Changes in new ISO/IEC 17024:2012. ISO/IEC 17024:2012 was published in July 2012.

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Presentation transcript:

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 ? Intention of the Revision: 1.Include “Development and maintenance of a scheme” from informative annex into the standard 2.Include IAF GD24: Take over the Structure of ISO series (e.g ) 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… What is new in ISO/IEC ?

3. Terms and Definitions 3.1 certification Process: evaluation was changed to assessment 3.2 certification scheme competence: -> see 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). What is new in ISO/IEC ?

3. Terms and Definitions 3.8 assessment: this process includes now the „evaluation“ 3.9 examination: -/ 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.. What is new in ISO/IEC ?

3. Terms and Definitions 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). What is new in ISO/IEC ?

3. Terms and Definitions 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 What is new in ISO/IEC ?

3. Terms and Definitions 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). What is new in ISO/IEC ?

3. Terms and Definitions 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). What is new in ISO/IEC ?

3. Terms and Definitions 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). What is new in ISO/IEC ?

Principles - Annex A (informative) Principles: Principles support the credibility of certification. The principles are included in the Annex A (informative). Principles are not requirements.. What is new in ISO/IEC ?

Principles - Annex A (informative) 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 What is new in ISO/IEC ?

Principles - Annex A (informative) 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. What is new in ISO/IEC ?

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),. What is new in ISO/IEC ?

4. General Requirements 4. 3 Management of impartiality 4.3.1top management commitment - statement publicly accessible / / no discrimination of applicants and candidates / CB shall identify threats to its impartiality on an ongoing basis.. What is new in ISO/IEC ?

4. General Requirements 4. 3 Management of impartiality 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.. What is new in ISO/IEC ?

4. General Requirements 4. 4 Finance and liability Remark: financial planning shall consider at least on certification cycle including recertification.. What is new in ISO/IEC ?

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.. What is new in ISO/IEC ?

5. Structural Requirements 5.2 Structure of the certification body in relation to training (this has mostly been taken from IAF GD24) A certain training can be a prerequisite of a certification scheme Maintain impartiality meads not promoting specific training services 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.. What is new in ISO/IEC ?

6. Resource requirements / / CB shall define competence requirements for personnel involved in the certification process -> application, examination, certification, recertification / Personal records shall include known conflicts of interest / / / 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). What is new in ISO/IEC ?

6. Resource requirements 6.2 Personnel involved in the certification activities 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) 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. What is new in ISO/IEC ?

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

6. Resource requirements 6.4Other resources: the CB has to use adequate premises, including examination sites, equipment and resources for carrying out its certification activities see also: -> Security policies / procedures on examination materials -> Technical equipment verified and calibrated What is new in ISO/IEC ?

7. Records and information requirements 7.1.3The 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. 7.2Information 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!. What is new in ISO/IEC ?

7. Records and information requirements 7.3Confidentiality: activities of related bodies (e.g. training center) have to be included in the management of confidentiality. 7.4Security; 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.. What is new in ISO/IEC ?

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

8. Certification Schemes 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. What is new in ISO/IEC ?

8. Certification Schemes 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).. What is new in ISO/IEC ?

8. Certification Schemes 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. What is new in ISO/IEC ?

8. Certification Schemes 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.. What is new in ISO/IEC ?

8. Certification Schemes 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. What is new in ISO/IEC ?

9. Certification process requirements 9.1 Application process: signed application where applicant confirms scope and compliance with: -> certification requirements -> scheme prerequisites. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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. What is new in ISO/IEC ?

9. Certification process requirements 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. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

9. Certification process requirements 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.. What is new in ISO/IEC ?

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 What is new in ISO/IEC ?

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). What is new in ISO/IEC ?