Testing and Certification according to ISO 17025 and ISO 17065 Maurizio Scavazzon TÜV SÜD Product Service GmbH Smart Grid Services UCAIug booth #370, Level 3, CIGRÉ 2014 Exhibition, Palais des Congrès, Paris, France 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

CIGRÉ 2014, Paris, France Maurizio Scavazzon Agenda Testing according to ISO 17025 Certification according to ISO 17065 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Some general definitions: TEST CERTIFICATION ACCREDITATION NOTIFICATION DIN EN 45020 07/98 pt. 13.1 DIN EN 45020 07/98 pt. 15.1.2 DIN EN 45020 07/98 pt. 12.11 Technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure. Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements. Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. Formal publication of an accredited certification body for EC directives in the official journal of the EC. 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

CIGRÉ 2014, Paris, France Maurizio Scavazzon “General Requirements for the Competence of Testing and Calibration Laboratories” ISO/IEC 17025:2005 Base line for accreditation For routine and non routine Testing Laboratories, not for research and scientific laboratories One man laboratories possible under certain circumstances Requirements of ISO 9001/9002: 08/94 contained Classification to first- second- and third-party laboratories 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Management requirements, Organization Laboratory shall be an entity that can be held legally responsible Laboratory shall work in a way to - meet the requirements of this standard - satisfy the needs of the clients - the regulatory authorities or organizations providing recognition Management system shall cover all work no influence on work from other parts of organizations with other interest (commercial) personnel and resources need to carry out duties Lab has to work confident, impartial, without diminish judgment and operational integrity specify the responsibility, authority and interrelationships of personnel quality manager independent from other duties and responsibilities deputies for key managerial personnel 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Factors determining the correctness and reliability of the tests Reliability of tests Human factors Accommodation and environmental conditions Test and calibration methods and method validation Equipment Measurement traceability Sampling Handling of the test and calibration items (Technical requirements of ISO/IEC 17025, chapter 5) 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

CIGRÉ 2014, Paris, France Maurizio Scavazzon Quality Management Quality system Document control establish, implement and maintain quality system, with policies, systems, procedures, instructions which are understood, available, implemented define objectives and policies which are documented (written) procedure to control all docs which are part of its quality system all docs shall be reviewed and approved, list with current revision status - no old docs, available where necessary - periodically reviewed uniquely identified, date/revision, pages, issuing authority(ies) 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

CIGRÉ 2014, Paris, France Maurizio Scavazzon Personnel Management requirements to personnel Technical requirements to personnel Laboratory have managerial and technical personnel (irrespective of other responsibilities) who have the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system and initiate actions if required Free from any undue internal and external pressures and influences Specify responsibilities, authority and interrelations of all personnel which activities can influence the quality of the result Appropropriate supervision of testing staff and trainees Laboratory management shall ensure the competence of personnel for operation specific equipment, perform tests, evaluate results, sign test reports Personnel responsible for opinions and interpretation at reports have relevant knowledge of technology including legislation, understanding significance of deviations Training programme: Management formulates goals for education, training and skills of personnel. Needs are identified and training programme is evaluated. 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Nonconformities and corrections Control of nonconforming (NC) work Corrective action (CA) lab shall have policy and procedure that shall be implemented in case of nonconforming work which defines: - responsibilities, authorities and actions - evaluation of the nonconforming work - corrective actions and decisions about acceptability of NC-work - where necessary, client is notified and work recalled - responsibility for resumption of work policy and procedure and designate appropriate authorities for implementation of corrective action after NC-work has been identified root cause analysis select and implement action most likely to eliminate problem monitor results of corrective action control appropriate areas of activity (internal audits) 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

CIGRÉ 2014, Paris, France Maurizio Scavazzon Agenda Testing according to ISO 17025 Certification according to ISO 17065 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Product, Process and Service Certification The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfills specified requirements. The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfillment of specified requirements by a third-party. 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 - 1 Scope of ISO 17065 The scope in ISO/IEC17065 specifies as in ISO/IEC Guide 65 three objects of conformity assessment: product, process and service. The scope together with Annex B gives information on the application of the standard for processes and services The scope is to be read in connection with the definition of “certification body” in clause 3.12: third-party conformity assessment body operating certification schemes 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 - 3 Impartiality Mechanism for safeguarding impartiality The requirements on impartiality in clause 4.2 have significantly been improved compared with the requirements in clause 4.2 o) of ISO/IEC Guide 65. The obligatory requirements of ISO 17001 are incorporated in clause 4.2. Clause 4.2 clarifies in detail what activities can be performed by the certification body and any part of the legal entity it belongs to and what activities can be performed by organizations with which the certification body has relationships Supplementing the impartiality requirements, a mechanism for safeguarding impartiality is specified in clause 5.2. This mechanism is based on the recommended requirements in ISO 17001. It clarifies and details the provisions in clause 4.2 e) of ISO/IEC Guide 65 to enable the participation of parties significantly concerned. According to ISO/IEC17065 a possible mechanism can be a committee established by one or more certification bodies, a committee implemented by a scheme owner, a governmental authority or an equivalent party 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 - 4 Four Eyes Principle Certification decision The four-eyes principle contained in clause 4.2 f of ISO Guide 65 is kept in ISO/IEC17065 by clarifying that the review and decision has to be performed by person(s) different from those who carried out the evaluation whereas review and decision can be done by the same person(s) As in ISO/IEC Guide 65 the certification decision shall be made by person(s) employed by or under contract with the certification body meaning that subcontracting or otherwise delegating the certification decision is not allowed. 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Application of the Standards Certification after Review ISO 17065 Certification Body Test Report Standards Test Procedure ISO 17025 Testing Laboratory Samples Customer 19.09.2018 CIGRÉ 2014, Paris, France Maurizio Scavazzon

Maurizio Scavazzon Global Product Manager Communication Protocols Any questions? Maurizio Scavazzon Head of Smart Grid Services Phone: +49 89 5008-4747 Fax: +49 89 5155-2444 maurizio.scavazzon@tuev-sued.de www.tuev-sued.de/smartgrid TÜV SÜD Product Service GmbH Smart Grid Services Barthstr. 16 / 3.OG 80339 Munich Germany Maurizio Scavazzon Global Product Manager Communication Protocols antonello.gaviano@tuev-sued.de Phone: +49 89 5791-2693 Fax: +49 89 5791-3437 19/09/2018 V-INM