the new iso/iec 17025:2017 - s3-eu-west-1.amazonaws.com · iso/iec 17025:2017 - general...

The new ISO/IEC 17025:2017 Proficiency testing and reference materials – an update

Overview

• Introduction in ISO/IEC 17025:2017, reference materials (RMs) and

proficiency testing (PT)

• Why use RMs and PT?

• Definition of “testing”, “procedure” and “calibration”

• Choosing you RM and PT provider

• RM and PT as drivers of quality

• Summary

• Literature

2

ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

• General requirements for the competence of testing and

calibration laboratories

• International standard

> First published in 1999

> 3rd edition published

> in November 2017 by ISO, Geneva, Switzerland

• 3 year transitional period

> Basis for competence

> Applicable to organisations of all sizes

> Enables greater comparability of operations and results

• Structure of standard changed significantly

> Now consistent with other 17000 series standards

3

ISO/IEC 17025:2017 (1)

• No significant changes in technical

requirements to 2005 version

• Laboratories develop own procedures based on

anticipated risk and opportunity

> Laboratories have greater freedom but more responsibility

• Covers all aspects of laboratory operations

which impact on quality of tests or calibrations

• Requirements consistent with good practice

and principles of valid analytical measurement

4

ISO/IEC 17025:2017 (2)

Analytical Quality

Exte

rnal

Sta

nd

ard

s (R

M,

CR

M)

Inte

rnal

Sta

nd

ard

s

Pro

ficie

ncy

Testin

g

Reference Materials & Proficiency Testing as

Pillars of Analytical Quality

5

• According to ISO 17025:2005, RMs and PT are main pillars to ensure

analytical quality!

Exte

rnal S

tan

dard

s

(RM

, CR

M)

ISO

Gu

ide 3

4/IS

O

17034:2

016

Inte

rnal S

tan

dard

s

(to b

e c

om

pare

d to

RM

/CR

M; s

ee IS

O

Gu

ide 8

0)

Pro

ficie

ncy T

estin

g

(ISO

/IEC

17043:2

010)

Analytical Quality

Reference Materials & Proficiency Testing as

Pillars of Analytical Quality

6

• According to the new ISO 17025:2017, RMs and PT are still the main

pillars to ensure analytical quality!

• Testing

> Determination of one or more characteristics of an object of conformity assessment,

according to a procedure (3.2, ISO 9000:2000)

• “Testing” typically applies to materials, products or processes

• Procedure

> Specified way to carry out an activity or a process

7

Some Relevant ISO Guide Definitions (1)

• Calibration

> Operation that, under specified conditions, in a first step establishes a relation between

the quantity values with measurement uncertainties provided by measurement

standards and corresponding indications with associated measurement uncertainties

and, in a second step, uses this information to establish a relation for obtaining a

measurement result from an indication.

8


ISO/IEC Guide 99:2007 - International Vocabulary of Metrology - Basic and General Concepts

and Associated Terms (VIM)

• ‘Calibration‘ is reliable measurement, traceable to national and

international standards and necessarily giving an uncertainty

• ‘Testing’ is what we might call ‘routine’ measurement – food

analysis, drinking water checks, product QC, etc. – and can include

qualitative tests, tests against product specifications etc.

9


• Alignment with the layout of other recent 17000-series standards

• Management requirements (Chapter 4) and technical requirements

(Chapter 5) in 2005 version replaced by:

> 4 General requirements

• Mandatory sections on impartiality & confidentiality common to new 17000 standards

> 5 Structural requirements

> 6 Resource requirements

> 7 Process requirements

> 8 Management requirements

10

ISO/IEC 17025:2017 – Key Changes (1)

eurolab – Handbook ISO/IEC 17025:2017

• Management system requirements (Chapter 8) – two options

> Option A – a management system meeting the requirements of the management

system requirements specified in the standard

> Option B – a management system in accordance with the requirements of ISO 9001

and capable of supporting the requirements of ISO/IEC 17025

• Other management requirements from 2005 version appear in

Chapters 4-7 in 2017 version

11

ISO/IEC 17025:2017 – Key Changes (2)


• RMs are considered as equipment

> Recognition that a multitude of names exist for RMs including

• Certified reference materials

• Reference standards

• Calibration standards

• Standard reference materials

• Quality control materials

• Reference material producers that meet the

requirements of ISO 17034 (or ISO Guide 34 as

predecessor during transition period) are

considered to be competent

12

Specific changes related to RMs and PT



1. Click the icon to add your

image

2. If the image is positioned

correctly then you are

done! If not, continue to 3.

3. Right click on the image

4. Select Format Picture

5. Select Crop

6. Adjust Offset Y until image

is positioned correctly.

7. Click OK

NOTE: Adjusting any other

values will distort the image

and/or the placeholder!

A closer look at reference materials

• “Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process” > RM is a generic term

> Intended use must be specified on the certificate of analysis

> Properties can be quantitative r qualitative

> Uses may include the calibration of a measurement system, assessment of a measurement procedure, assigning values to other materials and quality control

14

Reference Material (RM) - Definition

ISO Guide 30:2015 - Reference materials - Selected terms and definitions

• “Reference material (RM) characterised by a metrologically valid

procedure for one or more specified properties, accompanied by an

RM certificate that provides the value of the specified property, its

associated uncertainty, and a statement of metrological traceability”

> Metrologically valid procedures for the production and certification of RMs are given in,

among others, ISO 17034:2017 and ISO Guide 35:2017

> ISO Guide 31:2015 gives guidance on the contents of RM certificates

15

Certified Reference Material (CRM) - Definition


16

What are Reference Materials for?

Calibration of measuring apparatus

Evaluation of measurement procedures

For internal or external quality control

measurements and laboratories

Enable expression of functional properties

Important role in international

standadisation activities and accreditation

of laboratories


Reference

Material

ISO Guide 30 Introduction

• ISO/IEC 17025:2017 requires a laboratory to establish and maintain

metrological traceability of its measurement results

> Unbroken chain of calibrations

> Each one contributing to the overall measurement uncertainty

> Linking to an appropriate reference

• ISO/IEC 17025:2017 provides additional guidance on metrological

traceability in Annex A.

17

Why Reference Materials?


How to choose a reference material provider

18

• Accreditation

> RM producers show their competence by accreditation to ISO 17034:2016

> ISO 17034 covers the production of all RMs, including CRMs

> ISO 17034 describes the complete process including

• planning, production, handling and storage, processing, measurement procedures, data

evaluation, metrological traceability, homogeneity, stability, characterisation, accompanied

documents and labels

> Materials from non-accredited suppliers may require additional in-house verification

before they are fit for use.

19

How to choose your RM provider? (1)

ISO 17034:2016 - General requirements for the competence of reference material producers

• Portfolio and availability

> Look for a provider that include and hold in stock a wide range of products on stock to

provide the best choice of format for your application

• Experience

> Essential when producing complex mixtures and difficult compounds.

> Knowledge of analytical measurement helps understand end user issues

• Reliability

> Security of supply and resilience to un-planned events

• Innovation

> New product development pipeline to respond to changing requirements

20

How to choose your RM provider? (2)

ISO 17034:2016 - General requirements for the competence of reference material producers

21

Some example Certificates of Analysis (1)

22

Some example Certificates of Analysis (2)

Proficiency Testing

• Evaluation of participant performance against pre-established

criteria by means of interlaboratory comparisons

• Interlaboratory comparison

> Organisation, performance and evaluation of measurements or tests on the same or

similar items by two or more laboratories in accordance with predetermined conditions

24

Proficiency testing (PT)

ISO/IEC 17043:2010 - Conformity assessment - General requirements for proficiency testing

Method

validation

Proficiency Testing

Characterisation

of reference

materials

Interlaboratory Comparison (ILC)

25

Method

validation

Proficiency Testing

Characterisation

of reference

materials

Interlaboratory Comparison (ILC)

e.g. ISO 12828-1:2011;

EN ISO 16140

ICH Q2(R1)

or FDA Guidance to

Industry

e.g. ISO Guides 30, 31,

33, 34 and 35

ISO 17034

26

27

Proficiency

Testing

ISO/IEC 17043:2010

Performance evaluation

Trend analysis over time

Establishment of effectiveness and

comparability

Providing confidence

Identification of interlaboratory differences

Validation of uncertainty claims

Education of participants

What is Proficiency Testing for?


• Assuring the quality of tests and calibration results

> ……..monitoring shall be planned and reviewed and may include, but not be limited to,

the following;

• Regular use of certified reference materials and/or internal quality controls using secondary

reference materials

• Participation in interlaboratory comparisons or proficiency testing programmes

28

Why performance monitoring?

ISO/IEC 17025:2005


• Ensuring the validity of results

> …….. monitoring shall be planned and reviewed and shall include, where appropriate,

but not be limited to:

• use of reference materials or quality control materials;

> The laboratory shall monitor its performance by comparison with results of other

laboratories, where available and appropriate. This monitoring shall be planned and

reviewed and shall include, but not be limited to, either or both of the following:

• participation in proficiency testing;

– Proficiency testing providers that meet the requirements of ISO/IEC 17043 are considered to be competent.

• participation in interlaboratory comparisons other than proficiency testing

29

Why performance monitoring?

ISO/IEC 17025:2017


How to choose a proficiency testing provider

• PT providers show their competence by

accreditation to ISO/IEC 17043:2010 (as

referenced in ISO/IEC 17025:2017)

> Competence to develop and operate PT schemes

> Competence to conduct interlaboratory comparisons

> Competence to measure the properties being

determined

31

How to choose your PT provider? (1)


How to choose your PT provider? (2)

• Scheme breadth and depth

> Analytes / matrix that matches you analytical application

• Sample type and frequency

> Participation options that suit your workflow

• Scale

> For PT participant numbers is critical - bigger is better

• Reporting and results

> Speed – the earlier any issues are highlighted the sooner the laboratory can

take action

> Flexibility

32

1. Click the icon to add your

image

2. If the image is positioned

correctly then you are

done! If not, continue to 3.

3. Right click on the image

4. Select Format Picture

5. Select Crop

6. Adjust Offset Y until image

is positioned correctly.

7. Click OK

NOTE: Adjusting any other

values will distort the image

and/or the placeholder!

The power of RMs and PT

• RMs and PT are essential tools for

> Meeting accreditation requirements (e.g.

ISO/IEC 17025:2017)

> Internal quality control

> External performance evaluation

> Ongoing monitoring and trend analysis

> Providing confidence to customers

34

The power of PT and RM

RMs and PT are essential tools for providing confidence in results

Measurement results are critical to informing decisions made on safety, quality and

authenticity

These decisions can also have significant economic consequences

• ISO/IEC 17025:2017 has a new structure

• Accredited labs still demonstrate their competence of testing and

calibration

• RMs and PT were and still are the main pillars to ensure the quality

of analytical results

> Mandatory to use both

• RM producers show their competence by accreditation to ISO

17034:2016

• PT providers show their competence by accreditation to ISO/IEC

17043:2010

36

Summary

> ISO 9000:2000 - Quality management systems - Fundamentals and vocabulary

> ISO/IEC 17000:2004 - Conformity assessment - Vocabulary and general principles

> ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories

> ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

> ISO 17034:2016 - General requirements for the competence of reference material producers

> ISO/IEC 17043:2010 - Conformity assessment - General requirements for proficiency testing

> ISO Guide 30:2015 - Reference materials - Selected terms and definitions

> ISO/IEC Guide 99:2007 - International Vocabulary of Metrology - Basic and General Concepts and Associated Terms (VIM)

> eurolab - Handbook ISO/IEC 17025:2017

37

Literature

LGC is accredited to ISO 17034 and ISO/IEC 17043

If you have any question,

please contact me via email:

[email protected]

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