EOQ - PRU Questionnaire - European Organization for Quality

EOQ - PRU
PRU Agent Questionnaire
EOQ - PRU Questionnaire
Applicant Organization name:
Address:
Phone number:
e-mail address:
Representative name:
Date of filling-in the questionnaire:
Legend:
CB = personnel certification body
1. Scope of the CB management system Yes No Remarks
- The scope of the management system of the CB is completely defined, by mentioning the
types of certification and the applied competence standards or normative documents?
- Is the CB a legal entity or is a part of a larger legal entity? If the CB is a part of a larger legal
entity, the links with the other parts of the larger organization are clearly defined and demonstrate that
exists no conflict of interest and impartiality risks?
- Is the CB assuring that the activities of bodies related to CB do not compromise the
confidentiality, objectivity and impartiality of its certification?
- Does the CB offer or provide training?
- Is it assured the distinguishment between the certification of persons and any other activities?
1.2 Application/Exclusions
- Are defined and supported by arguments, the possible exclusions of the ISO 9001
requirements of the CB management system?
2. Normative reference
- The policies and procedures of the CB are complying with all applicable regulations and
statutory requirements?
3. Terms and definitions
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4. Quality management system
4.1 General requirements
- Has the organization established, documented, implemented a management system in
accordance with the requirements of ISO 9001 and 17024 and is maintaining and improving
continually its effectiveness?
- Are the processes needed for the management system and their application throughout the
organization identifiable?
- Are the sequence and interaction of these processes determined?
- Are the criteria and methods determined in order to ensure that both the operation and control
of these processes are effective?
- Is the availability of resources and information ensured, necessary to support the operation and
monitoring of these processes?
- Are these processes measured, monitored and analysed?
- Are actions implemented, necessary to achieve planned results and continual improvement of
these processes?
4.2 Documentation requirements
- Does the management system documentation include:
o documented statements of a quality policy and quality objectives?
o a management system manual?
o documented procedures required by the reference International standards?
o documents needed by the organization to ensure the effective planning, operation and control
of its processes?
o records required by the reference International Standards?
- Are there documents available which show the structure to safeguard impartiality including provisions
to assure the impartiality of the operations of the certification body?
- Does the management system manual contain:
- the scope of the management system, including details and justification for any exclusions?
- the documented procedures established for the management system, or reference to them?
- a description of the interactions between the processes of the management system?
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- Does a documented procedure exist to define the controls needed and required by the ISO
90012000 standard?
- Are required records established and maintained in order to provide evidence of conformity to
requirements and of the effective operation of the management system?
- Does a documented procedure exist in order to define the controls needed for the identification,
storage, protection, retrieval, retention time and disposition of records?
- Is the CB maintaining a records system in order to confirm the status of the certified persons and to
demonstrate that the certification process has been effectively fulfilled?
5. Management responsibility
5.1 Management commitment
- Is the top management able to provide evidence of its commitment to the development and
implementation of the management system?
- Is the top management able to provide evidence that the effectiveness of the management
system is continually improved by:
o communicating to the organization the importance of meeting customer as well as statutory
and regulatory requirements?
o establishing the quality policy?
o ensuring that quality objectives are established?
o conducting management reviews, and ensuring the availability of resources?
5.2 Customer orientation
- The policies and procedures of the CB and their administration are showing the fairness and
equitability to all candidates?
5.3 Quality policy
Does top management ensure that the quality policy:
- is appropriate to the purpose of the CB?
- includes a commitment to comply with requirements and continually improve the effectiveness
of the management system?
- provides a framework for establishing and reviewing quality objectives?
5.4 Planning (objectives)
Does top management ensure that:
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- the planning of the management system is carried out to meet the requirements in clause 4.1
of the standard ISO 9001, as well as the quality objectives?
- the integrity of the management system is maintained when changes to the quality
management system are planned and implemented?
5.5 Responsibility, authority and communication
- Is the CB assure the independency, impartiality, ethical operations, in relation to its applicants?
- Is the CB assuring its responsibilities to the granting, maintaining, renewing, expanding and
reducing the scope, or suspending and withdrawing the certification
- Are defined the CB management structures, competency requirements and responsibilities for:
o the evaluation, certification and surveillance
o the formulation of policies relating to the operation of the CB
o implementation of the policies and procedures
o the finances of the certification body, and
o the delegation of authority to any committees or individuals to undertake defined activities on
its behalf
- Is a scheme committee appointed, which is responsible for the development and maintenance
of the certification scheme for each type of certification being considered?
- How does the scheme committee represent the interests of all parties concerned with the
certification scheme?
- In which documented instructions are described the duties and responsibilities of the employed
or contracted persons and how are they communicated to all those involved? Are these documents
kept up-to-date?
- Did top management appoint a member of management who, irrespective of other
responsibilities, shall have responsibility and authority that includes:
o ensuring that processes needed for the quality management system are established,
implemented and maintained?
o reporting to top management on the performance of the quality management system and any
need for improvement?
o ensuring the promotion of awareness of customer requirements throughout the organization?
- Does top management ensure that appropriate communication processes are established
within the organization and that communication takes place regarding the effectiveness of the
management system?
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5.6 Management review
- Does top management review the CB’s management system, at planned intervals, to ensure
its continuing suitability, adequacy and effectiveness?
- Does this review include assessing opportunities for improvement and the need for changes to
the management system, including the quality policy and quality objectives?
- Are records from management reviews maintained?
- Does the input to management review include all information required by the ISO 9001:2000
standard?
- Does the output of the management review include any decisions and actions related to:
o improvement of the effectiveness of the quality management system and its processes ?
o improvement of product related to customer requirements?
o resource needs?
6. Resource management
6.1 Provision of resources
- Does the CB determine and provide the resources needed:
o to implement and maintain the management system and continually improve its effectiveness ?
o to enhance customer satisfaction by meeting customer requirements?
- Are ensured the necessary financial resources for the operation of a certification system and to
cover associated liabilities?
- Are there available data to demonstrated the financial viability of the CB?
6.2 Human resources
- Does the CB define the needed education, training, technical knowledge and experience for all
personnel who are acting in certification functions?
- Is the CB managing and controlling the suitability of all the staff it uses in particular areas,
whether they are employees, employed on contract or provided by external bodies?
- Are established and defined the competence requirements for the employed or contracted
persons involved in the certification process (for activities as applications review, authorizing and
selecting examiners, preparing, administering, monitoring, grading and evaluating examinations,
assessing subcontractors, handling nonconformities, appeals and complaints, deciding on certification,
implementing and maintaining the management system)?
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- Are the employed or contracted persons sign a document by which they commit themselves to
comply with the rules defined by the certification body, including those relating to confidentiality,
independence and impartiality?
- Do the personnel being active in any aspect of certification activities have the appropriate
education, experience and technical expertise which satisfy the defined competence criteria?
- The person(s) deciding on granting/withdrawing of certificates within the CB, have a level of
knowledge and experience sufficient to evaluate the information obtained from the certification
process?
- Has the CB established and implemented a system that identifies and documents the training
needs of personnel and how those training needs are met (training effectiveness evaluation)?
- Is the CB maintaining current documentation on the relevant qualifications of each individual
involved in certification activities, containing data required by the ISO 17024 standard?
- Are all the CB examiners meeting the competence requirements of the CB, defined in
accordance with the requirements of ISO 17024 standard?
- These criteria are always used for the selection of the examiners?
- Is the CB assessing and monitoring the conduct and performance of the examiners?
- The personnel who is monitoring the conduct of examinations is distinct from the examiners
and is meeting the criteria defined by the CB?
6.3 Infrastructure
- Does the CB determine and manage the work environment needed to achieve conformity to
the personnel certification schemes?
6.4 Work environment
- Does the CB determine and implement necessary measures to ensure security throughout the
certification system, including arrangements for the transport and handling of examination material?
- Has the CB defined and is implementing procedures for separation between examination
materials and training materials, for eliminating the risk of compromising impartiality and/or security?
7. Product/service realisation
7.1 Planning of product/service realization
- Does the CB plan and develop the processes needed for the personnel certification
realization?
- Is this planning consistent with the requirements of the other processes of the quality
management system?
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- Are the examinations planned and structured in order to ensure that all scheme requirements
are objectively and systematically verified, to produce sufficient documented evidence to confirm the
competence of the candidate?
7.2 Customer related process
- The procedures of the CB are not impeding or inhibiting the access by applicants and
candidates? If there are any exceptions, are they defined?
- If there are any changes in the requirements for certification, how are informed all interested
parties and the certified persons?
- Is ensured the non-restriction of certification on the grounds of financial or other limiting
conditions?
- Is the CB providing to all interested parties, current detailed description of the certification
process for each certification scheme and the requirements for certification, the applicants rights and
the duties of the certified persons (including where appropriate, a code of conduct)?
- Are the certification applicants completing an application containing all information required by
this standard?
- Does the CB review the candidates’ application to confirm that:
o the certification body has the capability to deliver the requested certification,
o the certification body is aware of and can, within reason, accommodate any special needs of
applicants, such as language and/or disabilities, and
o the applicant has the required education, experience and training specified by the scheme.
- Is communicated and assured that the certification body is the owner of the issued certificates?
- Is the CB providing to the certificate holders any certification marks or logos?
- The CB is ensuring that all interested parties are made aware, as and when appropriate, of the
existence of the appeals/complaints process and the procedures to be followed?
7.3 Design and development
- Is defined and described a process for the development and maintenance of certification
schemes, including the review and validation of the schemes, by the scheme committee?
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- Does the CB determine: the design and development stages, the review, verification and
validation activities that are appropriate to each design and development stage, and the
responsibilities and authorities for design and development activities?
- Are maintained corresponding records?
- Are defined the criteria for the competence evaluation of persons applying for certification?
- The candidates examination methods are evaluated at least annually and corrected, if needed
for ensure fairness, validity and reliability of theses methods?
- Did the CB define pro-active surveillance procedures (frequency, content of surveillance
activities) to monitor the certified persons’ compliance with the relevant provisions of the certification
requirements, during the validity time period of the certificates?
- Did the CB define adequate re-certification requirements in accordance with the competence
standards and other relevant documents, to ensure that the certified person continues to comply with
the current certification requirements?
- Did the CB define the methods and frequency for re-certification, taking into account any
applicable normative criteria and which are appropriate to the purpose of re-certification?
7.4 Purchasing
- Is the CB subcontracting any activities related to certification (e.g. examination) to an external
body or person?
- If yes, has the CB an agreement with the subcontractor, related to the sub-contracted
activities?
- If there are some sub-contracted certification activities, how is ensured, that the subcontractor
is competent and complies with the applicable provisions of the ISO 17024 standard and is not
involved, either directly or through their employer, with training or the maintenance of the certification
of persons in such a way that confidentiality and impartiality could be compromised
- Is the CB maintaining a list of subcontractors and how are the subcontractors assessed and
monitored by the CB?
7.5 Service provision
- Are defined the policies and procedures for: granting, maintaining, renewing, expanding and
reducing the scope, suspending and withdrawing of certificates?
- The requirements, evaluations and decisions on certification are relating to the scope of the
desired certification?
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- If the CB is providing also training, how is assured the independency of the evaluation and
certification of persons in relationship to the training activities, to ensure that confidentiality and
impartiality are not compromised?
- Is the CB implementing the policies and procedure related to the performance of certified
persons?
- Are implemented the methods and procedures for the evaluation of the competence of the
certification candidates?
- The pre-requisites, eligibility and other certification requirements are documented, indicating a
fair and equitable relationship with the certification scheme?
- Is verified that each certified person complies with the changed certification requirements?
- The requirement regarding confidentiality is including anyone (sub-contractors, as well) who
might gain access to information within the certification body?
- Are defined and maintained policies and procedures for the maintenance and release of
information?
- Is there any process installed in case an examiner has a potential conflict of interest in the
examination of a candidate?
- Does the CB examine competence, based on the requirements of the scheme, by written, oral,
practical, observational or other means?
- Has the CB defined and adopted reporting procedures, to ensure the documentation of the
performance and results of the evaluation, including the performance and results of examinations?
- Did the CB define the quantity and quality of needed information, based on which will be made
the decision on certification?
- Has the CB defined who is taking the decision on the certification of a candidate, based on the
information gathered during the certification process?
- The person(s) deciding on granting/withdrawing of certificates within the CB are participating in
the examination or training of the candidates?
- The issued certificates are containing at least, the following information:
o the name of the certified person and a unique certification number;
o the name of the certification body;
o a reference to the competence standard or other relevant documents, including issue, on which
the certification is based;
o the scope of the certification, including validity conditions and limitations;
o the effective date of certification and date of expiry?
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- Are there objective evidences for the implementation of the re-certification process?
- Has the CB documented procedures for the use of its mark, to ensure that its certified persons
do not use its mark in a way that may be likely to confuse employers or other parties?
- Did the CB define the content of the agreement to be signed by the certified persons, in
accordance with the requirements of the ISO 17024 standard? Are there available objective
evidences that all certified persons have signed such an agreement?
- Has the CB defined corresponding procedures to ensure that its certified persons do not use its
mark in a way that may be likely to confuse employers or other parties?
8. Measurement, analyses and improvement
8.1 General
- Does the CB plan and implement the monitoring, measurement, analysis and improvement
processes needed, in order to:
o assure conformity of the quality management system?
o continually improve the effectiveness of the quality management system?
8.2 Monitoring and measurement
- Does the CB monitor information relating to customer perception as to whether the CB has met
its requirements, as one of the measurements of the performance of the quality management system?
- Are the methods for obtaining and using this information determined?
- Does the CB conduct internal audits at planned intervals to determine whether the quality
management system:
o conforms to the planned arrangements, to the requirements of this International Standard and
to the quality management system requirements established by the organisation?
o is effectively implemented and maintained?
- Is an audit programme planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits?
- Are the audit criteria, scope, frequency and methods defined?
- Do the selection of auditors and the conduct of audits ensure objectivity and impartiality of the
audit process?
- Is it ensured that auditors do not audit their own work?
- Does a documented procedure exist about the responsibilities and requirements for planning
and conducting audits, and for reporting results and maintaining records?
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- Does the responsible for the area being audited ensure that actions are taken without undue
delay to eliminate detected nonconformities and their causes?
- Do follow-up activities include the verification of the actions taken and the reporting of
verification results?
- Is the CB implementing pro-active surveillance procedures to monitor the certified persons’
compliance with the relevant provisions of the certification requirements, during the validity time period
of the certificates?
8.3 Control of non-conforming product
- Is the CB ensuring in a documented manner that appeals and complaints are resolved
independently, in an unbiased manner?
- Has the CB procedures specifying the circumstances and conditions in which certificates will
be withdrawn if competence is not confirmed during surveillance?
- Has the CB procedures to be followed in case of misuse, including false claims as to
certification and false use of its marks (for example the suspending or withdrawal of certification)?
8.4 Analysis of data
- Does the CB determine, collect and analyse appropriate data to demonstrate the suitability
and effectiveness of the quality management system and to evaluate where continual improvement of
the effectiveness of the quality management system can be made ?
- Does this include data generated by monitoring and measurement and from other relevant
sources?
- Does the analysis of data provide information relating to all corresponding requirements of ISO
9001:2000?
8.5 Improvement
- Does the CB continually improve the effectiveness of the quality management system through
the use of the quality policy, quality objectives, audit results, analysis of data, corrective and
preventive actions and management review?
- Does the organization take action to eliminate the cause of nonconformities in order to prevent
recurrence?
- Are corrective actions appropriate to the impact of the problems encountered?
- Does a documented procedure exist to define requirements for:
o reviewing nonconformities (including customer complaints)?
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o determining the causes of nonconformities?
o evaluating the need for action to ensure that nonconformities do not recur?
o determining and implementing the action needed?
o records of the results of action taken?
o reviewing corrective action taken?
- Does the organization determine action to eliminate the causes of potential nonconformities in
order to prevent their occurrence?
- Are preventive actions taken appropriate to the effects of the potential problems?
- Does a documented procedure exist to define requirements for:
o determining potential nonconformities and their causes?
o evaluating the need for action to prevent occurrence of nonconformities?
o determining and implementing action needed?
o records of results of action taken?
o reviewing preventive action taken?
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