Revised ISO/IEC 17025:2017 has been published

 The International Organization for Standardization (ISO) has released the new version of ISO/IEC 17025- General requirements for the competence of testing and calibration laboratories. The main changes compared to the previous edition are : 

1. The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.

2. The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).

3. The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.

4. A new chapter introduces the concept of risk-based thinking.

Laboratories already accredited to ISO/IEC 17025:2005 will need to transition their processes to the new version within a three-year period from the publication date of the new standard. The Joint ILAC-ISO Communiqué explains this timeframe transition. 

Source:www.iso.org

Treatment of an observed bias: New leaflet issued by EURACHEM

An information leaflet has been prepared by the Eurachem Measurement Uncertainty and Traceability Working Group concerning the treatment of an observed bias. The leaflet discusses whether or not an observed significant bias should be corrected and the impact this may have on the measurement uncertainty (MU). The leaflet does not describe how to apply a correction or how to increase the uncertainty to take account of an uncorrected bias, though it does provide relevant literature sources.  

View the leaflet in English (pdf, 354 kB)

Source: www.eurachem.org

OECD Publishes Position Paper on GLP and ISO/IEC 17025

The Organisation for Economic Cooperation and Development (OECD) has  published the OECD Position Paper Regarding the Relationship between the OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025.
The Position Paper, as well as other documents in the OECD Series on principles of GLP and compliance monitoring, are publicly available from the OECD website.

Using repeated measurements to improve the standard uncertainty

Analysts often take multiple observations, and sometimes average the result of several observations to reduce the uncertainty associated with random variation. However, it is often unclear how the standard uncertainty associated with averaged results should be calculated from an observed standard deviation. Sometimes one should divide by the square root of the number of observations; sometimes the standard deviation is used unchanged, and sometimes some alternative formula is appropriate.

This information leaflet has been prepared by the Eurachem Measurement Uncertainty and Traceability Working Group to give further explanation of when the classical 'root n' formula can, and can not, be used. The leaflet amplifies principles described in the Eurachem Guide "Quantifying uncertainty in analytical measurement", which is available here.


Source: www.eurachem.org

ISO/IEC 17025 revision

The standard ISO / IEC 17025, which is used internationally for accreditation of all kinds of testing and calibration laboratories is being revised. The new standard has been already issued in the form of Committee Draft (CD) and has been put to a vote by the members of the ISO Committee on conformity assessment (CASCO). The main changes in the new version are:

Alignment the structure of ISO / IEC 17025 with the other conformity assessment standards (eg ISO / IEC 17020, ISO / IEC 17024). Specifically, the new standard is expected to have the following sections: General requirements, Structural requirements, Resource requirements, Process requirements, Management requirements.
More emphasis on independence and confidentiality issues. It is now required by laboratories to establish mechanisms for identifying and dealing with situations that endanger the impartiality-independence of the services offered.
In the case of complaints, the final decision on how to handle the complaint, should be taken by a person not involved in the activity test / calibration associated with this complaint.
Laboratories implementing a management system according to ISO 9001, may satisfy simultaneously certain managerial requirements of ISO / IEC 17025.

In the following months, versions of the standard in the form of drafts DIS, FDIS will be issued, while the final version of the standard is expected in the second half of 2016.

ILAC MRA Report - Total Number of Accredited Bodies / Laboratories

Full ILAC Report available here

Nuclear Magnetic Resonance (NMR) Method Development and Validation

EUROLAB has recently published a Technical Report on Guide to Nuclear Magnetic Resonance (NMR) Method Development and Validation – Part I: Identification and Quantification. This document may facilitate the accreditation process of such methods.

The document is now available on EUROLAB website and can be downloaded here. 

Source: www.eurolab.org 

World Accreditation Day 2014

June 9th, 2014 will mark World Accreditation Day, a global initiative jointly established by the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) to raise awareness of the importance of accreditation-related activities. The focus this year is on the role accreditation plays in providing confidence in the provision of energy. The day will be celebrated across the world.

ISO/IEC 17025 – A time for Change?

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 as soon as practicable.  

The General Assembly agreed an ILAC Resolution to allow accreditation bodies to hold a consultation period with their accredited laboratories until the end of January 2014. In response to this UKAS undertook a simple online survey of all of its 1,500 accredited laboratories.  At its close the survey had achieved a response rate of 26%, with 68% of those in favour of bringing forward a revision, 22% against, and 10% abstaining.

In line with the outcome of the survey, UKAS responded to ILAC in favour of bringing the revision forward.  The UK response was mirrored by the majority of other economies, with 84% of ILAC voting members submitting a ‘yes vote’ and therefore exceeding the 75% threshold for ballot approval. 

The ILAC Executive Committee has now commenced work on the preparation of a New Work Item Proposal (NWIP) to revise ISO/IEC 17025, for submission to ISO/CASCO.  If successful, this NWIP will bring the revision of ISO/IEC 17025 forward by up to two years, with a projected publication date of 2017.

Source: www.ukas.com 

Accreditation for Microbiology Laboratories

Eurachem has issued a new edition of its existing guide "Accreditation for microbiology laboratories". The guide, produced primarily in collaboration with the EA Laboratory Committee, provides microbiological laboratories with information and guidance on fulfilling the requirements of ISO/IEC 17025.
The new version of the guide can be downloaded from here.

Source: www.eurachem.org

Calibration of Standard Capacity Measures using the Volumetric Method

Due to the lack of international documentation on calibration of volume measurements using the volumetric method the EURAMET TC-Flow decided to create guidelines and to harmonize procedures and concepts in that field of metrology. The first calibration guide for volume measurements using the volumetric method: EURAMET Calibration Guide 21 includes several topics: 

• Specific definitions related with volumetric calibration,
• General techniques, such as ambient and water calibration conditions, cleaning, meniscus adjustment and expansion coefficient of water,
• The calibration procedure using the filling method and using the withdrawing method,
• The mathematic equation for determination of volume,
• The procedure for estimating measurement uncertainty and
• A practical case study is described. 

Main users of this guide will be accredited laboratories, industry and national metrology laboratories that are performing measurements on volume of liquid.

The Guide is available for downloading here

Source: www.euramet.org 

Sampling Uncertainty

The aim of sampling is to obtain a small portion of material (sample) from a selected system (sampling target) within a container which is representative of the material in that system. The sampling process should ensure that the sample is an unbiased reflection of the composition of the sampling target.  

Sampling becomes extremely important when considering the uncertainty of measurement. Until recently a “metrological gap” existed between analysts and end-users concerning the interpretation of measurement results and their associated uncertainties. Analysts concentrated on the analytical measurement process and estimated the uncertainty of the measurand of the sample received at the laboratory while the end user naturally interpreted the measurement result together with its uncertainty in order to characterize the sampling target as a whole. Therefore, the end user needs to know a precise estimate of an uncertainty that includes the uncertainty caused by sampling i.e. the combined uncertainty from sampling and analysis.  

Sampling uncertainty is defined as the part of the total measurement uncertainty attributable to sampling. Principles and procedures for estimating the uncertainty of measurement arising from sampling are described in the Guide published by Eurachem and CITAC as well as in the Nordtest handbook, which is intended for practical applications.    

Pre- and Post-analytical Proficiency Testing

EURACHEM through its Proficiency Testing Working Group has produced an information leaflet on Pre- and post-analytical proficiency testing aimed at PT participants and their customers. The Eurachem PT working group has released 11 new translations of this leaflet to accompany the English edition. The translations can be downloaded from http://www.eurachem.org/index.php/publications/leaflets/ptprepost. The leaflet focuses on cases where specific procedures,either before or after themeasurement, which are applied to the routine samples,but not to the PT test sample. Then, the PT result reflects only the quality of part of the measurement process.

Source: www.eurachem.org 

The role of measurement uncertainty in conformity assessment

The JCGM Working Group 1 (JCGM-WG1) produced and issued one more documnet to accompany the GUM.  The  Evaluation of measurement data – The role of measurement uncertainty in conformity assessment (JCGM 106:2012) has been approved and is available for download as PDF file in http://www.bipm.org/en/publications/guides/gum.html . This document provides guidance and procedures for assessing the conformity of an item (entity, object or system) with specified requirements. The procedures developed in this document can be used to realize an interval, called an acceptance interval, of permissible measured values of the property of interest. Acceptance limits can be chosen so as to balance the risks associated with accepting non-conforming items (consumer's risk) or rejecting conforming items (producer's risk).

Workshop: Key Challenges in Internal Quality Control (2012)

The Eurachem Education and Training Working Group organised an international workshop on internal quality control in Berlin on Wednesday 10 to Thursday 11 October 2012. The event was hosted by the German member of Eurachem, EUROLAB Germany. The workshop covered analytical results from a range of sectors and disciplines including chemical analysis, testing, laboratory medicine and microbiology. The main focus was on internal quality control performed in the laboratory for the continuous monitoring of operations and results of measurements, in order to decide whether results are reliable enough to be released.
The workshop included invited lectures, short communications, posters and break-out sessions.
A training course on internal quality control was held at the same venue the day before the workshop, Tuesday 9 October.

• Training course programme
• Programme and presentations: Day 1
• Programme and presentations: Day 2
• Posters
• Scientific Committee

 Source: www.eurachem.org

 

Quantifying Uncertainty in Analytical Measurement, 3rd Edition (2012)

This guide has been produced by a joint EURACHEM/CITAC Measurement Uncertainty Working Group.
The first edition of the EURACHEM Guide for “Quantifying Uncertainty in Analytical Measurement” was published in 1995 based on the ISO "Guide to the Expression of Uncertainty in Measurement". The second edition was prepared in collaboration with CITAC in 2000 in the light of practical experience of uncertainty estimation in chemistry laboratories and the even greater awareness of the need to introduce formal quality assurance procedures by laboratories. The second edition stressed that the procedures introduced by a laboratory to estimate its measurement uncertainty should be integrated with existing quality assurance measures, since these measures frequently provide much of the information required to evaluate the measurement uncertainty.
This third edition retains the features of the second edition and adds information based on developments in uncertainty estimation and use since 2000. The additional material provides:

• Improved guidance on the expression of uncertainty near zero;
• New guidance on the use of Monte Carlo methods for uncertainty evaluation;
• Improved guidance on the use of proficiency testing data:
• Improved guidance on the assessment of compliance of results with measurement uncertainty.

The guide therefore provides explicitly for the use of validation and related data in the construction of uncertainty estimates in full compliance with the formal ISO Guide principles set out in the ISO Guide to the Expression of Uncertainty in measurement. The approach is also consistent with the requirements of ISO/IEC 17025:2005.

Source: www.eurachem.org

International vocabulary of metrology (VIM) corrected 3rd edition - 2012

One of the most important events in the last decade for the future of measurement is the third edition of the International Vocabulary of Metrology, commonly called ‘‘VIM’’ (from the French title ‘‘Vocabulaire International de Metrologie’’). The corrected version (2012) of the third edition of the VIM has been approved by each and all of the eight JCGM Member organizations and is available at http://www.bipm.org/en/publications/guides/vim.html.

NMI Receives Accreditation To Cover Testing Of Gaming

NMi, the independent expert for testing, certifying and training in gaming, has been formally approved to cover testing of gaming following an extension of its ISO17025 accreditation. NMi becomes the first and only European-based lab to achieve the accreditation and one of the very few suppliers that can offer turnkey compliance within the newly regulated territory, covering all aspects of testing from software to operations either at their lab or on-site. NMi's UKAS accreditation can be found on the UKAS website:

http://ukas.org/testing/schedules/Actual/4403Testing%20Multiple.pdf

Source:http://www.igamingbusiness.com

UK accreditation for cookware testing

The first UK based accreditation for testing cookware has been granted to Amstel Testing Ltd by the United Kingdom Accreditation Service (UKAS). This accreditation is to ISO/IEC 17025:2005 for the main cookware testing clauses (BS EN 12983-1:2000+A1:2004). Additionally, Amstel is the only UKAS accredited laboratory in the UK covering standards for: non-stick endurance/hob suitability (DD CEN/TS 12983:2005 Part 2); ovenware (BS EN 13834:2007+A1:2009); stove-top kettles (BS EN 13750:2002); and glass lid thermal shock (BS 3193:2008).

Cookware testing by an accredited laboratory is important in the process of product development so that manufacturers can be confident in their product’s performance. In turn this ensures distributors, retailers and ultimately consumers can be sure the products they purchase have been appropriately tested.

Source: www.ukas.org

Terminology in Analytical Measurement: Introduction to VIM 3

A new guide has been produced by members of the Eurachem Education and Training Working Group and others co-opted to the Project group for this task.
This Eurachem Guide discusses a selection of the concepts in VIM 3 (International Vocabulary of Metrology), focusing on those most likely to be encountered in analytical laboratories. It aims to cover chemical, biological and clinical measurements and gives examples over and above those in the notes accompanying the definitions in VIM 3 .

The guide is intended for laboratory staff, accreditation bodies, for those commissioning measurements and for those using measurement results. Lecturers and trainers may also find this guide useful when teaching aspects of metrology.

Eurachem Guide is available at:
http://www.eurachem.org/guides/pdf/TAM_2011_Final_web.pdf