OPERATIONAL DOCUMENT ECS 033. General principles covering the use of Manufacturers' Testing Laboratories

Transcription

1 OPERATIONAL DOCUMENT ECS 033 General principles covering the use of Manufacturers' Testing Laboratories Approved by: ECS General Meeting, 22/ No. of pages: 7 Date of issue: January 2013 (Administrative update) Supersedes: OD ECS June 2009 Page 1 of 7 EEPCA, the European Electrical Products Certification Association 17, rue de l Amiral Hamelin, F Paris Cedex 16 Tel: secretariat@eepca.eu Document issued and distributed by EEPCA EEPCA 2013 all rights reserved

2 FRAMEWORK FOR DOCUMENTATION COVERING THE USE OF MANUFACTURERS TESTING LABORATORIES GENERAL PRINCIPLES REGARDING USE OF MANUFACTURERS TESTING LABORATORIES OD-ECS 033 (OD-CB 2027) ASSESSMENT OF MANUFACTURERS TESTING LABORATORIES OD-ECS 034 (OD-CB 2032) OPERATION OF TMP PROCEDURE OD-ECS 037 (OD-CB 2028) OPERATION OF WMT PROCEDURE OD-ECS 038 (OD-CB 2029) OPERATION OF SMT PROCEDURE OD-ECS 035 (OD-CB 2030) OD ECS January 2013 page 2 of 7

3 Table of Comparison of Programmes for TL, TMP, WMT, SMT Laboratory Type Testing Location TL TMP WMT SMT TL Manufacturer Manufacturer Manufacturer Definitions (who is doing the work) A laboratory successfully assessed within a ECS Scheme performs all necessary tests with own equipment in own facilities A representative of an accepted TL, under the responsibility of its CB performs the full test in a laboratory with its own or the equipment A representative of an accepted TL, under the responsibility of its CB witnesses all tests done by a laboratory which uses its own equipment A representative of an accepted CB or an accepted TL, on request of an CB, supervises the quality management system and the laboratory testing processes and witnesses some part of each agreed testing program at a laboratory, which uses its own equipment. Tested by * TL TL Manufacturer Manufacturer Witnessed by* none none CB or TL none OD ECS January 2013 page 3 of 7

4 Laboratory Type TL TMP WMT SMT Authorised (Reviewed and Approved) by* TL TL CB or TL Manufacturer Supervised by* none none none CB or TL by delegation CB Certificate Presence at each individual project CB CB CB CB Yes (100 %) Yes (100 %) Yes (100 %). Some part of each product testing program must be witnessed on site Equipment Requirements standard(s) except for allowed subcontracting identified as s in the IECEE CTL Lists standard(s) / part(s) of standard(s) standard(s) / part(s) of standard(s) standard(s) / part(s) of standard(s) Assessment/Re- Assessments/Follow up Assessments (for TL)/ Follow-up auditing (for Manufacturer) (See OD CB ) ECS Peer Assessment Programme Assessment by CB based on OD ECS 037 within scope of arrangement Assessment by CB or by a representative of an accepted TL, on the request of a CB, based on OD ECS 038 within scope of arrangement Assessments by CB, or by a representative of an accepted TL, on the request of the CB, based on OD ECS 035 within scope of arrangement OD ECS January 2013 page 4 of 7

5 Relationship between CB and operator of laboratory Ownership or technical control contract with one or more CB(s) in different category(ies) according to PD ECS 050 and EN ISO/IEC Agreement with more than one CB is possible TMPL shall not be permitted to participate for more one CB for the same product model Agreement with more than one CB is possible WMTL shall not be permitted to participate for more one CB for the same product model Agreement with more than one CB is possible SMTL shall not be permitted to participate for more one CB for the same product Model Agreement with more than one CB is possible Agreement between CB, TL and MTL An agreement TL(s) is required if different legal entities is required An Agreement MTL and TL is required. (See OD ECS 037) An Agreement MTL and TL is required. (See OD ECS 038) An Agreement MTL and TL is required. (See OD ECS 035) Registration of the MTL List of Testing Laboratories associated to a CB for the different agreements Yes Yes Yes Supervision / Training CBs are involved) Required (may be coordinated when multiple CBs are involved) *NB: Signing persons shall be chosen appropriately in order to avoid any conflict of interest. Through the according to scope of operation Through respective Through respective Through respective Participation in CMC Meeting Yes, through Member Body representation No No No Participation in CTL Meeting Yes On voluntary basis On voluntary basis On voluntary basis Participation in CB Proficiency Testing Program Required Not required under the IECEE CTL PTP programme, required under the responsibility of the relevant CB Not required under the IECEE CTL PTP programme, required under the responsibility of the relevant CB Required (may be coordinated when multiple CBs are involved) *NB: Signing persons shall be chosen appropriately in order to avoid any conflict of interest. OD ECS January 2013 page 5 of 7

6 General Principles covering the use of Manufacturers' Testing Laboratories 0. Foreword This document is harmonised, as far as applicable, with the current OD CB 2027:Ed.2.2 of the IECEE CB Scheme. 1. Introduction 1.1 Many manufacturers who use the ECS Schemes have capable test laboratories in terms of personnel, facilities, and equipment, for testing the types of product for which they have responsibility for design, development, and production. In recognition of the market needs to utilise these facilities, procedures have been established for obtaining Notification Test Results (NTRs) or marks, like ENEC, HAR, etc., under controlled conditions. These procedures are an alternative to testing at a TL. 1.2 Four Three different Procedures have been developed for using a test facility: Case A: Case B: Case C: Testing at Manufacturer s Premises (TMP) Procedure (see OD ECS 037) Witnessed Manufacturer s Testing (WMT) Procedure (see OD ECS 038) Supervised Manufacturer s Testing (SMT) Procedure (see OD ECS 035) The above cases shall be considered as a whole to be a progression from full control of testing by a TL to full confidence in the capability of the laboratory. 2. References All the following documents have to be used in conjunction with the above mentioned ODs: PD ECS 050, EN ISO/IEC 17025, EN ISO/IEC 17065, applicable ECS/CIG PDs & ODs, OSMs, IECEE CTL Decisions, applicable Documents and PAAG decisions. 3. Definitions 3.1 Testing Laboratory (TL): A laboratory independent of manufacturing interests that has been recognised within an ECS Scheme to test specified categories of products and to issue test reports. 3.2 Testing at Manufacturer s Premises Laboratory (TMPL): A laboratory being used by TL staff. 3.3 Witnessed Manufacturer s Testing Laboratory (WMTL): A laboratory being used for 100 % Witnessed Testing by the CB or, at the request of the CB, by a TL. OD ECS January 2013 page 6 of 7

7 3.4 Supervised Manufacturers Testing Laboratory (SMTL): A laboratory being used by an CB to conduct agreed testing within categories of products for which the manufacturer has design and production responsibility, generally with supervision of tests and quality processes. 3.5 Ownership of Manufacturer s Testing Laboratory (MTL): an MTL is a testing laboratory that is owned by a "Manufacturer" who has full responsibility for continued compliance of the MTL with the relevant requirements of EN ISO/IEC and CIG & ECS Operational Documents. In addition: a) an outsourced (third party) laboratory is not permitted to operate as a MTL. b) an MTL is not permitted to carry out testing of products made by other manufacturers. 4. General principles applicable to all the procedures listed in Clause 1.2 All testing carried out at Manufacturer s Testing Laboratories shall be in accordance to the relevant requirements of EN ISO/IEC and the applicable ECS procedures and decisions. Test results obtained shall be from a sample representative of production. The CB shall have the right to conduct any test prior to issuing a CB Test Certificate. The CB shall only allow Manufacturer's Testing for specific categories of equipment for which the manufacturer has a proven capability. A manufacturer permitted to use Manufacturer's Testing shall not use this fact for promotional or advertising purposes. The Secretariat of EEPCA shall maintain and publish a register of those manufacturers participating and the categories of product involved. OD ECS January 2013 page 7 of 7