Standards Writing and ISO-IEC 17011 · 2019. 10. 25. · The revision of ISO/IEC 17011 commenced...
Transcript of Standards Writing and ISO-IEC 17011 · 2019. 10. 25. · The revision of ISO/IEC 17011 commenced...
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
Standards Writing and ISO-IEC 17011
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;
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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)
Standards Writing and ISO-IEC 17011
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.
Standards Writing and 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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
Changes in the Standard
• What’s next?
• The next level – remote viewing?
Standards Writing and ISO-IEC 17011
Changes in the Standard
remote assessment
assessment of the physical location or virtual site
of a conformity assessment body, using
electronic means
Standards Writing and ISO-IEC 17011
Changes in the Standard
remote assessment
assessment of the physical location or
virtual site of a conformity assessment
body, using electronic means
Standards Writing and ISO-IEC 17011
Changes in the Standard
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)?
Standards Writing and ISO-IEC 17011
Changes in the Standard
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.
Standards Writing and ISO-IEC 17011
Changes in 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;
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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.
Standards Writing and ISO-IEC 17011
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…….
Standards Writing and ISO-IEC 17011
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’.
Standards Writing and ISO-IEC 17011
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….
Standards Writing and ISO-IEC 17011
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)];
Standards Writing and ISO-IEC 17011
ISO/IEC 17011:2017
CHEESE…………..Now that I have your attention………
Standards Writing and ISO-IEC 17011
Conclusion
Some times you ask for
something………
Standards Writing and ISO-IEC 17011
Conclusion
And you get………….
Something filled with …….
Standards Writing and ISO-IEC 17011
ISO/IEC 17011:2017