by Dr. George Anastasopoulos
ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the world, with more than 50.000 laboratories accredited, globally.
At the International Laboratory Accreditation Cooperation (ILAC) General Assembly in October 2013 the Laboratory Committee (which is composed of stakeholder representatives of accredited testing and calibration) recommended that ILAC request that ISO/CASCO establish a new work item to comprehensively revise ISO/IEC 17025:2005. CASCO is the ISO committee that works on issues relating to conformity assessment. CASCO develops policy and publishes standards related to conformity assessment; it does not perform conformity assessment activities. CASCO’s standards development activities are carried out by working groups made up of experts put forward by the ISO member bodies. The experts are individuals who possess specific knowledge relating to the activities to be undertaken by the working group.
A New Work Item Proposal (NWIP) was submitted by CASCO to ISO and approved in October 2014. An ISO/CASCO working group has since been established (WG44) and tasked with the revision of the standard titled: “Revision of ISO/IEC 17025 ISO/CASCO/WG 44.”
The development process for ISO standards is divided into separate stages including:
This stage covers the preparation of a working draft (WD) by the WG conforming to the ISO/IEC directives. The preparatory stage ends when a working draft is available as a first committee draft (CD).
This stage is when comments on the draft from national member bodies are taken into consideration, with a view of reaching consensus. The committee stage ends when all issues have been resolved and a CD is accepted for circulation as an enquiry draft i.e. a Draft International Standard (DIS). Further CDs may be necessary where consensus is not reached prior to a DIS being available. The revision of ISO/IEC 17025 is now during this stage. CD2 is already published for comments.
At the enquiry phase, the Draft International Standard (DIS) is circulated to all national member bodies for comment and vote. Typically, the national bodies’ mirror committees are responsible for monitoring and participating in the work of the relevant ISO committee. At this stage it is anticipated that the DIS will be released in the second half of 2016.
The DIS is approved if two-thirds of national member bodies are in favor and not more than one-quarter of the total number of votes cast are negative. If the DIS is approved the project will go straight to publication. However, should the draft be significantly revised following comments at the DIS stage (even if the DIS has been approved) a decision may be made to prepare a Final Draft International Standard (FDIS) and circulate it to national member bodies for a further vote.
At this stage the final draft is submitted for publication and only editorial corrections are made to the text. According to the WG44 work plan, it is expected that the revised version of the standard will be published in mid-end 2017.
About the New Standard – Changes
The format of the new standard will be significantly changed to be more in line with new ISO formatting guidelines. The basic format is similar to other new standards such as ISO/IEC 17020 and ISO/IEC 17065. It is expected that the new standards will be aligned to ISO 9001:2015 principles on resources and process. By following the new ISO 9001 philosophy it requires less documented procedures and policies and focuses more on the outcomes of a process. Example: no longer requires the laboratory to maintain a current job description (2005 – 5.2.4) but focuses on communicating to each person their duties, responsibilities and authorities (CD2 – 6.2.4)
Additional rigor is given in assuring the quality of results. Clarification/expansion of measurement decision risk is also expected to be included.
The new CD2 is now structured as follows:
- Normative references
- Terms and definitions
- General requirements
- Structural requirements
- Resource requirements
- Process requirements
- Management requirements
- Annex A – Metrological Traceability (Informative)
- Annex B – Management System (Informative)
Changes in the requirements of new ISO/IEC 17025 CD2
The following are the main changes introduced through CD2:
- Usage of term “Laboratory Activities” instead of testing/calibration laboratories
- New ISO 17025 would be applicable to organizations that are also performing sampling without, necessarily, providing testing/calibration services.
- “Laboratory” is now defined as a body that performs one or more of the following activities:
- sampling, associated with subsequent calibration and testing
- Liability insurance requirement (or reserves) is added
- Risk management requirements have been added as following:
4.1.4 The laboratory shall identify risks to its impartiality
7.1.7 a)…risk associated with the decision rule employed (such as false accept and false reject when a statement of conformity is requested )
8.1.2 a) actions to address risks (related to MS)
8.5 Actions to address risks and opportunities
8.5.1 Risks and opportunities associated with the laboratory activities
8.5.2 The laboratory shall plan actions to address these risks and opportunities;
8.7.3 Risk of recurrence of the non-conformities encountered (Corrective Actions)
8.9.4 The inputs to management review shall include; m) results of risk identification
- Updated requirements related to Internal QC/PT/ILC are defined at clause 7.8.1: Regularly monitor the validity of activities undertaken and the quality of the laboratory output:
a) regular use of reference materials or quality control materials;
b) regular use of alternative metrologically traceable instrumentation;
c) functional check of measuring and testing equipment;
d) use of check or working standards with control charts, where applicable;
e) periodic intermediate checks on measuring equipment;
f) replicate tests or calibrations using the same or different methods;
g) retesting or recalibration of retained items;
h) correlation of results for different characteristics of an item;
i) review of reported data by competent laboratory personnel;
j) intralaboratory comparisons;
k) blind test.
- New Documentation Requirements have been introduced:
- Quality Manual is NOT required anymore
- Reduced procedural requirements in Management Systems section
- Reduced records requirements in Management Systems section
The Next Step
ISO/CASCO/WG 44 will meet again at Geneva, Switzerland, from September 20 to 23, 2016. The output of that meeting is expected to be the DIS version of the standard.
About the Author
Dr. George Anastasopoulos (ganas @ iasonline.org), is the Director of Conformity Assessment Accreditation Services, for International Accreditation Service (IAS). He is also the General Secretary of the International Personnel Certification Association IPC. He has also been member of the Bonn-Germany based, Accreditation Panel of the United Nations Kyoto Protocol system UNFCCC/CDM. He is a Mechanical Engineer with a MSc and a PhD in Applied Mechanics from Northwestern University, Evanston, Illinois. He is also member of ISO/TC176 and ISO/CASCO technical committees which developed the new ISO 9001:2015 and new ISO/IEC 17025 (under development). Dr. George Anastasopoulos is awarded with the EOQ Presidential Georges Borel Award for international achievements being at the edge of the development, use and diffusion of quality at international level through his professional activities and behaviors, personally contributing to the development of the European Quality movement through his accomplishments with a global impact in the field of quality. Dr. Anastasopoulos presented many papers in technical and financial conferences, magazines and newspapers and is the author of many articles and books. He also presented many lectures as keynote speaker in topics such as Management Systems, Business Process Reengineering, Telecoms-FTTH-IT, Quality Assurance and Process Auditing. He participated in numerous consulting and research projects sponsored by government and industry in USA, European Union and many other countries worldwide.