Worldwide System for Conformity Testing and Certification of Electrical Equipment (IECEE) IECEE Copyright 2008 Definition of Product Consultancy, Independence and Impartiality for Certification Bodies and Testing Laboratories IECEE Lead Assessor Training, Geneva, CH 1/26

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH2/26 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: References Assessment Tool

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH3/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH4/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH5/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH6/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH7/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH8/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH9/26 An Example for Suggesting Appropriate Alternatives The following Normal Temperature Test was carried out on Tuner-Amplifier Model DEF-456 according to Sub- clauses 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 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH10/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH11/26 An Example for Suggesting Appropriate Alternatives 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. Other alternatives might be: 1) to increase the rating of the resistor, 2) to use a heat sink on the resistor.

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH12/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH13/26 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH14/26 IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996 G Impartiality and independence of the certification body should be assured at three levels: Strategy and Policy; Decisions on Certification; Evaluation. G 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 Copyright 2008IECEE Lead Assessor Training, Geneva, CH15/26 G 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 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. IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH16/26 G 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 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 IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH17/26 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 IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH18/26 CONSULTANCY G 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. IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH19/26 G 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. IAF Guidance Document 5:2006 on the Application of ISO/IEC Guide 65:1996

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH20/26 ISO/IEC 17025: References ISO/IEC 17025:2005 References 4.1.4influence on the testing activities 4.1.4Note: a third-party laboratory should be able to demonstrate that it is impartial b) management and personnel are free from pressures and influences that may adversely affect the quality of their work d) avoid activities that may diminish confidence in its competence, impartiality, judgement or operational integrity

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH21/26 ISO/IEC 17025: References There is no ILAC guidance on the application of ISO/IEC 17025:2005 IECEE-CMC OD-CB2040-Ed.1.3: There are no “JWG Common Understandings” related to independence and impartiality

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH22/26 Assessment Tool for “Independence and Impartiality” Including “Commercial Product Consultancy”

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH23/26 Assessment Tool for “Independence and Impartiality” Including “Commercial Product Consultancy”

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH24/26 Assessment Tool for “Independence and Impartiality” Including “Commercial Product Consultancy”

IECEE Copyright 2008IECEE Lead Assessor Training, Geneva, CH25/26 Assessment Tool for “Independence and Impartiality” Including “Commercial Product Consultancy”