Understanding the ISO/IEC Laboratory Accreditation Transition and Requirements for 2021

Understanding the ISO/IEC Laboratory Accreditation Transition and Requirements for 2021

Understanding the ISO/IEC Laboratory Accreditation Transition and Requirements for 2021

The International Standard Organization (ISO/IEC) announced in November 2017 that the new requirements for the competence of testing and calibration laboratories transition period would be until November 30, 2020.  At the end of the transition period, they will base the accreditation of a laboratory on ISO/IEC 17025:2017.

Due to the COVID-19 pandemic the International Laboratory Accreditation Cooperation (ILAC), has extended the transition period globally to June 1, 2021.

What is the ISO/IEC 17025 Standard?

The ISO/IEC 17025 standard stipulated the requirements for the competence of testing and calibration laboratories.  The requirements are pertinent to all organizations performing testing, sampling, and/or calibration.  ISO/IEC 17025 is the highest standard quality management system and recognized as the global standard of quality control.

Prior to the ISO/IEC 17025:2017 was the ISO/IEC 17025:2005.  They review the standards every 5 years to update and modernize practices when needed.  There are several differences between the two here is a comparison as to what has changed.

ISO/IEC 17025:2005

The 2005 version included scope, normative references, terms and definitions, management requirements, and technical requirements.

ISO/IEC 17025:2017

The 2017 version includes scope, normative references, terms and definitions, general requirements, structural requirements, resource requirements, process requirements, and management system requirements.

The terminology has been updated and these modifications are also in the International Vocabulary of Metrology (VIM).

The newest standard emphasis information technology.  Specifically, in the use of systems, provision of electronic test results, and the provision of electronic records.

Specifics on the Changes

Within each category mentioned above, there are additions and changes within what each maintains.

  • Scope – The revisions in the scope category specifically apply to testing, calibration, and sampling.
  • Structure – A new structure is applying to align the standard with other existing conformity standards. One of these is the conformity assessment.
  • Process Approach – It updates the process approach to be similar to ISO 9001 (quality management, ISO 15189 (quality of medical laboratories), and ISO/IEC 17012-1 (requirements for audit and certification bodies).
  • Terminology – An update in terminology and addition of phrases such as “laboratory” with clear definitions.
  • Risk-Based Thinking – The new concept ensures that risks are identifiable, consideration, and monitoring throughout the design and quality management system. There are in fact, commonalities with the ISO 9001:2015.

How Do These Changes Benefit Accredited Labs?

One of the biggest benefits a calibration lab will gain is international recognition for its commitment to quality, competency, and reliable results.  It is a way to assure customers that you have the technical competence to get their instruments done accurately.  Ultimately, it is a guarantee that your lab is explicitly performing at the highest level.

Looking for A Calibration Lab?

For laboratories that are seeking calibration labs, finding an ISO/IEC 17025:2017 accredited lab means you are working with the best.  The new standards will specifically ensure that the test results, reports, and records are compliant, and the instrumentation will perform to its standards. Do your due diligence and research calibration labs that understand the importance of exceptional service which you can find at SRP control systems ltd.