1. 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,

2. 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)
– Slide 2
Dr. Tilman Denkler

3. 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
Diploma in Geology M.A. economy and management Dr. rer. nat.
– Slide 3
Dr. Tilman Denkler

4. 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)
– Slide 4
Dr. Tilman Denkler

5. 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
– Slide 5
Dr. Tilman Denkler

6. Quality Infrastructure in about 5 minutes
– Slide 6
Dr. Tilman Denkler

7. 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
– Slide 7
Dr. Tilman Denkler

8. 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
– Slide 8
Dr. Tilman Denkler

9. 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
– Slide 9
Dr. Tilman Denkler

10. 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
– Slide 10
Dr. Tilman Denkler

11. 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
– Slide 11
Dr. Tilman Denkler

12. 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
– Slide 12
Dr. Tilman Denkler

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

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

15. 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
– Slide 15
Dr. Tilman Denkler

16. 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
– Slide 16
Dr. Tilman Denkler

17. Differences between inspection and certification
– Slide 17
Dr. Tilman Denkler

18. 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
– Slide 18
Dr. Tilman Denkler

19. 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
– Slide 19
Dr. Tilman Denkler

20. 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
– Slide 20
Dr. Tilman Denkler

21. Process of Certification
– Slide 21
Dr. Tilman Denkler

22. 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
– Slide 22
Dr. Tilman Denkler

23. 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
– Slide 23
Dr. Tilman Denkler

24. 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
– Slide 24
Dr. Tilman Denkler

25. Different types of product certification
– Slide 25
Dr. Tilman Denkler

26. 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
– Slide 26
Dr. Tilman Denkler

27. 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
– Slide 27
Dr. Tilman Denkler

28. 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
– Slide 28
Dr. Tilman Denkler

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

30. 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
– Slide 30
Dr. Tilman Denkler

31. 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
– Slide 31
Dr. Tilman Denkler

32. 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
– Slide 32
Dr. Tilman Denkler

33. 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
– Slide 33
Dr. Tilman Denkler

34. 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)
– Slide 34
Dr. Tilman Denkler

35. 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)
– Slide 35
Dr. Tilman Denkler

36. 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))
– Slide 36
Dr. Tilman Denkler

37. 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))
– Slide 37
Dr. Tilman Denkler

38. 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
– Slide 38
Dr. Tilman Denkler

39. 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 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.
– Slide 39
Dr. Tilman Denkler

40. 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))
– Slide 40
Dr. Tilman Denkler

41. 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))
– Slide 41
Dr. Tilman Denkler

42. 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))
– Slide 42
Dr. Tilman Denkler

43. 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.
– Slide 43
Dr. Tilman Denkler

44. Product certification based on ISO/IEC Guide 65
IAF Guidance on the Application of ISO/IEC Guide 65:1996:
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
– Slide 44
Dr. Tilman Denkler

45. 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
– Slide 45
Dr. Tilman Denkler

46. 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
– Slide 46
Dr. Tilman Denkler

47. 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))
– Slide 47
Dr. Tilman Denkler

48. 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).
– Slide 48
Dr. Tilman Denkler

49. 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))
– Slide 49
Dr. Tilman Denkler

50. 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))
– Slide 50
Dr. Tilman Denkler

51. 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))
– Slide 51
Dr. Tilman Denkler

52. 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))
– Slide 52
Dr. Tilman Denkler

53. 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 g))
requirements by law (in this case the supplier has to be informed about the provided information)
– Slide 53
Dr. Tilman Denkler

54. 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
– Slide 54
Dr. Tilman Denkler

55. 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
– Slide 55
Dr. Tilman Denkler

56. 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
– Slide 56
Dr. Tilman Denkler

57. 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
– Slide 57
Dr. Tilman Denkler

58. 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
– Slide 58
Dr. Tilman Denkler

59. 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))
– Slide 59
Dr. Tilman Denkler

60. 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)
– Slide 60
Dr. Tilman Denkler

61. 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))
– Slide 61
Dr. Tilman Denkler

62. 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))
– Slide 62
Dr. Tilman Denkler

63. 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
– Slide 63
Dr. Tilman Denkler

64. 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)
– Slide 64
Dr. Tilman Denkler

65. 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
– Slide 65
Dr. Tilman Denkler

66. 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
– Slide 66
Dr. Tilman Denkler

67. 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)).
– Slide 67
Dr. Tilman Denkler

68. 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)
– Slide 68
Dr. Tilman Denkler

69. 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).
– Slide 69
Dr. Tilman Denkler

70. 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))
– Slide 70
Dr. Tilman Denkler

71. Thanks for your attention
Questions?
– Slide 71
Dr. Tilman Denkler