TUV SUD BABT PRODUCTION QUALITY CERTIFICATION SCHEME

Transcription

1 TUV SUD BABT PRODUCTION QUALITY CERTIFICATION SCHEME Copyright TUV SUD BABT 2017 A Certification Body of: Page 1 of 33

2 Contents AMENDMENT RECORD 3 0. INTRODUCTION 3 1. PRE-CONDITIONS TO SUPPORT PRODUCTION QUALITY CERTIFICATION 6 2. ADDITIONAL REQUIREMENTS FOR PRODUCTION QUALITY CERTIFICATION 10 ANNEX A SUPPLEMENTARY REQUIREMENTS FOR PRODUCTION QUALITY ASSURANCE UNDER MODULE D AND PRODUCT QUALITY ASSURANCE UNDER MODULE E OF THE MARINE EQUIPMENT DIRECTIVE 15 ANNEX B SUPPLEMENTARY REQUIREMENTS FOR THE REGISTRATION OF A PRODUCTION CONTROL FACILITY UNDER THE CONSTRUCTION PRODUCTS REGULATION 17 ANNEX C SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF MACHINES UNDER MACHINERY DIRECTIVE 18 ANNEX D SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF MEASURING INSTRUMENTS 19 ANNEX E SUPPLEMENTARY REQUIREMENTS FOR MANUFACTURE OF PRODUCTS UNDER ANNEX II OF RADIO EQUIPMENT DIRECTIVE (RED) 21 ANNEX F SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF PRODUCTS FOR HOLDERS OF FQA AGREEMENTS UNDER RADIO EQUIPMENT DIRECTIVE (RED) 22 ANNEX G SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF COMPONENTS FOR USE IN PRODUCTS CERTIFIED UNDER RADIO EQUIPMENT DIRECTIVE (RED) 23 ANNEX H SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF PRODUCTS UNDER THE EMC AND LOW VOLTAGE DIRECTIVES 24 ANNEX I SUPPLEMENTARY REQUIREMENTS FOR THE MANUFACTURE OF EQUIPMENT USING AC MAINS POWER 25 ANNEX ZY DEFINITIONS USED IN THIS DOCUMENT 28 ANNEX ZZ CROSS REFERENCE IN REQUIREMENTS BETWEEN (PUBLISHED) BABT 340 ISSUE 8 AND BABT 340 ISSUE 10. (ISSUE 09 WAS ONLY PUBLISHED INTERNALLY) 33 Page 2 of 33

3 AMENDMENT RECORD Issue 09 (this was an internal draft and never published). The main changes were: Removal of acceptance of ISO9001 in lieu of auditing for certain requirements. Revision of requirements related to vendors Revision of manufacturing test requirements Addition of an annex for MID Module D Addition of an annex for RED annex III products Addition of an annex for RED annex IV FQA manufacturing sub-contractors Addition of an annex for component under the RED Addition of an annex for telecommunications terminal equipment under EMC and LVD. Removal of any reference to RTTE, LVD, Safety or CNC schemes which have been withdrawn. This replaces the published Issue 08, and the unpublished draft 09. There are formatting and grammatical changes. 0. Introduction 0.00 Scope This document defines the requirements to obtain a TUV SUD BABT Production Quality Certificate or related certificate (e.g. Marine Equipment Module D certificate). It provides an independent assessment service for manufacturers of electro-mechanical equipment in the following categories: Manufacture of certain product types under Modules D and E of the Marine Equipment Directive. Manufacture of certain product types in support of the Construction Product Regulation. Manufacture of machinery subject to the requirements for series production in the Machinery Directive. Manufacture of certain product types under Module D of the Measuring Instruments Directive. Manufacture of products under the relevant annexes of Radio Equipment Directive (RED). Manufacture of products for Holders of FQA agreements under RED. Manufacture of components for use in products certified under RED. Manufacture of products under the EMC Directive These categories are referred to as products throughout this document. The scheme operates under the TUV SUD BABT Certification Regulations. The current versions can be found on the website The scheme provides alternative levels of certification depending upon the type and extent of work performed and is therefore applicable to both manufacturers and sub-contract manufacturers. Customer specific production test requirements can be assessed and included within the certification. 0.1 TUV SUD BABT Production Quality Certification Certification to the requirements of this scheme will allow manufacturers to demonstrate by independent assessment that they have taken all measures necessary to ensure compliance of manufactured products with the technical documentation and production control requirements, as appropriate, of the relevant European Directives, product approval schemes or customer When an assessment concludes, TUV SUD BABT issues a Production Quality Certification clearly identifying the scope of certification of the manufacturing facility(s) together with an annex identifying, as relevant, the products and interfaces addressed, and any particular conditions associated with the Page 3 of 33

4 certification For equipment or products under the Marine Equipment Directive, or the Measuring Instruments Directive, as appropriate, a Module D or Module E certificate is issued in place of a PQC certificate. The Certified Body may issue an additional PQC certificate under those annexes TUV SUD BABT no longer take account of valid recognised ISO9001 certifications to the current version of ISO From issue the key elements of the management system are reviewed during certification and recertification audits; during surveillance audits the maintenance of the management system will be reviewed. 0.2 Production Quality Certification Requirements Various certification options are defined in this document. The requirements defined in Parts 1 and 2 are applicable for all of these options Part 1 of this document sets out the basic pre-conditions for Production Quality Certification. Part 2 identifies the minimum additional requirements that must be met for certification under this scheme. This section, in combination with Part 1, identifies the core requirements of the scheme needed to support all PQC certifications, irrespective of the certification scope The annexes to this document reference the specific requirements applicable to the certification scopes listed within. Individual certifications may address one or more of these scopes. The purpose of the controls required by these annexes is to ensure that a manufacturer continues to supply products that: Are not materially different from those specified by the customer; Are not materially different from samples used for conformity assessment against the requirements of relevant European Directives; Continue to comply with relevant European Directives on an ongoing basis; Meet the safety and functionality requirements for relevant product certification schemes; These requirements apply in addition to those required by Parts 1 and 2 of this document Some of the annexes include specific requirements referencing tests that MUST be included in the certification in order to qualify for that specific certification scope/annex Production Quality Certification can only be issued when the requirements of at least one of the attached annexes are met in order to adequately define the scope of certification Where the Quality Management System is covered by certification to another quality management standard by either TUV SUD BABT or another TÜV SÜD Certification Body a combined audit may be requested which would lead to common requirements being subject to only one audit. 0.3 Different Companies (Roles) involved with Production Quality Certification For the formal definitions of the following refer to Annex ZY Under European Legislation (Directives and Regulations) the person in whose name the product is supplied into the market place is referred to as the Manufacturer. They have overall responsibility for the compliance of the product. Page 4 of 33

5 0.3.3 The products of the Manufacturer are frequently built at another location under the control of another company. Many of the requirements of this document apply to the quality system under which the product was made. The Company who controls those requirements is referred to as the Fabricator Under European Legislation (Directives and Regulations) persons or companies established within Europe may be nominated to act as Authorised Representatives of the Manufacturer. Such persons may assume some of the responsibilities of the Manufacturer Dependent upon the annexes selected, certificates may be issued to differing parties. The person in whose name the certificate is Issued is referred to as the Holder. For Annexes A, B, C, and D only the following may be the Holder: Fabricator Authorised Representative Manufacturer Some products are sold under the name of another company other than the original Manufacturer (who normally retain the design rights). These are referred to as Brandnames. Where such products do not refer to the original Manufacturer on their labelling they assume responsibility for legal requirement for compliance of the products issued in their name. Such companies are referred to as Brandname Manufacturers Brandname Manufacturers of products under Annexes A, B, C and D are required to either nominate the original product Manufacturer as their Authorised Representative (which allows their products to come under the PQC certificate of the original product Manufacturer), or to hold a separate certificate listing the Brandname Manufacturer as Holder While Brandname Manufacturers are fully responsible for their products it is recognised that the most aspects of their products are adequately reviewed during the audit related to the original Manufacturer and the Fabricator. As such the main focus of auditing related to the Brandname Manufacturers will relate to the key differences and responsibilities (e.g. product labelling, user information, complaints and declarations). Page 5 of 33

6 1. Pre-Conditions to support Production Quality Certification 1.0 Scope This part describes the minimum level of general quality assurance control necessary to support the additional requirements as defined in Part 2 of this document and the relevant associated annexes. These requirements apply to the Fabricator unless specified otherwise. 1.1 Quality System Requirements reviewed during Certification and Re-Certification Audits Management Responsibility The Fabricator s management with executive responsibility shall as follows: a) Define and document its policy for quality, including its objectives for, and commitment to, quality; b) Define the responsibility and authority of all personnel who are involved in implementing the manufacturing quality requirements. c) Review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of the Manufacturer s stated quality policy and objectives. Records of such reviews shall be maintained. d) Appoint a management representative who, irrespective of other responsibilities, shall have authority for: Ensuring that a quality system is established, implemented and maintained in accordance with this document; and Reporting on the performance of the quality system to the Manufacturer s management for review and as a basis for improvement of the quality system Quality Manual The Fabricator s organisation shall establish and maintain a quality manual that includes: a) The scope of the quality management system. b) The documented procedures established in support of the quality management system. c) A description of the interaction between the processes of the quality management system Contract Review of requirements related to the product The Fabricator shall establish and maintain a mechanism for generating and reviewing contract requirements related to the product to ensure that: a) The product requirements are adequately defined. b) Differences between the contracts and any previously expressed requirements are resolved. c) The organisation has the capability to meet the defined requirements Document and Data Control The Fabricator shall establish and maintain a mechanism to ensure: a) The documents and data shall be reviewed and approved for adequacy by authorised personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established. b) Changes to documents or data shall be reviewed and approved by the same Page 6 of 33

7 functions/organisations that performed the original review and approval, unless specifically designated otherwise. c) Obsolescent documents shall be assured against unintended use and suitably identified if they are to be retained for any purpose Purchasing The Fabricator shall ensure the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final product carried out under controlled conditions. Documented work instructions shall be available as necessary. The Fabricator shall evaluate and select suppliers based on their ability to supply products in accordance with the organisation's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. Purchasing information shall describe the product to be purchased, including, where appropriate: a) Requirements for approval of product, procedures, processes and equipment, b) Requirements for qualification of personnel, and c) Quality management system requirements. d) The organisation shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier Process Control The Fabricator shall identify and plan all processes that directly affect product quality to ensure that they are carried out under controlled conditions. Documented work instructions shall be available as necessary. a) The Fabricator shall identify, plan and validate production processes that cannot be easily verified by subsequent inspection (e.g. soldering) and shall ensure that these processes are carried out under controlled conditions and by qualified personnel. b) The Fabricator shall demonstrate in-process inspection and final test procedures necessary to establish product conformity to the specified requirements. c) The Fabricator shall provide methods of handling, storage, packaging, preservation and delivery that prevent damage or deterioration to critical parts or products. d) Material and assemblies must be clearly identified throughout production with respect to their inspection/test status Control of Inspection Measuring and Test Equipment The Fabricator shall ensure that processes are in place for the control, calibration and maintenance of inspection, measuring and test equipment (including test software), whether owned by the Manufacturer or otherwise, that is used to demonstrate conformance of the product to specified requirements. Calibration must be traceable to national or international standards and must be recorded. In the event that traceability is not possible, then the methods used to calibrate the equipment must provide demonstrable confidence in the ability of the equipment to fulfil the required testing functions Quality Records Page 7 of 33

8 The Fabricator shall establish and maintain records to demonstrate continued compliance with the specified requirements and the effective operation of the quality system. Records shall be maintained by the use of permanent media, with appropriate procedures for their security and integrity Training The Fabricator shall ensure that personnel performing activities related to conformance of the product with specified requirements are qualified on the basis of appropriate education, training and/or experience as required. Appropriate records of training shall be maintained Internal Audits The Fabricator shall establish and maintain documented procedures defining the responsibilities and requirements for planning and conducting audits, reporting results and maintaining records. Audits shall be implemented to verify whether quality activities comply with planned arrangements and to determine the continuing effectiveness of the quality system. Management shall take timely corrective action to eliminate any non-conformity identified, and follow-up audit activities shall verify and record the implementation and effectiveness of the corrective and preventative actions taken Customer Complaints The Fabricator shall establish and maintain documented procedures for the handling of customer complaints. The implementation and effectiveness of the corrective and preventative actions taken shall be verified and recorded. 1.2 Quality System Review during Surveillance Audits TUV SUD BABT will verify the following: Status of corrective actions from the last TUV SUD BABT audit. Status of corrective actions from the last internal audit related to the requirements of BABT 340. Effectiveness of management review, internal audit, corrective & preventative actions and customer complaints. 1.3 Quality System Requirements if Certificate Holder is not the Fabricator The elements outlined below are the key requirements that must be in place within the quality system of the Holder. Where the Holder performs key activities as shown within the PQC Compliance Plan (e.g. component purchasing) additional areas may have to be reviewed. The requirements are based on ISO 9001 and should be readily met by quality systems designed to comply with the version of ISO 9001 current at the time of audit Internal Audits The Holder shall establish and maintain documented procedures defining the responsibilities and requirements for planning and conducting audits, reporting results and maintaining records. Audits shall be implemented to verify whether quality activities comply with planned arrangements and to determine the continuing effectiveness of the quality system. Management shall take timely corrective action to eliminate any non-conformity identified, and follow-up audit activities shall verify and record the implementation and effectiveness of the corrective and preventative actions taken Customer Complaints The Holder shall establish and maintain documented procedures for the handling of customer Page 8 of 33

9 complaints. The implementation and effectiveness of the corrective and preventative actions taken shall be verified and recorded. Page 9 of 33

10 2. Additional Requirements for Production Quality Certification This part identifies the minimum additional requirements that must be met for certification under this scheme. In combination with Part 1, it identifies the core requirements of the scheme needed to support all PQC certifications, irrespective of the certification scope. The requirements of this part plus those of the relevant annexes, describe the requirements applicable for the individual certification scopes. These requirements apply to the Fabricator unless specified otherwise. 2.1 Field of Application Where complex or modular equipment is manufactured at more than one site, it is not necessary to demonstrate full compliance with this document at each site if the overall requirements are met in full and agreed by the Holder. 2.2 Quality System Requirements Management Responsibility a) A management representative for the Fabricator shall be appointed having the responsibility and authority for the implementation of the relevant requirements of this document as applicable to the facility and the scope of the PQC certification requested or held by the Holder. (This may or may not be the person having the overall responsibility for implementation of the ISO 9001 requirements). Any change of management representative must be notified immediately to TUV SUD BABT. b) A management representative shall be appointed, having the responsibility and authority for the implementation of the relevant requirements defined in directives, or other scheme documentation as specified in the annexes of this document relevant to the activities of the facility. c) The quality system, procedures and processes, in so far as they affect compliance with the requirements of this document, shall be reviewed on at least an annual basis for their continuing suitability and effectiveness. Records of such reviews shall be maintained. (This may, or may not, be combined with an ISO 9001 QMS review as defined in Part 1 of this document. Where separate ISO 9001 certification is held, this requirement does not impose an annual review on the whole of the certified quality system, but only on those elements identified in this document and the relevant associated annexes) PQC Compliance Plan The PQC Compliance Plan shall be produced by the Holder and agreed with the Fabricator. It shall be available at the time of audit. The PQC Plan for a Brandname Holder may be included with the plan of the original Holder Quality System The Quality System of the Fabricator shall: Ensure that all personnel involved in implementing the requirements have appropriate knowledge, experience and training, in particular for the purposes of conducting product testing to demonstrate ongoing compliance with the requirements defined in the relevant directives/scheme documents/annex to this document. Reference the processes and procedures involved in ensuring ongoing compliance of the product with the relevant requirements of the directives, other scheme documentation as specified in the Page 10 of 33

11 annexes of this document relevant to the activities of the facility Contract Review Evidence that a contract review has been performed between the Manufacturer and the Fabricator must be available which demonstrates: Note: For Original Product Manufacturers, where the fabrication is performed within the same company structure such reviews often form part of the design release process rather than being addressed in a separate internal contract review. However, under these circumstances, evidence must be available in the production facility that all of the following issues have been adequately addressed before marked product is placed on the market. (i.e. shipped). a) Adequate information is provided defining the build standard of the product. Where specified in the relevant annex, any changes to the build standard or specification have been advised and agreed with the Manufacturer. b) Adequate information is available, prior to commencement of manufacture, to define all the relevant processes and test procedures sufficient to ensure ongoing compliance of the product with the relevant essential requirements. c) If relevant, a Declaration of Conformity (or similar required document) has been supplied for the product to be manufactured, traceable to the above build standard. d) If relevant, submitted information includes details of the user information to be shipped with the product and any specific marking requirements for the product as specified in the Directive/Regulation/Scheme documentation. e) Full information is provided detailing any component parts/materials or processes critical to compliance of the product with the appropriate technical requirements defined in the Directive/Regulation/Scheme. Full details of the acceptance criteria for such components are required. Critical components must be specified by both the type and Manufacturer used. f) Capability within the processes of the Fabricator exists to address any additional controls on critical component parts/materials. g) Where specified in the relevant annex, copies of related certificates are supplied. h) Full details of the manufacturing testing/inspection required to ensure the compliance of manufactured product with the appropriate technical requirements of the Directive/Regulation/Scheme have been supplied, and agreed between the product Manufacturer and the Fabricator and that adequate capability to conduct such testing is available. For tests performed on a 100% basis the Manufacturer shall define the acceptable quality level for a defined batch size. i) For tests performed on a sample basis the Manufacturer shall define the acceptable quality level where a double sample has been taken. j) Where specified in the relevant annex, evidence that TUV SUD BABT have agreed to the manufacturing test plan. k) The PQC Compliance Plan has been supplied by the Holder and agreed by the Fabricator. l) Full details of any marking to be applied to the product, (including any appropriate Notified Body numbers or associated information where specified in the relevant annex) have been provided, together with appropriate authorisation to affix the marking. m) Details of any additional ongoing compliance checks needed to ensure ongoing compliance with the requirements of the Directive/Regulation/Scheme have been provided, and that any stop ship arrangements have been agreed Document and Data Control Page 11 of 33

12 a) Any changes to the documented Quality System of the Fabricator that affect compliance with the requirements of any part of this document and relevant associated annexes must be advised to and agreed by TUV SUD BABT before being implemented into the quality system. b) All changes to the product must be agreed by the Manufacturer. This includes any temporary manufacturing changes. c) Any agreement/advice of change from the Manufacturer must include details of any updates to any related certificates and any updates to required declarations Purchasing / Receiving Inspection The Fabricator shall ensure that the acceptance criteria for critical components/materials and critical sub-assemblies are applied as specified by the Manufacturer and that purchased components, materials, sub-assemblies or assemblies conform to those requirements. The compliance of category 2 and 3 sub-contractors to the relevant requirements of this document shall be evaluated by either the Fabricator or the Manufacturer on at least an annual basis. The records of the evaluation and any necessary actions arising from the evaluation shall be maintained and be available at the time of next TUV SUD BABT audit. Where category 3 sub-contractors perform testing on products critical to the compliance of the product to the relevant directive and this testing is not repeated/verified by the Fabricator or Manufacturer then the sub-contractor shall provide the results of the testing with every batch of products. Note: TUV SUD BABT reserves the right to independently audit category 2 or 3 sub-contractors. The Fabricator shall maintain a list of category 2 and 3 sub-contractors which must be agreed by the Manufacturer. The Fabricator shall ensure that all critical components and sub-assemblies are specified and purchased as detailed by the Manufacturer. If relevant, this shall include any test or compliance requirements. If applicable, a requirement for a certificate of conformity shall be referenced in the purchase order or contract. The Fabricator shall establish a process to obtain assurance that received components, materials or sub-assemblies are compliant with the specified requirements and ensure that incoming components, sub-assemblies or assemblies are not used or processed until they have been inspected or otherwise verified for conformance to the defined requirements. Verification shall be in accordance with documented procedures. Components or sub-assemblies which have been recognised by TUV SUD BABT as certified or separately approved in their own right need only be checked to ensure that they are of the correct type, appropriately marked and undamaged. This includes components carrying the certification marks of TUV SUD BABT or TÜV SÜD. Components holding type approval from other nationally and internationally recognised organisations may also be accepted on this basis provided that the type approval scheme includes regular assessment of the ongoing manufacturing capability within its requirements (e.g.bsi, UL etc.) and that a valid copy of the type approval certificate is obtained from the component manufacturer and held on file. Any rejected critical items must be segregated prior to being scrapped or re-worked. The segregated area should be clearly marked and there must be a published procedure covering the placing and removal of stock Process Control Page 12 of 33

13 General The Fabricator shall define and implement processes and controls to ensure and monitor product conformance to Manufacturer s requirements, applicable European Directives/Regulations, third party approval requirements, certification agency requirements and if relevant, external standards. Prior to shipment of product, the processes of the Fabricator must ensure: a) The build standard of the product is as agreed with the Manufacturer and matches the information supporting a valid declaration (e.g. Declaration of Conformity) or if relevant, certificate. b) Manufactured products which make use of AC power between 50 and 1000 volts shall meet the requirements of Annex I of this document. c) Results of any periodic validation tests notified to the Manufacturer do not indicate non-compliant results. d) No stop notices have been placed on the product by the Manufacturer or other relevant authority. e) Any marking related to the appropriate Directive/Regulation/Scheme has been checked on an appropriate sampling basis for conformance with the Directive/Regulation/Scheme requirements and includes the use of appropriate information (e.g. Notified Body number and year indication) where specified in the relevant annex. f) The product is properly identified with type, batch and/or serial number and the name of the Manufacturer or person responsible for placing the product on the market Compliance testing Prior to shipment of product, the processes of the Fabricator must ensure: a) All testing/inspections/calculations required to demonstrate on-going compliance with the appropriate technical requirements of the Directive/Regulation/Scheme have been satisfactorily completed with compliant results. b) For tests performed on a 100% basis all failing items shall be removed from the production lots. If the acceptable quality level for the lot has been exceeded, production shall be ceased until the root cause is found and rectified. c) For tests performed on a sampling basis where testing of a sample (or any part of a sample) results in a failure to meet the requirements, a further sample may be taken from the lot and tested. If a further sample is made, then the sum acceptable quality level for both samples is defined by the Manufacturer. If the combined sample falls within the acceptable quality level, the lot may be accepted. However the failing samples must be separated for either re-work or destruction. Where the AQL for both samples is exceeded then the lot shall be quarantined for either: 100% test; with failures quarantined for rework/destruction; Quarantined for inspection and rework then repeated sample testing; Quarantined for destruction; d) Non-compliant products cannot get into the marketplace, and any relevant marking is removed or obliterated either prior to disposal or during the disposal process (e.g. incineration) Quality Records Retention times for quality records shall be clearly defined in the quality system documentation and be appropriate for the processes involved. a) The following records shall be retained for at least 1 year or until the next TUV SUD BABT audit (whichever is longer): Page 13 of 33

14 Inspection records (e.g. Certificate of Conformity). Test records. Vendor audits of critical suppliers (where applicable). All relevant declarations (e.g. DoC) related to products manufactured by the Fabricator. b) The following records shall be kept for at least 10 years after the last product has been manufactured: The Quality Manual and TUV SUD BABT Compliance Plan(s) or equivalent documentation. Details of any amendments to the Quality System documentation together with the notification of agreement from TUV SUD BABT where required (see Clause 2.2.5a). Reports from TUV SUD BABT on all routine surveillance audits and unannounced audits, and any product tests arising from such audits. Vendor audits of critical sub-contractors and/or key sub-contracted activities. Records of all complaints and remedial actions relative to the quality system. The Manufacturer shall keep copies of all relevant declarations (e.g. DoC s) related to products manufactured by the Fabricator. Please note: This may be verified outside of the audit Internal Quality Audits a) The effective implementation of the quality system, procedures and processes, in so far as they affect compliance with the requirements of this document and any relevant associated annexes shall be verified at least once per calendar year by means of internal audit. The audit results and follow up actions shall be formally documented and made available to TUV SUD BABT on request. If separate ISO 9001 certification is held, this requirement does not impose an annual audit on the whole of the certified quality system, but only on those elements identified in this document and the relevant associated annexes. b) If the Holder is not the same company as the Fabricator, the Holder shall verify those aspects related to compliance with the requirements of this document which are under their control (as specified in the PQC Compliance Plan) and make such records available at the time of audit at the facility. c) If the Holder is not the same company as the Fabricator, the Fabricator shall advise the Holder of the results of any audit related to the requirements of this document, and any necessary corrective actions. d) If separate ISO 9001 certification exists, and the above audit is combined with an ISO 9001 QMS audit, the planning documents and audit records should clearly identify coverage of the individual requirements as defined in this document. Page 14 of 33

15 ANNEX A Supplementary Requirements for Production Quality Assurance under Module D and Product Quality Assurance under Module E of the Marine Equipment Directive 1. Introduction This annex applies to the manufacture of products to be placed on the european market under the requirements of Module D or Module E of Directive 2014/90/EU as amended by all effective amendments, and for which a Declaration of Conformity with the relevant essential requirements of the Directive exists. The requirements outlined in this PQC scheme and annexure relate only to appropriate manufacturing controls as required for Modules D or E in Annex B of the directive. They also address the Designer-Fabricator interfaces in order to assure the operation of a suitable process of quality assurance and control leading to the on-going compliance of the manufactured product with the validated design requirements. They do not address requirements related to the design, design verification or design validation associated with the preparation of Declarations of Conformity. Requirements for Module E (Product Quality Assurance) The requirements for Module E in the directive are identical to the requirements for Module D. For Module E, TUV SUD BABT will permit some of the full system requirements to be replaced by equivalent documentation only related to the particular products covered by Module E certificate. Brandname Products Such products must be covered by a Module D/E certificate held by a party listed on the Module B certificate as either the Holder or Authorised Representative. If the original product certificate Holder is from within the EU they may be listed as the Authorised Representative on the Brandname Holders Module B certificate. In these circumstances the Module D certificate covering the original product may also have the Brandname certificate details added to it. Where the Holder of the Module D for the original product is from outside the EU then they are not qualified to be listed as the Authorised Representative and consequently the Holder of the Brandname Product Module B certificate will require a separate Brandname certificate. The Module D/E certificate Holder must either be the Holder of the Module B type examination certificates covered by this certificate, or be the Authorised Representative of the Manufacturer listed on the Module B certificate. Where a Module B certificate is held by the Manufacturer, but the Module D/E is held by the Authorised Representative the obligations in these requirements related to the Module D Holder are applied to the Manufacturer who is the Holder of the Module B certificate. When applying this annex the following interpretations shall be made: a) References to certificates related to this annex refer to all Module D/E certificates and annexes (for main and Brandname Manufacturers) and all the Module B type examination certificates referenced on the Module D/E certificates. b) References to declarations related to this annex refer to Declarations of Conformity to the Marine Equipment Directive. Page 15 of 33

16 c) References to marking relate to the wheel mark as defined in annex D of the directive. The mark shall also include the Notified Body number (0168) and the year (in yy or yyyy format) in which the marking was placed on the actual item (Note: the year indicator changes every January). d) Changes to the build standard must be advised to and agreed by the Manufacturer. e) The manufacturing test plan must be agreed with TUV SUD BABT. 2. Implementation. These requirements only apply to Module D or E certifications under the MED Directive 2014/90/EU 2.1 Contract Review Evidence that a contract review has been performed between the Manufacturer and the Fabricator must be available which demonstrates: a) Copies of all technical files related to the Module B TEC certificates shall be supplied to the Fabricator Quality Records The following records shall be kept for at least 10 years after the last product has been manufactured: a) The technical file related to the Module B TEC certification. End of Annex A Page 16 of 33

17 ANNEX B Supplementary Requirements for the Registration of a Production Control Facility under the Construction Products Regulation 1. Introduction This annex applies to the manufacture of products to be placed on the european market under the requirements of Regulation 305/2011 as amended by all effective amendments, and for which a Declaration of Performance with the relevant essential requirements of the Regulation exists. The requirements outlined in this PQC scheme and annexure relate only to appropriate manufacturing production controls as required in the Regulation and cited standards. They also address the Designer- Fabricator interfaces in order to assure the operation of a suitable process of quality assurance and control leading to the ongoing compliance of the manufactured product with the validated design requirements. They do not address requirements related to the design, design verification or design validation associated with the preparation of Declarations of Performance. Brandname Products Such products must be covered by a PQC certificate held by a party listed on the Certificate of Constancy of Performance as either the Holder or Authorised Representative. Where the original product certificate Holder is from within the EU they may be listed as the Authorised Representative on the Brandname Holders Certificate of Constancy of Performance. In these circumstances the PQC certificate covering the original product may be cited provided the Quality System(s) included in the PQC certification include products from the Brandname certificate Holder. Where the Holder of the PQC certificate for the original product is from outside the EU, they are not qualified to be listed as the Authorised Representative and consequently the Holder of the Brandname Certificate of Constancy of Performance will require a separate Brandname PQC certificate. With the permission of all the Holders the audits and reports related to all the certificates may be combined. When applying this annex the following interpretations shall be made: a) References to compliance to the directive relate to the requirements of this regulation and the factory production control requirements invoked in the standard cited on the PQC certificate. b) References to certificates relate in this annex to all Certificates of Constancy of Performance for products dependent upon manufacture at facilities listed on the PQC certificate. c) References to Declarations of Conformity relate in this annex to Declarations of Performance to the Construction Products Regulation. d) References to marking relate to the CE Mark as defined in articles 8 and 9 of the regulation. The mark shall also include the Notified Body number (0168) and the year (in yy format) in which the marking was first placed on any product under the Declaration of Constancy of Performance (e.g. does not change until the DoCoP changes). e) Changes to the build standard must be advised to and agreed by the Manufacturer f) The production test plan must be agreed with TUV SUD BABT. For VMS certification, the test plan may relate to the test module. The test plan must be traceable to the relevant requirements for the product from annex ZA of the applied standard. g) Where the test plan relates to a test plan for a test module, the test plans generated for each implementation shall be traceable back to the agreed plan. End of Annex B Page 17 of 33

18 ANNEX C Supplementary requirements for the Manufacture of Machines under Machinery Directive 1. Introduction This annex applies to the manufacture of machinery to be placed on the european market under the requirements of Directive 2006/42/EC as amended by all effective amendments, and for which a Declaration of Conformity with the relevant essential requirements of the directive exists. The requirements outlined in this PQC scheme and annexure relate only to appropriate manufacturing production controls as required in the directive and cited standards. They also address the Designer- Fabricator interfaces in order to assure the operation of a suitable process of quality assurance and control leading to the ongoing compliance of the manufactured product with the validated design requirements. They do not address requirements related to the design, design verification or design validation associated with the preparation of Declarations of Conformity. Brandname Products Such products must be covered by a PQC certificate held by a party listed as either the Holder or Authorised Representative on the type examination certificate or Machinery Directive Attestation certificate. Where the original product certificate Holder is from within the EU they may be listed as the Authorised Representative on the Brandname Holders PQC certificate. In these circumstances the PQC certification covering the original product may have the Brandname product included within its scope. Where the Holder of the PQC certificate including the original product is from outside the EU, they are not qualified to be listed as the Authorised Representative and consequently the Holder of the Brandname PQC certificate will require a separate Brandname PQC certification. Where a Machinery Directive type examination certificate or Machinery Directive Attestation certificate is held by the Manufacturer, but the PQC certificate is held by the Authorised Representative the obligations in these requirements related to the PQC Holder shall be applied to the Manufacturer who is the Holder of the type examination certificate or Machinery Directive Attestation certificate. These requirements (as well as the general requirement in Parts 1 and 2 of this document) are applied to the Fabricator unless stated otherwise in this annex. a) References to declarations refer to either a Declaration of Conformity as required by Article 5.1a of the directive (for complete machines) or a Declaration of Incorporation as required by Article 13 1C (for partly complete machines). Refer also to annex II of the directive. b) Where partly completed machinery is to be included in any machine covered by this PQC, the criteria for acceptance of a critical part must include a Declaration of Incorporation for that partly completed machine c) References to certificates relate to type examination certificates for the products under manufacture and type examination certificates of any partly complete machine intended for inclusion within a machine manufactured under this PQC Certificate. d) Changes to the build standard must be advised to and agreed by the Manufacturer. e) References to marking relate to the specific marking requirements for both the product and the packaging supporting the requirements of article 5(1f) of the directive as required by article 16 and annex III of the directive. The CE marking must be checked on an appropriate sampling basis for conformance with the requirements of annex VII of the directive. The details of the marking shall also include any specific marking required related to the type and use of the product. End of Annex C Page 18 of 33

19 ANNEX D Supplementary requirements for the Manufacture of Measuring Instruments 1. Introduction This annex applies to the manufacture of products to be placed on the european market under the requirements of either Module D of Directive 2014/32/EU and for which a Declaration of Conformity with the relevant essential requirements of the directive exists. The requirements outlined in this PQC scheme and annexure relate only to appropriate manufacturing controls as required for modules of the directive. They also address the Designer-Fabricator interfaces in order to assure the operation of a suitable process of quality assurance and control leading to the on-going compliance of the manufactured product with the validated design requirements. They do not address requirements related to the design, design verification or design validation associated with the preparation of Declarations of Conformity. Brandname Products Such products must be covered by a Module D certificate held by a party listed on the Module B certificate as either the Holder or Authorised Representative. Where the original product certificate Holder is from within the EU they may be listed as the Authorised Representative on the Brandname Holders Module B certificate. In these circumstances the Module D certificate covering the original product may also have the Brandname certificate details added to it. Where the Holder of the Module D for the original product is from outside the EU then they are not qualified to be listed as the Authorised Representative and consequently the Holder of the Brandname Product Module B certificate will require a separate Brandname certificate. The Module D certificate Holder must either be the Holder of the Module B type examination certificates covered by this certificate, or be the Authorised Representative of the Manufacturer listed on the Module B certificate. Where a Module B certificate is held by the Manufacturer, but the Module D certificate is held by the Authorised Representative the obligations in these requirements related to the Module D Holder are applied to the Manufacturer who is the Holder of the Module B certificate. When applying this annex the following interpretations shall be made: a) References to certificates related to this annex refer to all Module D certificates and annexes (for main and Brandname manufacturers) and all the Module B type examination certificates referenced on the Module D certificates. b) References to declarations related to this annex refer to Declarations of Conformity to the relevant Measuring Instruments Directive. c) References to marking relate to the CE mark as defined the applicable directive. The mark shall also include the supplementary metrology marking M the year (in yy format) in which the marking was placed on the actual item and the TUV SUD BABT Notified Body number (0168) and (note: the year indicator changes every January). d) References to critical components relate to Measuring Directive Critical Components. e) Changes to the build standard must be advised to and agreed by the Manufacturer. f) The manufacturing test plan must be agreed with TUV SUD BABT. Page 19 of 33

20 2. Implementation. 2.1 Contract Review For testing performed on a 100% basis the Manufacturer shall define the acceptable quality level of a defined batch size. For testing performed on a sample basis the Manufacturer shall define the acceptable quality level where a double sample has been taken. 2.2 Process Control % Testing All failing items shall be removed from the production lots. Where acceptable quality level for the lot has been exceeded, production shall be ceased until the root cause is found and rectified Sample Testing Where testing of a sample (or any part of a sample) results in a failure to meet the requirements, a further sample may be taken from the lot and tested. The acceptable quality level for the first sample is zero. Where a further sample is made then the sum acceptable quality level will be defined at a time of contract review and may depend upon the sample size. The results of both the original testing and the testing on any additional sample must be reviewed. Where the combined sample falls within the acceptable quality level, the lot may be accepted. However, the failing samples must be separated for either re-work or destruction. Where the acceptable quantity level for both samples is exceeded then the lot shall be quarantined for either: 100% test; with failures quarantined for re-work or destruction; Quarantined for inspection and re-work then repeated sample testing; Quarantined for destruction. End of Annex D Page 20 of 33

21 ANNEX E Supplementary Requirements for Manufacture of Products under Annex II of Radio Equipment Directive (RED) 1. Introduction This annex applies to the manufacture of products to be placed on the european market under the requirements of Annexes II, or III of Directive 2014/53/EU, and for which a Declaration of Conformity with the relevant essential requirements of the directive exists. The requirements outlined in this scheme and annexure relate only to appropriate manufacturing controls as required by clause 3 of annex II of the directive. They also address the Customer Supplier interfaces in order to assure the operation of a suitable process of quality assurance and control leading to the on-going compliance of the manufactured product with the validated design requirements. They do not address requirements related to the design, design verification or design validation associated with the preparation of Declarations of Conformity. The requirements of annex II of the directive are invoked by annex III of the directive in full. As these annexes do not invoke any additional requirements in relation to the actual process of manufacturing the product, this scheme is appropriate for product placed on the european market under any one of these three annexes. When applying this annex the following interpretations shall be made: a) References to essential requirements refer to the essential requirements defined in article 3 of RED. b) References to Declarations refer to Declaration of Conformity as required by Articles 10.3, 10.9, 18 and annex VI of the directive. c) References to marking relate to the specific marking requirements for both the product and the packaging supporting the requirements of articles 10.7, of the directive the marking as required by article 19 and 20 of the directive. Note: For products under articles II and III of the directive the marking must not include the Notified Body number. End of Annex E Page 21 of 33