These documents are published by international agencies that are, by agreement, the authorities on these subjects or have developed consensus with other bodies on the contents.
- The Guide to the expression of uncertainty in measurement (GUM) is the pre-eminent international consensus-based document for all things related to metrology and uncertainty. It is published on the JCGM website with the current version of the VIM (International Vocabulary for Metrology) and these may be downloaded for free by anyone. Any laboratory that is accredited for calibration should have controlled versions of these documents in their Master Document List.
- GUM - http://www.bipm.org/en/publications/guides/gum.html
- VIM3 - http://www.bipm.org/en/publications/guides/vim.html
- ILAC-ISO-IAF Agreement on the Equivalence of ISO/IEC 17025 to ISO 9000: Following the development of the 2005 version of ISO/IEC 17025, three organizations came to agreement on how the standard related to ISO 9000. The second occasion of this "peace treaty" was following the 2008 update to ISO 9001. This agreement was signed by the Chairs of the ISO, ILAC and IAF to describe the relationship between the two standards. In essence, all three organizations agreed that ISO/IEC 17025 was sufficient for a laboratory to demonstrate conformance to an international standard focussed on their competence in the production of technically valid results. Accredited laboratories can use this document to show their ISO 9001-registered clients to demonstrate that 17025 accreditation need not be supplemented by registration to ISO 9001 in order to meet a client's needs or the needs of the client's registrar.
- Complying with ISO/IEC 17025 - a Practical Guidebook (published by UNIDO): This publication discusses the issues of implementing 17025-conformant quality systems in laboratories in developing economies. Many of the challenges faced by labs working in developed economies are the same, but some are unique to developing economies. This practical approach has been used in many developing economies where UNIDO assistance has helped build the conformity assessment infrastructure needed to have laws, public policy, and enforcement based on technically valid results. This is the start of good national conformity assessment capacity needed to support policies and laws regarding health, environment, trade, safety and other regulated areas.
These documents are published by MOTIVA Training to provide assistance to organisations seeking to understand or implement a QMS conformant to ISO/IEC 17025. MOTIVA also publishes samples of conformant policies, procedures and forms for use by laboratories on this page.
- MOTIVA T02 - 17025 Guide. This document is an amalgam of the requirements in ISO/IEC 17025 and a set of implementation approaches that are fairly straightforward. The aim of the document is to help the laboratory implement a quality system that works harder for the lab staff, than they are working for it.
- Internal Calibration Worksheet (Excel) for liquid-in-glass (LIG) thermometers, analytical balances, and pipettes. This form provides an easy-to-use quick method for those laboratories that wish to calibrate their own working instruments of these types. Note that the uncertainties generated from internal calibration will not be nearly as precise as using competent professionals in this work.
- ISO/IEC 17025 Introduction Test. This PowerPoint file is a less-than-serious examination of the requirements within ISO/IEC 17025. It is normally used to wake up participants at the beginning of the MOTIVA Understanding 17025 Course.
- Principles behind ISO/IEC 17025. This document was originally used to demonstrate to the members of ISO TC 176 that the rationale underlying ISO/IEC 17025 was not the same as ISO 9000. This document is also published by a few of the North American accreditation bodies. It is presented here in MOTIVA colours as the author is Ned Gravel.
Design and Build a Laboratory (or other CAB) QMS
MOTIVA publishes a self examination document, leading to the most appropriate steps to the design and implementation of a QMS. This work can be the set of steps from determining the need for a QMS right through to applying for accreditation from an ILAC signatory body.
Download it here and determine where your CAB is now. Determine how long it will take and what effort your CAB will have to undertake to have a conformant QMS in placc.
This document does not promote any consulting services, but it does shed strong light on what it takes to succeed in this effort. As MOTIVA staff can attest, it can be a long and lonely journey - but it need not be.