Definition of Product Consultancy, Independence - IEC - ILAC

advertisement
Worldwide System for
Conformity Testing and Certification
of Electrical Equipment (IECEE)
Definition of Product Consultancy,
Independence and Impartiality for
Certification Bodies and Testing
Laboratories
IECEE Lead Assessor Training, Geneva, CH
1/26
IECEE Copyright 2008
Definition of Product Consultancy, Independence
and Impartiality for Certification Bodies and Testing
Laboratories
An Initial Inquiry from the Head of CASCO
What is Product Consultancy?
What is Not Product Consultancy?
An Example for Suggesting Appropriate Alternatives
Introduction to Independence and Impartiality –
ISO/IEC Guide 65 – References and IAF Guidance
ISO/IEC 17025:2005 - References
Assessment Tool
IECEE Lead Assessor Training, Geneva, CH
2/26
IECEE Copyright 2008
An Initial Inquiry From the Head of CASCO
In the course of the revision of ISO/IEC Guide 65 into ISO/IEC 17065,
CASCO requested any information about an IECEE definition for
“product consultancy” as this would be of assistance to the CASCO
WG 29 in agreeing on a definition.
The IECEE response from the IECEE Secretariat to the inquiry noted
that the IECEE principles developed in concert with the Peer
Assessment Committee include that "commercial consultancy" exists
whenever a Testing Laboratory and/or a Certification Body provides
the customer with the solution(s) to overcome a non-conformity or
discrepancy of the product against an IEC Standard.
This exchange between the Head of ISO CASCO and consultation
with the IECEE PAC has led to the development of this presentation.
IECEE Lead Assessor Training, Geneva, CH
3/26
IECEE Copyright 2008
What is Product Consultancy?
What is “commercial” consultancy and what is not “commercial”
consultancy is always a tricky issue for NCBs and their CBTLs.
 It is particularly important for an NCB or CBTL not to suggest
actual design changes that might bring the product in
compliance with the IEC Standard's requirements.
 If an NCB or CBTL/ACTL makes an error in suggesting a
change when, in fact, by test it could prove to be unacceptable,
a gross mistake has been made and the NCB or CBTL/ACTL
can be put in an uncomfortable position.
 It is not the NCB’s or CBTL's/ACTLs job to redesign products
to comply with the IEC Standard's requirements (i.e.
"commercial design consultancy").
IECEE Lead Assessor Training, Geneva, CH
4/26
IECEE Copyright 2008
What is Not Product Consultancy?
Should the NCB or CBTL/ACTL wish to be more helpful to the
customer, it would be proper to suggest appropriate alternatives
in accordance with the IEC Standard, or with published
interpretations or decision sheets. The format for describing a
particular situation and suggesting an appropriate alternative(s)
is generally the following:
• Description of product construction,
• Statement as to why the particular construction is
not acceptable,
• Reference to the appropriate IEC Standard requirement by
Sub-clause, published interpretation or decision sheet,
• Suggestion of appropriate alternative(s), and,
• Action required of the Applicant.
IECEE Lead Assessor Training, Geneva, CH
5/26
IECEE Copyright 2008
What is Not Product Consultancy?
In the extreme, any guidance given to a customer can be
considered to be “commercial consulting.”
In practice, however, certification bodies try to expedite the
certification process to help the customer and themselves by
providing some generic advice.
Some organizations even have specific rules on what kind of
advice is not considered to be “commercial consulting.”
The following are some generic criteria that I have seen:
IECEE Lead Assessor Training, Geneva, CH
6/26
IECEE Copyright 2008
What is Not Product Consultancy?
1. It is not a unique method of solving a problem but rather
one of a number of well-known solutions.
2. It is not based on someone else’s proprietary information,
such as a unique construction seen in a product of
another customer.
3. The same type of advice is given to all customers, as may
be applicable. There may be a printed list of alternative
methods of overcoming common problems; and, such a
list is provided to all customers.
4. The customer must understand that it is the customer who
is responsible for choosing any specific design and
ensuring that it complies with the requirements.
IECEE Lead Assessor Training, Geneva, CH
7/26
IECEE Copyright 2008
What is Not Product Consultancy?
The ultimate objective in avoiding “commercial consulting”
is the need to maintain independence and the avoidance of
any (real or perceived) conflict of interest that could arise if
a specific solution proposed by a NCB or CBTL/ACTL did
not address the identified problem.
IECEE Lead Assessor Training, Geneva, CH
8/26
IECEE Copyright 2008
An Example for Suggesting Appropriate
Alternatives
The following Normal Temperature Test was carried out
on Tuner-Amplifier Model DEF-456 according to Subclauses 33.1 to 33.8 of IEC Standard 60ZZZ and
Published Interpretation TC-AA BBB.
At the conclusion of the Normal Temperature Test,
Resistor R45 operated at 122.4 degrees C in an ambient
of 26 degrees C. This result is not acceptable as the
temperature rating of the printed wiring board with which
the resistor is in contact is only 105 degrees C.
IECEE Lead Assessor Training, Geneva, CH
9/26
IECEE Copyright 2008
An Example for Suggesting Appropriate
Alternatives
• Either a printed wiring board with a temperature rating
according to the test results needs to be provided, or
• the resistor should be sufficiently elevated from the
printed wiring board to ensure that the adhesive bond
between the conductor foils and base material is not
subjected to this temperature.
IECEE Lead Assessor Training, Geneva, CH
10/26
IECEE Copyright 2008
An Example for Suggesting Appropriate
Alternatives
Other alternatives might be:
1) to increase the rating of the resistor,
2) to use a heat sink on the resistor.
Please inform us of the intended means to resolve this
comment. If any additional test work is necessary, we will
inform you of our sample and cost requirements.
IECEE Lead Assessor Training, Geneva, CH
11/26
IECEE Copyright 2008
Introduction to Independence and
Impartiality – ISO/IEC Guide 65
ISO/IEC Guide 65:1996 References
4.2 Organization
a) be impartial
e) documented structure which safeguards impartiality
m) documented structure that assures freedom from pressures
which might influence the results of the certification process
n) certification committee structure that assures that such
committees are free from pressures that might influence
decisions
n) certification committee structure that is balanced where no
single interest predominates
IECEE Lead Assessor Training, Geneva, CH
12/26
IECEE Copyright 2008
Introduction to Independence and
Impartiality – ISO/IEC Guide 65
o) ensure that activities of related bodies do not affect
confidentiality, objectivity and impartiality
1) supply or design products of the types it certifies
2) provide advice or consulting services
3) provide any other products or services which could
compromise the confidentiality, objectivity or impartiality
IECEE Lead Assessor Training, Geneva, CH
13/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
G.4.2.8 Impartiality and independence of the certification
body should be assured at three levels:
• Strategy and Policy;
• Decisions on Certification;
• Evaluation.
G.4.2.9 Impartiality, as required by clause 4.2.a) of ISO/IEC
Guide 65 can only be safeguarded by a structure, as
required by clause 4.2.e) of ISO/IEC Guide 65, that enables
“the participation of all parties significantly concerned in the
development of policies and principles regarding the content
and functioning of the certification system”.
IECEE Lead Assessor Training, Geneva, CH
14/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
G.4.2.10 The structure required by ISO/IEC Guide 65, clause
4.2.e) for the safeguarding of impartiality should be separate
from the management established to meet the requirements
of ISO/IEC Guide 65, clause 4.2.c), unless the entire
management function is performed by a committee or group
that is constituted to enable participation of all parties as
required by ISO/IEC Guide 65, clause 4.2.e).
G.4.2.11 The structure required by ISO/IEC Guide 65, clause
4.2.e) should also be such that commercial or other financial
considerations do not prevent the consistent, objective
provision of the certification body´s service.
IECEE Lead Assessor Training, Geneva, CH
15/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
G.4.2.12 Clause 4.2.e) of ISO/IEC Guide 65, requires that the
documented structure of the certification body contains provision
for the participation of all the significantly concerned parties. This
should normally be through some kind of committee.
G.4.2.13 This structure shall be formally established at the
highest level within the organization either in the documentation
that establishes the certification body’s legal status or by some
other means that prevents it being changed in a manner that
compromises the safeguarding of impartiality. Any change in this
structure should take into account advice from the committee, or
equivalent, referred to in clause 4.2.e).
This committee, or equivalent shall
IECEE Lead Assessor Training, Geneva, CH
16/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
a) assist in developing the policies relating to impartiality
of its certification activities
b) counteract any tendency on the part of the owners of a
certification body to allow commercial or other
considerations to prevent the consistent objective
provision of certification activities
c) advise on matters affecting confidence in certification,
including openness and public perception
IECEE Lead Assessor Training, Geneva, CH
17/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
CONSULTANCY
G 4.2.19 Consultancy services on matters which are barriers
to certification would be participation in an active creative
manner in the development and ongoing monitoring/
improvement of the product, process, or service, by, for
example:
a) providing specific support/advice on elements of the design,
b) preparing or producing manual, handbooks or procedures,
c) involvement in the supplier’s monitoring, review and decision
making process applicable to the product.
IECEE Lead Assessor Training, Geneva, CH
18/26
IECEE Copyright 2008
IAF Guidance Document 5:2006 on the
Application of ISO/IEC Guide 65:1996
G.4.2.30 The certification body is allowed to explain its
findings and/or clarify the requirements of the normative
documents but shall not give prescriptive advice or
consultancy as part of an evaluation. This does not
preclude normal exchange of information with the clients
and other interested parties.
IECEE Lead Assessor Training, Geneva, CH
19/26
IECEE Copyright 2008
ISO/IEC 17025:2005 - References
ISO/IEC 17025:2005 References
4.1.4 influence on the testing activities
4.1.4 Note: a third-party laboratory should be able to
demonstrate that it is impartial
4.1.5 b) management and personnel are free from
pressures and influences that may adversely
affect the quality of their work
4.1.5 d) avoid activities that may diminish confidence in
its competence, impartiality, judgement or
operational integrity
IECEE Lead Assessor Training, Geneva, CH
20/26
IECEE Copyright 2008
ISO/IEC 17025:2005 - References
There is no ILAC guidance on the application of ISO/IEC
17025:2005
IECEE-CMC OD-CB2040-Ed.1.3:2007-08-10
There are no “JWG Common Understandings” related to
independence and impartiality
IECEE Lead Assessor Training, Geneva, CH
21/26
IECEE Copyright 2008
Assessment Tool for “Independence and
Impartiality” Including “Commercial Product
Consultancy”
IECEE Lead Assessor Training, Geneva, CH
22/26
IECEE Copyright 2008
Assessment Tool for “Independence and
Impartiality” Including “Commercial Product
Consultancy”
IECEE Lead Assessor Training, Geneva, CH
23/26
IECEE Copyright 2008
Assessment Tool for “Independence and
Impartiality” Including “Commercial Product
Consultancy”
IECEE Lead Assessor Training, Geneva, CH
24/26
IECEE Copyright 2008
Assessment Tool for “Independence and
Impartiality” Including “Commercial Product
Consultancy”
IECEE Lead Assessor Training, Geneva, CH
25/26
IECEE Copyright 2008
Download