Transcript Cross reference 17020:1998 – 17020:2012

ISO/IEC 17020:2012
Conformity assessment – Requirements for the operation of various types of
bodies performing inspection
Presentation on the new standard
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The aim of this presentation is to support all interested parties concerned
by the implementation of this new standard, e.g. conformity assessment
bodies, accreditation bodies, industries with general information and
contribute to an harmonized transition.
This is an open presentation without any copyrights and can be used by
anyone.
We welcome any proposals for improvement of this presentation or
translation in national languages.
ISO CASCO Secretary
Sean MacCurtain
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ISO CASCO Convenor WG 31
Marcus Schmid
Table of content
Key activities of inspection
History of inspection
History of ISO/IEC 17020
Transition period of ISO/IEC 17020:2012
ISO/IEC 17020 / WG 31 - Maintenance Group
Aim of the revision
The main changes and improvements:
• Content
• Obligatory requirements of ISO/PAS
• Impartiality and independence
• Competence of inspectors
• Subcontracting
• Inspection schemes
• Commodity inspections
• Inspection reports and certificates
• Management system requirements
Cross reference 17020:1998 – 17020:2012
Cross reference 17020:2012 – 17020:1998
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Key activities of inspection (1)
The main objective of the Standard is to promote confidence in bodies
performing inspection.
Inspection bodies carry out assessments on behalf of private clients,
their parent organizations, or authorities, with the objective of
providing information about the conformity of inspected items with
regulations, standards, specifications, inspection schemes or contracts.
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Key activities of inspection (2)
safety,
fitness for
purpose,
quality,
quantity,
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Inspection
parameters
continued safety
compliance of
installations or
systems in
operation.
Key activities of inspection (3)
examination of
materials, products,
installations, plants,
processes, work
procedures or
services,
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determination of their
conformity with
requirements and
subsequent reporting
of results activities to
clients, when
required, to
authorities.
Inspection
activities of
inspection
bodies
Key activities of inspection (4)
Inspection can concern all stages during the lifetime of
these items, including the design stage.
Inspection normally requires the exercise of professional
judgement in performing inspection, in particular when
assessing conformity with general requirements.
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History of inspection
Inspection has a long history. With the industrialisation in the 18th century
based on the use of steam engines and the accident risk associated the first
inspection bodies were established.
These bodies named steam boiler inspection bodies were independent of
the companies operating the steam engines and their professional
judgement resulted in short time in considerable reduction of accidents.
Independent inspection is today used in a wide variety of industrial sectors
and other branches.
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History of ISO/IEC 17020 (1)
The inspection standard
was originally developed
by the European
Standardisation
Organisations
CEN/CENELEC as EN
45004 published in
March 1995.
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This standard was taken
over by ISO/CASCO
without changes as
ISO/IEC 17020 and
published 1998.
In 2008 the CASCO
Working Group 31 was
established to revise the
existing ISO/IEC 17020.
After 5 meetings the WG
finished in July 2011
The final ballot was
positive. The revised
standard (2nd edition)
was published in March
2012.
History of ISO/IEC 17020 (2)
Stage
Revision
Ballot
WD1:
WD2:
CD:
DIS:
FDIS:
2009-06-03
2010-03-01
2010-05-17
2011-01-13
2011-09-21
- - 2010-08-27
2011-06-13
2012-01-17
Result
81 %
81 %
92 %
Comments
444
316
764
539
63
Publication : 2012-03-01 (english and french)
2012-07-01 DIN EN ISO/IEC (german version)
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Transition period of ISO/IEC
17020:2012
ILAC resolution 2012-07-18:
• “The ILAC membership agrees to a threeyear transition period for the
implementation of ISO/ IEC 17020: 2012
from the date of publication of the English
language version of the standard.
The standard was published on 1 March
2012, therefore the three year transition
period will conclude on 1 March 2015.”
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ISO/IEC 17020 / WG 31 - Maintenance
Group
Maintenance
Group
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•
•
•
•
Keith Mowry (Certification body side)
Lal Ilan (accreditation side)
Tommy Scriven (Industry)
Dr. Monika Wloka (standard development
side)
• Marcus Schmid (convenor)
Aim of the revision
Initiated by the result of the systematic review 2008
improvements where
necessary
Take into account the
CASCO PAS
maintaining the
proven parts of the
existing standard
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CASCO common
structure
The
general
aims of the
revision
implementing the
relevant parts of the
IAF/ILAC Guidance A4
on the
implementation of
ISO/IEC 17020
The main changes and improvements
Content
Alignment with the new structural requirements for standards for
conformity assessment bodies decided by CASCO resulting in the
following 8 chapters in the revised standard instead of 16 in the existing
17020:
•
•
•
•
•
•
•
•
Scope
Normative references
Terms and definitions
General requirements
Structural requirements
Resource requirements
Process requirements
Management system requirements
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The main changes and improvements
Obligatory requirements of ISO/PAS
CASCO has established common elements in the form of PAS
for the use in standards for conformity assessment bodies. The
obligatory requirements of the following PAS are included in
the revised standard:
• PAS 17001 on Impartiality included in clause 4.1
• PAS 17002 on Confidentiality included in clause 4.2
• PAS 17003 on Complaints and appeals included in
clause 7.5
• PAS 17005 on Use of management systems included
in clause 8
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The main changes and improvements
Impartiality and independence (1)
The requirements on impartiality and independence which are crucial for performing
inspection activities are considerably improved by implementing the relevant parts of
the IAF/ILAC guidance A4 in clause 4.1 and the normative Annex A.
The three types of inspection bodies (Types A, B and C) describing the different
degree of independence are kept.
Type A bodies are third-parties independent of the parties involved in the design,
manufacture, supply, installation, use or maintenance of inspected items.
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The main changes and improvements
Impartiality and independence (2)
Type B are in-house inspection bodies forming a separate
independent part of an organisation involved in the mentioned
activities.
Type C bodies must not be a separate part within the organisation
but there must be a clear separation between inspection activities
and other activities meaning that a person cannot inspect items
designed, manufactured, maintained etc. by him.
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The main changes and improvements
Competence of inspectors (1)
The inspectors of the Types A, B and C have to fulfil the same
competence requirements which are specified in clause 6.1 of the
standard.
The inspectors must have appropriate qualifications, training,
experience and a satisfactory knowledge of the requirements of
the inspections to be carried out.
This is of special importance as many inspection activities involve
professional judgement to determine conformity with general
requirements.
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The main changes and improvements
Competence of inspectors (2)
Inspectors shall be trained on a continuing base to
keep pace with developing technology and
inspection methods.
Inspectors have to be monitored (referred to as
supervision in the former edition of 17020) by
experienced persons including on-site observations.
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The main changes and improvements
Subcontracting
The inspection body shall itself normally perform the
inspections that it contracts to undertake. The wellproven requirement in case of Subcontracting are
basically kept.
The reasons for subcontracting of inspections were
specified based on the relevant IAF/ILAC guidance A4 by
examples such as unforeseen overload, incapacitated staff
members or temporarily unfit equipment.
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The main changes and improvements
Inspection schemes
In the process part of the standard (clause 7) it is required
that the inspection body uses methods and procedures
which are defined in requirements against which
inspection is to be performed.
It is clarified that such requirements can also be specified
in inspection schemes. A definition of inspection schemes
is now contained in the standard (clause 3.7).
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The main changes and improvements
Commodity inspections
Inspection can provide information about inspected items
without determination of conformity.
Commodity inspections have been considered in the standard
as inspections activities and covered by a note to the definition
of inspection (clause 3.1) saying that inspection procedures and
schemes can restrict inspection to examination only.
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The main changes and improvements
Inspection reports and certificates
Requirements on reports and certificates have been
considerably improved
The standard provides a list of elements that have to be
included in a report or certificate (clause 7.4.2) and of
optional elements that can be included (informative
Annex B).
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The main changes and improvements
Management system requirements
The management system requirements are concentrated in
chapter 8.
• According to PAS 17005 the certification body has two options
to establish and maintain a management system that is
capable of achieving the consistent fulfilment of the
requirements of ISO/IEC 17020.
• The requirements of option A are provided in detail in clauses
8.2 to 8.8.
• Option B gives the possibility to use ISO 9001 as an alternative
to fulfil the requirements contained in clause 8.2 to 8.8.
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Cross reference 17020:1998 –
17020:2012 (1)
17020:1998
17020:2012
1.1
1
1.2
Introduction, 4. paragraph
1.3
Introduction, 5. paragraph
1.4
Introduction, 6. paragraph
2.1
3.1
2.2
3.5
3
5.1
3.1
5.1.1
3.2
5.1.2
3.3
5.1.3
3.4
5.1.4
3.5
5.1.5
3.6
Note 2: restriction to examination possible
Not included
4.1
4.1.2 to 4.1.5
4.1 1st sentence
4.1
remark
Applies to Type A, B, C and any stage
2nd
sentence
4.1.2
6.1.12
4.2
4.1.6
4.2.1
4.1.6 a)
4.2.2
4.1.6 b)
4.2.3
4.1.6 c)
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PAS 17001 included
Partly covered
Cross reference 17020:1998 –
17020:2012 (2)
17020:1998
17020:1998
5
6
6.1
4.2
5.2
5.2.2
6.2 1st sentence
6.2 2nd sentence
6.3
6.4
6.5
6.6
7
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
8
8.1
8.2
8.3
5.2.3
5.2.4
5.2.5
6.1.8
5.2.6
5.2.7
8
8.2.1
8.1.1
8.2.1
8.2.3
8.2.3
8.3
8.6
8.7
8.5
6.1
6.1.2
6.1.3
6.1.5/6.1.6/6.1.7
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17020:1998
PAS 17002 included
Supervision replaced by monitoring
PAS 17005 included
Cross reference 17020:1998 –
17020:2012 (3)
17020:1998
8.4
8.5
8.6
9
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
9.12
9.13
9.14
9.15
10
10.1
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17020:1998
17020:1998
6.1.10
Not included
6.1.11
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
6.2.7
6.2.8
6.2.9
6.2.10
6.2.11
6.2.12
6.2.13
6.2.14
6.2.15
7.1
7.1.1
Cross reference 17020:1998 –
17020:2012 (4)
17020:1998
17020:1998
10.2
7.1.2
10.3
7.1.3
10.4
7.1.4
10.5
7.1.5
10.6
7.1.7
10.7
7.1.8
10.9
7.1.9
11
7.2
11.1
7.2.1
11.2
7.2.3
11.3
7.2.2
11.4
7.2.4
12.1
7.3.1
12
7.3
12.2
7.3.1
12.3
8.4.2
13
7.4/Annex B
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17020:1998
Extended based on IAF/ILAC A4 guidance
Cross reference 17020:1998 –
17020:2012 (5)
17020:1998
17020:1998
17020:1998
13.1
7.4.1
13.2 1st sentence
7.4.2
13.2 1st/2nd sent.
7.4.4
13.3
7.4.2 e)
13.4
7.4.5
14
6.3
14.1
6.3.1 1st sentence
14.2 1st sentence
6.3.1 2nd sentence
14.2 3rd sent.
6.3.2
14.3
6.3.4
14.4
6.3.3
15
7.5/7.6
16
5.2.2 Note
Annex A
Annex A.1
Based on IAF/ILAC guidance A4
Annex B
Annex A.2
Based on IAF/ILAC guidance A4
Annex C
Annex A.3
Based on IAF/ILAC guidance A4
Annex D
8
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Note 1 added based on IAF/ILAC guidance A4
PAS 17003 included
Cross reference 17020:2012 –
17020:1998
17020:2012
17020:1998
Introduction, 4. paragraph
1.2
Introduction, 5. paragraph
Introduction, 6. paragraph
1.3
1.4
1
2
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
4.1
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
1.1
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Remark
Applies to Type A, B, C and any stage
Normative references not included
2.1
New definition
New definition
New definition
2.2
New definition
New definition
New definition
New definition
New definition
4
4.1
1st
sentence
PAS 17001 included
PAS 17001 included
PAS 17001 included
PAS 17001 included
PAS 17001 included
Cross reference 17020:2012 –
17020:1998 (2)
17020:2012
4.1.6
4.1.6 a)
4.1.6 b)
4.1.6 c)
4.2
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.2
5.2.1
5.2.2
5.2.2 Note
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
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17020:1998
4.2
4.2.1
4.2.2
4.2.3
5
3
3.1
3.2
3.3
3.4
3.5
6
Remark
PAS 17002 included
PAS 17001 included
6.1
16
6.2 1st sentence
6.2 2nd sentence
6.3
6.5
6.6
Cross reference 17020:2012 –
17020:1998 (3)
17020:2012
6.1
6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
6.1.6
6.1.7
6.1.8
6.1.9
6.1.10
6.1.11
6.1.12
6.1.13
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
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17020:1998
Remark
8
8.1
8.2
8.3
8.3
8.3
6.4
8.4
8.6
4.1 2nd sentence
5
9
9.1
9.2
9.3
9.4
9.5
Supervision replaced by monitoring
Based on IAF/ILAC guidance A4
PAS 17001 included
PAS 17002 included
Cross reference 17020:2012 –
17020:1998 (4)
17020:2012
17020:1998
6.2.6
6.2.7
9.6
9.7
6.2.8
9.8
6.2.9
9.9
6.2.10
9.10
6.2.11
9.11
6.2.12
9.12
6.2.13
9.13
6.2.14
9.14
6.2.15
9.15
6.3
14
6.3.1 1st sentence
14.1
6.3.1 2nd sentence
14.2
6.3.1 Note
Based on IAF/ILAC guidance A4
6.3.2
14.2
6.3.3
14.4
6.3.4
14.3
7.1
10
7.1.1
10.1
7.1.2
10.2
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Remark
3rd
sentence
Cross reference 17020:2012 –
17020:1998 (5)
17020:2012
17020:1998
7.1.3
10.3
7.1.4
10.4
7.1.5
10.5
Remark
7.1.6
7.1.7
10.6
7.1.8
10.7
7.1.9
10.8
7.2
11
7.2.1
11.1
7.2.2
11.3
7.2.3
11.2
7.2.4
11.4
7.3
12
7.3.1
12.1/12.2
7.3.2
7.4
13
7.4.1
13.1
7.4.2
13.2 1st sentence
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Extended based on IAF/ILAC A4 guidance
Cross reference 17020:2012 –
17020:1998 (6)
17020:2012
7.4.2 e)
17020:1998
Remark
13.3
7.4.3
7.4.4
13.2 2nd/3rd sentence
7.4.5
13.4
7.5
15
PAS 17003 included
7.6
15
PAS 17003 included
8
7/Annex D
PAS 17005 included
8.1.1
8.1.2
7.2
8.1.3
8.2.1
8.2.2
8.2.3
8.2.4
8.3
PAS 17005 included
PAS 17005 included
7.1/7.3
7.4/7.5
7.6
8.4
8.4.2
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12.3
Cross reference 17020:2012 –
17020:1998
17020:2012
17020:1998
8.5
7.9
8.6
7.7
8.7
7.8
Remark
8.8
Annex A.1
Annex A
Based on IAF/ILAC guidance A4
Annex A.2
Annex B
Based on IAF/ILAC guidance A4
Annex A.3
Annex C
Based on IAF/ILAC guidance A4
Annex B
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Based on IAF/ILAC A4 guidance
Presentation preapared by:
Marcus Schmid
is Director Management Systems
Voith Turbo GmbH & Co KG, and
Director Quality Management
Voith Turbo Rail Division. Mr.
Schmid is Convenor of ISO/CASCO
working group WG 31, which
developed ISO/IEC 17020. He is
also member of the DIN Quality
Management, Statistics and
Certification Standards
Committee, and chairs the DIN
mirror committee to WG 31.
Tel. +49 (0) 7321 37-8155
[email protected]
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Gerd-Hinrich Schaub
is a consultant of the Association of
the TÜV (VdTÜV) and technical
advisor of the International
Confederation of Inspection and
Certification Organisations
(CEOC). His main focus is
conformity assessment, product
marking and accreditation. He is a
member of several ISO/CASCO
working groups and committees
of accreditation associations
(ILAC and EA).
Tel. +49 (0) 201-49 39 22
[email protected]