Standards Writing and ISO-IEC 17011 · 2019. 10. 25. · The revision of ISO/IEC 17011 commenced 2014 when the Working Group (WG) produced the first of 2 committee drafts. In October

Standards Writing and

ISO-IEC 17011

Neville Tayler

18 September 2019

ISO/IEC 17011:2017

Coming to a theater near to you soon…….

A story of intrigue, undue influence,

misinformation, the mystery of the

decade….who changed the requirement?

Can you solve this mystery?

Standards Writing and ISO-IEC 17011

Introduction

In November of 2017 The International Standards

Organisation (ISO) along with the International

Electrotechnical Commission (IEC) published the second

edition of ISO/IEC 17011.

The Standard was revised by ISO CASCO WG 42. This

working group was chaired by Dr Cynthia Woodley

nominated by ANSI and Mr Alister Dalrymple from AFNOR


Introduction

Dr Cynthia Woodley, has noted in a Blog that she

has written that the key objective of the revision of

the Standard were

• Alignment of the standard with the common

structure of other CASCO documents;

• Incorporation of the mandatory wording required

of ISO CASCO Standards;

• Identification of PT as an accreditation activity;


Introduction

Dr Cynthia Woodley, has noted in a Blog that she has written

that the key objective of the revision of the Standard were:

• Adding new sections and new definitions;

• Introduction of risk and risk based assessments;

• Incorporation of criteria for AB assessors, including an

Annex pertaining to knowledge and skills.


Introduction

The revision of ISO/IEC 17011 commenced 2014 when the

Working Group (WG) produced the first of 2 committee

drafts.

In October 2015 the WG received 1771 comments to the

first committee draft (CD1);

In March 2016 the WG received 1410 comments to the

CD2;

In November 2016 the WG received 583 comments to the

draft International standard (DIS)


THE REVISION PROCESS

On 1 October 2015, comments were submitted to

SANAS Quality Manager, who was chosen lead

the South African Mirror group charged with the

revision of ISO/IEC 17011.


The Revision Process

On 5 April 2017 ANSI submitted an appeal to

ISO CASCO in terms of the CASCO rules to

prevent the standard from moving from the

DIS to an International Standard without going

through the FDIS voting, due to what they

described as a technical error in the DIS.


THE ANSI APPEAL

ANSI were successful in having the text in clauses 7.6.4

and 7.6.6 amended, such as to state that competence is

determined through conformity, rather than the existing

draft text that required that the assessment team establish

(i) the competence of the CAB, and (ii) its conformance

with requirements.


THE ANSI APPEAL

This change essentially makes it possible for an

Accreditation Body (AB) to change the focus from

determining the competence through assessment

(witnessing for example) to one where the focus could be

compliance (or conformance) through the review of

documentation.


The Revision Process

This change essentially makes it possible for

an Accreditation Body (AB) to change the

focus from

• determining the competence through

assessment (witnessing for example),

too

• one where the focus could be compliance

(or conformance) through the review of

documentation.


THE REVISION PROCESS

The voting on the ISO/IEC FDIS 17011 commenced on 14

August 2017 and closed on 9 October 2017.

The Standard was subsequently published as a full

international standard in November 2017.


Voting

The second edition has introduced a number of

changes in concept including

• The manner in which the scopes of

calibration laboratories must be recorded;

• The concept of a remote assessment;

• The concept of a ‘virtual’ site.


Changes in the Standard

• What’s next?

• The next level – remote viewing?



remote assessment

assessment of the physical location or virtual site

of a conformity assessment body, using

electronic means



remote assessment

assessment of the physical location or

virtual site of a conformity assessment

body, using electronic means



On-site assessments

Clause 7.9.3 The time between consecutive on-site assessments

shall not exceed two years. However, if the accreditation body

determines that an on-site assessment is not applicable, it shall use

another assessment technique to achieve the same objective as the

on-site assessment being replaced and justify the use of such techniques

(e.g. remote assessment).assessment of the physical location or virtual

site of a conformity assessment body, using electronic means.

So that implies that you don’t need actually need to do an on-

site assessment (Where a physical presence is required)?



The second edition of ISO/IEC 17011 introduced

minimum requirements for the scopes of

accreditation of calibration laboratories that

differed from the previous edition of the standard.



The requirements for the presentation of a scope of a

Calibration Laboratory were expressed in the 2004

version of ISO/IEC 17011 as

c) for calibration laboratories:

1) the calibrations, including the types of measurements

performed, the measurement ranges and the best

measurement capability (BMC) or equivalent;


ISO/IEC 17011:2004

On release of the CD of what is now ISO/IEC 17011 was

published on 31 July 2015, the requirement had changed to

The Calibration and Measurement Capability, expressed in

terms of

• Measurand or Reference Material;

• Calibration/Measurement Method/procedure and/or type

of instrument/material to be calibrated/method;

• Measurement range/s and or additional parameters e.g.

frequency;

• Uncertainty of measurement.


ISO/IEC 17011:2017

On release of the DIS of ISO/IEC 17011 was sent out for

voting on 25 Aug 2016 the requirement had changed to

The Calibration and Measurement Capability, expressed in

terms of

• measurand or Reference Material;

• calibration/measurement method/procedure and type of

instrument/material to be calibrated/measured;

• measurement range/s and or additional parameters e.g.

frequency;

• uncertainty of measurement.


ISO/IEC 17011:2017

On release of the FDIS of what is now ISO/IEC 17011:2017, the

requirement had changed to

The Calibration and Measurement Capability (CMC), expressed in

terms of

• measurand or reference material;

• Calibration or measurement method or procedure and type of

instrument or material to be calibrated or measured;

• measurement range and or additional parameters where

applicable e.g. frequency…….;

• uncertainty of measurement uncertainty.


ISO/IEC 17011:2017

Finally the standard was published in November 2017.

ILAC confirmed an transition period of 3 years, i.e. All

Accreditation Bodies are expected to have transitioned to

the revised standard by 1 November 2020.

AFRAC then decided on a transition period of only 2 years.

AB’s recognized within Africa must therefore transition to

the new standard by 1 November 2019.

And the clock started ticking on 1 November 2017…….


ISO/IEC 17011:2017

Lets now delve into the changes which affect calibration laboratories

2004 version does not require calibration scopes to include either the

method or procedure.

The CD draft produced in July 2015 included an option to include the

method or procedure (and/or);

In the DIS produced in 2016 the requirement was changed to make it

a requirement that all calibration scopes now include the method or

procedure.

In 2017 the FDIS still included the and, but replaced the / used in all

previous revision with ‘or’.


ISO/IEC 17011:2017

The applicable clause as approved in the final document published

as ISO/IEC 17011:2017 is:

calibration or measurement method or procedure and type of

instrument or material to be calibrated or measured;

(calibration or measurement method or procedure) and (type of

instrument or material to be calibrated or measured);

This is the accepted interpretation (based on knowledge that ‘/’

was replaced by ‘or’, but….


ISO/IEC 17011:2017

But… is the following interpretation incorrect given that the editors

failed to use a comma in the sentence, to indicate any order of

preference:

[(calibration or measurement method)] or [(procedure and type of

instrument)] or [(material to be calibrated or measured)];


ISO/IEC 17011:2017

CHEESE…………..Now that I have your attention………


Conclusion

Some times you ask for

something………


Conclusion

And you get………….

Something filled with …….


ISO/IEC 17011:2017

Neville Tayler

[email protected]

18 September 2019

Documents

Standards Writing and ISO-IEC 17011 · 2019. 10. 25. · The revision of ISO/IEC 17011 commenced 2014 when the Working Group (WG) produced the first of 2 committee drafts. In October