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Changes in ISO/IEC 17025:2017 in general

Jongseon Park, Ph.D

KRISS, Korea

May 8, 2018 2

Head, Center for Measurement and Training Services

Division of Technology Services, KRISS

W: +82-42-868-5409/ Cell: +82-10-5454-1968

Fax: +82-42-868-5556

[email protected]

Professional Career

Dec. 2012 ~ Present Center for Calibration and Training Services, KRISS / Head

Jan. 2018 ~ Present CASCO Korea committee / Member

Dec. 2012 ~ Present KRISS / Deputy Quality Manager

Dec. 2012 ~ Present APMP TCQS / KRISS delegate

Dec. 2012 ~ Dec. 2015 APMP TCQS / Chair (JCRB delegate)

2001 ~ Present KOLAS Assessor

2001 ~ Present Center for Quality Management, KRISS / Principal Quality Officer

1993 ~ 2000 Technical Information Center, KRISS / Librarian

Education

Feb. 2011 Ph. D. in Management Science, Chungnam National University, Daejeon, Rep. of Korea

Apr. 1993 MLS, University of Pittsburgh, USA

Jongseon Park

mailto:[email protected]

Contents

May 8, 2018 3

• National Quality Infrastructure

• ISO/IEC 17025

• Main changes in ISO/IEC 17025:2017

- Options in management requirements

• Overview of KRISS

• CIPM MRA

• Conversion of new standards in Korea

National Quality Infrastructure

May 8, 2018 4

Dr. Clemens Sanetra, Rocío M. Marbán, A NATIONAL QUALITY INFRASTRUCTURE, PTB, 2007

ISO/IEC 17025

May 8, 2018 5

• is basis for laboratory accreditation programs

• provides a defined and ordered process for operating all facets of a laboratory

• specifies the general requirements that testing and calibration laboratories have to meet if they wish to demonstrate that – they operate a management system and– are technically competent and – are able to generate technically valid test

results and calibrations

Historical Summary

ISO 9000 Series- 1987 (1st)

ISO 9000 Series- 1994 (2nd)

ISO Guide 25- 1978 (1st)

ISO/IEC Guide 25- 1982 (2nd)

ISO/IEC Guide 25- 1990 (3rd)

ISO/IEC 17025- Dec 1999 (1st)

ISO 9001- 2000 (3rd)

ISO/IEC 17025- Nov. 2017 (3rd)

ISO 9000 TC/176Established (1979)

ISO 9001- 2008 (4th)

ISO 9001- 2015 (5th)

ISO/IEC 17025- May 2005 (2nd)

May 8, 2018 6

ISO/IEC 17025:2005

May 8, 2018 7

Organization

Mngt. System

Records Document Improvement

Preventive Actions

Mngt. Review Internal Audits

Corrective Actions

Service to Customer

Review ofContract Subcontracting Purchasing

NonconformingWork

Complaints

Handling Methods/ValidationReporting the Results

Environments Equipments

Traceability

Assuring Results

Personnel

Sampling

4.1

4.2

4.3

4.44.64.5

4.7

4.8

4.9

4.15

4.104.13

4.12

4.11

4.14

5.2

5.3

5.4

5.5

5.6

5.7

5.8

5.9

5.10

ISO/IEC 17025:2017

1. Scope

2. Normative references

3. Terms and definitions

4. General Requirements

5. Structural Requirements

6. Resource Requirements

7. Process Requirements

8. Management Requirements

May 8, 2018 8

Main changes in general

• A new structure– to align the standard with the other existing

ISO/IEC conformity assessment standards such as the

ISO/IEC 17000 series on conformity assessment.

May 8, 2018 9

Management requirements(15 sub-clauses)

Technical requirements(10 sub-clauses)

General requirements

Structural requirements

Resource requirements

Process requirements

Management requirements

(2 sub-clauses)

(6 sub-clauses)

(11 sub-clauses)

(9 sub-clauses)

[ISO/IEC 17025:2005] [ISO/IEC 17025:2017]


4. General Requirements

4.1 Impartiality

4.2 Confidentiality

5. Structural requirements

6. Resource requirements

6.1 General

6.2 Personnel (5.2)

6.3 Facilities and environmental conditions (5.3)

6.4 Equipment (5.5)

6.5 Metrological traceability (5.6)

6.6 Externally provided products and services (4.5, 4.6)

May 8, 2018 10


7. Process Requirements7.1 Review of requests, tenders and

contracts (4.4)

7.2 Selection, verification and validation of methods (5.4)

7.3 Sampling (5.7)

7.4 Handling of test or calibration items (5.8)

7.5 Technical records (4.13.2)

7.6 Evaluation of measurement uncertainty (5.4.6)

7.7 Ensuring the validity of results (5.9)

7.8 Reporting of results (5.10)

7.9 Complaints (4.8)

7.10 Nonconforming work (4.9)

7.11 Control of data and information management (5.4.7 + α)

8. Management system requirements

8.1 Options

8.2 Management system documentation (Option A) (4.2)

8.3 Control of management system documents (Option A) (4.3)

8.4 Control of records (Option A) (4.13)

8.5 Actions to address risks and opportunities (Option A) (4.12 + α )

8.6 Improvement (Option A) (4.10)

8.7 Corrective actions (Option A) (4.11)

8.8 Internal audits (Option A) (4.14)

8.9 Management reviews (Option A)(4.15)

May 8, 2018 11


Annex A Metrological Traceability

A.1 General

A.2 Establishing metrological traceability

A.3 Demonstrating metrological traceability

Annex B Management system options

B.1 Growth in the use of management systems generally has increased the need to ensure that laboratories can operate a management system that is seen as conforming to ISO 9001, as well as to this document. As a result, this document provides two options for the requirements related to the implementation of a management system.

B.2 Option A ~

B.3 Option B ~

B.4 Both options are intended to achieve the same result in the performance of the management system and compliance with Clauses 4 to 7.

May 8, 2018 12


• The scope revised – to cover all laboratory activities including testing,

calibration and the sampling associated with subsequent calibration and testing.

3.6laboratorybody that performs one or more of the following activities:— testing;— calibration;— sampling, associated with subsequent testing or calibration

Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.

May 8, 2018 13


• The process approach

– matches the process approach of related

standards such as ISO 9001 (quality

management), ISO 15189 (quality of medical

laboratories) and ISO/IEC 17021-1

(requirements for audit and certification

bodies).

– puts the emphasis on the results of a process

instead of the detailed description of its tasks

and steps.

May 8, 2018 14


May 8, 2018 15

Procedure

Process

specified way to carry out an activity or a process

NOTE 1 Note 1 to entry: Procedures can be documented or not.

set of interrelated or interacting activities that use inputs to deliver an intended results

Note 1 to entry: Whether the “intended result” of a process is called output (3.7.5), product (3.7.6) or service (3.7.7) depends on the context of the reference.

Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.

Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.Note 4 to entry: Processes in an organization (3.2.1) are generally planned and carried out under controlled conditions to

add value.Note 5 to entry: A process where the conformity (3.6.11) of the resulting output cannot be readily or economically valida

ted is frequently referred to as a “special process”.Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system standards gi

ven in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified to prevent circularity between process and output, and Notes 1 to 5 to entry have been added.


May 8, 2018 16

Procedure

Process

Task 1 Task 2 Task 3Start End

ProcessInput Output

Resources

Management


May 8, 2018 17

Procedure Process

Procedures exits - they are staticProcesses behave - they are dynamic

Procedures focus on satisfying the rules

Processes focus on satisfying the stakeholders

Procedures are driven by completion of the task

Processes are driven by achievement of a desired output

Procedures define the sequence of steps to execute a task

Processes transform inputs into outputs through use of resources

Procedures are implementedProcesses are operated and managed

Procedures are discontinuous Processes flow to conclusion

Procedures are driven by humansProcesses are driven by physical forces some of which may be human

ISO/IEC 17025:2017

May 8, 2018 18

Figure B.1 — Possible schematic representation of the operational processes of a laboratory


• Stronger focus on information technologies– recognizes and incorporates the use of computer

systems, electronic records and the production of electronic results and reports, because modern-day laboratories work increasingly with information and communication technologies.

– to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favor of electronic versions.

7.11 Control of data and information management

May 8, 2018 19


• Introducing risk-based thinking

– describes the commonalities with the new

version of ISO 9001:2015, Quality

management systems – Requirements.

4.1.4 The laboratory shall identify risks to its impartiality~

7.8.6 Reporting statements of conformity~ • ~ taking into account the level of risk associated with the decision rule

employed ~

8.5 Actions to address risks and opportunities

8.5.1 The laboratory shall consider the risks and opportunities associated with the laboratory activities ~

May 8, 2018 20



May 8, 2018 21

ISO 9001:2008Preventive Action

PROCESSINPUT OUTPUT



May 8, 2018 22

PROCESSINPUT OUTPUT

ISO 9001:2015Risk Based Thinking


• The terminology updated – Examples include changes to the International

Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

3. Terms and definitions• 3.1 impartiality, 3.2 complaint, 3.3 interlaboratory

comparison, 3.4 intralaboratory comparison, 3.5 proficency testing, 3.6 laboratory, 3.7 decision rule, 3.8 verification, 3.9 validation

Notes• 6.4 RM, CRM, 6.5.1 measurement traceability, etc.

May 8, 2018 23

Options in management requirements

• Management systems shall be implemented in

accordance with;

☞ Both options are intended to achieve the same result.

※ Annex B explain the option A and B additionally.

Option A

→ (as a minimum) the system shall address the;

· management system documentation

· control of management system documents

· control of records

· actions to address risks and opportunities

· improvement

· corrective action

· internal audits

· and management review

Option B

→ the system has established and maintains in accordance with

the requirements of ISO 9001

May 8, 2018 24


• ISO 9001:2015 vs ISO/IEC 17025:2017 (option A)

4. Context of the

organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

ISO 9001:2015 ISO/IEC 17025

4. General requirements



7. Process requirements

8. Management requirements (Clause 8.1 ~ 8.9)

= minimum requirements for management system

May 8, 2018 25


• ISO 9001:2015 vs ISO/IEC 17025 (option A)

Annex B – Management system

B.2 Option A lists the minimum requirements for implementation of a management system in a laboratory. Care has been taken to incorporate all those requirements of ISO 9001 that are relevant to the scope of laboratory activities that are covered by the laboratory’s management system. Laboratories that comply with clauses 4 to 7 of ISO/IEC 17025 and implement option A of clause 8 will therefore also operate in accordance with the principles of ISO 9001.

May 8, 2018 26


• ISO 9001:2015 vs ISO/IEC 17025 (option B)

ISO/IEC FDIS 17025ISO 9001:2015

4. General requirements



7. Process requirements

4. Context of the

organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

May 8, 2018 27


• ISO 9001:2015 vs ISO/IEC 17025 (option B)

Annex B – Management system

B.3 Option B allows laboratories to establish and maintain a management system in accordance with the requirements of ISO 9001 in a manner that supports and demonstrates the consistent fulfilment of clauses 4 to 7 of ISO/IEC 17025. Laboratories that implement option B of clause 8 will therefore also operate in accordance with ISO 9001. Conformity of the management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. This is accthrough compliance with clauses 4 to 7 of ISO/IEC 17025.

May 8, 2018 28

Overview of KRISS(Korea Research Institute of Standards and Science)

History at a Glance

June 2014

•Affiliated with National Research

Council of Science and Technology

under the MSIT

* Ministry of Science and ICT

2018

•43rd Anniversary of

KRISS

Feb 1999

•Officially designated by

law as NMI of Korea

•Framework Act on National S

tandards

Oct 1991

•Renamed as KRISS

•Korea Research Institute

of Standards and Science

May 1979

•Began Calibration

Services

Dec 1975

•Established as KSRI

•Korea Standards

Research Institute

▶ 2014

▶ 1975

▶ 1991▶ 2018 ▶ 1999

▶ 1979

30

▶

Legal Ground

Sept 1980

Constitution (Article 127 - Clause 2)

“The State shall establish a system of national standards.”

Feb 1999

Framework Act on National Standards (Article 13)

→ Officially designated KRISS as the NMI of Korea

•Joined the CIPM MRA as the NMI of Korea in 1999

31

Facts & Figures

* As of February 2018

■Human Resources ■Budget (USD, 2018)

Graduate Students

218

PermanentEmployees

470(303 with Ph.D)

Post-Doc.

32

Total

720People

18%

ContributionBy Gov’t

89

Others

23

65%

17%

Gov’t Contract Research

25

Total

137Million

32

* 1100 KRW = 1 USD

May 8, 2018

National Standards System of Korea

•MOTIE: Ministry of Trade, Industry & Energy

•KATS: Korea Agency for Technology and Standards

•KSA: Korea Standards Association

•KOLAS: Korea Lab Accreditation Scheme

•APMP: Asia Pacific Metrology Program

•PASC: Pacific Area Standards Congress

•APLMF: Asia Pacific Legal Metrology Forum

•APLAC: Asia Pacific Lab Accreditation Cooperation

Laboratory

Accreditation

Legal

MetrologyStandardization

ILAC

APLAC

OIML

APLMF

ISO/IEC

PASC

Measurement

Standards

BIPM

APMP

33May 8, 2018

International Cooperation in Partnership

■ INTERNATIONAL NETWORK IN THE FIELD OF METROLOGY

Global Partnership with over 40 institutes, including three international

metrology organizations and six regional metrology organizations.

SIM

NIST

INM

INTN

CENAM

EURAMET

AFRIMET

S

APMP

IMEKO

GSO

GULFME

T

COOMETLGC

NP

L

LNE

FhG/Fhl

MASM

CMS/ITRI

NMISA

PTB

NIS

NIM

VMINIMT

NMC

ITDI

NMIA

NMIJ

SAS

O

ADQCC-EMI

NMIE

UME

IRMM

INRIM

Empa

34

CMI

BIPM

VNIIM

VNIIOFI

RCM-LIPI

ILAC MRA and CIPM MRA

35

CIPM MRA

Reducing WTO/TBT by

providing comparability

NMI

Accredited

Cal. Lab.

Country A

NMI

Industry

Country B

Accredited

Cal. Lab

Industry

Country C

ILAC MRA

Meter Convention (1886)

CIPM-MRA,1999 → Effect, 2005~

Accredited

Cal. Lab.

Industry

Traceability

Dissemination

of Measurement

Standards

May 8, 2018

CIPM: International Committee for Weights and Measures

ILAC: International Laboratory Accreditation Cooperation

MRA: Mutual Recognition Arrangement

NMI

CIPM MRA

36May 8, 2018

❖ International comparison of measurements

▪ key comparisons (KC) and supplementary comparisons (SC)

❖ Quality systems and demonstrations of competency

▪ ISO/IEC 17025 (and/or ISO Guide 34) and Peer Review

Objectives & PROCESS

MUTUAL RECOGNITION OF NATIONAL MEASUREMENT STANDARDS AND

OF CALIBRATION AND MEASUREMENT CERTIFICATES

ISSUED BY NATIONAL METROLOGY INSTITUTES (NMIS)

• Establishing the degree of equivalence of NMS maintained by NMIs

• Mutual recognition of calibration and measurement certificates issued by NMIs

CIPM MRA

37May 8, 2018

Demonstration of QS by following APMP pathway [b]

Technical

Capability

Recognized by

Peer Reviews

APMP GUIDELINE FOR ACCEPTING QS(APMP-Q2)

⚫ pathway (a): third party accreditation

⚫ pathway (c): attestation by a team consisting of quality system expert and technical peers

QMS

Certified to

ISO 9001

Conversion of New 9001 and 17025 in Korea

38May 8, 2018

For ISO 9001:2015

• KRISS expects to have re-assessment for the conversion at the end of August, 2018.

- Documents required to be revised in accordance with ISO 9001:2015 has been prepared (except the procedure for issues and risk control).

• Internal audit is planed in June, 2018.

Conversion of New 9001 and 17025 in Korea

39May 8, 2018

For ISO/IEC 17025:2017 and ISO 17034

• KS Q ISO/IEC 17025 will be issued in a few months.

- Final review stage in CASCO Korea committee.

- Guide for laboratory and assessor for applying KS Q ISO/IEC 17025 will be published by KOLAS in 2018.

- KOLAS accredited laboratory have to receive the assessment by November, 2020.

• KRISS expects to apply new ISO/IEC 17025 and ISO 17034 simultaneously in 2019.

Thanks for your attention !

Questions and comments?

May 8, 2018 40