P004 Assessor qualifications and monitoring assessor and technical expert competences

Transcription

1 Version 26 Page 1 de 13 P004 Assessor qualifications and monitoring assessor and technical Modifications: p. 6, 7, 8, 9 South Lane Tower I 1, avenue du Swing L-4367 Belvaux Tél.: (+352) Fax: (+352) olas@ilnas.etat.lu Checked by Monique Jacoby Approved by Dominique Ferrand

2 1. Definitions: Quality Assessor / Lead Assessor (LA) P004 Assessor qualifications and Version 26 Page 2 de 13 Person who is competent and experienced in the evaluation of a CAB in accordance with the accreditation standards, and more particularly, in the evaluation of the general organization. The quality assessor must be listed in the National Register of Quality and Technical Assessors. The function of lead assessor is always given to a quality assessor. Missions of the team leader: assists OLAS, if necessary, in the selection of the assessment team, draws up the assessment program, does the document review in the context of an initial assessment coordinates the work of the team on site, supervises the assessment team, represents OLAS and the assessment team in relation to the OEC management, carries out the evaluation of the quality management system makes all the decisions on the running of the assessment, writes an assessment report covering the requirements for which he is responsible and coordinates the drawing up and validates the final assessment report. If more teams are necessary to assess a CAB, each team is supervised by a Lead Assessor. To assure the coordination of the assessment OLAS appoints one of the quality assessors to assure the function of the lead assessor. Junior Quality Assessor Quality assessor who does not have practical experience of 4 missions. The junior quality assessor may be given to do a part of the quality assessment by the lead assessor. The junior quality assessor cannot issue invoices for his work neither to OLAS, nor to the CAB. Technical Assessor Person who is competent and experienced in one or more technical areas and the evaluation of CABs following accreditation and technical standards in association with the concerned area. He is appointed to perform technical assessments, accompanied by a lead assessor. When, for organizational reasons, it s necessary (for example the follow-up assessments on the field of inspection, testing or certification), the technical assessor can also realize an assessment, even if he s not accompanied by the lead assessor. The technical assessor must be listed in the National Register of Quality and Technical Assessors. Each technical assessor is responsible for writing the part of the audit report that applies to him. The final assessment report remains however under the responsibility of the lead assessor. Technical Expert Person having the necessary professional experience to contribute to the evaluation of the technical conformity of a CAB. Experts do not act independently and report to the lead assessor. After participation in at least 3 complete audits rewarded with positive feedback, an occasional supervision during the assessment may be sufficient. In the frame of a witness assessment of a certification body, an expert can be sent alone on mission as far as he s qualified for the certification standard concerned. The technical expert must be registered in the «National Register of Quality and Technical Assessors». National Register of Quality and Technical Assessors The National Register of Quality and Technical Assessors (Register) is the list of quality, technical, junior assessors or experts recognized as competent and inscribed by OLAS to realize the accreditation assessments of the CAB.

3 Version 26 Page 3 de Competence criteria applicable to assessors and experts Any assessor demonstrating that he is a quality, technical assessor, or expert qualified by an accreditation body, which is a member of EA (European co-operation for Accreditation), is considered to have the required qualifications to be inscribed inside of the National Register of Quality and Technical Assessors of OLAS. Thus, the selection criteria listed below do not apply. 2.1 Selection criteria Apart from a duly justified derogation, granted by OLAS, the selection criteria for assessors and experts are as follows: Education Quality assessors must hold a diploma awarded by a higher education institution. Equivalencies to the minimum educational requirements may be granted depending on the person s professional experience and its current and past positions. Working experience Quality assessors must have at least 5 years of professional experience, including 2 years of activities related to quality management within the last 4 years prior to the application. A professional experience related to the domain for which he is applying is considered an asset. Technical assessors and experts must have at least 5 years of professional experience, including 2 years of relevant experience in the technical area for which they apply within the last 4 years prior to the application. Guidelines for the definition of «relevant professional experience» of technical assessors and experts is provides as an appendix to this document. Assessment experience Quality assessors must have participated in at least 4 accreditation assessments as a junior quality assessor before being formally qualified as a quality assessor. Quality assessors who are already qualified for an accreditation standard, do not have to perform a juniorate in order to be qualified for an additional standard, but they are monitored and evaluated by an observer from OLAS during their first assessment. If a technical assessor becomes a quality assessor, the juniorate is reduced to 1 accreditation assessment. Technical assessors have to have participated in at least 1 accreditation assessment in presence of the lead assessor, before being formally qualified as a technical assessor. There is no minimum assessment experience required from technical experts. Language proficiency Assessors and experts have to be able to perform an assessment in one of the three official national languages (Luxembourgish, French and German) or in English. 2.2 Assessor and expert training To be registered in the OLAS National Register of Quality and Technical Assessors, assessors must have followed an assessor training for at least one accreditation standard. The training may be split into several modules, which have to cover the following aspects: - assessment techniques, - the accreditation standard for which thy apply, - the OLAS accreditation system. OLAS recognizes any training of quality or technical assessors organized by another accreditation body signatory of the multilateral agreement of EA. In order to be registered in the OLAS National Register of Quality and Technical Assessor, each assessor and expert must prove the obtained qualifications.

4 Version 26 Page 4 de 13 Competence for an additional standard may be gained through participation in a training module of a least 2 days on this standard. Competence for a new version of a standard, for which an assessor is already qualified, may be gained through: - participation in a training or a assessor harmonization meeting (delivered by OLAS or any other accreditation body who is member of EA), - preparation and conduct of trainings, - professional experience (e.g. performing assessments). There is no training requirement for technical experts. Depending on their professional experience or accomplished training courses, they can be more or less autonomous during assessments (see procedure P002 Performing assessments). Initial training According to its needs and those identified annually from its assessors and experts, as well as from the members of the AC, OLAS organizes trainings on accreditation standards, on the accreditation system or on assessment techniques (standard ISO 19011). These training courses may be organized in collaboration with a training organization. Training on accreditation standards and assessment techniques must be held by trainers specialized in accreditation with the experience of at least 20 accreditation assessments. The trainers must be listed in the National Register of Quality and Technical Assessors and must be approved as trainers by OLAS. Training on the OLAS accreditation system is held by OLAS personnel in charge of accreditation files. As part of the initial training, each new auditor is required to familiarize himself / herself with the OLAS procedures and policies and to complete the OLAS form "F041 Fragebogen für neue Begutachter und Sachverständige". An individual correction is sent to the auditor by OLAS before carrying out his first mission. Trainings must contain practical exercises and/or examinations to test the acquired knowledge. Training of quality assessors includes a juniorate, during which the junior quality assessor can realize part of the quality assessment under the responsibility of the lead assessor. Insofar as possible, training is conducted to comply with the ILAC guide G3:08/2012 Guide Guidelines for Training Courses for Assessors Used by Accreditation Bodies. Ongoing training Ongoing training of assessors and experts is achieved through the following tools: Annual organization of a Day of the Accreditation Community, to ensure update of the knowledge of the assessors and experts, as well as of the members of the Accreditation Committee and OLAS staff. OLAS invites all accredited CABs and CABs preparing accreditation to this day, in order to have a real exchange inside of the accreditation community. - During this day OLAS informs the participants of the important modifications in the documentation serving as basis to accreditation. OLAS sends the documents used during the meeting to all absent persons. - Systematic information of assessors and experts in case of modification of accreditation requirements, in order to take into account the expressed opinions. - Informations by the accreditation managers during preparation of the assessments. - Sending of newsletters Auditor s special, whenever necessary, containing information on modifications of the OLAS quality system, updates of forms,etc.

5 Version 26 Page 5 de 13 - Sending of annual questionnaires on the OLAS system (F043 - Questionnaire pour auditeurs et experts - formation continue) and/or audit circumstances.

6 Version 26 Page 6 de Procedure for approval of assessors and experts and registration into the Register Request of additional information Verification of the application Step 1. Receipt of application The case manager OLAS controls with the help of the form F026 Qualification des auditeurs et des experts that the forms F002A and/or B Application for Quality and Technical Assessors are complete. Application complete? Approval of assessors and experts Step 2. Approval of assessors and experts If the file is complete, an ad hoc committee composed of one or more members chosen because of their technical competence examines the file and controls that the competence criteria defined in chapter 2 of the present procedure are well respected before validating. Step 3. Entry into the register Yes Entry / renewal of registration in the Register Requirements met? No Notification of refusal of registration / radiation from the Register If the competence criteria are met, OLAS the case manager / administrative assistant updates the assessor database and sends a notification letter with the mention of their denomination: «quality assessor», «junior quality assessor», «technical assessor», «technical expert» or «trainer», the standard(s) and technical domain (s) (if applicable) for which they are qualified. If the competence criteria are not met, a notification of refusal of the registration is sent by the head of OLAS department.

7 Version 26 Page 7 de 13 Step 1. Receipt of application The case manager OLAS controls with the help of the form F026 Qualification des auditeurs et des experts that the forms F002A and/or B Application for Quality and Technical Assessors contain at least: the complete name and address, the language(s) in which the assessment can be held, the initial or potential complementary formation(s), the signed and dated professional code of conduct, accreditation assessment experience, the accreditation standard and domain for which he applies. Step 2. Approval of assessors and experts Approval of assessors and experts is done by an ad hoc committee, whose members are chosen for their technical competences with regard to matters to be analysed. They can be selected among the members of the accreditation committee, the personnel of OLAS or be external experts. They have to: have signed the code of ethics F019 Code d éthique et de déontologie pour les collaborateurs externes à l OLAS (exernal experts) or F020 Code d éthique et de déontologie pour les membres du comité d'accréditation (members of the accreditation committee); have educational or professional experience related to an accreditation standard (for qualification of quality assessors); have educational or professional experience related to the concerned domain (for qualification of technical assessors and experts). In order to be registered in the Register, the applicant has either to meet the competence criteria of OLAS, ort to be qualified by another accreditation body which is member of EA. The ad hoc committee formally approves assessors and experts, after verification that the competence criteria are met. Correspondence between qualifications by other accreditation organisms and the domains of accreditation defined by OLAS (Appendix A005) is also validated the ad hoc committee. OLAS needs for assessors in the specified domain are also taken into account for the validation of the registration. Step 3. Entry into the register If the competence criteria are met, the OLAS case manager / administrative assistant updates the assessor database and sends a notification letter with the mention of their denomination: «quality assessor», «junior quality assessor», «technical assessor», «technical expert» or «trainer», the standard(s) and technical domain (s) (if applicable) for which they are qualified. If the competence criteria are not met, a notification of refusal of the registration is sent by the head of OLAS department. As soon as they are listed in the National Register of Quality and Technical Assessors, quality and technical assessors or experts qualified by another accreditation body, which is member of EA, are managed in the same way as the assessors and experts qualified by OLAS.

8 Version 26 Page 8 de Monitoring and evaluation of assessors and experts 4.1 On-site monitoring of assessors and experts Technical assessors and experts, as well as junior quality assessors are monitored during each assessment. The results of each monitoring are recorded into form F011A - Evaluating the services of a technical assessor or junior quality assessor. When the quality assessor is also technical assessor or if a technical assessment is carried out as part of an accreditation according to ISO/IEC 17021, the technical part is evaluated on-site by an OLAS observer. Each quality assessor is monitored by OLAS on-site at least once every three years. The results of each monitoring are recorded on the evaluating form of the assessor s services by an observer of the OLAS F011B Evaluating the services of an assessor or expert. On this occasion, the observer takes the opportunity to evaluate also the efficiency of the services of technical auditors and experts, where possible. When an on-site monitoring is not possible, OLAS shall evaluate the technical assessor s services by other means such as participation in training, review of audit reports or the results of the evaluation by customers via the form F011C Evaluating the effectiveness of a quality and/or technical assessor. Each newly registered quality assessor in the national register of assessors is monitored by OLAS during his first assessment. 4.2 Evaluation of the performances competences of the assessors and experts In addition to the monitoring forms F011A and F011B, the following forms are completed after each assessment: form F009 Evaluating the assessment report by the committee, form F010 Customer satisfaction with regard to the accreditation procedure by the assessed organization including parts on assessor and experts evaluation, If an assessor or an expert is evaluated insufficient in one or several criteria of the evaluation forms, OLAS considers these results like a complaint against itself (cf chapter 6 of the present procedure). If one or several criteria of the evaluation forms are evaluated fair, OLAS can react considering the criticality of the concerned criteria. For the evaluation of the competences of a quality assessor by the means of the form F011B the criteria evaluated under the columns «opening meeting», «assessment» et «closing meeting» are converted by a scale from 1 to 5 after the following manner : 4.3 Yearly Examination of the performances competences A yearly examination of the competences of the quality and technical assessors and the experts having already assessed for OLAS, is done by OLAS during the management review. This examination is based on the overview of the results found on the evaluation forms and on the associated comments and remarks. 4.4 Notification of the appreciations to the assessors and the experts The notification of the appreciations to the assessors and the experts is managed on case by case basis in function of the results of evaluations and the number of yearly assessments realized for OLAS. Nevertheless, in the case of a correct objection against an assessor or an expert following an assessment, OLAS applies then the policy described in the chapters 6 or Renewal of the registration in the National Register of Quality, Technical Assessors and Experts The registration of an assessor is valid for a period of 3 years. The registration process is described in chapter 3 of the present procedure.

9 Version 26 Page 9 de 13 The registration can be renewed. It is based on the annual examination of competence of the assessors and the experts. The renewal of the inscription of an assessor or an expert is managed by OLAS the case manager or the administrative assistant. They contact the assessors or the expert two months before the end of its inscription to have at his disposal all the supporting documents proving the maintaining of his competences. These supporting documents are made of the F002A and/or B application form updated curriculum vitae, recent qualification or training certificates and a list of the assessments performed for another accreditation body signatory of the multilateral agreement of EA during the last 3 years (F028). Criteria for renewal are identical to the competence criteria. For the assessor or expert having realized assessments for OLAS during a period of 3 years, the case manager makes sure that before its renewal the result of the evaluation of competences is positive. Before being renewed, the assessor or expert has to return at least the last annual questionnaire on the OLAS system and/or audit circumstances. In general, absence of participation in continual training specified in chapter 2.2 can also justify refusal of the registration renewal. When the registration is ending, OLAS the administrative assistant or the case manager sends a reminder to the assessors or experts that are late. If no supporting document is sent to OLAS 2 months after the end of validity, the head of OLAS department sends a notification of withdrawal and the quality manager takes the assessor or expert out of the Register published on the Internet. The information recorded in the database is archived following the radiation of the assessor or the expert, by OLAS the case manager or the administrative assistant. Only the validation of the initial qualification is ensured by the committee ad hoc, as described in chapter 3. If later on, the deleted assessor or the expert wishes to register himself again in the Register, the registration is managed as an initial qualification. 6. Complaints against an assessor or an expert In case of an objection against an assessor or an expert (one comment of a client on one F010, one letter of complaint or an insufficient appreciation on one of the evaluation forms) OLAS first asks for complementary explication to the assessor in order to have all the information necessary to evaluate the situation. If the complaint is justified the head of OLAS department can submit the assessors or experts file for the opinion of the Committee. Following this opinion, the head of OLAS department can formulate a warning, remove the assessor from the Register or decide to close the case. Proven non-compliance with the professional code of conduct constitutes serious misconduct. 7. Withdrawal of an assessor or an expert of the Register OLAS can withdraw an assessor or an expert: on proposal of the Committee following a negative result of the evaluation of an assessor or, if the assessor does not wish to renew his registration in the Register or does not reply within 2 months following expiration of his registration. If the assessor or expert does not fulfil anymore the competence criteria defined in chapter 2. The decision of withdrawal is taken by the head of OLAS department. The concerned assessor or expert gets a notification. The assessors or the experts can lodge an appeal against the decisions of OLAS with the AC or the administrative tribunal. 8. Internal assessors

10 Page 10 de Version OLAS orders the realization of its internal assessments to external assessors. In opposition to the assessors used for the accreditation of CAB s, they may be not registered in the National Register of Quality and Technical Assessor. To realize an internal assessment they must prove their competence for the standard ISO/CEI either for having put it in practice during the creation or the administration of other accreditation bodies, either because they are qualified as assessors in the frame of mutual recognition assessments for EA.

11 Page 11 de Version Annexe Guidelines for the definition of «relevant professional experience» For the definition of «relevant professional experience», for the qualification of technical assessors and experts set out under 2.1, OLAS uses the following non exhaustive list. 1. Accreditation of laboratories A relevant professional experience may be justified by one or more experiences or knowledge acquired in: in a laboratory or in sectors of activity identical to those the technical assessor (or expert) will have to assess; general principles related to the management and techniques used in a laboratory; terminology as well as standards and regulations related to the domains concerned; general metrology principles, in particular those related to the domain to be assessed; more specific metrology knowledge, if a laboratory proceeds itself at internal calibration of his equipment. 2. Accreditation of inspection bodies A relevant professional experience may be justified by one or more experiences or knowledge acquired in: in inspection activities or in sectors of activity identical to those the technical assessor (or expert) will have to assess; technical characteristics of products, equipments, facilities, processes to be assessed; terminology as well as standards and regulations related to the domains concerned; general metrology principles, in particular those related to the domain to be assessed. 3. Accreditation of management system certification bodies A certification assessor working for a management system certification body is not accepted as accreditation assessor / expert, except in some exceptional and motivated cases. In that situation, his activity as certification assessor will be mentioned in the notification to the organism that will be assessed. Notification of qualification (inscription, re-inscription, etc.) of technical assessors with regard to their competences in technical domains SMQ1, SMQ4 and SMQ5 is realized according to the clusters as defined in the documents IAF MD17 : 2015 (SMQ1 et SMQ4) and EA-3/13 M :2016 (SMQ5). A technical assessor qualified for a critical domain of a cluster, is automatically qualified for all noncritical domains of the same cluster. For the QMS/SMQ domain (Quality management system): For the identified critical EA codes (see P002 Step 1), the assessment team has to be supported by a technical assessor or expert having a relevant training and/or professional work experience to cover the domain concerned. Relevant professional experience is defined, for the area of activity concerned, as experience and knowledge required to dealing with: procedures and technical characteristics of products; practices specific to the area of activity. Quality assessors with a qualification according to the standard ISO/IEC are also authorized to perform technical assessments in all areas of non-critical EA code, in accordance to OLAS procedure P002. Notification of registration / written renewal sent to the concerned technical assessors with regard to their qualification for ISO/IEC SMQ1, will only include the fields of «critical» EA codes or, if applicable, with following detail: qualification for all non-critical SMQ1 areas.

12 Page 12 de Version For the EMS domain (Environmental management system): A relevant professional experience is defined as experience and knowledge required in the environmental sector (production, prevention, environmental manager, competent body) to dealing with: specific terminology; applicable environmental legislation; environmental aspects of products and their impact; critical environmental aspects related to processes and products; the most recent environmental technologies to prevent any pollution. For the medical device domain (ISO 13485): According to document IAF MD8 :2015, technical assessors and experts have to have the following knowledges and skills: principles and applications of quality systems.; understanding of applicable GHTF SG4 and SG3 documents. (Being maintained by IMDRF) understanding of ISO 13485; understanding of general regulatory requirements relevant to medical device manufacturers; overview of medical devices, their intended use, safety and risks; the legal framework, including the regulatory requirements, their enforcement, and the role of the auditing organization; information on CAB s client products, processes and organization to determine competence needed by the audit team and for the certification decision; understanding CAB s client s products, processes and organization ; ability to confirm that the CAB s processes are appropriate to support IAF ISO scheme; ability to confirm that the CAB is competent to conduct a certification of the manufacturers, taking into account the processes and products involved; identification of medical devices including complexities, technologies, intended use and risk classifications; knowledge on identifying and evaluating factors that impact an appropriate certification program for a medical device manufacturer seeking certification in a regulatory environment.; understanding of work performed at an accredited CAB.; understanding of IAF Mandatory Documents for ISO scheme. For the information security management systems domain (ISO 27001): According to document IAF MD13 :2015, technical assessors and experts have to have the following knowledges and skills: ISMS related terminology and principles including ISO/IEC 27000; understanding of Audit techniques included in ISO/IEC and ISO/IEC TR 27008; deeper level of knowledge of standard ISO/IEC and ISO/IEC 27006; deeper level of knowledge of standard ISO 27001; deeper level of knowledge of General legal and regulatory requirements related to ISMSs; Generic ISMS related technology including: - information security technologies and practices, - information and communication technology, - risk assessment and risk management; CAB s client process and operation associated with ISMS.

13 Page 13 de Version Accreditation of product and person certification bodies A certification assessor working for a product or person certification body can be accepted as accreditation assessor / expert. His activity as certification assessor will be mentioned in the notification to the organism that will be assessed. Relevant professional experience is defined as experience and knowledge required to dealing with: procedures and technical characteristics of products; practices specific to the area of activity; standards applicable to the products and domains concerned; sampling, test and inspection methods within the context of product certifications; and/or issues related to the organisation of exams within the context of person certifications.