Академический Документы
Профессиональный Документы
Культура Документы
17065 2012
Conformity assessment -
Requirements for bodies
certifying products,
processes and services
Course Overview
Course objectives
Participant objectives
1
Accredited product certification
Objectives of Product
Certification
2
Objectives of Product
Certification cont.
Accredited Certification
Product Certification Body to
Accreditation
Accredits ISO/IEC 17065 and Scheme
Bodyy
Rules
3
Accredited Certification
ACCREDITS ACCREDITS
ONFIDENCE
ONFIDENCE
ISO/IEC
Product Product 17065
Certification Certification
Scheme
Bodies Bodies
CO
CO
Rules
CERTIFIES CERTIFIES
Scheme
Rules and
Supplier Supplier Product
Standards
International Accreditation
Infrastructure
Southern African
Interamerican Accreditation Development Community in
Cooperation (IAAC) Accreditation (SADCA)
4
Factors for mutual recognition
ISO/IEC 17065:2012
5
ISO/IEC 17065 – Overview
6 Resource requirements
7 Process requirements
8 Management system requirements
Annex A (informative)
Annex B (informative)
6
Clause 1 Scope
ISO/IEC 17000
ISO/IEC 17021 (Previously Guide 62),
ISO/IEC 17020 (Previously Guide 39 –
Inspection)
ISO/IEC 17025 (Previously Guide 25 –
Laboratories)
7
Other Useful References
8
ISO/IEC 17065 – Overview (cont’d)
9
ISO/IEC 17065 – Overview (cont’d)
10
Clause 4 General requirements
(cont’d)
4.1 Legal and contractual matters
4.1.1 Legal responsibility
The certification body shall be a legal entity
4.1.2 Certification agreement
4.1.2.1 Legally enforceable agreement for the provision
of certification activities
4.1.2.2 Agreement shall ensure client to comply with
with::-
a) Client always fulfils certification requirements
b) Certified product continues to fulfil product
requirements
4.1.2.2 (cont’d)
c)) Th client
The li t make
k the
th necessary arrangements t for
f
conducting the evaluation, investigating
complaints, and the participation of observers.
observers.
d) Client only make claims consistent with scope of
certification
e)) Client does not bring
g the certification bodyy into
disrepute or make misleading statements
f) Client discontinues the any reference to
certification when certification suspended,
withdrawn or terminated
11
Clause 4 General requirements
(cont’d)
4.1.2.2 (cont’d)
g)) C ifi i
Certification d
documents shall
h ll be
b reproduced
d d iin
full
h) Client complies with certification body and
scheme requirements in communication media
i) Client to comply with the scheme requirements
for use of mark
j) Client keeps records of complaints relating to
certification;; takes appropriate action and
certification
documents actions taken
k) Client informs certification body of changes
4.1.3 Use
U off license,
li certificates
tifi t and
d marks
k off
conformity
4.1.3.1Certification body to exercise control over the
use of the mark and other mechanisms to
indicate a product is certified
4.1.3.2Suitable action shall be taken to address
misleading information, the misuse of licences,
certificates, marks and other mechanisms for
indicating the product is certified.
12
Clause 4 General requirements
(cont’d)
13
Clause 4 General requirements
(cont’d)
4.2 (cont’d)
4.2.6 Certification body or any part of the same legal
entity shall not be involved in the design,
manufacture, installation, distribution, or
maintenance of the certified product, (Same for
processes and services)
services).. It cannot offer
consultancy or internal auditing
auditing..
4.2.7 Certification body shall ensure activities of
entities with which it has a relationship do not
compromise impartiality
4.2.8 Independence of personnel involved in the
review and certification decision making process
4.2 (cont’d)
4.2.9 Certification body
body’s
s activities not to be linked with
an organisation providing consultancy
consultancy..
Certification body not to state or imply any
advantages if specified consultancy used
used..
4.2.10 Certification body to specify period during which
personnel that were involved in consultancy of a
product cannot review or make the certification
decision..
decision
4.2.11 Certification body to respond to any risks to
impartiality it becomes aware of
of..
4.2.12 All personnel to act impartially
14
Clause 4 General requirements
(cont’d)
4.5 Confidentiality
4.5.1 Certification
C tifi ti b d responsible
body ibl through
th h legally
l ll
enforceable commitments.
commitments.
Information not in public domain considered
proprietary.
proprietary.
Certification body to inform client in advance
of information intended for the p
public domain
4.5.2 When required by law to release confidential
information the client shall be notified
4.5.3 Information obtained about the client from
other sources shall be treated as confidential
Workshop
15
Clause 4 General requirements
(cont’d)
4.4 Non
Non--discriminatory
y conditions
4.4.1 Policies and procedures shall be non
non--
discriminatory
4.4.2 Services to be accessible to all applicants that
are in scope of operations.
operations.
4.4.3 Access to certification shall not be conditional
4.4.4 Certification body shall confine its certification
activities to the scope of certification
16
Clause 5 Structural Requirements
17
Clause 5 Structural Requirements
(cont’d)
5.1.3 (cont’d)
h) decisions on certification;
i) delegation of authority to committees or
personnel,
j) contractual arrangements;
k) provision of adequate resources;
l) responsiveness to complaints and appeals;
m) personnel competence requirements;
n) management system.
5.1.4 Formal rules for the appointment of committees
18
Clause 5 Structural Requirements
(cont’d)
19
Resources
6.1 Certification
C tifi ti bodyb d personnell
6.1.1 General
6.1.2 Management of competence for personnel
involved in the certification process
6.1.3 Contract with personnel
6.2 Resources for evaluation
6.2.1 Internal resources
6.2.2 External resources (outsourcing)
20
Clause 6 Resource requirements
(cont’d)
21
Clause 6 Resource requirements
(cont’d)
22
Clause 6 Resource requirements
(cont’d)
23
Clause 6 Resource requirements
(cont’d)
24
Clause 7 Process requirements
7.1
1 General
7.2 Application
7.3 Application review
7.4 Evaluation
7.5 Review
7.6 Certification decision
7.7 Certification documentation
25
Clause 7 Process requirements
(cont’d)
7 .1 General
7.1.1 Certification body shall operate certification
schemes
7.1.2 Products to be evaluated against requirements
specified in standards and other normative
documents
7.1.3 Explanations on application of documents to be
formulated by relevant and impartial persons or
committees with the necessary technical
competence..
competence
7 .2 Application
Certification body shall obtain necessary information as
required by the certification scheme
scheme..
7 .3 Application review
7.3.1 Certification body to review information to ensure
ensure::-
a) sufficient for certification
b) any known
k diff
differences are resolved
l d
c) scope of certification sought is defined
d) the means to evaluate are available
e) certification body is both competent and capable
26
Clause 7 Process requirements
(cont’d)
27
Clause 7 Process requirements
(cont’d)
7 .4 Evaluation
7.4.1 Certification body shall have a plan for the evaluation
activities to allow for the necessary arrangements to
be managed.
7.4.2 Certification body shall assign personnel to perform
each evaluation task that it undertakes with its
internal resources.
resources
7.4.3 Certification body shall ensure all necessary
information and/or documentation is made available
for performing the evaluation tasks.
7.4.4 Ce
Certification body shall carry out evaluation activities
with its internal and outsourced resources in
accordance with the evaluation plan. Products shall
be evaluated against requirements covered by the
scope of certification and other requirements
specified in the certification scheme.
7.4.5 Certification body shall only rely on evaluation results
completed prior to the application for certification.
certification
It takes responsibility for the results and satisfies itself
that the body performing the evaluation fulfils the
requirements contained in 6.2.2 and those specified
by the certification scheme.
28
Clause 7 Process requirements
(cont’d)
7.4.6 Ce
Certification body shall inform the client of all
nonconformities.
7.4.7 If nonconformities have arisen, and client wishes to
continue the certification process, certification body
shall provide information regarding the additional
evaluation tasks needed to verify that nonconformities
have been corrected.
7 4 8 If the client agrees to completion of the additional
7.4.8
evaluation tasks, the process specified in 7.4 shall be
repeated to complete the additional evaluation tasks.
7.4.9 The results of all evaluation activities shall be
documented prior to review.
7 .5 Review
7.5.1 Certification body shall assign at least one person to
review all information and results related to the
evaluation.
Review shall be carried out by person(s) who have
not been involved in the evaluation process7
7.4.1
7 5 2 Recommendations for a certification decision based
7.5.2
on the review shall be documented, unless the
review and the certification decision are completed
concurrently by the same person.
29
Clause 7 Process requirements
(cont’d)
7 .6 Certification decision
7.6.1 Certification body shall be responsible for, and shall
retain authority for, its certification decisions.
7.6.2 One person to be assigned to make the certification
decision based on all information related to the
evaluation, its review, and any other relevant
information.
information
The certification decision shall be carried out by a
person or group of persons that has not been
involved in the process for evaluation.
30
Clause 7 Process requirements
(cont’d)
31
Clause 7 Process requirements
(cont’d)
32
Clause 7 Process requirements
(cont’d)
33
Clause 7 Process requirements
(cont’d)
7.9 Surveillance
7 9 1 If surveillance is required by the certification scheme,
7.9.1 scheme
or as specified in 7.9.3 or 7.9.4, the certification body
shall initiate surveillance of the product(s) covered by
the certification decision in accordance with the
certification scheme.
7.9.2 When surveillance utilizes evaluation, review or a
certification decision,
decision the requirements in 7.4,
7 4 7.5
7 5 or
7.6, respectively, shall be fulfilled.
34
Clause 7 Process requirements
(cont’d)
7.10 Changes
Ch affecting
ff ti certification
tifi ti
7.10.1 Certification scheme changes that affect the
client, shall be communicated to all clients.
Implementation of the changes to be verified and
actions taken as required by the scheme.
7.10.2 Other changes affecting certification to be
considered, including changes initiated by the client.
Appropriate action shall be decided.
35
Clause 7 Process requirements
(cont’d)
7.10.3 (cont’d)
These actions shall be completed in accordance with
applicable parts of 7.4, 7.5, 7.6, 7.7 and 7.8.
Records shall include the rationale for excluding
any of the above activities (e.g. when a
certification requirement that is not a product requirement
changes and no evaluation,
changes, evaluation review or decision activities
are necessary).
36
Clause 7 Process requirements
(cont’d)
37
Clause 7 Process requirements
(cont’d)
7.12 Records
7 12 1 Certification body shall retain records to demonstrate
7.12.1
that all certification process requirements have been
effectively fulfilled.
7.12.2 Certification body shall keep records confidential
including those being transported, transmitted and
transferred.
7 12 3 If the certification scheme involves complete re-
7.12.3 re
evaluation of the product within a determined cycle,
records shall be retained for current and previous
cycle. Otherwise, records shall be retained for a
period defined by the certification body.
.
38
Clause 7 Process requirements
(cont’d)
39
Clause 7 Process requirements
(cont’d)
40
ISO/IEC 17065 Training
Workshop
41
Clause 8 Management System
requirements (cont’d)
Option A – prescribed elements
8.2 General management system documentation
8.3 Control of documents
8.4 Control of records
8.5 Management review
8.5.1 General
8.5.2 Review inputs
8.5.3 Review outputs
8.6 Internal audits
8.7 Corrective actions
8.8 Preventive actions
42
Clause 8 Management System
requirements (cont’d)
8.2.3 Top management shall appoint a member of
management who, irrespective of other
responsibilities, shall have responsibility and
authority that include the following:
a) ensuring that processes and procedures needed
for the management system are established,
implemented and maintained;
b)) reporting
p g to top
p management
g on the p
performance
of the management system and any need for
improvement.
43
Clause 8 Management System
requirements (cont’d)
8.3 Control of documents
8 3 1 Proced
8.3.1 Procedures
res to control documents
doc ments (internal and
external) related to the fulfilment of this
International Standard shall be established.
8.3.2 Procedures shall define the controls needed to:
a) approve documents for adequacy prior to issue;
b) review, update and re-approve documents;
c)) ensure that changes and the current revision
status of documents are identified;
d) ensure that relevant versions of applicable
documents are available at points of use;
8.3.2 (cont’d)
e) ensure that documents remain legible and readily
identifiable;
f) ensure that documents of external origin are
identified and their distribution controlled;
g) prevent the unintended use of obsolete
d
documents, t andd to
t apply l suitable
it bl identification
id tifi ti t
to
them if they are retained for any purpose.
44
Clause 8 Management System
requirements (cont’d)
45
Clause 8 Management System
requirements (cont’d)
8.5.2 Review inputs
Input to management review shall include the following:
a) results of internal and external audits;
b) feedback from clients and interested parties;
c) feedback from the mechanism for safeguarding
impartiality;
d) the status of preventive and corrective actions;
e)) follow-up p actions from p previous management
g
reviews;
f) the fulfilment of objectives;
g) changes that could affect the management system;
h) appeals and complaints.
46
Clause 8 Management System
requirements (cont’d)
47
Clause 8 Management System
requirements (cont’d)
48
Clause 8 Management System
requirements (cont’d)
8.7.4 Procedures for corrective actions shall define
requirements for the following:
a) identifying nonconformities (e.g. from complaints
and internal audits);
b) determining the causes of nonconformity;
c) correcting nonconformities;
d) evaluating the need for actions to ensure that
nonconformities
f iti do
d nott recur;
e) determining and implementing the actions needed
in a timely manner;
f) recording the results of actions taken;
g) reviewing the effectiveness of corrective actions.
49
Clause 8 Management System
requirements (cont’d)
8.7.4 Procedures for preventive actions shall define
requirements
q for the following:
g
a) identifying potential nonconformities and their
causes;
b) evaluating the need for action to prevent the
occurrence of nonconformities;
c) determining and implementing the action needed;
d) recording the results of actions taken;
e) reviewing the effectiveness of the preventive
actions taken.
The procedures for corrective and preventive actions do
not necessarily have to be separate.
Workshop
50
ISO/IEC 17065 Training
51
ISO/IEC Guide 67:2004 Fundamentals of
Product Certification (cont’d)
System Type 1a
type testing may or may not be
statistically significant
significant.. Certificate of
Conformity covers population
System Type 1b
type testing, sampling covers entire
population of the product (is statistically
significant).. Certificate of Conformity
significant)
covers each product represented by the
sample..
sample
52
ISO/IEC Guide 67:2004 Fundamentals of
Product Certification (cont’d)
System Type 2
type testing
market surveillance and samples from
the market assessed
System Type 3
type testing
Factory surveillance and samples from
the point of production assessed
System
y Type
yp 4
type testing
surveillance testing of samples from the
factory and/or from the open market
System Type 5
type testing
assessment of a quality management system
for producing the product
surveillance of QMS and testing of samples
from the factory and/or open market.
market.
53
ISO/IEC Guide 67:2004 Fundamentals of
Product Certification (cont’d)
54
Guide 67 vs ISO/IEC DIS 17067
55
Table 1 – Building a product certification
scheme
Conformity assessment functions and activitiesa within product Types of product certification schemes
certification schemes c
1a 1b 2 3 4 5 6 Nd,b
I) Selection, including planning and preparation activities, specification of x x x x x x x x
requirements, e.g. normative documents, and sampling, as applicable
II) Determination of characteristics,
characteristics as applicable by:
b x x x x x x x x
a) Testing
b) inspection
c) design appraisal
d) assessment of services or processes
e) other determination activities, e.g. verification
III) Review x x x x x x x x
Examining the evidence of conformity obtained during the determination stage
to establish whether the specified requirements have been met
IV) Decision on certification x x x x x x x x
Granting, maintaining, extending, reducing, suspending, withdrawing
certification
V) Attestation, licensing
a) Issuing a certificate of conformity or other statement of conformity x x x x x x x x
(attestation)
a) Granting the right to use certificates or other statements of conformity x x x x x x x
c) Issuing a certificate of conformity for a batch of products x
c) granting the right to use marks of conformity (licensing) is based on x x x x x x
surveillance (VI) or certification of a batch.
VI Surveillance, as applicable (see 5.3.4 to 5.3.8), by:
a) testing or inspection of samples from the open market x x x
b) testing or inspection of samples from the factory x x x
c) assessment of the production, the delivery of the source or the operation of x x x x
the process
c) management systems audits combined with random tests or inspections x x
6 .1 General
6 .2 Relationship between product certification
scheme and product certification system
6 .3 Scheme owner
6 .4 Development of product certification
schemes
6 .5 Content of a scheme
6.5.1 General
6.5.2 Sampling
6.5.3 Acceptance of conformity assessment
results
56
ISO/IEC 17067 Clause 6 - Development and
operation of a product certification scheme
65
6.5 C t t off a scheme
Content h (cont’d)
6.5.7 Surveillance
6.5.8 Non
Non--conforming products
6.5.9 Reporting to scheme owner
6.5.10 Subcontracting of the operation of the
scheme
6 5 11 Marketing
6.5.11
6.5.12 Fraudulent claim of certification
57
ISO/IEC 17067 Clause 6 - Development and
operation of a product certification scheme
66
6.6 M i t
Maintenance and
d iimprovementt off a
scheme
6.6.1 Review of scheme operation
6.6.2 Changes in specified requirements
6.6.3 Other changes to the scheme
67
6.7 Scheme documentation
58
ISO/IEC 17007 – Guidance for drafting
normative documents suitable for use for
conformity assessment (cont’d)
59
ISO/IEC 17007 – Guidance for drafting
normative documents suitable for use for
conformity assessment (cont’d)
60
AB Requirements for Standards
3. Definitions
3.1 Mark of conformity (legally registered)
3.2 Certificate of conformity
4. Who needs information on conformity
4.1 Manufacturer – product conforms
4.2 Purchaser – product meets requirements
4 3 Insurance and inspection companies –
4.3
risk management
4.4 Regulatory bodies – products covered by
legislation conform
61
ISO/IEC Guide 23 (cont’d)
5 Categories of purchasers
5.
5.1 Consumer – little technical knowledge
5.2 Informed purchaser – sufficient
knowledge to understand standards in own
field
6. Category of standards
6.1.1 Comprehensive – specify essential
characteristics, requirements, test methods
6.1.2 Specific standards for one or more
specific properties
62
ISO/IEC Guide 23 (cont’d)
63
ISO/IEC Guide 23 (cont’d)
9. Types of marks
9 1 Recommended mark for
9.1 ABC
comprehensive standards:
ABC 59-1974
9.2 Recommends certificate for
specific standards ABC
BUT if a mark must be used,, this
is recommended form: ABC 59-1974 –
Colour fastness only
10. International marks...
Should the CAB be identified?
ISO/IEC Guide 27
64
ISO/IEC Guide 27 (cont’d)
2. Definitions:
2.1 recall
2.2 misuser
2 3 producer of a subsequent
2.3
hazardous product (POSHP)
2.4 hazardous
65
ISO/IEC Guide 27 (cont’d)
66
ISO/IEC Guide 27 (cont’d)
67
ISO/IEC Guide 27 (cont)
68
ISO/IEC Guide 27 (cont’d)
ISO/IEC 17030
69
ISO/IEC 17030 (cont’d)
Clause 4
4.1 - Owner responsible for protecting mark
4.2 – Owner shall
Have rules governing use
Minimise misunderstanding
Mark and accompanying info not misleading
Measures to protect and monitor use
Take actions to resolve misuse
Action complaints
70
ISO/IEC 17030 (cont’d)
71
ISO/IEC 17030 (cont’d)
Clause 7
71O
7.1 Ownership
nership and control
Provide info on request
Maintain a register of objects of CA
Description of rights and obligations of licensee
7.2 Licence
Agreement
g should ensure licensee follows the
rules of the scheme
The licence shall require the licensee to:
Control use of mark
Take corrective action
Keep a record of complaints
72
ISO/IEC 17030 (cont’d)
Workshop
73
Scheme Development
Wh
When d
developing
l i or revising
i i th specific
the ifi
requirements for the Scheme, the owner of
the Scheme should consider the following
following::
74
Scheme Development (cont’d)
75
Scheme Development (cont’d)
76
ISO/IEC 17065 Training
Workshop
Summary
77
Thank you
78