ISO 17025

Testing and Calibration of Laboratories

Business and Quality Management

Contents

  1. Introduction
  2. Overview
  3. Global adoption
  4. Benefits
  5. Auditing
  6. Choosing a registrar
  7. Route to registration
  8. Costs
  9. Contributing editor

Introduction

ISO/IEC 17025 is the global recognized standard that was developed specifically for testing and calibration laboratories that intended seeking accreditation. It is also the basis for accreditation from an accreditation body. The current release was published in 2005. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory namely competence of staff; environment control; testing methodology; equipment and measurement traceability; and reporting of test and calibration results.

Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements as well as at the same time are able to generate technically valid results for which they hold accreditation. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.

Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s symbol or endorsement, as an indication of their accreditation.

Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation, issued by the accreditation body. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory or testing and calibration service. Laboratory accreditation bodies publish the scopes of accreditation for their accredited laboratories in either hardcopy directories or on the internet.

Overview

ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organizations that produce testing and calibration results. A second release of the standard was made in 2005 after it was agreed that it needed to be more closely aligned with the 2000 version of ISO 9001 in term of its quality system words which include greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.

In the current global scenario, an essential pre-requisite of trade is that any product or service is accepted formally in one economy, must also be free to circulate in other economies without having to undergo extensive re-testing. WTO recognises that non-acceptance of test or calibration results and measurement data is a Technical Barrier to Trade. Thus, accreditation is considered as the first essential step for facilitating mutual acceptance of test or calibration results and measurement data. In seeking of recognition, laboratories need to demonstrate full compliance with both sections of ISO/IEC 17025 namely Management and Technical requirements and successfully go through the third party assessment i.e by accreditation body.

Many countries around the world have one or more organizations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC 17025 as the basis for accrediting their country’s testing and calibration laboratories. This has helped countries employ a uniform approach to determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible. In order for accreditation bodies (at various part of the world) to recognise each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

Though, the Management Requirements of ISO/IEC 17025 has similarity with ISO 9001, it cannot be interpreted to be the same as certification against the ISO 9000 series Standards. Confidence in accreditation can only be obtained by a transparent system of control over the accredited laboratories and an assurance given by the accreditation body that the accredited laboratory constantly fulfils the accreditation criteria. Thus, demonstration of compliance with Management and Technical Requirements will allow the laboratories to operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001 and at the same time has the people, with the skills and knowledge, the environment with the facilities and equipment, the quality control and the procedures that are required to produce valid results.

Is ISO/IEC 17025 relevant to your organization?

This International Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. The standard is also applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities.

In addition to the use of this international standard by laboratories in developing their management system for quality, administrative and technical operations, laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. However, this International Standard is not intended to be used as the basis for certification of laboratories.

Global adoption

Following the increasing number of accreditation bodies representing various countries around the world joining as member of ILAC or APLAC by signing Mutual Recognition Agreements (MRAs) and continue efforts by ILAC and APLAC in promoting the acceptance of laboratories accreditation schemes across countries, the accreditation numbers to ISO/IEC 17025 has been steadily increasing.

As of to date, over 40 laboratory accreditation bodies have signed a multi-lateral recognition agreement called the ILAC Arrangement, which greatly enhances the acceptance of data across the national borders of the signatory countries. Full details for the ILAC Arrangement and the list of signatories can be found on the ILAC website.

Benefits

  • Increase of confidence in Testing/ Calibration data and of personnel performing work.
  • Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
  • Potential increase in business due to enhanced customer confidence and satisfaction.
  • Customers can search and identify the laboratories accredited by The Accreditation Member Body for their specific requirements from their website or Directory of Accredited Laboratories.
  • Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
  • Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
  • Improved national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.

Auditing

Two types of auditing are required to become accredited to the standard: auditing by an external accreditation body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment especially on demonstration of technical competency, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified.

Choosing a registrar

If you are considering seeking accreditation for your facility, the first thing you’ll need to do is contact the appropriate accreditation body to see whether they can accredit your range of testing or calibration services.

Most national accreditation bodies can provide comprehensive accreditation for:

  • Facilities undertaking any sort of testing, product or material evaluation, calibration or measurement;
  • Private or government laboratories;
  • One-person operations or large multi-disciplinary organizations;
  • Remote field operations and temporary laboratories.

Route to registration

Laboratories can have either all or part of their testing and calibration activities accredited. The accreditation process involves a thorough evaluation of all the elements of a laboratory that contribute to the production of accurate and reliable test or calibration data.

The evaluation process can take one to several days (usually 2 to 3 stages of assessment, vary among accreditation bodies), and involves the use of specialist technical assessors who evaluate the specific types of testing or measurement being performed. The assessment criteria are based on the international standards ISO/IEC 17025, which are used for evaluating laboratories throughout the world. Laboratory accreditation bodies use this standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test and calibration data, including the:

  • Technical competency of staff
  • Validity and appropriateness of test or calibration methods
  • Traceability of measurements and calibrations to national standards
  • Suitability, calibration and maintenance of test or calibration equipment
  • Testing or calibration environment
  • Sampling, handling and transportation of test or calibration items
  • Quality assurance of test and calibration data

At the end of the assessment a detailed report on the evaluation is presented to the laboratory, highlighting any areas that require attention and corrective action prior to the laboratory being recommended for accreditation.

Once accredited, the laboratory is re-evaluated periodically to ensure its continued compliance with requirements, and to check that its standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.

Costs

Internal Cost

The answer depends on a number of factors. There are costs to both implement and to maintain your accreditation. In terms of costs to implement, if you choose a full do-it-yourself approach, the only real costs will be the time for resources dedicated to the implementation process and in time spent writing documents and training your staff. If you have little experience with ISO 9000, or have limited internal resources, you might choose to get some outside professional help through a management system consultant. There are advantages by recruiting a consultant as you are able to guarantee your registration within a given period.

Certification Costs

Costs of registration are dependent on the size of your organization. Most registrars charge a certain rate per day to be on-site at your facility. This day rate will vary depending on your country, the typical day rate in the United Kingdom will vary between £300 - £800.00 auditor day depending on the registrar. Small companies with less than 20 staff could expect one auditor on site for 1-3 days; Large companies can expect several auditors on site for up to up to 10-15 days.

Other fees include application fees, certificate fees or annual licence fees.

To maintain your certification, the registrar must return annually to audit a portion of your system. These costs will be less than the original visit, since the time spent will be shorter. Once every three years, the registrar returns to audit your entire system.

Contributing editor

Stanley Law

After obtaining a Bachelor of Science (Honours) Degree in Chemistry from University of Malaya in 1999, Stanley embarked on a career in an established plantation-based company (Senior Chemist cum Assistant QA Manager) and then moved on to an airline company (Service Quality Controller) prior to joining Neville Clarke as consultant in 2006.

The previous two employments provided Stanley valuable working experiences in the development, implementation and maintenance of the ISO 9001, ISO 14001 and ISO/IEC 17025 management systems. While as the Senior Chemist cum Assistant QA Manager, Stanley acquired invaluable management skills in the daily operation of the QA laboratory.

Since joining Neville Clarke, Stanley has successfully trained and assisted many companies from various field including manufacturing, trading, logistic, construction, engineering, hotel management, electronics, commissioning, repair & maintenance, laboratory management and etc in the development, implementation and maintenance of Quality Management System (QMS), Environmental Management System (EMS) and Occupational Health & Safety Management System (OH&S) as well as ISO/IEC 17025 Laboratory Management System for Testing and Calibration Laboratories. In addition, Stanley is a certified lead auditor for the earlier mentioned management systems and the Licentiate Member of Malaysian Institute of Chemistry.

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