PROCEDURE FOR ACCREDITATION OF CERTIFICATION BODIES. Table of Contents

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1 PROCEDURE FOR Table of Contents 1 Objective 2 2 Scope 2 3 Definitions 2 4 Accreditation criteria 2 5 Accreditation process 3 6 Accreditation of management systems certification bodies 8 7 Accreditation of products certification bodies 11 8 Accreditation of personnel certification bodies 15 Total of Pages: 18 CHANGES Updated formatting, references and editorial amendments. Removal of annexes. Alignment with current practice and clarifications. NOTE This is a translated version from the Portuguese version, and the latter shall prevail in all cases and for all purposes. INSTITUTO PORTUGUÊS DE ACREDITAÇÃO PORTUGUESE ACCREDITATION INSTITUTE Rua António Gião, 2, 4º Tel: Caparica Fax: acredita@ipac.pt Internet

2 1 Objective The present document describes the accreditation system of entities responsible for: - Management systems certification - Product, process or service certification - Personnel certification This document complements and specifies the accreditation criteria and methodology described in the General Regulation for Accreditation (DRC001), and therefore must be read and applied together. 2 Scope The provisions contained in this document apply to all accredited or applicant certification bodies, and are generically referred to in this document as accredited or applicant body, respectively. As each entity is unique, and all possible circumstances can t be foreseen, exceptional and justified deviations to this procedure may occur, which will be afterwards updated, if necessary. Exceptions to these document may arise from national and international legislation, or mandatory requirements from EA or IAF. 3 Definitions For the purpose of this document, it is adopted the definitions included in the accreditation standards or documents, as well as those indicated below. 3.1 Certification specification: The normative document (or set of normative documents) that define the requirements and the characteristics of the certification object (a management system, product or profession). 3.2 Certification procedure: The normative document (or set of normative documents) that define the methodology for the assessment of conformity with the certification specification (3.1). 3.3 Certification scheme: The set of rules, procedures and additional requirements applicable to a given type of management system certification, product certification or personnel certification - see Proprietary scheme: Certification scheme (3.3) where its rules, procedures and requirements are defined by a body external and independent to the certification body, identified as the scheme owner, which licenses the use of the corresponding mark (if it exists) and/or recognizes the certification within the scope of the scheme. 3.5 Regulatory scheme: Certification scheme (3.3) where accreditation is legally required to perform the conformity assessment activity, normally with a public or governmental body acting as the scheme owner. 4 Accreditation criteria The accreditation criteria are the requirements that the certification body must comply to be granted accreditation or to be maintained. These are general requirements (applicable to all scopes of accreditation), and specific requirements (applicable according to the accreditation scheme or sector), which are always complementary to the general ones. 4.1 General criteria All certification bodies must comply with the requirements and general duties defined or referred to in the General Regulation for Accreditation (DRC001). The certification bodies must also fulfil the requirements established by EA or IAF mandatory documents applicable to their scope of activity, as well as eventual specific requirements established in regulatory or proprietary sector schemes (see 5.10). The applicable documents listed in this procedure are those in force at the time of issue of this procedure, and each certification body must verify and update as it needs to use. Page 2 of 28

3 Additionally, for the certification bodies to obtain and maintain their accredited status they cannot provide any certification service against the normative documents used for accreditation. 4.2 Specific criteria The specific criteria for the each accreditation schemes are described in sections 6, 7 and 8 of this document and in Specific Accreditation Requirements (OECxxx), when applicable. 5 Accreditation process The accreditation process is described in the General Regulation for Accreditation, which should be consulted as a reference document - only particular situations are detailed hereafter. 5.1 Application The following application documents must be filled in and sent to IPAC: General application form (DIC002) Specific application form for each accreditation scheme: DIC010 for management system certification bodies, DIC011 for products, processes or services certification bodies, and DIC012 for personnel certification bodies; Form for the registration of certification activities (DIC017); all the elements listed in the application forms; all the additional documents considered important, such as the ones that mention any additional requirements to the accreditation process, for example, requirements from a regulator, scheme owner or a licensing agency When a certification body requires accreditation for several accreditation sectors, IPAC can, based on the diversity and specificities required for its assessment and evaluation, request that independent applications are presented for each or defined groups of sectors, which will be managed separately. IPAC considers that applications for different accreditation schemes or standards are to be handled as distinct applications. 5.2 Preparation for Evaluation In order for the programming of the evaluation to be carried out in an adequate manner, the certification body should send to IPAC all the information that is requested by IPAC, as established in the General Regulation for Accreditation, which generically describes how IPAC prepares for assessment. 5.3 Evaluation methods This section describes the different elements available for evaluation, and in Specific Accreditation Requirements (OECxxx) the corresponding application for a given accreditation scheme or sector, if necessary Office Assessments The assessment process at the certification body s office undergoes as established in the international standards and as described in the General Regulation for Accreditation. Office assessments are always carried out in initial, renewal and surveillance assessments. Assessments may occur in a single act, or may be distributed in two phases - initial assessments are normally performed in 2 phases. The objective of the phase 1 is to: To know the facilities and logistics of the applicant and to collect information on the scope, dimension and characteristics of its activity; To evaluate the implementation of the main requirements and to report corrections needed; To evaluate the resources and plan the second phase of the assessment. As a result of the phase 1 a report will be draw up and sent to the certification body, describing the conclusions and eventual findings that are identified. The certification body should reply indicating the corrective actions that will be implemented and the corresponding deadline. When this reply allows IPAC to conclude that the conditions are met to proceed, namely by having been solved fundamental deficiencies, IPAC will complete the programming of the phase 2 and will inform the certification body correspondingly. Page 3 of 28

4 Page 4 of 28 The phase 2 of the assessment should complete the evaluation of the competence and conformity of the certification body with the applicable requirements for accreditation. For the requirements assessed and closed in phase 1, and which haven t suffered any change, it will be sufficient to mention the conclusions of phase 1. The initial assessment can be performed in a single act or phase (including the aspects referred to phase 1 and phase 2) namely in the following cases: If the certification body seek accreditation for similar accreditation standards (with several common or comparable requirements) to those that already have accreditation or have been accredited in the last four years; If the result of the document review indicates its feasibility; If the certification body is accredited to the same accreditation standard by a signatory of the relevant EA or IAF mutual recognition agreement On-site witnessing Through on-site witnessing, IPAC can observe the conformity assessments activities (audits, controls, exams, etc) performed under the responsibility of the certification body. The objective is to evaluate the correct application of certification procedures and the technical competence of the certification body staff involved - i.e., the witnessing findings are focused on the performance of the certification body staff and not on its customer performance. These witnessing involve a witnessing team (ETI) from IPAC and a witnessed team (EAT) from the certification body. It s up to the applicant or accredited certification body to: Communicate to their clients the witnessing programmed by IPAC and how they will be performed; Contract with its clients the possibility that the ETI are present during the evaluation done by the certification body and allow the sending of the client and certification body documentation needed to perform the witnessing; Make sure that the witnessing occurs within the foreseen timeframes. However, the certification body s client may refuse an element of an ETI, if sound evidence can be presented to presume lack of independence or impartiality. If a certification body client refuses without proper justification to perform a witnessing programmed by IPAC, the certification body shall take the appropriate actions and cannot consider or declare the corresponding certification accredited - noting the dispositions of DRC002, section 5.2, which mandates to issue an accredited certificate and this being prevented by the refusal of the client, it invalidates the emission of any certificate. Likewise, in the case of unjustified refusal, IPAC may inform the regulatory bodies and/or scheme owners, as well as other accreditation bodies or the general public, as applicable and relevant. The certification body must send to IPAC at least one week before the witnessing date all the documents necessary for preparation namely the same documents sent to the certification body personnel. If not, IPAC may choose to perform another evaluation (namely a control visit), at a later date to be agreed with the certification body. Eventual changes to a witnessing already agreed and confirmed by IPAC within 15 days from the scheduled date, and that IPAC cannot agree or aren t caused by force majeure, may imply: the payment of the corresponding costs incurred; the suspension of the corresponding accreditation scope, if that disables IPAC from covering it. The witnessing goes through different stages: Meeting of the ETI with the EAT to evaluate the audit preparation, as well as to explain the witness role and prepare its presentation to the client, or, if relevant, discuss other subjects that are needed or convenient. Witnessing of the evaluation conducted by the EAT, without interfering with its performance or commenting it with the certification body's client; however the ETI can request the EAT to examine the client's documentation whenever needed and relevant; A final meeting of the ETI with the EAT (made whenever possible at the end of the evaluation and in the absence of the certification body's client) to clarify any questions and provide a summary on the IPAC witnessing conclusions, including eventual findings - this will be delayed if the certification body's evaluation was not finished and/or the corresponding report not issued, or IPAC will further wait for the certification body's decision, in which cases only the evidences will be confirmed. During a witnessing, the following evaluation parameters are taken into account: Planning by the certification body (duration, program and plan, documentation, etc.). Performance of the EAT (competence of the team, mandate, scope coverage, closing of previous findings, course of action, sampling of activities and persons, evidence gathering, identification and classification of findings, reporting, etc.); Conformity assessment of client to meet applicable requirements; Other parameters (e.g., consultancy, confidentiality, legal compliance, activities after-and before the witnessing, as relevant)

5 Whenever requested the certification body must send to IPAC a copy of all documents derived from its conformity assessment activity and decision-making process. As an outcome of the witnessing a written Witnessing Report containing the findings and conclusions shall be sent to the certification body within 15 days after the witnessing finishes. The certification body should respond, as if it was an Assessment Report. On-site witnessing can complemented by a documental review of other certification process phases that weren t covered by the witnessing, including then in the report the corresponding conclusions Documental witnessing The documental witnessing consists in the review by IPAC of all the documentation that supports a certification decision, aiming to determine the certification body competence and the fulfilment of all the applicable procedures and requirements. It s the certification body responsibility to establish with its clients the necessary agreements and mechanisms that allow IPAC to perform these assessments, including the access to the corresponding documentation. The documentation required for the documental witnessing should be at least: Scope of certification (applicant or certified) Records of contract review, including the certification planning; Records of the certification body personnel involved (qualification and corresponding supporting evidence); Records of evaluations (e.g. audits, controls, exams, as applicable) made by the certification body and replies and clarifications provided by the clients; Records of analysis and decision-making made by the certification body. The documental witnessing is done in premises agreed with the certification body and IPAC may request the presence of the certification body in order to provide clarifications. A Witnessing Report containing the findings and conclusions shall be sent to the certification body, to which it shall respond, as if it was an assessment report Control visits The control visits are visits made by IPAC to the certification body clients, outside the auditing program of the certification body, aiming to confirm the adequacy and correctness of the corresponding auditing and decisions made by the certification body. These visits are seen as additional resources to be considered in the following cases: When it is impossible to perform the scheduled witnessing, or when the witnessing hasn t been conclusive or complete, a control visit may be proposed to the certification body. In cases of appeals, claims or serious complaints about the service performed by the certification body or its client, IPAC may ask for a visit. Visits are arranged, on a case-by-case basis with the certification body, which has the responsibility to establish the appropriate contractual and logistics arrangements and contacts with its clients to allow an adequate visit. Previously to the visit, IPAC will establish and communicate to the certification body the subjects to be discussed during the visit, which will be conducted by an ETI. During the visit, normally the client will start by making a brief introduction of how it is organized to fulfil the certification requirements; then the certification body representative will describe the activities performed during the auditing process, and the ETI may request additional information or clarifications to the certification body's representative, namely about the objective evidence gained and the findings recorded and their resolution. At the end of the visit, a summary with the conclusions of the visit shall be made in private to the certification body representative, and a written report will be prepared within 15 days after the control visit end. The certification body should respond, as if it was an Assessment Report Accreditation for regulatory schemes In the case of regulatory areas which require an accreditation previously to being authorized to certify and make impossible the existence of clients in such scopes (e.g. because a provisional authorization regime has not been foreseen), witnessing on-site can be postponed to the first possible occurrence, without prejudice of granting or extending the accreditation if the remaining assessments have been satisfactorily closed. The on-site witnessing can also be replaced by control visits to previously existing clients, if possible and applicable. Page 5 of 28

6 In these cases, the issue by the certification body of certificates or other documents covered by accreditation is subject to the previous authorization by IPAC, following the satisfactory closure of the onsite witnessing (or other assessments) that are performed 5.4 Accreditation decision The decision making process is described in the General Regulation for Accreditation. The accreditation scopes shall be defined in Technical Annexes with reference to: the accreditation standards and normative documents; the object of certification, i.e. the type of management system, products or persons that are certified; to the permanent sites of the certification body where activities covered by accreditation are performed; the accredited certification activities, as described hereafter in sections 6, 7 and 8, identifying in a table the certification specifications and procedures. The accredited certification activities are grouped in accreditation sectors, as defined in the following sections. 5.5 Surveillance and Renewal The process for surveillance and renewal is generically described in the General Regulation for Accreditation accreditation cycles comprise four years. The first accreditation cycle starts with the first surveillance and ends with the first reassessment, with annual assessments, aiming for 12 months interval follow-up and extraordinary assessments are not counted for the annual assessments in the cycle, except when combined with the annual surveillance or reassessment. The second cycle starts with the first surveillance after renewal, followed by annual assessments aiming to keep the 12 months interval, and end in the next reassessment. The following accreditation cycles are composed in a similar manner. 5.6 Extension IPAC considers as an extension of accreditation the enlargement or modification of the accreditation scope to new certification specifications and/or procedures. A formal application for extending the accreditation scope should be made using the appropriate forms (DIC010, DIC011 or DIC012, as applicable) and enclosing the items required in the corresponding form. Extensions that cannot be programmed by IPAC within three months after their reception, for reasons attributable to the certification body, can be closed by the IPAC for the not-possible to program activities. If after 12 months of the extension application have not occurred the evaluation actions needed, for reasons attributable to the certification body, the application will be terminated (in non- evaluated). IPAC considers as a major extension those that application scope covers new accreditation sectors or new proprietary schemes, not previously covered by accreditation; the remaining extension requests or normative updates are considered to be minor extensions. 5.7 Conversion of old certificates to the accredited scope For a certification body to include in its accredited scope valid certifications issued previously to the granting or extension of accreditation, it is necessary that: It possesses and implements a procedure to convert these certifications; It is possible to demonstrate the correct enforcement of the certification procedure to each client; It has been evaluated and demonstrated null or irrelevant the impact to the intended conversions of all findings identified in IPAC s assessments; if not, the certification body must be able to demonstrate that additional audits have been made and/or has taken appropriate measures to correct the negative impacts; in the remaining cases that it is not possible to correct immediately the impacts, it is only possible to convert the certificates after the necessary corrections have been made; All the conversions are made at the same time or in a single step (so that no discrimination between clients occurs) after IPAC approval. 5.8 Provision of certifications services During application and annually until 31 January of each year, certification bodies must send to IPAC the information required in the form for recording certification activities (DIC017). Page 6 of 28

7 There can only be provision of IPAC accredited certification services from sites explicitly mentioned in the Technical Annex to the Accreditation Certificate. For that, the certification body must request to IPAC its inclusion and undergo an evaluation process, so that it can be verified the compliance with the accreditation criteria as well as confirming the volume, nature and criticality of the activities done in that site. The evaluation process of certification services provided in a foreign country can be made involving the local accreditation body (if there s one). The maintenance evaluation regime for foreign sites will normally be similar to the national sites, with adjustments namely due to the volume, nature and criticality of certification activities and performance information provided by the local accreditation body. IPAC may take decisions (and sanctions) independently for each site. 5.9 Certification Marks The conformity marks of certification bodies must comply with the requirements of ISO/IEC Conformity assessment - General requirements for third-party marks of conformity Certification schemes The certification scheme should be documented and publicly available, and describe or make reference to: The certification object (system, product, process, service or profession) to be certified; The certification specification; The certification procedure; The requirements imposed to the CB and any interpretation and particularity; The additional requirements of the accreditation process. The appraisal and acceptance of certification sector schemes by IPAC will follow the applicable EA and IAF documents, in particular EA-1/22. In the case of certification schemes that have an international dimension, or are subject to an appraisal or endorsement by EA or IAF, IPAC will await the outcome of that process before proceeding (as stated in the document EA-1/22). Certification specifications and procedures can be normative documents external or developed by the certification body and cannot contradict the applicable legislation. The certification specifications and procedures must also comply with the applicable EA or IAF guidelines, and IPAC may request an opinion from the Accreditation or Standardisation Technical Committees as relevant, or to EA or IAF, before developing and providing the corresponding accreditation scheme. When there is more than one IPAC accredited certification body for a given product category, IPAC can request that the corresponding certification specifications and procedures become harmonized, either by mutual agreement or through the standardisation process. Page 7 of 28

8 6 Accreditation of management systems certification bodies 6.1 Reference documents At the time of issue of this procedure, the following documents are applicable: ISO/IEC Conformity assessment Requirements for bodies providing audit and certification of management systems ISO/IEC Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: requirements OGC009 Guia Interpretativo da ISO/IEC OEC024 Requisitos específicos de acreditação - certificação de sistemas de gestão IAF MD 1 Certification of Multiple Sites Based on Sampling IAF MD 2 Transfer of Accredited Certification of Management Systems IAF MD 4 Use of Computer Assisted Auditing Techniques ( CAAT ) for Accredited Certification of Management Systems IAF MD 7 "Harmonization of Sanctions to be applied to Conformity Assessment Bodies" IAF MD 10 "Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011" IAF MD 11 "Application of ISO/IEC for Audits of Integrated Management System" IAF MD 12 Assessment of Certification Activities for Cross Frontier Accreditation IAF MD17 Witnessing Activities for the Accreditation of Management Systems Certification Bodies Regulamento (CE) 1893/2006 (NACE revision 2) The documents specifically applicable for each management systems are listed in OEC Accreditation scope The table mentioned in section 5.4 describing the accreditation scope has the following layout, with the accreditation sectors covered by the accreditation scope presented in succession: Sistema de Gestão Management System Ann - <DESIGNAÇÃO DO SECTOR DE ACREDITAÇÃO> <NAME OF THE ACCREDITATION SECTOR> Identification and characterization of the accreditation units for each accreditation sector The definition of accreditation scopes is based on 'accreditation units', which constitute the minimal individual scopes for which competence has to be demonstrated, as established in OEC024. The accreditation sectors correspond to the different management system certification schemes, and are described in the table below. Page 8 of 28

9 Accreditation Sectors [A01] Quality management system - QMS [A02] Environment management system - EMS [A03] Sustainable Forestry management system - SFMS [A04] Occupational Health and Safety management system OHS MS [A05] Research, Development and Innovation management system - RDI MS [A06] Information Security management system ISMS [A07] Vocational Training management system - VT MS [A08] Food Safety management system - FSMS [A09] FSSC [A010] Information Technology Services management system - ITSMS [A011] Energy management system - EnMS 6.3 Specific criteria for accreditation The specific criteria that a certification body shall fulfil to obtain and maintain the accreditation are described in ISO/IEC 17021, with the understanding and interpretation given by OGC009 and EA or IAF applicable documents, and any additional applicable documents as indicated below. Accreditation Sector Certification standard Additional accreditation requirements QMS ISO 9001 ISO/IEC TS EMS ISO ISO/IEC TS SFMS NP 4406 CFFP and PEFC applicable documents HSW MS OHSAS or NP 4397 RDI MS NP 4457 ISMS ISO/IEC ISO/IEC VT MS NP 4512 FSMS ISO ISO/TS FSSC FSSC ISO/TS and FSSC applicable documents ITSMS ISO/IEC EnMS ISO ISO Granting and Extension In order for IPAC to decide on the granting or extension for one accreditation unit, the certification body must demonstrate to be competent for the certification in question, namely by having taken at least a certification decision for a process within that accreditation unit Maintenance For a certification body to keep its accreditation, it is necessary to continue to evidence its competence, namely by continuing to take certification decisions for each accreditation unit within the accreditation scope. When the certification body does not have clients in an accreditation unit for a period over 4 years, it is considered that it cannot demonstrate to maintain the specific competence and therefore the accreditation will be suspended or withdrawn if it persists. Page 9 of 28

10 6.4 Evaluation process The evaluation process of a MS certification body by IPAC includes the performance of initial and annual office assessments, combined with witnessing for the initial accreditation and during each accreditation cycle. The following criteria are considered for the selection of the assessments to be made: Dimension, diversity and criticality of the accreditation scope; Type, volume and changes of the certification body activity; Regulatory or sector scheme requirements applicable; Result of previous assessments of IPAC; Certification procedure established, including the type and frequency of audits to the clients; Geographic dispersion of its operations and/or the existence of critical sites of the certification body or bodies under its organizational control; Type and volume of subcontracted activities; Experience of the certification body in the application of the certification standards. For the programming of the witnessing to be made, IPAC follows IAF MD17 and OEC024, except where otherwise established in a specific accreditation scheme. It is up to IPAC to select the evaluations to be witnessed on-site, or subjected to documental review or control visits, according to the risk and previous experience. IPAC programs its evaluations for the maintenance of accreditation based on the information sent by the certification body to the 6.5 National Directory of Certified Clients. Whenever requested by IPAC, the certification body shall send to IPAC the detailed planning of its audit activities in the required scope, with the following minimum information: Identification of the clients to be audited; Certification standard and identification of the certification scope; Type of audit; Name of auditors; Location(s) and planned date(s) for the audits Evaluation grouping For evaluation proposes, IPAC may establish key-sectors and sectoral groups: Each key-sector corresponds to an accreditation unit that includes activities that are considered critical or too complex for the management system certification in question, and for that reason, the evaluation must be individualized and specified. Each sectoral group corresponds to a group of accreditation units that include activities that although distinct, involve similar competence in the selection, training, qualification, auditors performance, and in decision-making process. For this reason, and the less complexity and criticality of the activities inside sectoral groups, comparing to key- sectors, the competence demonstrated for some elements of a sectoral group can be considered representative and endorse competence for the other elements of that sectoral group. The groupings made for each management system are displayed in OEC National Directory of Certified Clients The certification body must send to IPAC an harmonized list of all accredited MS certified clients, with the following information, for each accreditation sector: The identification of the client, MS, IAF code or identifier applicable, certification scope description, location by district or by country (if abroad) The certification body shall send this information to IPAC until 10th January and 10th July in order to update and make available a database of companies with accredited certification in IPAC website. Page 10 of 28

11 7 Accreditation of products certification bodies 7.1 Reference documents At the time of issue of this procedure, the following documents are applicable: NP EN Requisitos gerais para organismos de certificação de produtos IAF GD5 Guidance on the application of ISO/IEC Guide 65 ISO/IEC " Conformity assessment Requirements for bodies certifying products, processes and services ISO/IEC "Conformity assessment Fundamentals of product certification and guidelines for product certification schemes" OEC003 Product certification bodies Social responses OEC006 Requisitos específicos de acreditação Certificação BRC OEC007 Requisitos específicos de acreditação - Certificação GlobalGap OEC014 Requisitos específicos de acreditação Organismos Notificados para o Regulamento dos Produtos de Construção OEC019 Requisitos específicos de acreditação - Certificação de Sistemas de Valorização de Resíduos OEC020 Requisitos específicos de acreditação - Certificação IFS EA-3/12 "EA Policy for the Accreditation of Organic Production Certification" EA-6/02 EA Guidelines on the Use of ISO/IEC and ISO/IEC for Certification to EN ISO 3834 EA-6/04 EA Guidelines on the Accreditation of Certification of Primary Sector Products by Means of Sampling of Sites 7.2 Scope of accreditation In the following text, where it is read 'product' it may also be read 'process' or 'service', as relevant and applicable Description of the accreditation scope The table mentioned in section 5.4 describing the accreditation scope has the following layout, grouped and ordered by accreditation sectors, presented in succession, and within each, by product categories - see 7.2.2: Produto/ Processo/ Serviço Product/ Process/ Service Cnn - <DESIGNAÇÃO DO SECTOR DE ACREDITAÇÃO> <NAME OF THE ACCREDITATION SECTOR> Cnn.mm - <Identification of the product category > Especificação de Certificação Certification criteria Procedimento de Certificação Certification procedure <Products or types of products > < certification specification > < certification procedure > In case of technical areas subject to frequent changes in versions of normative documents (external) that constitute the certification specification, the certification body may request a flexible description of the accreditation scope, which will omit the version of the certification specification, assuming that it always refers to the version in force. This implies that: the certification body demonstrates its ability to appropriately and timely detect and implement new versions of the certification specification in question. For this, the certification body shall establish (and keep) a comparative table between the versions with changes, followed by an assessment of the impact and possible measures that must be implemented to conform with the new version; the new version of the certification specification does not significantly change the competences and methodologies needed for assessing the conformity of products or categories of products, without which it will need to request confirmation of the change to IPAC; the certification body always keep an updated List of Accredited Certifications under Flexible Scope in a format similar to the Technical Annex, identifying for each of the certifications under flexible description which version of the normative document of each certification scheme. The certification body must designate a responsible for the approval and supervision of the said List, which should be available to the public and be submitted to IPAC for preparing assessments or whenever requested. It must be kept track of the different versions of the List for a period equivalent to an cycle of accreditation or certification (whichever is greater). Page 11 of 28

12 In conditions similar to the above, the certification body may also request that it is omitted the version of the certification procedure, in which case the List of Accredited Certifications under Flexible Scope maintained by the certification body shall identify the corresponding version. However, the certification body cannot introduce new versions that contain significant changes to the conformity assessment methodology, without the previous communication to and acceptance by IPAC. If the certification body does not comply with the above conditions, IPAC may suspend or withdraw this flexible scope description, without prejudice to other sanctions or actions. This flexible scope description may not be applicable to certification schemes that the scheme owner does not foresee Structure of accreditation scopes For the purpose of describing the accreditation scope, IPAC identifies: accreditation sectors as groupings of product categories in accordance to a classification system for products from the United Nations (ISIC) and the EA codes; product categories in accordance with the 3 digits of NACE codes (Regulation (EC) 1893/2006), or as defined by the sectoral scheme, when applicable. The accreditation sectors are presented in the table below. [C01] Products of agriculture, forestry and fishing [C02] Products of extractive industries [C03] Food products, drinks and tobacco [C04] Textile products [C05] Leather products [C06] Wood, cork and its workmanships [C07] Paper and pulp products [C08] Coke and Petrochemical products [C09] Nuclear products [C10] Chemical products and synthetic or artificial fibres [C11] Pharmaceutical products [C12] Rubber and plastic products [C13] Non-metallic mineral products (except cement, whitewash, plaster, hardened and its products) [C14] Cement, whitewash, plaster, hardened and its products [C15] Metallurgic and metallic products [C16] Machines and equipment [C17] Electrical and optical equipment [C18] Aircraft and spatial vehicles [C19] Transport material [C20] Products of other transforming industries [C21] Construction [C22] Publishing service [C23] Service of printing and reproduction and related activities [C24] Service of construction and naval repairing [C25] Service of recycling [C26] Service of production and distribution of electricity [C27] Service of gas production and distribution by pipelines [C28] Service of production and distribution of water [C29] Service of construction [C30] Service of commerce and retail [C31] Service of repairing of vehicles, motorcycles and goods of personal and domestic use [C32] Service of lodging and restoration [C33] Service of transport, storage and communications [C34] Financial and real estate services; Lease of machines and equipment without staff and personal and domestic goods [C35] Information technology and related services [C36] Services of research and development; Architecture, engineering and similar techniques [C37] Public administration, defence and social security [C38] Education Services [C39] Services of health and social protection [C40] Other services 7.3 Specific criteria for accreditation The criteria to fulfil to obtain and maintain the accreditation are described in ISO/IEC 17065, with the interpretation given in the corresponding IAF/EA/IPAC documents, as well as applicable additional documents in the case of proprietary schemes. Page 12 of 28

13 7.3.1 Granting and Extension Before IPAC grants or extends the accreditation for the certification of a new product, the certification body must be able to demonstrate its competence for such certification, namely by: a) Demonstrating to be competent to take appropriate and correct certification decisions for each product or product category included in the application scope; b) Operating or having available a certification scheme appropriate for accreditation for each product or product category included in the application scope Extension for a new product The extension of the accreditation scope for a new product in a product category not previously under accreditation will always imply the assessment of the applicable certification scheme, through an office assessment and/or a witnessing. The extension can be assessed by document review if the certification body is already accredited in the product category where the new product falls in and the past performance and similarity of competences needed so advises, taking into account the risk involved Extension by changes in the certification normative documents An application to change (including updating of) normative documents (procedures and specifications) related to products already included in the scope of accreditation shall be asked to IPAC with the following information: Specific Form for product certification bodies (DIC011) containing the desired changes; Comparison Table between the normative documents, noting ( if necessary, point to point) alterations and differences between them, followed by an assessment of the impact and possible adaptation measures that must be implemented. Depending on the impact that differences and changes will have on the competence already assessed and recognized to the certification body, the change request will be assessed on-site or by document review. It is the responsibility of the certification body to ensure that the normative documents used continue to apply to products or categories of products covered by accreditation and any modification must always be communicated promptly to IPAC Maintenance For a certification body to keep its accreditation, it is necessary that it continues to evidence its competence, namely by continuing to take certification decisions for each product category included in the accreditation scope during each accreditation cycle. When the certification body does not have clients in a product category for a period over 4 years, it is considered that it cannot evidence to keep the specific competences and therefore the accreditation shall be suspended or withdrawn. 7.4 Evaluation process The IPAC evaluation process of a certification body includes the performance of annual office assessments combined with witnessing for the initial accreditation and during each accreditation cycle. The following criteria is used for the setting up of evaluation programmes: Dimension, diversity and criticality of the accreditation scope; Type, volume and changes of the certification body activities; Regulatory or sector scheme requirements applicable; Result of previous IPAC assessments; Types of certification schemes and regulatory environment; Complexity of the certification body activity; Geographic dispersion of its operations and/or the existence of critical sites of the certification body or bodies under its organizational control; Type and volume of subcontracted testing or inspection activities; Experience of the certification body in the application of the certification schemes. Page. 13 de 28

14 The following guidelines are followed to program the evaluation to be made, except when otherwise established in the specific accreditation scheme: Granting and Extension Maintenance One witnessing for each accreditation sector; One evaluation in granting and one evaluation for each accreditation sector in extensions. In each accreditation cycle, all accreditation sectors shall be evaluated. The evaluation of regulatory or sectoral schemes operated under external license will be preferably made by witnessing and as established in the corresponding scheme, when applicable. It is up to IPAC to select the evaluations to be witnessed, or subjected to documental review or control visits, according to the risk and previous history. Whenever requested, the certification body shall send to IPAC the detailed planning of its conformity assessment activities related to the certification processes, with the following minimum information: Identification of the clients and products types to be certified; Certification specifications and procedures; Type of conformity assessment activities to be applied; Identification of the personnel and assessment means; Location(s) and planned dates for the conformity assessments. 7.5 Certification specifications Service certification specification The certification specification adopted shall refer (directly or by reference) the following items: Objective of the certified service: indication of the goals that distinguish the certified from the noncertified service; Requirements of the certified service: indication of the requirements (including legal requirements) that must be fulfilled to obtain certification - these requirements must be auditable, that is, it can be proved and differentiated its conformity or not; Process certification specification The certification specification adopted shall refer (directly or by reference) the following items: Objective of the certified process: indication of the characteristics that distinguish the certified from the non-certified process; Requirements of the certified process: indication of the requirements (including legal requirements) that must be fulfilled to obtain certification - these requirements must be auditable, that is, it can be proved and differentiated its conformity or not; 7.6 Marks of conformity for a certified service The certification body shall not allow that its marks of conformity for a certified service be confused with the conformity marks of products (tangible), and as such, it shall not allow namely that they can be affixed on goods (e.g. certification of the service of repairing a good versus certification of that good). The certification body must provide that when one of its client, with a certified service, makes publicity of the certification in the location where the service is provided, then such publicity must include the description of the service characteristics (parameters and parametric values), as well as reference to the document containing the applicable certification specification. Page. 14 de 28

15 8 Accreditation of personnel certification bodies 8.1 Reference documents At the time of issue of this procedure, the following documents are applicable: ISO/CEI Conformity assessment General requirements for bodies operating certification of persons ISO/IEC TS Conformity assessment Vocabulary related to competence of persons used for certification of persons 8.2 Scope of accreditation It is considered as profession the activity performed by a person for a specific purpose, requiring a set of competencies for the proper performance of this activity Description of the accreditation scope The table mentioned in section 5.4 describing the accreditation scope has the following layout, grouped and ordered by accreditation sectors, presented in succession, and within each, by product categories - see 8.2.2: Profissão Professional Dnn - <DESIGNAÇÃO DO SECTOR DE ACREDITAÇÃO> <NAME OF THE ACCREDITATION SECTOR> Dnn.mm - <Identification of the professional subgroup > Especificação de Certificação Certification criteria Procedimento de Certificação Certification procedure <Profession> < certification specification > < certification procedure > In case of technical areas subject to frequent changes in versions of normative documents (external) that constitute the certification specification, the certification body may request a flexible description of the accreditation scope, which will omit the version of the certification specification, assuming that it always refers to the version in force. This implies that: the certification body demonstrates its ability to appropriately and timely detect and implement new versions of the certification specification in question. For this, the certification body shall establish (and keep) a comparative table between the versions with changes, followed by an assessment of the impact and possible measures that must be implemented to conform with the new version; the new version of the certification specification does not significantly change the competences and methodologies needed for assessing the competencies of the persons, without which it will need to request confirmation of the change to IPAC; the certification body always keep an updated List of Accredited Certifications under Flexible Scope in a format similar to the Technical Annex, identifying for each of the certifications under flexible description which version of the normative document of each certification scheme. The certification body must designate a responsible for the approval and supervision of the said List, which should be available to the public and be submitted to IPAC for preparing assessments or whenever requested. It must be kept track of the different versions of the List for a period equivalent to an cycle of accreditation or certification (whichever is greater). In conditions similar to the above, the certification body may also request that it is omitted the version of the certification procedure, in which case the List of Accredited Certifications under Flexible Scope maintained by the certification body shall identify the corresponding version. However, the certification body cannot introduce new versions that contain significant changes to the conformity assessment methodology, without the previous communication to and acceptance by IPAC. If the certification body does not comply with the above conditions, IPAC may suspend or withdraw this flexible scope description, without prejudice to other sanctions or actions. This flexible scope description may not be applicable to certification schemes that the scheme owner does not foresee. Page. 15 de 28

16 8.2.2 Structure of accreditation scopes For the purpose of describing the accreditation scope, IPAC identifies: accreditation sectors as professional groups in accordance with the 2nd level of the ISCO classification system from ILO/UNO and the Portuguese Classification of Professions (CPP); professional subgroups in accordance with the 3rd level of the classification above mentioned. The accreditation sectors are presented in the table below. [D01] Chief executives, senior officials and legislators [D02] Administrative and commercial managers [D03] Production and specialised services managers [D04] Hospitality, retail and other services managers [D05] Science and engineering professionals [D06] Health professionals [D07] Teaching professionals [D08] Business and administration professionals [D09] Information and communications technology professionals [D10] Legal, social and cultural professionals [D11] Science and engineering associate professionals [D12] Health associate professionals [D13] Business and administration associate professionals [D14] Legal, social, cultural and related associate professionals [D15] Information and communications technicians [D16] General and keyboard clerks [D17] Customer services clerks [D18] Numerical and material recording clerks [D19] Other clerical support workers [D20] Personal service workers [D21] Sales workers [D22] Personal care workers [D23] Protective services workers [D24] Market oriented skilled agricultural workers [D25] Market oriented skilled forestry, fishery and hunting workers [D26] Subsistence farmers, fishers, hunters and gatherers [D27] Building and related trades workers, excluding electricians [D28] Metal, machinery and related trades workers [D29] Handicraft and printing workers [D30] Electrical and electronic trades workers [D31] Food processing, wood working, garment and other craft and related trades workers [D32] Stationary plant and machine operators [D33] Assemblers [D34] Drivers and mobile plant operators [D35] Cleaners and helpers [D36] Agricultural, forestry and fishery labourers [D37] Labourers in mining, construction, manufacturing and transport [D38] Food preparation assistants [D39] Street and related sales and service workers [D40] Refuse workers and other elementary workers [D41] Commissioned armed forces officers [D42] Non commissioned armed forces officers [D43] Armed forces occupations, other ranks Page. 16 de 28