transition to iso/iec 17025: 2017 key challenges and ... · gap analysis documentation updated to...

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Transition to ISO/IEC 17025: 2017

Key Challenges and Opportunities

Presenter : Sam Thema

[email protected]

17th September 2019

Presentation Outline

▪ Introduction to ISO and CASCO

▪ Evolution of ISO/IEC 17025

▪ Revision Timeline

▪ Objectives of transition

▪ Key changes in the new standard

▪ Transition to the new standard: SANAS Snapshot

▪ Methodology employed (Challenges & Opportunities)

▪ Findings – Quantitative

▪ Findings – Quantitative

▪ Recommendations

Introduction to ISO & CASCO

▪ It all started in 1946 when a delegate from

25 countries meet in London to discuss the future of

international standardization

This was the birth of the

INTERNATIONAL ORGANISATION FOR STANDARDIZATION

(ISO)

President’s committee

Council standing committees

Policy Development committee

Advisory Group

General Assembly

Council

Central Secretariat

Technical

committees

TMB

CSC/SP CSC/FIN CSC/OVECSC/NOM

CPAG

COPOLCO DEVCO

ITSAG

ISO Committee on Conformity Assessment (CASCO) works on issues

relating to CONFORMITY ASSESSMENT

CASCO

Introduction to ISO & CASCO -Cont.

Structure of ISO

Terms and Definitions – ISO 17000: 2004

Requirement for accreditation bodies – ISO/IEC 17011:2017

Requirements for

certification bodies

Re

qu

ire

me

nts

fo

r th

e c

om

pe

tence

of r

efe

ren

ce

ma

teria

l p

rod

uce

rs (

ISO

17

03

4: 2

01

6)

Re

qu

ire

me

nts

fo

r p

roficie

ncy te

stin

g

(IS

O/I

EC

17

04

3: 2

01

0

Genera

l R

equirem

ents

for

the c

om

pete

nce o

f

testin

g a

nd

ca

libra

tio

n la

bo

rato

rie

s

(IS

O 1

70

25

: 2

01

7)

Ma

na

ge

me

nt syste

ms

(IS

O/I

EC

17

021

Re

qu

ire

me

nts

fo

r In

sp

ectio

n b

od

ies

(IS

O 1

70

20

: 2

01

2)

Pe

rso

nn

el

(IS

O/I

EC

17

024

Pro

duct, p

rocesses a

nd S

erv

ices

(IS

O/I

EC

17

065

Mutu

al re

cognitio

n / P

eer

assessm

ent

ISO

/IE

C 1

70

40

, IS

O G

uid

e 6

98

Supplie

r decla

ration o

f confo

rmity

ISO

/IE

C 1

70

50

, Te

il1

un

de

r 2

The ISO CASCO Toolbox

Introduction to ISO & CASCO -Cont.

Evolution of ISO/IEC 17025

1978

ISO/IEC

Guide 25

(1st Edition)

1982

ISO/IEC

Guide 25

(2nd Edition)

1990

ISO/IEC

Guide 25

(3rd Edition)

ISO/IEC

17025:1999

ISO 9001:1994

ISO 9002:1994

ISO 9001:2000ISO/IEC 17025:2005 Aligns with

ISO/IEC 17025:2017 ISO 9001:2015Aligns with

Vote to

revise

ISO/IEC

17025

WG 44

meeting

WG 44

meeting

CD 1

CD1

Ballot

WG 44

meeting

Result: 80%

Approval; 2,606

comments

CD2

Ballot

WG 44

meeting

DIS

Result: 96%

Approval; ~2,100

comments

WG 44

meeting

CD 2

DIS

Ballot

Result: 91%

Approval;

9% Negative

~2,000 comments

WG 44

meeting

FDIS

FDIS

Ballot

Oct

2014

Feb

2015Aug/Sept

2015

June

2015Feb

2016

May

2016

Dec

2016

Sep

2016

Aug

2017July

2017Nov

2017

Publication

Result: 99%

Approval;

1% Negative

Revision Timeline

Objectives of revision

▪ Align structure and content with other recently revised

ISO standards (Other CASCO toolbox standards)

▪ Focus on outcomes rather than prescriptive requirements

▪ Update language to reflect current practices and

technologies

▪ Development in Information Technology (IT) techniques

▪ Emphasis on the results of a process instead of the

detailed description of its tasks and steps

High level Changes

Type of

change

Description of change Clause(s)

New Total restructure of the clauses From 4 now to 8

New Process approach A.2.3. and 8.2.4 (Process

and procedure

interchangeable)

Changed Control of data and Information

management

7.11

Changes in the new standard

Changes in the new standard- Cont.

Type of

change

Description of change Clause(s)

New Action to address risks and

opportunities

Clause 8.5

Removed Preventive actions Previously clause 4.12

New Options to implement ISO 9001

or Clause 8.0

Clause 8.1

High level Changes

Other high level Changes

▪ The scope has been revised to cover testing, calibration

and sampling associated with subsequent calibration

and testing

▪ The process approach matches that of standards using

the high level structure (HLS) such as ISO 9001:2015

▪ Stronger focus on Information Technologies

Changes in the new standard- Cont.

Transition to the new standard:

SANAS Snapshot

Programmes

Total No of

Facilities to be

assessed to ISO

17025: 2017

Number of

Facilities

assessed

against

ISO 17025:

2017

Number of

Facilities

successfully

converted

No. of CoF

due to

transition

Veterinary,

pharmaceutical &

Forensic

37 10 10 0

General Testing 301 133 50 23

Testing

(Mechanical &

Physical)

114 57

20

3

Calibration 184 > 50 18 2

Total 636 > 250 98 28

Methodology Employed

PHASE 1

QUALITATIVE Data Collection: Face to

Face Interview with ASSESSORS AND

ACCREDITATION MANAGERS

PHASE 2

QUANTITATIVE Data Collection:

On-line Survey - Questionnaire Administer

to SANAS ACCREDITED

FACILITIES/LABORATORIES

PHASE 3

DATA ANALYSIS

&

INTERPRETATION

QUALITATIVE

PHASE 1

LITERATURE REVIEW

FACE TO FACE

INTERVIEWS

SANAS

ACCREDITATION

MANAGERS

FACE TO FACE

INTERVIEWS

ASSESSORS

QUANTITATIVE

PHASE 2

On-line survey

Population 636

Sample Size

(Simple

random

Sampling)

51

Response rate 45%

THEMATIC CONTENT ANALYSIS STATISTICAL ANALYSISQUANTITATIVE

PHASE 3

Parallel

Methodology- Cont.

Findings- Quantitative

0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8

Experience of SANAS accreditated on the transition to the new standard

Strongly Agree Agree Neutral Disagree Strongly Disagree

Overall an large number of respondents AGREE that

addressing and Implementation of Metrological Traceability

is not challenging (Approximately 82 % of respondents)

0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



39% of respondents AGREE whilst 35% DISAGREE

(35%) that process orientation of the new standard is

a challenge

Findings- Quantitative - Cont.

0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



26% of respondents AGREE whilst approximately 48%

DISAGREE that flexibility of the new standard is a

challenge


0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



Approximately 35% of the respondents STRONGLY

AGREE, 17% AGREE whilst 26% DISAGREE that

Statement of conformity & Decision Rule is

challenging


0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



35% of respondents STRONGLY AGREE whilst

approximately 35% AGREE that Risks and

Opportunities challenging. Only 30% DISAGREE


0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



26% of respondents AGREE whilst approximately 48%

AGREE that Interpretation of new the requirement is

challenging


0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



Approximately 35% of the respondents STRONGLY

AGREE whilst 52% AGREE that the transition Plan

was communicated clearly by SANAS


0

2

4

6

8

10

12

14

16

18

20

1 2 3 4 5 6 7 8



39% of the respondents STRONGLY AGREE whilst 52%

AGREE that the transition Plan was communicated

ON TIME by SANAS


Findings - Qualitative

Challenges Opportunities

Statement of conformity & Decision

Rule (e.g. Microbiology)

Re-writing the entire quality manual

gave a fresh look to the QMS

Addressing Risk & Opportunities Risk & Opportunities assessment

improved the laboratory strategic

approach

Getting the sequence and structure

a challenge

Re-aligning the entire Quality

Manual to be in line with the Lab’s

operations

Lack of top management support is

a challenge

More flexibility to tailor the QMS to

the Laboratory’s needs

Findings - Qualitative

Challenges Opportunities

Addressing impartiality a challenge Implementation of impartiality and

confidentiality improved the

relationship with interested parties

Negative staff attitude toward

change to the new standard

Assessors not ready and

interpreting the standard differently

Implementation of impartiality and

confidentiality improved the

relationship with interested parties

Transition period too short and

standard not available on time from

the local standard body

Other Challenges

Identified

▪ Incomplete Transition plan

▪ Addressing Risks associated on health & safety and

not covering laboratory activities

▪ Laboratories addressing risks However not effectively

establishing Actions to address them

▪ Not effectively evaluating actions taken after risk

assessment (PDCA)

▪ Opportunities not identified - Only Risks considered

▪ Few laboratories are realising the positive output

from risk assessing e.g. To achieve the necessary

improvement as required by clause 8.5.1 d (ISO/IEC

17025)

Other Challenges

Identified

1) Establish a complete transition plan

▪ Gap Analysis

▪ Documentation updated to meet ISO/IEC 17025:2017

requirement

▪ Training staff on the new requirement

▪ Implementation of the management system

▪ Internal audits based on ISO/IEC 17025:2017

▪ Management review based ISO/IEC 17025:2017

Recommendations for

Seamless Transition

2) Enhance knowledge on Risks & Opportunities

3) Enhance knowledge on “ the statement of conformity

& decision rule”

4) Harmonising the interpretation of the new standard -

Assessors

Recommendations for

Seamless Transition

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