1. 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
CIGRÉ 2014, Paris, France Maurizio Scavazzon

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

3. Some general definitions:
TEST
CERTIFICATION
ACCREDITATION
NOTIFICATION
DIN EN /98
pt. 13.1
DIN EN /98 pt
DIN EN /98 pt
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.
CIGRÉ 2014, Paris, France Maurizio Scavazzon

4. 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
CIGRÉ 2014, Paris, France Maurizio Scavazzon

5. 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
CIGRÉ 2014, Paris, France Maurizio Scavazzon

6. 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)
CIGRÉ 2014, Paris, France Maurizio Scavazzon

7. 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)
CIGRÉ 2014, Paris, France Maurizio Scavazzon

8. 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.
CIGRÉ 2014, Paris, France Maurizio Scavazzon

9. 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)
CIGRÉ 2014, Paris, France Maurizio Scavazzon

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

11. 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.
CIGRÉ 2014, Paris, France Maurizio Scavazzon

12. 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
CIGRÉ 2014, Paris, France Maurizio Scavazzon

13. 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 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 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
CIGRÉ 2014, Paris, France Maurizio Scavazzon

14. 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.
CIGRÉ 2014, Paris, France Maurizio Scavazzon

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

16. Maurizio Scavazzon Global Product Manager Communication Protocols
Any questions?
Maurizio Scavazzon
Head of Smart Grid Services
Phone:
Fax:
TÜV SÜD Product Service GmbH Smart Grid Services
Barthstr. 16 / 3.OG
80339 Munich
Germany
Maurizio Scavazzon
Global Product Manager Communication Protocols
Phone:
Fax:
19/09/2018
V-INM