5782751.ppt

Changes in new ISO/IEC 17024:2012

ISO/IEC 17024:2012 was
published in July 2012

ISO/IEC 17024:2012 will be
used for:
-> regulated/mandatory
-> non-regulated
certification schemes.

ISO/IEC 17024:2012 took
over the structure of
ISO/IEC 17021:2011

What is new in ISO/IEC 17024-2012?
Intention of the Revision:
1. Include “Development and maintenance of a
scheme” from informative annex into the standard
2. Include IAF GD24:2009
3. Take over the Structure of ISO 17000-series (e.g.
17021)
4. Consider ISO/PAS 17001—5 that contains principles
and requirements for the elements of impartiality,
confidentiality, complaints and appeals, disclosure of
information and use of management system as it
relates to standards for conformity assessment.

???
…more documentation, security, data safety…
… more clear requirements on scheme design
…more systematic approach on impartiality…

3. Terms and Definitions
3.1 certification Process: evaluation was changed to assessment
3.2 certification scheme competence: -> see 3.6
3.3 certification requirements: -/-
3.4 scheme owner: -> can be the certification body itself
3.5 certificate: -/-
3.6 competence: ability to apply knowledge and skills to achieve
intended results (Same as ISO 17021:2011 definition)
3.7 qualification: demonstrated education, training and work experience,
where applicable (≠ personal attributes)

3.8 assessment: this process includes now the „evaluation“
3.9 examination: -/-
3.10 examiner: person competent to conduct and score an examination
(3.9), where the examination requires professional judgment
3.11 invigilator: person authorized by the certification body who
administers or supervises an examination (3.9), but does not evaluate the
competence (3.6) of the candidate
3.12 personnel: including internal, external persons as well as
committee members.

3.13 applicant: must be a natural person – not a legal entity/person
3.14 candidate applicant: who has fulfilled specified prerequisites and
has been admitted to the certification process (-> e.g. the application has
been accepted)
3.15 impartiality: presence of objectivity (-> Conflicts of interest do not
exist or are resolved)

3.16 fairness: equal opportunity for success provided to each candidate
in the certification process (this has been taken from IAF GD24)
3.17 validity: evidence that the assessment measures what it is intended
to measure, as defined by the certification scheme (this has been taken
from the IAF GD24)
3.18 reliability: indicator of the extend to which examination scores are
consistent across different examinations forms and different examiners
(this has been taken from the IAF GD24) => “calibration“ of examinations
/ examiners

3.19 appeal: request by applicant, candidate or certified person for
reconsideration of any decision made by certification body related to
her/his desired certification status (=> the request can only be issued by
the applicant, candidate or certified person!)
3.20 complaint: expression of dissatisfaction other than appeal by an
individual or organisation to a certification body relating to the activities
of that body or a certified person, where response is expected (-> has
been taken from ISO/IEC 17000:2000)

3.21 interested party: individual, group or organisation affected by the
performance of a certified person or the certification body (-> user of the
services, consumer, government authority)
3.22 surveillance: period monitoring, during the period of certification, of
a certified person‘s performance to ensure continued compliance with
the certification scheme (=> not an obligatory requirement of a scheme)
.

Principles - Annex A (informative)
Principles:
Principles support the credibility of certification.
The principles are included in the Annex A (informative).
Principles are not requirements .

Certification of persons is:
1. to recognize an individual’s competence
2. that only those who demonstrated competence are awarded
certification
3. a valid assessment, by a third party, reconfirmed at defined
intervals
4. to provide confidence to interested parties in its competence,
impartiality and integrity

1. Impartiality -> not influenced by other interest or other parties
2. Competence -> competence of the personnel of CB
3. Confidentiality and openness -> balance between conf. & openness
4. Responsiveness to complaints and appeals -> effective resolution of
complaints / appeals to protect the CB
5. Responsibility -> CB is responsible to obtain sufficient objective
evidence upon which to base a certification decision

4. General Requirements
4.1 Legal Matters: -> CB shall be a legal entity that it can be held legally
responsible
4.2 Responsibility for decision on certification: -> no delegation outside
the defined certification body (e.g. by external technical reviewer)
4. 3 Management of impartiality:
1. documented organisational structure
2. risk analysis on conflicts of interests
3. top management commitment (GM / Head CB)
4. impartiality statement (publicly accessible without
request (e.g. website),

4. 3 Management of impartiality
4.3.1 top management commitment - statement publicly accessible
4.3.2 -/-
4.3.3 -/-
4.3.4 no discrimination of applicants and candidates
4.3.5 -/-
4.3.6 CB shall identify threats to its impartiality on an ongoing basis.

4. 3 Management of impartiality
4.3.8 A balanced involvement of interested parties
(certified person, user of the services of certified person, employer of
certified person, consumer, governmental authority)
REMARK: a conflicts of interests exists, when the design of a complete
package including training, examination and certification has been made
by a training institute.

4. 4 Finance and liability
Remark: financial planning shall consider at least on certification cycle
including recertification.

5. Structural Requirements
5.1 Management and organization structure - key responsibilities:
a. policies and procedures relating for operation
b. implementation of policies and procedures
c. finance
d. resources
e. development and maintenance of the schemes
f. assessments
g. decisions on certification
h. contractual arrangements.

5. Structural Requirements
5.2 Structure of the certification body in relation to training
(this has mostly been taken from IAF GD24)
5.2.1 A certain training can be a prerequisite of a certification scheme
5.2.2 Maintain impartiality meads not promoting specific training
services
5.2.3 Providing training and certification from the same legal entity
requires monitoring and “firewalls” to safeguard impartiality –
examiners cannot assess a candidate they have trained within the last
two years.

6. Resource requirements
6.1.1 -/-
6.1.2 -/-
6.1.3 CB shall define competence requirements for personnel involved in
the certification process -> application, examination, certification,
recertification
6.1.4 -/-
6.1.5 Personal records shall include known conflicts of interest.
6.1.6 -/ -
6. 1.7 -/-
6.1.8 -/ -
6.2.1 Declaration of conflict of interests from all CB – personnel -> to
consider conflicts as well between candidates and certifier (no
requirements on how to handle conflicts)

6.2 Personnel involved in the certification activities
6.2.1 Declaration of conflict of interests from all CB–personnel -> to
consider conflicts as well between candidates and independent certifier
(requirements on how to handle conflicts)
6.2.2 Requirements for examiners:
a) understand the relevant certification scheme
b) are able to apply the examination procedures and documents
c) have competence in the fields to be examined
d) are fluent, both in writing and orally, in the language of examination
e) have identified any known conflicts of interest

6.2.2.2 Monitor the performance of the examiners and the reliability of
the examiners‘ judgements: those objectives can only by reached by –
on-site observation
6.2.3.2 Conflicts of interest by other personnel involved in the
assessment have to be handled and recorded.
6.3 Outsourcing (-> Subcontracting): the responsibility for
certification remains at the certification body and cannot outsourced
(see clause 4.2) .

6.4 Other resources: the CB has to use adequate premises,
including examination sites, equipment and resources for carrying out its
certification activities
see also:
-> 7.4.2 Security policies / procedures on examination materials
-> 9.3.4 Technical equipment verified and calibrated

7. Records and information requirements
7.1.3 The certified person has to inform the certification body of
matters that can affect the capability of the certified person to perform
the job (physical or mental capability) – this duty of the certified person
shall be part of enforceable arrangements.
7.2 Information upon request: if an individual holds a current, valid
certificate / scope of certification (depending on legal restrictions)
Information publicly available without request: scope of certification and
general description, list of all pre-requisites of the scheme.
The certification scheme itself must not be made publicly available!

7. Records and information requirements
7.3 Confidentiality: activities of related bodies (e.g. training center)
have to be included in the management of confidentiality.
7.4 Security; more focus now on:
a. the security of the examination process
b. prevention of fraudulent examination practices
Candidates have to sign an agreement indicating their commitment not
to release confidential examination materials or participate in fraudulent
test-taking practices.

8. Certification Schemes
8.1 There shall be certification scheme for each category of certification
Category of certification (see also ISO 17011 clause 7.9.5 a) – example:
-> welders, NDT persons, nurses, construction inspectors….,
The category of persons shall be identified in the scope of accreditation.

8.2 Elements of certification scheme:
a. scope of certification
b. job and task description (job profile)
c. required competence
d. abilities (when applicable)
e. prerequisites (when applicable)
f. code of conduct (when applicable)
Abilities: physical capabilities such as vision, hearing and mobility
Code of conduct: ethical or personal behavior required by the scheme

8.3 Requirements for certification process:
a. criteria for initial certification and recertification
b. assessment methods for initial certification and recertification;
c. surveillance methods and criteria (if applicable);
d. criteria for suspending and withdrawing certification;
e. criteria for changing the scope or level of certification (if applicable).

8.4 Development and review of Certification Scheme
(from the Annex A of ISO/IEC 17024:2003)
a) involvement of appropriate experts
b) use of an appropriate structure that fairly represents the interests of
all parties significantly concerned, without any interest predominating
(Note: the previous format based on a scheme committee is not a
requirement)
c) the identification and alignment of prerequisites, if applicable, with
the competence requirements
d) the identification and alignment of the assessment mechanisms with
the competence requirements

8.4 Development and review of Certification Scheme
Job or practice analysis:
-> identify the tasks
-> identify the required competence for each task
-> identify prerequisites
-> confirm the assessment mechanisms, examination content
-> identify the recertification requirements and interval.

8.6 When the certification body is not the scheme owner of a
certification scheme it implements, the certification body shall ensure
that the requirements on Certification Schemes are met.
-> contractual agreement with scheme owner
-> CB participate in scheme committee

9. Certification process requirements
9.1 Application process: signed application where applicant confirms
scope and compliance with:
-> certification requirements
-> scheme prerequisites

9.2. Assessment process: CB has to
verify the methods
for assessing candidates to ensure fair and valid assessment.
The assessment process can be subcontracted to another body.

9.3 Examination process – requirements on the design of examinations:
a. results of each single examination
comparability of: b. in content and difficulty
c. validity of fail / pass decisions

9.3 Examination process:
Technical equipment shall be verified or calibrated where appropriate.
Statistical data has to be collected from each examination and analysed
in defined intervals.

9.4 Decision on certification:
Decision based on sufficient information – sufficient for traceablity in
the event of appeals or complaints.
Decision on certification can not be outsourced.
For decision knowledge of and experience with the certification process
is required.

9.4 Certificates shall contain following information:
a. name of certified person
b. unique identification
c. the name of the certification body
d. reference to the certification scheme, standard – incl. issue date
e. scope of the certification
f. the effective date of certification and date of expiry.
Designed to reduce the risk of counterfeiting.

9.5 Suspending, withdrawing or reducing the scope of certification:
The acceptable intervall for suspension has to be defined by the CB.
CB shall have enforceable arrangements with any certified person to
stop the use of all references to a certifies status in case of withdrawal.

9.6 Recertification process: the CB shall ensure that recertification
process confirms continued competence of the certified person and
ongoing compliance with current scheme requirements by the certified
person.
regulatory requirements
changes to normative documents
changes in scheme requirements
Recertification period: situation of industry / service field
risks resulting from incompetent person
development in technology
interested parties
surveillance methods – if relevant

9.6 Recertification process: The selected recertification activity
/activities shall be adequate to ensure that there is impartial assessment
to confirm the continuing competence of the certified person.
On-site assessment
professional development
Recertification shall structured interviews
consider at least: confirmation cont. work experience
examination
checks on physical capability in
relation to the competence concerned

9.7 Use of certificates, logos and marks: The CB shall require that a
certified persons signs an agreement for the following reasons:
a. -/ -
b. to make claims regarding certification only with respect to the scope
for which certification has been granted
c. -/-
d. to discontinue the use of all claims to certification that contain any
reference to the certification body or certification upon suspension or
withdrawal of certification, and to return any certificates issued by the
certification body.

9.8 Appeals against decisions on certifications:
A description of the appeals-handling process shall be publicly accessible
without request.
The CB shall provide the appellant with progress reports and the
outcome.
The CB shall give formal notice to the appellant of the end of the appeals
–handling process.

9.8 Complaints:
A description of the complaints-handling process shall be accessible
without request.
The CB shall confirm wether the complaint relates to certification
activities for which it is responsible.
Any substantiated complaint about a certified person shall also be
referred by the certification body to the certified person in question at
an appropriate time.

10. Management system requirements
10.1 General: the CB has to implement a management system:
Option A: management system with specific elements according 10.2
Option B: management system based on ISO 9001 incl. 10.2

10. Management system requirements
Specific elements of management system according to 10.2:
Management system documentation
Controls of documents
Controls of records
Management review (incl. input / output specification)
Internal Audits (every 12 month – or longer when proven stability)
Corrective actions (incl. determining causes of nonconformity)
Preventive actions (incl. reviewing effectiveness of action taken)

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