacturing costs. Using a supplier accredited to this internationally-recognised standard can also help to facilitate access to export markets. It is also worth bearing in mind that should a problem arise which results in legal action, the use of an accredited body to carry out independent evaluations can help to demonstrate due diligence.

By its very nature, ISO/IEC 17025:2005 has to encompass every type and level of testing, measurement and calibration. UKAS must therefore ensure that the facilities it accredits and which offer these services are consistent, reliable and maintain a high level of performance. Making sure that accreditation keeps pace with advances in technology presents an exciting challenge. A laboratory accredited by UKAS can prove its competence, impartiality and sustainable performance and ensure that everyone from specifiers, purchasers and suppliers to consumers can have confidence in the quality of goods and in the provision of services throughout the supply chain. 

For laboratories which had already achieved accreditation to the previous ISO 17025 standard when the new edition was published, ILAC set a two year transition period to comply with its new requirements. Broadly speaking, these put greater emphasis on the responsibilities of top management, on the need to demonstrate a commitment to the continual improvement of the management system and on customer satisfaction. These improvements notwithstanding, customers themselves will probably notice very little change but should feel confident not only that they are assured of purchasing quality technical expertise, but also that their supplier’s management systems meet the principles of ISO 9001:2000.
 
There are differences between the purpose, criteria and emphasis of the ISO 9001:2000 quality system standards and those of the accreditation standard, ISO/IEC 17025:2005. For laboratories concerned with demonstrating technical competence underpinned by a quality system, ISO/IEC 17025:2005 is the appropriate standard. Similarly, suppliers seeking competent testing facilities should ensure that those facilities are accredited to ISO/IEC 17025:2005, with a scope of accreditation appropriate for the testing or calibration required.

Once laboratories and their customers understand the differences between the processes of laboratory accreditation and certification, they will begin to appreciate the real benefits that accreditation can bring to their businesses.

Anyone wishing to know how to become accredited or wanting an accredited supplier can find out more from the UKAS website on www.ukas.com.

By Graham Talbot, UKAS Technical & External Affairs Director
Graham Talbot is the Technical & External Director of UKAS. He is currently also Vice-Chairman of the European cooperation for Accreditation (EA), Chair of the Marketing & Communications Committee of the International Laboratory Accreditation Cooperation (ILAC) and a member of the ILAC Executive Board.