Healthcare

ISO/IEC 17025

Even military testing and calibration labs like the Navy Standards Laboratory (WPP) opt to get ISO/IEC 17025 certified.[1]

ISO/IEC 17025 is an International Organization for Standardization (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the ISO 9000 family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.

History

ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures."[2] In the mid- to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard and introduce tight compatibility with ISO 9001, which was also being revised, such that ISO 9001 would be treated as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to testing and calibration laboratories.

ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release — ISO/IEC 17025:2005 — was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.[3][2]

ISO/IEC 17025:1999 became defunct in May 2007.

The standard

The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. Two annexes are also included. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.

The standard is organized as follows[4][5]:

Scope

The scope of the standard is described over six points. It states what type of testing and calibration is covered; who it's applicable to; the purpose for the standard; what's not covered; and how it relates to ISO 9001.

Normative references

This section states both ISO/IEC 17000 and the International Vocabulary of Metrology (VIM) are vital to applying the standard.

Terms and definitions

This sections simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM.

Management requirements

The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this section. The requirements are broken down into 15 subsections:

4.1 Organization

4.2 Management system

4.3 Document control

4.4 Review of requests, tenders and contracts

4.5 Subcontracting of tests and calibrations

4.6 Purchasing services and supplies

4.7 Service to the customer

4.8 Complaints

4.9 Control of nonconforming testing and/or calibration work

4.10 Improvement

4.11 Corrective action

4.12 Preventive action

4.13 Control of records

4.14 Internal audits

4.15 Management reviews

Technical requirements

The requirements for staff competence, methodologies, equipment testing and calibration, and test methods are outlined in this section. The requirements are broken down into 10 subsections:

5.1 General

5.2 Personnel

5.3 Accommodation and environmental conditions

5.4 Test and calibration methods and method validation

5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

5.8 Handling of test and calibration items

5.9 Assuring the quality of the test and calibration results

5.10 Reporting the results

Annexes

Two annexes and a bibliography are included. Annex A: Nominal cross-references to ISO 9001:2000 provides links between this standard and ISO 9001, important as this standard includes requirements not covered in ISO 9001. Annex B: Guidelines for establishing applications for specific fields gives accreditation seekers explanations of specific requirements to better complete their applications.

Accreditation

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.[6] It is also the basis for accreditation from an accreditation body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.[2]

National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories can use either a domestic organization or some other internationally recognized body in cases where the domestic organization "has either no international recognition or where it lacks recognition in parts of the world relevant to the laboratory’s operations."[2] Laboratories typically select a range of common and frequently used methodologies that could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.

Further reading

External links

References

  1. "Navy Standards Laboratory (WPP), Naval Surface Warfare Center, Corona Division". Lab Accreditation Bureau. http://l-a-b.com/company/navy-standards-laboratory-wpp-naval-surface-warfare-center-corona-division/. Retrieved 20 February 2015. 
  2. 2.0 2.1 2.2 2.3 "Complying with ISO 17025" (PDF). United Nations Industrial Development Organization. October 2009. pp. 106. http://www.unido.org/fileadmin/user_media/Publications/Pub_fr/Complying_with_ISO_17025_A_practical_guidebook.pdf. Retrieved 20 February 2015. 
  3. Hoolihan, Daniel D. "ISO/IEC 17025:1999 versus 2005" (PDF). Hoolihan EMC Consulting. http://gsi.nist.gov/global/docs/mra/2005_Hoolihan_17025.pdf. Retrieved 20 February 2015. 
  4. "ISO/IEC 17025:2005(en) - General requirements for the competence of testing and calibration laboratories". ISO Online Browsing Platform (OBP). International Organization for Standardization. 2005. https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en. Retrieved 20 February 2015. 
  5. "ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories". Activation Laboratories Ltd. http://actlabs.com/page.aspx?menu=60&app=206&cat1=732&tp=2&lk=no. Retrieved 20 February 2015. 
  6. Honsa, Julie D.; Deborah A. McIntyre (2003). "ISO 17025: Practical Benefits of Implementing a Quality System". Journal of AOAC International 86 (5): 1038–1044. http://aoac.publisher.ingentaconnect.com/content/aoac/jaoac/2003/00000086/00000005/art00023. Retrieved 28 February 2012.