Quality Infrastructure and Accreditation in Germany Dr. Tilman Denkler Workshop “Certification for agricultural commodities and accreditation for certifying bodies (March 14th to April 1st 2011)” Berlin, 2011-03-28

Content What is a Quality Infrastructure? Tasks of BAM in the area of Quality Infrastructure Introduction to the principles of product certification General and special requirements of ISO/IEC Guide 65 Accreditation of certification bodies The German accreditation body DAkkS (separate presentation) 2011-03-28 – Slide 2 Dr. Tilman Denkler

Tilman Denkler Scientific employee at BAM Federal Institute for Materials Research and Testing Section S.3 – "International Technology Transfer" - iCATT Lead assessor at DAkkS Employee, lead assessor and case manager at DAP from 2003 - 2007 Diploma in Geology M.A. economy and management Dr. rer. nat. 2011-03-28 – Slide 3 Dr. Tilman Denkler

What is a Quality Infrastructure? “Quality infrastructure refers … to all aspects of metrology, standardization, testing, quality management, certification and accreditation that have a bearing on conformity assessment (abbreviated as MSTQ). This includes both public and private institutions and the regulatory framework within which they operate.”(BMZ 2004) 2011-03-28 – Slide 4 Dr. Tilman Denkler

2011-03-28 – Slide 5 Dr. Tilman Denkler Source: Ulrich Harmes-Liedtke (2010): The Relevance of Quality Infrastructure to Promote Innovation Systems in Developing Countries 2011-03-28 – Slide 5 Dr. Tilman Denkler

Quality Infrastructure in about 5 minutes 2011-03-28 – Slide 6 Dr. Tilman Denkler

Locations of BAM 2011-03-28 – Slide 7 Dr. Tilman Denkler Branch Fabeckstraße Unter den Eichen 44 – 46 Branch Adlershof Richard-Willstätter-Straße 11 BAM Test Site Technical Safety – BAM TTS An der Düne 44, Baruth/Mark Headquarter Lichterfelde Unter den Eichen 87 2011-03-28 – Slide 7 Dr. Tilman Denkler

iCATT at the BAM Federal Institute for Materials Research and Testing Analytical Chemistry; Reference Materials Chemical Safety Engineering Containment Systems for Dangerous Goods Materials and Environment Materials Engineering Materials Protection and Surface Technologies Section S.1 Quality in Testing Section S.2 Accreditation; Conformity Assessment Section S.3 International Technology Transfer iCATT - International Conformity Assessment Technology Transfer Safety of Structures Non-Destructive Testing Accreditation, Quality in Testing 2011-03-28 – Slide 8 Dr. Tilman Denkler

Tasks of BAM in the field of quality infrastructure Preparation of Reference Materials Development of testing and reference methods Test and approval of dangerous goods and Containment Systems for Dangerous Goods Analysis of damage mechanism and damage analysis Participation in more than 500 standardisation committees (ISO, CEN, DIN) Notified Body: 89/106/EEC: Construction products   93/15/EEC: Explosives for civil uses 94/9/EC: Equipment explosive atmospheres (ATEX) 97/23/EC: Pressure equipment (PED) 1999/36/EC: Transportable pressure equipment  (TPED) 2007/23/EC: Pyrotechnic articles Collapsed high-voltage pylon 2011-03-28 – Slide 9 Dr. Tilman Denkler

Tasks of BAM in the field of quality infrastructure – Department S Secretariat of the German Accreditation Advisory Board (AKB) Working group product requirements (Ecodesign energy-using products/PCP/MS) Secretariat of Eurolab-Germany Database for proficiency testing schemes EPTIS Standardisation committees the field of conformity assessment CEN TC und ISO CASCO Technology transfer (iCATT) Research in the area of QI: Cooperation with the TU Berlin Accreditation, Quality in Testing 2011-03-28 – Slide 10 Dr. Tilman Denkler

iCATT Profile Working group for technical cooperation within the BAM (S.3) 10 staff members Transfer of know-how in the fields of conformity assessment, accreditation and management systems 2011-03-28 – Slide 11 Dr. Tilman Denkler

Our Mission To support our partner countries in establishing and upgrading internationally recognised quality infrastructure systems with the aim: Safety and reliability to ensure an effective consumer protection Removal of technical barriers to trade and export promotion Facilitation of mutual recognition of the accreditation of conformity assessment bodies (testing and calibration laboratories, certification and inspection bodies) Integration in regional and international trade systems 2011-03-28 – Slide 12 Dr. Tilman Denkler

Our competences iCATT offers customized training and consultancy services in the following integrated fields of competence: 2011-03-28 – Slide 13 Dr. Tilman Denkler

Our experience (1) Over 15 years of experience in international project management Successful implementation of 34 international projects worldwide technical infrastructure of the BAM 2011-03-28 – Slide 14 Dr. Tilman Denkler

Our experience (2) Active participation of our staff in accreditation issues Close cooperation with German Accreditation Advisory Board, national organizations like DIN, PTB and GIZ as well as with international partners from industry and the scientific community 2011-03-28 – Slide 15 Dr. Tilman Denkler

Conformity assessment Types of conformity assessment bodies Conformity assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled Certification Bodies Testing Laboratories Inspection Bodies third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks Accreditation Body 2011-03-28 – Slide 16 Dr. Tilman Denkler

Differences between inspection and certification 2011-03-28 – Slide 17 Dr. Tilman Denkler

General requirements for certification Products (including Processes and Services): ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems Management Systems: ISO/IEC 17021:2011 Conformity assessment -- General requirements for bodies providing audit and certification of management systems Persons ISO/IEC 17024:2003 Conformity assessment -- General requirements for bodies operating certification of persons 2011-03-28 – Slide 18 Dr. Tilman Denkler

additional documents on product certification includes guidance on the use of certificates and marks ISO/IEC Guide 23:1982 Methods of indicating conformity with standards for third-party certification systems includes annexes with examples for application form, certificate of conformity, licensing agreements, ... ISO/IEC Guide 28:2004 Conformity assessment -- Guidance on a third-party certification system for products includes checklists as example for the evaluation of quality management systems ISO/IEC Guide 53:2005 Conformity assessment -- Guidance on the use of an organization's quality management system in product certification describes different types of product certification systems ISO/IEC Guide 67:2004 Conformity assessment -- Fundamentals of product certification 2011-03-28 – Slide 19 Dr. Tilman Denkler

Additional relevant documents Competence of subcontractors: for inspections used in the certification system (replaces ISO/IEC Guide 39:1988) ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection for testings used as criteria in the certification system (replaces ISO/IEC Guide 25:1990) ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories 2011-03-28 – Slide 20 Dr. Tilman Denkler

Process of Certification 2011-03-28 – Slide 21 Dr. Tilman Denkler

Product Certification System Function of parties involved in the certification process (1) Owner of the certification system defines Product Certification System checks Accreditation body implements attests competence Certification body Testing laboratory Inspection body subcontracts 2011-03-28 – Slide 22 Dr. Tilman Denkler

Product Certification System Function of parties involved in the certification process (2) Product Certification System requirements (i. e. QMS) requirements (i.e. auditor qualification) Applicant/ Supplier check fulfilment of requirements (QMS) Certification body requirements on the product subcontracts produces Check fulfilment of require- ments Product/ Service/ Process Testing laboratory Inspection body 2011-03-28 – Slide 23 Dr. Tilman Denkler

Owner of the certification system Contractual arrangements between parties involved in the certification process Owner of the certification system Accreditation body SQF contract Contract necessary contract Applicant/ Supplier Certification body Contract necessary Contract necessary marks/labels Product/ Service/ Process Testing laboratory Inspection body 2011-03-28 – Slide 24 Dr. Tilman Denkler

Different types of product certification 2011-03-28 – Slide 25 Dr. Tilman Denkler

Possible influences and pressures as well as expectations related to product certification bodies customer of the customer of the CAB owner of the CAB customer of the CAB society, state, interested parties CAB employees related bodies Pressure because of 2 Pressure because of business relations Pressure because of former/actual employment Financial pressure, attempts to influence the results of conformity assessments Financial pressure Expectations reliable results, competence, impartiality competence, practice-oriented operation reliable results 2011-03-28 – Slide 26 Dr. Tilman Denkler

What customers are expecting from certification bodies? use of recognised methods of testing and evaluation use of methods with recognised quality and reliability criteria reliable results with an extensive acceptance results in an acceptable time at acceptable costs Accreditation: The formal recognition of technical competence technical and procedural criteria independence impartiality quality management 2011-03-28 – Slide 27 Dr. Tilman Denkler

The accredited certification bodies benefit by: a „credential“ of qualification to provide a determined (accredited) service regular, objective „check-up“ a continuous potential of improvement an entrée to a given market that would otherwise be closed to the laboratory the reduction of numerous CAB audits by the customers, the increase in international recognition of competence, mutual recognition the promotion of the up-to-date level of technological development in the accredited field of certification an increased performance of staff the fulfilment of staff obligations as a result of the quality management ensuring the traceability of all activities and of the results ensuring the traceability to national and international certification rules and instructions 2011-03-28 – Slide 28 Dr. Tilman Denkler

An introduction to the principles of product certification based on ISO/IEC Guide 65 contents interpretation application 2011-03-28 – Slide 29 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 Content: Introduction Scope References Definitions Certification body Certification body personnel Changes in certification requirements Appeals, complaints and disputes Application for certification Preparation for evaluation Evaluation Evaluation report Decision on certification Surveillance Use of licences, certificates and marks of conformity Complaints to supplier 2011-03-28 – Slide 30 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 Introduction: certification of a product is a means of providing assurance that it complies with specific standards ISO/IEC Guide 65 specifies requirements for independent certification bodies operating third-party-certification systems the requirements are general criteria, which may have to be amplified certification systems for particular products will often need explanatory documentation 2011-03-28 – Slide 31 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 Scope (1): ISO/IEC Guide 65 specifies requirements, that a third-party operating a product certification system shall meet product is used in the widest sense, including processes and services standard is used in a wide sense, including other normative documents 2011-03-28 – Slide 32 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 Scope (2): as described in ISO/IEC Guide 53 the certification system may include one or more of the following: Type testing or examination Testing or inspection of samples (from open market and/or suppliers stock) Testing or inspection of every or a particular product (new or in use) Batch testing or inspection Design appraisal coupled with assessment of production and/or quality management system 2011-03-28 – Slide 33 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.1 General provisions (1) non-discriminatory policies and procedures of CB (4.1.1) procedures not used to inhibit or impede the access by applicants (4.1.1) CB accessible for all applicants (in the field of operation) (4.1.2) no undue financial or other conditions (4.1.2) membership in an association or group or number of already issued certificates are not allowed to be a condition for applicants (4.1.2) 2011-03-28 – Slide 34 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.1 General provisions (2) Evaluation criteria must be outlined in specific standards, which have to meet the requirements of ISO/IEC Guide 7 (4.1.3) If explanation of the standards is needed, it has to be done by competent and impartial persons/committees and published by the certification body (4.1.3) CB´s shall confine requirements, evaluation and decision on certification on those matters related to the considered scope (4.1.4) 2011-03-28 – Slide 35 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (1) The structure of the CB shall foster confidence. Therefore the CB shall: be impartial (4.2 a)) be responsible for decisions related to granting, maintaining, extending, suspending and withdrawing its certifications (4.2 b)) 2011-03-28 – Slide 36 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (2) The structure of the CB shall foster confidence. Therefore the CB shall: identify the management responsible for: performance of testing, inspection, evaluation and certification (4.2. c)1)) formulation of policy related to the operation of the CB and supervision of their implementation (4.2. c)2)) (4.2. c)4)) decisions on certification (4.2. c)3)) supervision of finances (4.2. c)5)) delegation of authority to committees/persons (4.2. c)6)) technical basis for granting certification (4.2. c)7)) 2011-03-28 – Slide 37 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (3) The structure of the CB shall foster confidence. Therefore the CB shall: be a legal entity (4.2 d)) do evaluation and decision on certification by different persons (4.2 f)) have rights and resposibilities relevant to its certification activities (4.2 g)) have financial stability and resources (4.2 i)) cover liabilities (4.2 h)) usually done by an insurance policy 2011-03-28 – Slide 38 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (4) The structure of the CB shall foster confidence. Therefore the CB shall: have a documented structure, which safeguards impartiality (4.2 e) IAF Guidance on the Application of ISO/IEC Guide 65:1996: G 4.2.14 Application of clause 4.2.e) of ISO/IEC Guide 65 requires judgment on whether all parties significantly concerned in the system are able to participate. What are essential is that all identifiable major interests should be given the opportunity to participate, and that a balance of interests, where no single interest predominates, is achieved. The members should normally be chosen at least from among representatives of the following groups: manufacturers or suppliers, users, consumers, conformity assessment experts. For practical reasons there may be a need to restrict the number of persons. 2011-03-28 – Slide 39 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (5) The structure of the CB shall foster confidence. Therefore the CB shall: employ sufficient number of competent personnel under a responsible senior executive (4.2. j)) have a quality management system (QMS) (4.2. k)) distinguish between product certification and other activities by policies and procedures (4.2. l)) have policies/procedures for resolution of complaints/appeals/disputes (4.2. p)) 2011-03-28 – Slide 40 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (6) The structure of the CB shall foster confidence. Therefore the CB shall: be free from any commercial, financial and other pressures (which might influence certification process) (4.2. m)) have formal rules and structures for the appointment and operation of committees involved in the certification process. Such committees shall be free from any commercial, financial and other pressures (which might influence their decisions) (4.2. n)) 2011-03-28 – Slide 41 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.2 Organization (7) The structure of the CB shall foster confidence. Therefore the CB shall: ensure that activities of a related body do not affect the confidentiality, objectivity or impartiality of the certification body (4.2 o)). and NOT: supply or design products it certifies (4.2 o)1)) give advice or provide consultancy (4.2 o)2)) provide any products or services which could compromise the confidentiality, objectivity or impartiality of the certification process/decision (4.2 o)3)) 2011-03-28 – Slide 42 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 A related body is one which is linked to the CB by: common ownership, in whole or part, directors contractual arrangement a common name informal understanding or other means such that the related body has a vested interest in any certification decision or has a potential ability to influence the process. 2011-03-28 – Slide 43 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 IAF Guidance 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 2011-03-28 – Slide 44 Dr. Tilman Denkler

Methods of assuring impartiality of CB´s descibed in chapter 4.2: A related body linked to the CB by: common ownership, in whole or part, directors contractual arrangement a common name informal understanding other means Do activities affect the confidentiality, objectivity or impartiality of the certification body? Supplies or design products it certifies gives advice or provides consultancy provides any products or services which could compromise the confidentiality, objectivity or impartiality Zertifizierungs- stelle Certification Body Documented Structure safeguards impartiality 2011-03-28 – Slide 45 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4 Certification body (CB) 4.3 Operations The CB shall evaluate conformance with relevant product standards according to requirements of specific product certification system. Based on this the CB shall: specify relevant standards specify other requirements (i. e. for sampling, testing, inspection) specify requirements for suitability and competence of persons/bodies carrying out testing, inspection and certification/registration 2011-03-28 – Slide 46 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.4 Subcontracting CB´s are allowed to (permanently) subcontract parts of the certification process (e.g. inspection, testing), but NEVER decisions about granting, maintaining, extending, suspending and withdrawing its certifications. In the case of subcontracting the CB shall: have a documented agreement covering: arrangements confidentiality conflict of interests take full responsibility for subcontracted work (4.4 a)) ensure competence and impartiality of subcontractors (4.4 b)) obtain the applicant´s consent (4.4 c)) 2011-03-28 – Slide 47 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.5 Quality system (1) Policy: Management shall define/document policy, objectives and commitment to quality and ensure, that the policy is understood, implemented and maintained (4.5.1). Quality management system (QMS): An effective, documented QMS shall be implemented and operated by the CB (4.5.2). Quality Manager: A person with defined authority for implementing and maintaining the QMS and reporting to the management shall be designated. The person needs direct access to the highest executive level of the CB (4.5.2). 2011-03-28 – Slide 48 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.5 Quality system (2) Quality manual (1): The QMS shall be documented in a manual and associated procedures, containing/referring to: quality policy statement (4.5.3 a)) description of legal status incl. names of owners/controlling persons (4.5.3 b)) names, qualifications, experience and terms of reference of certification personnel (internal & external) (4.5.3 c)) organization chart and a description of the organization (4.5.3 d)) 2011-03-28 – Slide 49 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.5 Quality system (3) Quality manual (2): The QMS shall be documented in a manual and associated procedures, containing/referring to: policy/procedures for: management reviews (4.5.3 f)) administrative processes (4.5.3 g)) document control (4.5.3 g)) recruitment, selection, training and performance monitoring of certification body personnel (4.5.3 i)) assessing, recording and monitoring subcontractors competence (4.5.3 j)) handling of non-conformities (4.5.3 k)) dealing with appeals, complaints and disputes (4.5.3 m)) conducting internal audits (4.5.3 n)) 2011-03-28 – Slide 50 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.5 Quality system (4) Quality manual (3): The QMS shall be documented in a manual and associated procedures, containing/referring to: policy/procedures for: evaluating products (4.5.3 l)) implementing the certification process (4.5.3 l)) conditions for issue, retention and withdrawal of certification documents (4.5.3 l)1)) use/application of documents of the certification process (4.5.3 l)2)) list of approved subcontractors (4.5.3 j)) operational and functional duties and services pertaining to quality (4.5.3 h)) 2011-03-28 – Slide 51 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.6 Conditions and procedures for granting, maintaining, extending, suspending and withdrawing certification Conditions for above shall be specified (4.6.1) There shall be documented procedures for: granting, maintaining, suspending and withdrawing certification (4.6.2 a)) extension/reduction of scope of certification (4.6.2 b)) re-evaluation in case of significant changes in (4.6.2 c)) product design standards, to which compliance is certified ownership/structure/management of the supplier re-evaluation in the case, that any other information indicates, that the product no longer complies with the requirements (4.6.2 c)) 2011-03-28 – Slide 52 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 4.10 Confidentiality The CB shall safeguard the confidentiality of information (obtained in a certification process) (4.10.1) at all organizational levels at all committees and external bodies/individuals. The confidentiality regulations shall be consistent with existing laws. Information (about a particular product/supplier) shall not be disclosed without a written consent of the supplier (4.10.2). Exceptions: requirements of this standard (i.e. 4.8.1 g)) requirements by law (in this case the supplier has to be informed about the provided information) 2011-03-28 – Slide 53 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 5 Certification body personnel 5.1 General Personnel shall be competent (5.1.1), particularly with regard to: making required technical judgements framing policies implementing policies Duties and responsibilities shall be described in clearly documented instructions (5.1.2). These instructions shall be: available for the personnel maintained up to date 2011-03-28 – Slide 54 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 5.2 Qualification criteria The CB shall define the minimum qualification criteria (5.2.1). The CB shall ensure and document how any contracted personnel satisfy the requirements of this standard (5.2.2). The CB shall maintain and keep up to date the following information of personnel involved in the certification process (5.2.3): name and address organization affiliation and position educational qualification and professional status experience and training date of the updating of records performance appraisal 2011-03-28 – Slide 55 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.1 Information on the procedure (1) The CB shall provide to applicants the following up-to- date information (8.1.1): detailed description of the evaluation procedure of each certification scheme detailed description of the certification procedure of each certification scheme documents describing the requirements for certification applicants rights duties of certified suppliers fees to be paid by applicants fees to be paid by suppliers of certified products 2011-03-28 – Slide 56 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.1 Information on the procedure (2) The CB shall require that a supplier: always complies with the (relevant provisions) of the certification program (8.1.2 a)) makes all necessary provisions for the conduct of the evaluation (8.1.2 b)): provision for examining documentation access to all areas access to all records (incl. internal audit reports) access to personnel access to documentation about the resolution of complaints 2011-03-28 – Slide 57 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.1 Information on the procedure (3) The CB shall require that a supplier: only makes claims regarding certification in respect of the certified scope (8.1.2 c)) does not misuse its certification in a way, that may disrepute the CB (8.1.2 d)) does not make any statement regarding its certification, which the CB may consider misleading or unauthorized (8.1.2 d)) In the case of suspension or cancelation of certification (8.1.2 e)) : stops using advertising matter containing a reference to the certification returns all certification documents the CB requires 2011-03-28 – Slide 58 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.1 Information on the procedure (4) The CB shall require that a supplier: only uses certification to indicate, that products are certified as being in conformity with specific standards (8.1.2 f)) endeavours to ensure, that no certificate/report (or parts of these) is used in a misleading manner (8.1.2 g)) only makes reference to the certification in a way, which complies with the requirements of the CB (8.1.2 h)) 2011-03-28 – Slide 59 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.1 Information on the procedure (5) The CB shall provide the following information to the applicant: any explanations needed, if the desired scope of certification is related to a specific system or type of system operated by the CB (8.1.2 f)) additional application information on request (8.1.4) 2011-03-28 – Slide 60 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.2 The application (1) The CB shall require the completion of an official application form (8.2.1) which is: signed by an authorized representative of the CB (8.2.1) The application form shall include (or have attached): the scope of the desired certification (8.2.1 a)) a statement, that the applicant agrees to comply with the requirements of the CB (8.2.1 b)) a statement, that the applicant agrees to supply any information needed (8.2.1 b)) 2011-03-28 – Slide 61 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 8 Application for certification 8.2 The application (2) The applicant shall provide following information: corporate entity (8.2.2 a)) name and address (8.2.2 a)) legal status (8.2.2 a)) Definition of products to be certified (8.2.2 b)) If known by the applicant: certification system and standards, against which each product is to be certified (8.2.2 b)) 2011-03-28 – Slide 62 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 9 Preparation of evaluation Before proceeding with the evaluation the CB shall review the application to assure that: the requirements for certification are: clearly defined (9.1 a)) documented (9.1 a)) understood (9.1 a)) differences in understanding between CB and applicant are resolved (9.1 b)) the CB has the capability to perform the certification 2011-03-28 – Slide 63 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 9 Preparation of evaluation The CB shall prepare a plan of the evaluation (9.2) (and send it to the applicant, so that necessary arrangements can be managed) assign personnel appropriately qualified (9.3) assign personnel, which has not been involved in/employed by a body involved in: design supply installation maintenance of such products in a manner and within a time period, which could conflict with impartiality (9.3) 2011-03-28 – Slide 64 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 10 Evaluation The CB shall evaluate the products of the applicant against the standards covered by the scope according to all certification criteria specified in the scheme 2011-03-28 – Slide 65 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 11 Evaluation report (1) The CB shall have adequate reporting procedures, ensuring - as a minimum - that: the report documents the findings related to all certification requirements (11 a)) a full report on the outcome of the evaluation is promptly brought to the applicant (11 b)), identifying nonconformities extent of further evaluation required extent of further testing required 2011-03-28 – Slide 66 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 11 Evaluation report (2) The CB shall repeat only the necessary parts of the evaluation procedure, if the applicant can show that remedial action has been taken within a specified time limit (11 b)). 2011-03-28 – Slide 67 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 12 Decision on certification The CB shall take a decision on certification on the basis of: information gathered during evaluation (12.1) any other relevant information The CB shall not delegate authority to an outside person or body for: granting certification (12.2) maintaining certification (12.2) extending certification (12.2) suspending certification (12.2) withdrawing certification (12.2) 2011-03-28 – Slide 68 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 13 Surveillance (1) The CB shall have documented procedures to enable surveillance to be carried out in accordance with the criteria applicable to the relevant certification system (13.1) and document its activities (13.3). 2011-03-28 – Slide 69 Dr. Tilman Denkler

Product certification based on ISO/IEC Guide 65 13 Surveillance (2) The CB shall require the supplier to inform it about changes such as: intended modification of: the product (13.2) the manufacturing process (13.2) the QMS (if relevant) (13.2) the product design (4.6.2 c)) changes in ownership/structure/management of the supplier (4.6.2 c)) 2011-03-28 – Slide 70 Dr. Tilman Denkler

Thanks for your attention Questions? 2011-03-28 – Slide 71 Dr. Tilman Denkler