Transcript OIML Certification System

46th CIML, 10-14 October 2011
Acceptance of test results from
Manufacturers' Test Laboratories (MTL)
within the MAA
Agenda item 10.3.3
Roman Schwartz
R. Schwartz, 46. CIML 2011
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Manufacturers' Test Laboratories (MTL) within the MAA
References:
1.
Working Document (version 3) - 46th CIML Meeting 2011,
item 10.3.3:
OIML TC3/SC5 proposal for a CIML Resolution on the
acceptance of manufacturers' test results within the MAA
2.
Addendum 10.3 to 46th CIML Working Document,
No 2:
TC3/SC5 Report to the CIML (22 March 2011):
Taking into account test results from Manufacturers' Testing
Laboratories (MTL) under controlled supervision by the
Issuing Participants in DoMCs
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Background
43rd CIML Meeting, 2008, Resolution No 20:
"... For the time being, Issuing Participants shall not issue OIML MAA
Certificates in the event that results of tests outside the scope of the DoMCs
are taken into account (e.g. test results from manufacturers) in the Evaluation
Reports. In this case an OIML Basic Certificate may still be issued as long as
the MAA does not provide this possibility.
The Committee supports the intention of TC 3/SC 5 to further discuss
the acceptance of manufacturers’ test results, with the aim of ultimately
including them in the scope of the MAA if consensus can be reached on the
conditions to be applicable to manufacturers ISO/IEC 17025 test
laboratories."
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What happened since 2008? (1)
April 2009:
Two voluntary, complete peer assessments of the MTLs of two
well-known European weighing instrument manufacturers were
performed in accordance with the OIML MAA rules
(organized by PTB):
 Assessment team:
 2 assessors: lead (Brian Beard, ZA) and technical/ metrological
expert (Michael Denzel, DE) were chosen from the official MAA list
of experts (OIML/ILAC/IAF)
 3 observers (from ZA and DE)
 Duration: 5 days (1 day for preparation + 2 days for each MTL)
 Assessment reports:
Complete final reports (including non-conformities found) were made
available to CPR and TC3/SC5 members
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Conclusions of the assessors for both MTLs
 “…The quality system was found to be suitable and effective for
the activities of the laboratory and it was adequately entrenched
and maintained.
 Four non-conformities were found and these related to the lack
of policies and procedures regarding the formal registering of
application for type approvals with the Issuing Authority, ...
 Once the above non-conformances have been addressed it is
concluded that the laboratory will be suitable as a test laboratory
for providing test results according to OIML R 76 to the … Issuing
Authority for evaluation of conformity under the DoMC for R 76.”
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What happened since 2008? (2)
June 2009:
4th CPR meeting (Bern/CH):
 Presentation and discussion of conclusions of the final assessment reports
 Subsequent CPR inquiry  agreement on an MTL proposal  TC3/SC5
October 2010:
TC3/SC5 meeting (Paris/FR):
 Discussion of a new MTL concept developed on the basis of CPR proposals
 MTLs under controlled supervision by the Issuing Participants in DoMCs
 Proposal to add (for the time being) an option for IPs in a DoMC to accept
MAA Reports with MTL test data "on a voluntary basis"
 Subsequent inquiry  agreement on MTL Report and Draft CIML Resolutions
September 2011:
5th CPR meeting (Braunschweig/DE):
 Presentation of the new concept and discussion of the Draft CIML
Resolutions
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MTL under controlled supervision by an IP
DoMC
Assess.
team
Complete
MAA
assessment
B10:2011
procedure
(CIML Res.
according to
item 10.3.2)
ISO/IEC 17025...
... with additional
New
safeguards:
revision
of / or 1. Controlled
supervision
Amendment 2. Independence
to
+ impartiality
B10:2011 3. Initial intercomparison
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IP1: TL + MTL
IP2: TL
UP: no TL
CPR
2.
MTL
1.
IP1
3.
Discussion in
TC3/SC5 about
a "fast track"
 Draft CIML
Resolutions
(item 10.3.3)
OIML MAA
Certificate
+
MAA Type
Evaluation
Report
IP2
voluntary
acceptance
UP
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Draft CIML Resolution proposed by TC3/SC5
Further to Resolution No 20 at the 43rd CIML Meeting,
Issuing Participants may request the registration of
Manufacturers’ Testing Laboratories (MTLs) under a
DoMC, provided that the conditions agreed by TC 3/SC 5
and laid down in a respective amendment to OIML B 10 are
met. OIML MAA Type Evaluation Reports that contain test
results from MTLs may be accepted by Participants on
a voluntary basis.
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Draft Resolution No. ...1 (Agenda item 10.3.3)
Draft Resolution No. …
The Committee,
Noting the report of TC 3/SC 5 on the issue of the acceptance of
manufacturers’ test results within a DoMC under the MAA,
Recalling its Resolution No. 20 at the 43rd CIML Meeting,
Decides
- that Issuing Participants may request the registration of Manufacturers’
Testing Laboratories (MTLs) under a DoMC, provided that the conditions
agreed by TC 3/SC 5 and laid down in a respective amendment to OIML B
10 are met,
- that OIML MAA Type Evaluation Reports that contain test results from
MTLs may be accepted by Participants on a voluntary basis.
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Amended Resolution No. ...1 (Agenda item 10.3.3)
As an outcome of the discussions at the 5th CPR meeting (September
2011), an improved (unambiguous) version of this Resolution is
suggested which is in line with the intention of TC3/SC5:
Draft Resolution No. …
The Committee,
Noting the report of TC 3/SC 5 on the issue of the acceptance of
manufacturers’ test results within a DoMC under the MAA,
Recalling its Resolution No. 20 at the 43rd CIML Meeting,
Decides
- that Issuing Participants may request the registration of Manufacturers’
Testing Laboratories (MTLs) under a DoMC, provided that the conditions
agreed by TC 3/SC 5 and laid down in a respective amendment to (or
revision of) OIML B 10 are met, and that after this amendment to (or
revision of) B10, OIML MAA Type Evaluation Reports that contain test
results from MTLs may be accepted by Participants on a voluntary basis.
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Draft Resolution No. ...2 (Agenda item 10.3.3)
Only in case of a positive CIML vote on Resolution ...1 the CIML is
asked to vote on another Resolution as regards MTLs:
Draft Resolution No. …
The Committee,
Recalling its Resolution No. xx,
Approves as a new work item for OIML TC 3/SC 5:
- the revision of OIML B 10 “Framework for a Mutual Acceptance
Arrangement on OIML Type Evaluations (MAA)” to include appropriate
conditions for the registration of Manufacturers’ Testing Laboratories
(MTLs) under a DoMC,
Decides
- that the registration of MTLs under a DoMC remains excluded from the
scope of the MAA, until this revision of OIML B 10 is approved.
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Amended Resolution No. ...2 (Agenda item 10.3.3)
Again, as an outcome of the discussions at the 5th CPR meeting
(September 2011), a slightly changed version is suggested which
brings this Resolution in line with Resolution No. ...1:
Draft Resolution No. …
The Committee,
Recalling its Resolution No. xx,
Approves as a new work item for OIML TC 3/SC 5:
- the amendment to (or revision of) OIML B 10 “Framework for a Mutual
Acceptance Arrangement on OIML Type Evaluations (MAA)” to include
appropriate conditions for the registration of Manufacturers’ Testing
Laboratories (MTLs) under a DoMC,
Decides
- that the registration of MTLs under a DoMC remains excluded from the
scope of the MAA, until this amendment to (or revision of) OIML B 10 is
approved.
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Conclusion
• After 6 years of discussions and 3 years of hard work, the presented concept of
MTLs under controlled supervision by the Issuing Participants in DoMCs can be
considered as mature enough to provide appropriate and effective safeguards that
justify MTLs to be included in the scope of the MAA as soon as possible.
• Nevertheless, in case of a positive CIML vote on the two MTL Resolutions,
TC3/SC5 will have to re-discuss and elaborate the details in order to properly
implement the concept in B10 on the basis of the MTL report of 22 March 2011.
• The inclusion of MTLs in the scope of the MAA will certainly raise the number of
MAA Certificates, because Issuing Participants will no longer be obliged to issue
OIML Basic Certificates when they make use of test results from MTLs.
• Opponents or still relunctant Participants in a DoMC will have the option to accept
MAA Certificates and related MAA Type Evaluation Reports on a voluntary basis,
until sufficient experiences have been gained with the new MTL concept which is
similar to MTL concepts in other international certification schemes (e.g. IEC CB).
• The CIML vote on the two MTL Resolutions will be a very important decision with
far-reaching consequences for IPs, manufacturers and the future of the MAA.
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