SAS Rules for Accreditation Purposes in the context of Notification - Designation of Conformity Assessment Bodies (CAB)

Transcription

1 Federal Department of Economic Affairs, Education and Research EAER State Secretariat for Economic Affairs SECO Swiss Accreditation Service SAS SAS Rules for Accreditation Purposes in the context of Notification - Designation of Conformity Assessment Bodies (CAB) Document N. 729.ew 729ew, , rev e Page 1 of 18

2 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Table of Contents Introduction... 3 Simplified definitions... 4 A. Harmonised standards which are referred to by modules of the New and Global Approach... 7 B. Interpretation of harmonised standards for the application of conformity assessment procedures according to the selected modules Accreditation of CAB according to Module H (ISO/IEC 17021) General Requirements Technical Requirements Specific Technical Tasks Specific Criteria for the Auditing Personnel Boards Associated with or Superior to the Certification Body (e.g. Committees for safeguarding Impartiality [ISO/IEC 17021, Article 6.2 resp. ISO/IEC clause 5.2]) Accreditation of CAB according to Modules D and E (ISO/IEC 17021) Sub-contracting by Designated / Notified bodies (Blue Guide) Application of Mandatory or Informative EA Rules (EA document 2/17 M) and Subordinate European Legal Bases (Regulation (EC) No 765/2008 / Decision No 768/2008/EC) C. Application in the Context of Accreditation D. Amendments to the former version of June 2017, rev. 07 of this document ew, , rev e Page 2 of 18

3 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Introduction Accreditation serves to formally acknowledge the competence to conduct certain conformity assessments according to relevant international standards. Accreditation is the internationally accepted instrument of confidence building. In Switzerland, the accreditation of conformity assessment bodies is formally based on the Accreditation and Designation Ordinance (OAccD) SR , regarding content on the standards cited in the attachment of this ordinance. The accreditation confirms that a conformity assessment body possesses the competence to perform a range of clearly defined services. Competence entails professional skills as well as management knowledge. Accredited bodies operate a quality management system and assure in that way the quality of their every-day services. Therefore, the reports and certificates of accredited bodies enjoy high trustworthiness. According to the OAccD, the Swiss Accreditation Service SAS grants accreditation following a positive assessment. Insofar as international agreements in designation refer to accreditation, an accreditation according to OAccD will justify the assumption that the requirements for the designation of the respective field of activities are fulfilled. If the accreditation concerns procedures regulated by law, the SAS will involve the responsible public authorities. According to the OAccD, the Federal Authority competent in the field is the Designation Body. If with regard to the qualification of the competence of the body is referred to accreditation, the designation body acts in accordance with the SAS. Beside the legal regulations in the context of the New and Global Approach of the EC, there exist purely national regulations and decrees which are, in some cases, only relevant on the national level. In principle, the criteria specified in this document are valid correspondingly in all areas in which the accreditation refers to legally regulated conformity assessment procedures, insofar as they are not replaced by specific regulations. In the fields subject to the Mutual Recognition Agreement (MRA - RS ) with the European Community, accredited bodies can obtain notification for a specified field from the responsible Authorities. In this event, the rules and national ordinances are recognised as equivalent to the Directives by the Commission and the corresponding specific rules of the EA are applicable. In Switzerland, it is the national legal framework which takes precedence. The regulations specified in this document define the accreditation criteria for the legally regulated area and also serve for the collaboration between the SAS and the responsible Federal Office. For the accreditation standards in the transition period, the coexisting versions are recognized as valid. The transition rules and conditions are published on the SAS website. Note: the French version of this document is the SAS official reference. 729ew, , rev e Page 3 of 18

4 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Simplified definitions Quality 1) Degree up to which a set of inherent characteristics fulfils requirements. Conformity Accordance with determined requirements. Testing 2) Technical procedure consisting of the determination of one or more characteristics of a product, a procedure or a service, according to a specified method. Conformity assessment 4) Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. Testing Body Body who performs tests (generally of products) Conformity Assessment Body Bodies that evaluate and confirm the conformity of products, management systems or personnel. Such bodies are - Inspection bodies (non-recurring assessment) - Certification bodies: assessment of conformity and subsequent surveillance of the mass production phase. - Testing bodies Note: the term Certification Body is sometimes generically used in EU documents in place of Conformity Assessment Body, normally used by accreditation bodies. The distinction between inspection and product certification bodies is provided in Chap ANNEX 6 of the Blue Guide (see definition below). Accreditation 4) Procedure in which a body grants as an authority the formal approval for a body to perform certain tasks. Notified Body - NB Notified Bodies are responsible for applying conformity assessment procedures as defined in the New Approach Directives applying when a third party is required (Blue Guide). Notification Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Remark: The SAS does not assume the responsibility of the Notifying Authority. It is acknowledged that accreditation and notification are two different activities which are performed separately. 1) according to ISO 9000:2005 2) according to ISO/CEI 17000: ew, , rev e Page 4 of 18

5 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Designation Regarding formal recognition within the framework of an international agreement, designation attests that a body satisfies the conditions to perform examinations, conformity assessments, record-taking and certification as per the requirements of the relevant agreement (AkkBV). Competent / Responsible Authority The Notifying Authority, in Switzerland these are the Federal Offices responsible for the areas covered by the MRA. Formally, the SECO AFNT (Non-Tariff measures) sector is responsible for officially notifying Swiss bodies to the Commission. Essential Requirements The essential requirements are elements necessary to the protection of the public interest. They are mandatory, only products meeting the essential requirements may be marketed or put into service. Essential requirements are applied in respect of the hazards inherent in a given product. They are set out in the Annexes of the Directives (Blue Guide) Old Approach The old approach imposes strict product specifications for marketing. These are traditional national regulations following requirements itemised in the legislation. New Approach (Blue guide) The new approach is a re-working of technical harmonisation within the European Union (EU) on a new basis, limited to harmonisation of essential product requirements alone, in application of the reference to standards and the principle of mutual recognition to eliminate technical barriers to the free movement of goods. It is based on technical harmonisation and standardisation under the following principles: - Legislative harmonisation is limited to the adoption of essential requirements that products in the Community Market must fulfil if they are to benefit from free circulation. - The technical specifications of products corresponding to the essential requirements of the Directives will be laid down in harmonized standards; - The application of harmonised standards and other standards is left to the manufacturer, who may still apply other specifications to meet the requirements; - Manufactured products conforming to harmonised standards benefit from a presumption of conformity to the corresponding essential requirements. In the new approach, the essential requirements are harmonised and rendered mandatory by the Directives. Global Approach (Blue guide) The global approach has introduced a modular approach in which conformity assessment is split into several operations (modules). These modules differ for each product development stage (e.g. design, prototyping, production), the type of assessment (e.g. documentation controls, type approval, quality assurance) and the person performing the assessment (manufacturer or third party). Harmonised Standard Harmonised standards are European standards adopted by European standardisation bodies and defined as per the general guidelines agreed by the Commission and the European standardisation bodies, under a mandate awarded by the Commission and after consultation with Member States. NANDO New Approach Notified and Designated Organisations This is the electronic database of the EU used to publish notified bodies. The Member States are responsible for the content for their national area of responsibility ( 729ew, , rev e Page 5 of 18

6 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) MRA (Mutual Recognition Agreement) Mutual Recognition Agreement (MRA) for declarations of conformity between Switzerland and the European Community. On this basis, the Community and Switzerland mutually accept reports, certificates, authorisations and conformity marks delivered by recognised bodies conforming to the procedures provided for in the agreement and the producer s declaration of conformity attesting to conformity with the requirements of the other Party in the areas covered by Art. 3 see: See also Blue Guide Chap ew, , rev e Page 6 of 18

7 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) A. Harmonised standards which are referred to by modules of the New and Global Approach The following applicable table is reproduced from the Blue Guide on the implementation of EU product rules (version of 04/2014) by the European Commission, Chap Annex 6 - using harmonised standards to assess the competence of conformity assessment bodies: Module EN Standard(s) applicable (+ability to decide on conformity), A1, A2 or ( to be taken into account for testing required), or ( to be taken into account for testing required) ( to be taken into account for testing required), B or (EN to be taken into account for testing required) (+ability to decide on conformity), C1, C2 or ( to be taken into account for testing required), or ( to be taken into account for testing required) (+product related knowledge) D, D (+product related knowledge) E, E (+ability to decide on conformity), F, F1 or (EN to be taken into account for testing required), or (EN to be taken into account for testing required) (EN to be taken into account for testing required), G or (EN to be taken into account for testing required) (+product related knowledge) H (+product related knowledge) ( H to be taken into account for testing required), or (+product related knowledge) ( to be taken into account for testing required) The titles and current revision statuses of the standards are available at the SN EN versions apply in Switzerland. Important note concerning the corresponding tabulated statement in EA document 2/17 M: in the case that, as is also partially the case in the aforementioned table, an accreditation standard must be supplemented with criteria from other accreditation standards, the SAS will, in principle, award multiple accreditations (a body with several accreditations). For areas in which certification of persons is required, the SAS applies the standard The use of the preferred standard (see tables 2 and 3 in 3.1 of EA document 2/17 M) must be encouraged (see chap. 4 of this document selection of the standard by Authorities) and, wherever possible, SAS uses the preferred standard as the basis for accreditation for notification. Any accreditation for notification not using the preferred standard shall be justified. 729ew, , rev e Page 7 of 18

8 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Regulation (EU) No 305/2011 (CPR) concerning construction products does not refer to the modules. In this case, the table below is the applicable table: Annex V (modified on 27/05/2014) to CPR on the Assessment and Verification of Constancy of Performance of Construction Products Assessment and verification systems for constancy of performance Manufacturer - M The manufacturer shall draw up the declaration of performance and determine the product-type based on the constancy of performance assessments and verifications M M M M M performed according to the 5 systems: Performance is assessed on the basis of testing (inc. sampling), calculations, values drawn from tables and M M product description documentation Factory Production Control (FPC) M M M M M Additional testing of samples taken by them at the factory according to the prescribed test plan M M M Product Certification Body - Pc (NB) Certificate of constancy of performance on the basis of the following assessment and verification results: Pc Pc Performance is assessed on the basis of testing (inc. sampling), calculations, values drawn from tables and Pc Pc product description documentation Initial inspection of the manufacturing plant and of factory production control Pc Pc Continuous surveillance, assessment and evaluation of factory production control (FPC) Pc Pc Testing of samples taken by the certification body at the manufacturing plant or the manufacturer s storage facilities Pc FPC Certification Body (NB) Certificate of conformity of factory production control on the basis of the following assessments and verifications: FPc Initial inspection of the manufacturing plant and of factory production control FPc Continuous surveillance, assessment and evaluation of factory production control (FPC) FPc Test Laboratory - L (NB) Assesses performance on the basis of tests (sampling done by the manufacturer), calculations, values taken L from tables and the product s descriptive documentation Notified Body (NB) notification as: Product / FPC Certification Body ISO/IEC 17065* X X X Test Laboratory ISO/IEC X * 17065, Chap / to be considered ( / to be taken into account for testing and inspections / surveillance) Letter = task re. corresponding accreditation (NB) See chap of the EC brochure "CE Marking of construction products, step by step". 729ew, , rev e Page 8 of 18

9 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Explanation - Definition of Modules (Blue guide): Here again, the SAS refers directly to the guide and the following table in particular (Chap for further information also see the table in Chap ANNEX 4 of the Blue Guide): Modules A Internal production control A1 Internal production control plus supervised product testing A2 Internal production control plus supervised product checks at random intervals B EU-type examination C Conformity to EU-type based on internal production control C1 Conformity to EU-type based on internal production control plus supervised product testing C2 Conformity to EU-type based on internal production control plus supervised product checks at random intervals D Conformity to EU-type based on quality assurance of the production process D1 Quality assurance of the production process Description Covers both design and production. The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination). Covers both design and production. A + tests on specific aspects of the product carried out by an inhouse accredited body or under the responsibility of a notified body chosen by the manufacturer (the legislator may restrict manufacturer s choice). Covers both design and production. A + product checks at random intervals carried out by a notified body or in-house accredited body (the legislator may restrict manufacturer s choice). Covers design. It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated. A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type. Covers production and follows module B. The manufacturer himself ensures the conformity of the products to the approved EU-type. Covers production and follows module B. C + tests on specific aspects of the product carried out by an inhouse accredited body or under the responsibility of a notified body chosen by the manufacturer (the legislator may restrict manufacturer s choice). Covers production and follows module B. C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body (the legislator may restrict manufacturer s choice). Covers production and follows module B. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU-type. The notified body assesses the quality system. Covers both design and production. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system. 729ew, , rev e Page 9 of 18

10 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Modules E Conformity to EU-type based on product quality assurance E1 Quality assurance of final product inspection and testing F Conformity to EU-type based on product verification G Conformity based on unit verification H Conformity based on full quality assurance Description Covers production and follows module B. The manufacturer operates a product quality (=production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system. The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process. Covers both design and production. The manufacturer operates a product quality (=production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system. The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process. Covers production and follows module B. The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type. Module F is like C2 but the notified body carries out more systematic product checks. Covers both design and production. The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type). Covers both design and production. The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system. 729ew, , rev e Page 10 of 18

11 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Modules H1 Conformity based on full quality assurance plus design examination Description Covers both design and production. The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate. Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design. The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen representative of the production envisaged, so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body. 729ew, , rev e Page 11 of 18

12 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) B. Interpretation of harmonised standards for the application of conformity assessment procedures according to the selected modules 1. Accreditation of CAB according to Module H (ISO/IEC 17021) 1.1 General Requirements The following regulations are valid for certification bodies that are already accredited according to the standard ISO/IEC for the certification of quality management systems and SAS Document No. 509 SAS Interpretation of particular requirements of the EN and ISO/IEC series standards for the accreditation of certification bodies. Insofar as they exist, the relevant documents of the EC and EA 3) and the IAF 4) are also applicable. The tabulated statement in Chap ANNEX 5 of the Blue Guide provides important details concerning ISO 9000 and the modules referring to quality assurance systems. 1.2 Technical Requirements Certification bodies performing conformity assessments according to Module H are tasked with controlling and approving the quality control system implemented by the manufacturer for the design, manufacture, final control and testing of the product intended to be marketed according to current legislation (see table above for definitions of the modules). As such, the management of the certification body must have competent auditing personnel according to the requirements of the standards in the ISO/CEI series. They will apply their staff purposefully, evaluate their performance at regular intervals and are responsible for the decision of certification. To comply with these demands, they themselves need professional skills comparable with those necessary to manage a product certification body (according to standard ISO/CEI 17065) or an inspection body (according to standard ISO/IEC 17020). EA document 2/17 M requires the ability to make professional judgments related to product requirements where required. To this end fulfilment of clauses 6.1.2, and to in shall be demonstrated. These professional skills also include knowledge of the legal regulations and subject-specific technical standards the essential requirements in the applicable Directive which must be fulfilled by the product in question and the risks associated with these products general advances in the technical field (State of the art) re. the technology involved. 3) EA European Co-operation for Accreditation 4) IAF International Accreditation Forum 729ew, , rev e Page 12 of 18

13 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) 1.3 Specific Technical Tasks Within the framework of the management system, the management of the certification body appoints personnel competent to intervene in a specific regulated field. The personnel establishes the procedure and subject-specific criteria for the certification in order to hand over corresponding information to the manufacturer in a timely manner. The persons or committee(s) responsible for the decision on certification must also be technically skilled. The certification body controls and ensures that personnel responsible for a specific technical field have, through ongoing training, the technical skills required in point 1.2. The certification body maintains a directory that provides information about the audit personnel (qualified personnel in the body, qualified auditors and technical experts) responsible for a specific field. Their expertise, experience and continuing education in the field, as well as the experience in auditing (for auditors) are apparent in the directory. The directory is compiled in a manner to primarily assist the administrative department in putting together auditing teams. 1.4 Specific Criteria for the Auditing Personnel The auditing teams possess the necessary technical skills to evaluate the requirements of the management system according to standard ISO 9001 and further standards as well as the design of the products (specifically the assessments to ensure the safety and reliability of the product - essential requirements of the Directives) and the measures to guarantee the quality of all particular products in their mass production phase and final controls. The auditing teams possess in particular detailed knowledge about legally binding and fundamental requirements of the products to be assessed as well as associated risks. They know the legal regulations as well as the relevant product-specific standards. 729ew, , rev e Page 13 of 18

14 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) This means that the certification body has qualified audit personnel available, who are either permanent employees or working as freelance auditors under a valid contract or external technical experts also under a valid contract. The certification body makes sure that the technical skills of the auditors re. the technical experts correspond to the current level of knowledge. Extensive knowledge about products as well as knowledge about production, use and disposal of the products is necessary to assess risks and evaluate the producers' quality assurance measures. Technical experts as well as freelance auditors are informed about the procedures of certification and special technical requirements of the corresponding bodies. 1.5 Boards Associated with or Superior to the Certification Body (e.g. Committees for safeguarding Impartiality [ISO/IEC 17021, Article 6.2 resp. ISO/IEC clause 5.2]) No specific technical skills are required for these committees. However, the groups interested in certification are adequately represented in them. The manufacturers of products within the specific field are granted appropriate access to such boards. The persons and boards taking part in the decision on certification must possess an overview of the field, the applicable standards and the legal regulations, and they must be capable of assessing the risks associated with the products. 2. Accreditation of CAB according to Modules D and E (ISO/IEC 17021) For the assessment of risks and the corresponding product-specific measures to ensure quality by producers, the same set of subject-specific skills and criteria are valid for both the central bodies and the audit personnel, analogue to Module H. Not stipulated is the competence for the assessment of the product design, since a type examination (Module B) by a notified body has taken place. 3. Sub-contracting by Designated / Notified bodies (Blue Guide) Chap of the Blue Guide is applicable, as are all corresponding accreditation requirements (standards), requirements of the EA, the EU, the OAccD and the equivalent Swiss legal bases (MRA). In short: A notified body can have part of its work carried out by another body, whether a subcontractor or a subsidiary, on the basis of established and regularly monitored competence. The notified body s subcontractor must be technically competent and meet, under the same conditions, the same criteria of impartiality and objectivity applying to the notified body. However, notification is not necessary. The conformity assessment procedure may be subcontracted when subdivided into technical and assessment operations and the methodology used to perform technical operations is sufficiently precise. All subcontractors of the notified body must nevertheless be entrusted with a substantial and coherent portion of the technical operations. Subcontracting is subject to a contract providing transparency and trust in all operations of the notified body. A notified body using subcontractors will remain, under all circumstances, responsible for the activities covered by notification. Subcontracting will not imply any delegation of powers or responsibilities. Certificates will be issued in the name of and under the responsibility of the 729ew, , rev e Page 14 of 18

15 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) notified body. The certification body also possesses the expertise to handle such tasks themselves. It needs therefore the skills defined under 1.2 in any case. Concerning the expertise of the subcontractors, see Art. 18 of the OAccD requiring the corresponding accreditation. The subcontracting conditions apply to all subcontractors, whether established within the Community or not. 4. Application of Mandatory or Informative EA Rules (EA document 2/17 M) and Subordinate European Legal Bases (Regulation (EC) No 765/2008 / Decision No 768/2008/EC) As a non-eu State, Switzerland has its own legal basis recognised as equivalent by the EU based on the MRA and its 20 product sectors: Agreement between the Swiss Confederation and the European Community relating to mutual recognition regarding conformity assessment (MRA) Federal law on Technical Barriers to Trade (LETC) Ordinance on Accreditation and Designation (OAccD) A list with the authorities contact persons, who are responsible for areas being legally regulated is managed internally within SAS («Liste Kontaktperosen Fachämter»). SAS Document 743 provides a Checklist for the assessment of conformity assessment bodies to be designated according to OAccD, Annex 5. For detailed explanations concerning its application, see its chap. A. This document describes the general basis of application. In application of these bases, the SAS, re. most of the responsible Authorities, applies the following accreditation principles for the purposes of notification: - Accreditation, according to the OAccD (including the harmonised reference standards listed in the Annex), is the basis for the recognition of competence and the organisation of designated / notified bodies. The Blue Guide and this document, Chap. A, govern the choice of standards to be applied. It is for the national Notifying Authorities, generally in close cooperation with the SAS, to allow accreditation of a NB against any of the suitable harmonised accreditation standard or to limit accreditation to some or one of them. T. - The SAS systematically practices, as applicable, the principle of additional requirements, by incorporating additional harmonised standards (generally by multiple accreditations) including the requirements for notified bodies defined in the corresponding legal bases, which themselves include, select and occasionally specify the criteria defined in Decision 768 re. the non-mandatory Annex of EA document 2/17 M. Therefore, the recommendations of EA document 2/17 M for the selection of harmonised standards and additional requirements (see 3.1 of EA 2/17 M) are systematically considered and covered - see also Chap. C below. - As is noted in Chap. B, in the accreditation process, an assessment of competence always includes a technical assessment of the ability of the body to be notified to perform technically competent conformity assessments as described in the module or its equivalent (CPR). - Scoping - definition and publishing of areas / scopes under notification: the principles set forth in EA document 2/17 M form the basis for compliance: transparency, comprehension, completeness, compatibility with NANDO as far as possible. Implementation is described later in this document. 729ew, , rev e Page 15 of 18

16 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) C. Application in the Context of Accreditation Responsibilities For each regulated area, in particular those belonging to the MRA, the competent authority and a contact person within SAS (LA) will be appointed and will be recorded by the SAS in the internal document «Liste Kontaktpersonen Fachämter». This document sets forth as well the Swiss and European legal bases for reference. The LA is central for the treatment of internal and external applications, national and international collaborations, internal and external training for its field and decisions (as accreditation proposals in the official form) directly relating to its field and for the development of application documents, publications, etc. He informs and instructs other SAS LA involved in the area (see internal training below), all of this again in collaboration with the area Head of Unit who is himself responsible for appointing the assessment teams. Collaboration with the Authorities The principle of collaboration and the obligation to do so is specified in the OAccD Ordinance, Article 11. In practice, the designated SAS LA (see SAS internal document «Liste Kontaktpersonen Fachämter») is in regular contact, several times per year, with the competent Authority. The SAS is in a collegial relationship of equals with the Authorities that is highly effective. The contact person is invited to participate in SAS assessments concerning them - an agreement is sometimes established with this person on the collaboration method, in particular the degree of delegation to the SAS to proceed with the assessment of the body based on the legal bases for a designated / notified body. In many cases, this person is present and is also holds the role of technical accreditation expert. Certain Authorities do not wish to participate but to be kept informed. Decisions of the SAS on the granting, extension or withdrawal of accreditation in these areas, are reported to Authorities by the SAS. Certain authorities do not use the accreditation system and in this case there are no tasks or obligations for the SAS. In the case of a review of the legal bases, the responsible authorities shall inform the SAS of the applicable transition conditions and any specific evaluations to be carried out (see also next paragraph). Documents issued by international Accreditation Umbrella Organisations, Authorities and the Commission Documents issued by international Accreditation Umbrella Organisations and the Commission are systematically received through the official channels (EA / ILAC / IAF / Authorities, etc.) and analysed by the area appointed LA and Heads of Unit. The SAS uses the following practices regarding the principal international documents in force for this area: - EA document 2/17 M: see Chap. A and 4 above. The non-mandatory Annex identifies potential gaps in the accreditation standard used, previously selected according to Chap. A. But the national legal basis and, in particular, its specific requirements for notified bodies, must still be referred to. This means to perform the assessment also based on the corresponding requirements for the notified bodies of the Directives re. equivalent Swiss Laws and Ordinances (see MRA). In Switzerland, only national Laws and Ordinances are to be considered. - Guidelines and other subject-specific EU and Swiss documents: all subject-specific, technical and administrative documents published by the Commission (eur-lex.europa.eu / ec.europa.eu, etc.) and the competent Authorities are recognised and used as the bases for assessment of the NB by the Authorities and the SAS. The Blue Guide is one of the fundamental references, as are the documents issued by the Standing Committees (construction), and CERTIF documents. Their occasional non-mandatory status is known and recognised. Information essentially circulates via the responsible Authorities and the Group of Notified Bodies (GNB). 729ew, , rev e Page 16 of 18

17 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) Definition and Publication of Accredited Scopes For each specific area, a publication system for scopes of notified bodies has been gradually created (since many years ago). As far as possible, the SAS scopes are similar with the decrees of designation (technical fields covered) established by the Authorities and handed over to the SAS. Essentially, it refers to: - the standard and accreditation type - if relevant referring to an additional accreditation (see multiple accreditations above); - the relevant Swiss Law (RS xxx.xxx); - the corresponding EU Directives / Regulations; - the corresponding modules, Annexes and other relevant elements of the Directive / Regulation; - the NB number or other NANDO reference; - the technical area in question - products / product types (varies according to Directives and accreditations); - the product specifications / characteristics; - the harmonised technical standards or documents summarising them; - any other additional information required (comments, Annexes, restrictions etc.). Document EA-2/17 M provides examples in its Annex A (informative). Concerning the publication and management of versions of technical standards, the SAS refers to chap. 11 of document 707. Documentation The electronic database of the SAS contains four fields for documentation concerning the status and notification of the accredited body. All elements and documents produced and received concerning accreditation re. notification (from the perspective of the SAS) of an accredited notified body are documented according to SAS rules, as are all documents relating to an accredited body. The SAS report provides summarised information about proof of the NB s technical and organisational skills and abilities based on this document and valid references (see above). Planning - Assessment - Notification Procedure The requirements relating to a notification, in particular technical, are fully assessed for initial notification and then by sampling during each SAS assessment activity with a notified body. During renewal or modification of the content / area of notification, an official confirmation / report is drafted for the competent Authorities. The SAS notification procedure includes at least the following activities (unless otherwise decided by the Authorities): - An exchange of information with the authorities regarding the notification application made by the body to the Authority. The SAS / Authority collaboration process is defined. - During preparation and assessment of the notified body, the LA incorporates the requirements for the area (according to these rules and elements of the legal bases in particular) in his work. - The notified body must demonstrate its technical and organisational skills and abilities according to the MRA Annex 2, letter A, figure 1 for the notified area, confirmed by the SAS team and the accreditation awarded. - The SAS informs the Authorities of the results of its assessments re. the accreditation of NB and publishes scopes with the particulars specified in this document. The SAS notification procedure may - by agreement with the competent authorities - include the following additional activities: - a review of the official notification application regarding the accredited area - direct collaboration with a representative of the Authority who may act as technical expert if necessary - participation by the Authority in the information meeting or during the preliminary visit with the (future) NB 729ew, , rev e Page 17 of 18

18 SAS: SAS Notification Rules for Accreditation Purposes in the context of- Notification - Designation of Conformity Assessment Bodies (CAB) - an assessment of additional and specific requirements laid down by the competent Authority - if required, an addition extraordinary assessment - direct collaboration with a representative of the Authority in the publication of scopes and listing on NANDO SAS Communication in Technical Areas The LA in charge of the case re. area (see SAS internal document «Liste Kontaktpersonen Fachämter») is available to colleagues and applicants (interested bodies) to answer questions and to provide all documentation and information required, the latest versions in particular. They may also draft instructional documents for colleagues and third parties. Some of these can be found on the SAS website. D. Amendments to the former version of June 2017, rev. 07 of this document Chapter «References» omitted Numbering adjusted Reference to the document no. 110-Annex 05 replaced with the internal SAS document «Liste Kontaktpersonen Fachämter» Annex 1: EA-2/17 M 729ew, , rev e Page 18 of 18

19 Federal Department of Economic Affairs, Education and Research EAER State Secretariat for Economic Affairs SECO Swiss Accreditation Service SAS Unclassified EA-02/17 M: 2016 Document on accreditation for notification purposes Document no. 729ew Annex1 729ew Annex1, Edition June /1

20 EA-2/17 EA Document on Accreditation for Notification Purposes Publication Reference EA-2/17 M: 2016 EA Document on Accreditation for Notification Purposes PURPOSE The document presents the policy agreed by EA Members for accreditation of Conformity Assessment Bodies for notification purposes. November 2016_rev03

21 EA-2/17 EA Document on Accreditation for Notification Purposes Authorship This document has been written by the Horizontal Harmonization Committee. Official language The publication may be translated into other languages as required. The English language version remains the definitive version. Copyright The copyright of the publication is held by EA. The publication may not be copied for resale. Further information For further information about this document, please contact the EA Secretariat. Please check the EA website for updates ( Category: Members Procedural document Mandatory Date of approval: 23/11/2016 Implementation: 23/11/2017 Transitional period: None Editorial changes: -- November 2016_rev03 Page 1 sur 27

22 EA-2/17 EA Document on Accreditation for Notification Purposes CONTENTS 1. SCOPE GENERAL PROVISIONS Competence, impartiality and consistent performance of the Notified Body The fulfilment by the Notified Body of the requirements established by each Union Harmonization Legislation HARMONIZED STANDARDS TO BE USED BY NABs TO ASSESS COMPETENCE FOR EACH MODULE INCLUDING THE ADDITIONAL REQUIREMENTS Harmonized Standards suitable for the accreditation Notified Bodies (table)... 6 ANNEX A (INFORMATIVE) ANNEX B (INFORMATIVE) November 2016_rev03 Page 2 sur 27

23 EA-2/17 EA Document on Accreditation for Notification Purposes 1. SCOPE This document contains the policy agreed by EA for accreditation of Conformity Assessment Bodies by National Accreditation Bodies as a basis for notification by Notifying Authorities to become Notified Bodies to work within the scope of Union Harmonization Legislation. 1 This document is a Members procedural document with a mandatory status. It is intended to apply to all National Accreditation Bodies (NABs) that assess and accredit Conformity Assessment Bodies (CABs) for notification purposes, unless the Notifying Authority has officially established and published different requirements. It identifies the requirements that shall be used by National Accreditation Bodies when accrediting Conformity Assessment Bodies seeking notification. Note 1 In the context of this document, the term Notified Body (NB) is used for all Conformity Assessment Bodies (CABs) which are seeking notification or which are already notified. Note 2 In this document the following abbreviations are used: CAB NB NAB NA UHL HS NLF Conformity Assessment Body. Notified Body National Accreditation Body Notifying Authority Union Harmonization Legislation Harmonized Standard with requirements for the operations of Conformity Assessment Bodies New Legislative Framework 1 See: November 2016_rev03 Page 3 sur 27

24 EA-2/17 EA Document on Accreditation for Notification Purposes 2. GENERAL PROVISIONS The main purpose of accreditation, when used as a tool to support notification of CABs in the framework of UHL elaborated according to the provisions of Decision (EC) 768/2008, is to give confidence to the NA on: 1) competence, impartiality and consistent performance of the Notified Body to perform the tasks it is notified for; 2) the fulfillment by the Notified Body of the requirements established by each Union Harmonization Legislation. 2.1 Competence, impartiality and consistent performance of the Notified Body Accreditation is defined in Regulation (EC) 765/2008 as an attestation by a National Accreditation Body that a Conformity Assessment Body meets the requirements set by Harmonized Standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity. Therefore, NABs have to use Harmonized Standards (HS) for assessment when accreditation is used as the basis for notification. It is widely accepted, however, that the conformity assessment activities described in the modules defined in Decision (EC) 768/2008, do not restrict the use of Harmonized Standards to one for each module, as the conformity assessment activities are not described in a way which fits exactly with the descriptions in the HS. This means that, for each module, different standards could be used for accreditation of the NB, but some of them have to be supplemented by additional requirements. In this respect, NABs, as the bodies responsible for declaring fulfillment of the requirements for the NB, are responsible for identifying those standards that are suitable to be used for accreditation, considering the conformity assessment activities for which the CAB is seeking accreditation. It is the responsibility of the national authorities to judge whether accreditation granted by the NAB is suitable for notification purposes. EA has developed a table (see Table 1 in section 3.1 of this document) which identifies those Harmonized Standards that NABs may use to assess Conformity Assessment Bodies and their competence for each module, and among these Harmonized standards, the one which is the preferred standard (as identified by EA see Table 2 in section 3.1). Table 1 includes the additional requirements (taken also from other Harmonized Standards) which are needed to underpin the standard for an appropriate assessment of the competence and performance of the NBs operating under each module. 2.2 The fulfilment by the Notified Body of the requirements established by each Union Harmonization Legislation The specific requirements to be fulfilled by NBs are established in each Union Harmonization Legislation. To be accredited, Notified Bodies shall be assessed by NABs using: 1) one Harmonized Standard as described in section 3.1 in this document as applicable to the module requested; and November 2016_rev03 Page 4 sur 27