Federal Public Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE NATIONAL INSTITUTE OF METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY - INMETRO

Ministerial Act No 295 of 27 July 2010

PUBLIC CONSULTATION

RE: General Certification Requirements ORIGIN: Inmetro/MDIC

THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY - INMETRO, in the exercise of his powers granted by Article 4 (§3) of Law No 5966 of 11 December 1973, Article 3 (indent I) of Law No 9933 of 20 December 1999 and Article 18 (indent V) of the Regulatory Framework for Self-governing Bodies, approved by Decree No 6275 of 28 November 2007, resolves to:

Article 1 Make the draft texts of the Final Ministerial Act and General Certification Requirements available on the website www.inmetro.gov.br.

Article 2 Declare that the period of 60 (sixty) days for the submission of suggestions and criticism in relation to the draft texts shall start on the date of publication of this Ministerial Act in the Brazilian Official Journal.

Article 3 Advise that criticism and suggestions with regard to the above-mentioned texts should be sent to the following addresses:

- National Institute of Metrology, Standardisation and Industrial Quality – Inmetro Quality Directorate - Dqual Conformity Assessment Programme Division – Dipac Rua Santa Alexandrina, 416 – 8º andar – Rio Comprido CEP 20261-232 – Rio de Janeiro – RJ, or - E-mail: dipac.consultapublica@inmetro.gov.br

Article 4 Establish that, at the end of the period stipulated in Article 2 of this Ministerial Act, Inmetro shall make contact with the parties that have shown interest in the subject, so that they may appoint representatives for the subsequent discussions aimed at consolidating the final text.

Article 5 Publish this Public Consultation Act in the Brazilian Official Journal, at which point it shall come into effect.

JOÃO ALZIRO HERZ DA JORNADA

Federal Public Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE NATIONAL INSTITUTE OF METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY - INMETRO

DRAFT TEXT OF FINAL MINISTERIAL ACT

Ministerial Act No of 2010

THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY - INMETRO, in the exercise of his powers granted by Article 4 (§3) of Law No 5966 of 11 December 1973, Article 3 (indent I) of Law No 9933 of 20 December 1999 and Article 18 (indent V) of the Regulatory Framework for Self-governing Bodies, approved by Decree No 6275 of 28 November 2007;

Whereas subsection 4.2 (f) of the Terms of Reference of the Brazilian Conformity Assessment System, approved by Conmetro Resolution No 04 of 2 December 2002, gives Inmetro authority to establish the guidelines and criteria for conformity assessment activity;

Whereas the quantity and complexity of demands for the establishment of Conformity Assessment Programmes – CAPs are increasing and there is a need to review and streamline the manner of dealing with these;

Whereas it is important to continually improve the Process of Assisted Establishment of Conformity Assessment Programmes – CAPs;

Whereas there is a need to ensure greater standardisation, conciseness and streamlining in setting up Conformity Assessment Programmes – CAPs;

Whereas the General Certification Requirements – GCRs are designed to establish systems common to all Conformity Assessment Programmes – CAPs that adopt the certification scheme;

Whereas the General Certification Requirements – GCRs are complemented by the Conformity Assessment Requirements – CARs applicable to each object that is subject to certification;

Whereas the existence of general requirements for each conformity assessment scheme makes the interpretation of Conformity Assessment Programmes – CAPs clearer, resolves to:

Article 1 Approve the General Certification Requirements – GCRs available on the website www.inmetro.gv.br or from the address:

National Institute of Metrology, Standardisation and Industrial Quality – Inmetro Conformity Assessment Programme Division – Dipac Rua Santa Alexandrina 416 – 8º andar – Rio Comprido 20261-232 Rio de Janeiro/RJ

Federal Public Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE NATIONAL METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY INSTITUTE - INMETRO

Article 2 Make known that the Public Consultation that gave rise to the General Certification Requirements – GCRs now approved was disclosed in Inmetro Act No xxx, of xx xxx xxxx, published in the Brazilian Official Journal of xx xxx xxxx , section xx, page xx.

Article 3 Determine that all Conformity Assessment Programmes – CAPs that adopt the certification scheme must comply with the content of the document now approved.

Sole Paragraph: Conformity Assessment Programmes – CAPs which use the certification scheme, approved 60 (sixty) days after the entry into force of this Ministerial Act, must apply and quote the General Certification Requirements – GCRs now approved.

Article 4 Make known that the Conformity Assessment Requirements – CARs must include specific information complementary to the General Certification Requirements – GCRs, in accordance with the specific features of the object to be certified.

§1 The Conformity Assessment Requirements – CARs must determine the following points: I – Objective (specific to the certification programme); II – Complementary documents (statutory basis of the certification programme in question); III – Abbreviations (only those not given in this document);

IV – Definitions (only those not given in this document); V – Definition of the certification model used; VI – Specific stages in the certification process (which must include the following items as a minimum, complementing the GCRs):

• Application for Commencement of the Certification Process (request for complementary documents); • Initial Audit of the Quality Management System (where applicable); • Initial Testing Schedule (types of tests, sampling and acceptance and rejection criteria); • Issue of the Certificate; • Maintenance Assessment; • Maintenance Audit (where applicable); • Maintenance Audits at varying intervals (where applicable); • Maintenance Testing Schedule (types of tests, sampling and acceptance and rejection

criteria); • Renewal Assessment; • Renewal Audit (where applicable); • Renewal Testing Schedule (types of tests, sampling and acceptance and rejection

criteria); VII – Conformity Identification Seal.

§2 Exceptionally, the Conformity Assessment Requirements – CARs may not, depending on the

specific features of the object to be assessed, adopt all the provisions contained in the document now approved or may supplement its content.

Federal Public Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE NATIONAL METROLOGY, STANDARDISATION AND INDUSTRIAL QUALITY INSTITUTE - INMETRO

§3 In cases where, without prejudice to the terms of the preceding paragraph, it is necessary to make changes, adjustments or additions to the content of the document now approved, these must be clearly identified and defined in the Conformity Assessment Requirements – CARs.

Article 5 Determine that the Conformity Assessment Requirements – CARs approved prior to the entry into force of this Ministerial Act shall be adjusted to the document now approved, insofar as they have been revised.

Article 6 This Ministerial Act shall enter into force on the date of its publication in the

Brazilian Official Journal.

JOÃO ALZIRO HERZ DA JORNADA

ANNEX TO INMETRO ACT No XXX/ 2010

GENERAL CERTIFICATION REQUIREMENTS 1 OBJECTIVE This document establishes the General Certification Requirements – GCRs common to all Conformity Assessment Programmes – CAPs which use the Product Certification scheme. The specific features of each CAP must be set out in Conformity Assessment Requirements – CARs, which must give details of the subject matter, having regard to the specific features of the subject of certification. 2 ABBREVIATIONS AB Accreditation Body ABNT Brazilian Technical Standards Association BCAS Brazilian Conformity Assessment System CAB Conformity Assessment Body CAP Conformity Assessment Programme CARs Conformity Assessment Requirements Cgcre General Accreditation Co-ordination Office Conmetro Brazilian Metrology, Standardisation and Quality Council DOU Brazilian Official Journal Dqual Quality Directorate EMS Environmental Management System GCRs General Certification Requirements IEC International Electrotechnical Commission ISO International Organization for Standardization MoU Memorandum of Understanding PCB Product Certification Body QMS Quality Management System RBLMQ-I Brazilian Legal Metrology and Quality Network – Inmetro SCB Systems Certification Body TQRs Technical Quality Requirements 3 COMPLEMENTARY DOCUMENTS Law No 8078 of 11 September 1990 Providing for consumer protection and other

measures Law No 9933 of 20 December 1999 Providing for the powers of Conmetro and

Inmetro, setting up the Metrological Services Tax and establishing other measures

Conmetro Resolution No 04/2002 Providing for approval of the Terms of Reference of the Brazilian Conformity Assessment System – BCAS and internal regulations of the Brazilian Conformity Assessment Committee – BCAC

Conmetro Resolution No 05/2008 Providing for approval of the Regulations on the Registration of Objects liable to Compulsory

Conformity Assessment through a programme co-ordinated by Inmetro

Inmetro Act No 179/2009 Approving the Regulations on the use of Marks, Accreditation Symbols, Recognition of Conformity with the Principles of Good Laboratory Practice – GLP and Inmetro Identification Seals

Standard ABNT NBR ISO 9001:2008 Quality Management Systems – Requirements Standard ABNT NBR ISO/IEC 17025:2005 General requirements for the competence of

testing and calibration laboratories Standard ABNT NBR ISO 14001:2004 Environmental Management Systems –

Requirements with guidance for use Inmetro User Manual Conformity Identification Seals 4 DEFINITIONS The definitions appearing in Standard ABNT NBR ISO/IEC 17000:2005 and Conmetro Resolution No 04/2002 shall apply to CAPs established by Inmetro which use the Certification scheme, with the necessary adaptations and additions to the BCAS, described in the following subsections. Specific definitions used in each CAP must be described in the respective CARs. 4.1 Accreditation This refers to the third-party attestation concerning a conformity assessment body, confirming that its competence to carry out specific conformity assessment tasks has been formally demonstrated. 4.2 Sample Consists of one or more product units taken at random from and representative of the universe to be inspected. 4.3 Audit A systematic, independent and documented process for obtaining records, statements of fact or other relevant information and assessing them in an objective manner to determine to what extent the specific requirements have been met. 4.4 Authorisation to use the Conformity Identification Seal Authorisation given by Inmetro to the applicant, based on the principles and policies adopted within the BCAS and in accordance with the requirements laid down in the relevant regulations, as regards the right to use the Conformity Identification Seal on products, processes, services and systems regulated by Inmetro. Pursuant to Act No 179/2009, use of the seal is restricted to objects that have been assessed on the basis of Conformity Assessment Programmes set up by Inmetro. 4.5 Authorisation to use the Conformity Identification Seal on advertising material A document issued by Dqual that gives authorisation to use the Conformity Identification Seal on advertising material referring to products regulated by Inmetro, in compliance with Inmetro Act No 179/2009.

4.6 Conformity Assessment A standardised process with pre-established rules, duly monitored and assessed, designed to foster an adequate degree of confidence that a product, process or service, or a professional, meets the requirements pre-established by standards or regulations at the least possible cost to society. 4.7 Certification Attestation issued by a third party concerning the conformity of an object. 4.8 Conformity Certificate Issue of a statement based on a decision taken after critical analysis of whether fulfilment of the specified requirements has been demonstrated. 4.9 Consumer Consumer means any individual or legal entity that purchases or uses a product or service as end user (source: Consumer Protection Code). 4.10 Appointment Governmental authorisation given to a CAB to carry out specific conformity assessment activities. 4.11 Undertaking A public or private, national or foreign legal entity, legally established in the country, which carries out product manufacture, creation, construction, processing, import, export, distribution or marketing activities. 4.12 Maintenance Testing Periodic test carried out during maintenance of the conformity assessment process. 4.13 Initial Testing Test carried out with a view to granting the Certificate of Conformity. 4.14 Family Group of product models, used for the same purpose, from the same manufacturer, which have one or more of the following characteristics in common: dimensions, mass, raw material, configuration, use, etc. 4.15 Control Activity involving administrative policing powers, which has the purpose of checking that regulated objects and objects subject to compulsory conformity assessment available on the national market comply with the requirements established in laws, resolutions, technical regulations and conformity assessment regulations, making them liable to the penalties provided in Article 8 of Law No 9933/99. 4.16 Inmetro Statutory Instruction – ISI Document defining the technical requirements that the product, process, service, person or Quality Management System must meet in voluntary assessments. The requirements are established by means of Ministerial Act and must be met by undertakings, Conformity Assessment Bodies – CABs and other relevant parties.

4.17 Accredited Laboratory A public, private or mixed enterprise, accredited by Cgcre/Inmetro according to the criteria established by the latter on the basis of the principles and policies adopted within the BCAS. 4.18 Conformity Assessment Schemes The principal tools used within the BCAS to certify conformity, such as Certification, Supplier’s Conformity Declaration, Inspection, Testing and Labelling. 4.19 Descriptive Notes Document submitted by the undertaking, describing the design of the object to be assessed with a view to succinctly setting out the most important information. 4.20 Model An assembly with precise specifications established on the basis of manufacturing characteristics, i.e. same design, production process, dimensions and other regulatory requirements. 4.21 Certification Model The model adopted in consideration of the nature of the product, production process, raw material characteristics, economic aspects and level of confidence required (source: Conformity Assessment – 5th edition, 2007, with the exception of model 9). 4.21.1 Certification Model 1 – Type test Provides evidence of conformity of an item at a given time. It is a unique and one-off testing operation with limited effects. As the simplest and most restricted form of Certification, its costs are minimal, but there is no monitoring of the conformity of the remaining production of the same model. It is not, therefore, a systematically managed conformity assessment. 4.21.2 Certification Model 2 – Type test followed by verification by means of testing samples taken from the market This is a model based on type testing, but combined with further action to check whether production continues to be in conformity. It includes tests on samples taken from the market. 4.21.3 Certification Model 3 – Type test with further action to test samples taken from the factory This is a model based on type testing, but combined with further action to check whether the production continues to be in conformity. It includes tests on samples taken from the factory. This model provides for permanent supervision of the manufacturer’s production and may trigger corrective actions when non-conformity is shown. 4.21.4 Certification Model 4 – Type test followed by verification by means of testing samples taken from the market and the factory Combines Models 2 and 3, by taking samples for testing from both the market and the factory. Depending on the number of samples tested, this model can combine the advantages of Models 2 and 3, although it is more costly.

4.21.5 Certification Model 5 – Type test, assessment and approval of the manufacturer’s Quality Management System, monitoring by means of audits at the factory and testing of samples taken from the market and the factory This is a model based, like the previous ones, on type testing, but accompanied by assessment of the measures taken by the manufacturer in respect of the Quality Management System for his production, followed by regular monitoring by means of audits of factory quality control and verification tests on samples taken from the market and factory. This model is the most commonly used in the BCAS and provides a full and reliable system of conformity assessment of large-scale mass production. 4.21.5.1 Certification Model 5*– Type test, assessment and approval of the manufacturer’s Quality Management System, monitoring by means of audits at the factory and testing of samples taken from the market and the factory at varying intervals This is a model based on Model 5, but the Maintenance Assessment varies in frequency depending on the results of the previous assessment. 4.21.6 Certification Model 6 – Assessment and Approval of the Manufacturer’s Quality Management System This is the model in which the ability of an industry to manufacture a product conforming to a given specification is assessed. This model is not adequate for Product Certification, as it does not assess the conformity of the end product but rather the ability of the undertaking to produce a particular product in conformity with a pre-established specification. 4.21.7 Certification Model 7 – Batch testing This is the model in which samples taken from a batch of products, which may or may not be imported, are subjected to tests, with an assessment of its conformity to a given specification being issued on the basis of the results. 4.21.8 Certification Model 8 – 100% testing This is the model in which the whole universe of products is tested to check fulfilment of the requirements laid down in the standard or technical regulation covering that product. 4.21.9 Certification Model 9 – Type test, assessment and approval of the manufacturer’s Environmental Management System, monitoring by means of audits at the factory and testing of samples taken from the market and the factory This is a model based on type testing, accompanied by assessment of the measures taken by the manufacturer in respect of the Environmental Management System for his production, followed by regular monitoring, by means of audits, of the factory’s environmental control and verification tests on samples taken from the market and factory. This model must be applied whenever there is environmental legislation applicable to the product to be certified and/or whenever it is deemed necessary to ensure environmental control due to the significance of the impact on the environment caused by the process. This model increases the environmental security of the conformity assessment process. The frequency of maintenance audits may be altered in accordance with the results of the previous audit and progressive audit cycle criteria may be applied. 4.22 Object Any product, process, service or person liable to conformity assessment as prescribed in Conformity Assessment Requirements – CARs.

4.23 Special Control Operation Simultaneous control throughout the national territory of objects liable to compulsory conformity assessment, generally associated with their peak consumption period. 4.24 Accreditation Body Body authorised to perform accreditation activities. 4.25 Conformity Assessment Body – CAB Body that provides conformity assessment services. 4.26 Product Certification Body – PCB Body that conducts the Certification procedure and awards the Certificate of Conformity for products assessed on a voluntary or compulsory basis according to national, regional and international standards or technical requirements. 4.27 Systems Certification Body – SCB Body that handles and awards Certification of Quality Management Systems assessed on a voluntary or compulsory basis according to national, regional and international standards. 4.28 Delegated Body National, federal, state or municipal public institution, which belongs to the Inmetro Brazilian Legal Metrology and Quality Network – RBMLQ-I – and has a formal agreement with Inmetro. 4.29 Conformity Assessment Programme – CAP Defines the requirements for assessing the conformity of an object in relation to the regulatory basis, providing an adequate level of confidence in conformity at the lowest possible cost to society. It is made up of the Conformity Assessment Requirements – CARs specific to the object, the regulatory basis (Technical Standard or Technical Quality Requirements – TQRs) and the document now approved, General Certification Requirements – GCRs, for both compulsory and voluntary assessments. 4.30 Object Registration Act whereby Inmetro, in compulsory assessments and in the form and cases provided in Conmetro Resolution No 05/2008, authorises use of the Conformity Identification Seal and marketing of the object, subject to the existence of the Certificate of Conformity. 4.31 Conformity Assessment Requirements – CARs Document that contains specific requirements and establishes a systematic procedure for assessing the conformity of a particular object, in accordance with the requirements laid down in the Technical Standard or Technical Quality Requirements – TQRs and General Certification Requirements – GCRs. NB 1: Conformity Assessment Requirements – CARs are prepared and established by Inmetro, by means of Ministerial Act, to be met by undertakings, Conformity Assessment Bodies – CABs and other relevant parties. NB 2: CARs are based on quality management tools designed to foster confidence in conformity with a technical standard or regulation, at the lowest possible cost to society.

4.32 Technical Quality Regulation – TQR Document defining the technical requirements that a product, process, service, person or quality management system subject to compulsory assessment must fulfil. Established by means of Ministerial Act, to be met by undertakings, Conformity Assessment Bodies – CABs and other relevant parties. 4.33 General Certification Requirements – GCRs Document defining the general requirements applicable to all Conformity Assessment Programmes – CAPs that adopt the Certification Scheme. 4.34 Technical Manager Professional formally linked with the applicant, legally authorised and duly registered with the respective industry body, capable of taking technical responsibility for the activities carried out by the applicant. 4.35 Conformity Identification Seal Identification showing that the object assessed conforms to the criteria established in the CARs, GCRs and Inmetro Act No 179/2009 and to the characteristics defined in the CARs or Inmetro Conformity Identification Seal User Manual. 4.36 Applicant Undertaking requesting Authorisation to use the Conformity Identification Seal. 4.37 Verification of Conformity Preventive action, the purpose of which is to verify that an object, when on the market, still conforms to the specified requirements, with a view to checking the effectiveness of the CAP and identifying opportunities to improve that programme. 5 STAGES IN CONFORMITY ASSESSMENT The conformity assessment process is made up of various stages. Each stage corresponds to a series of procedures depending on the Certification Model or Models adopted. NB: The compulsory or voluntary nature of each programme is determined in the Ministerial Act publishing the CARs for the object in question. 5.1 Certification Models The Certification Models are defined in Chapter 3 – Definitions, in subsections 3.25 to 3.33 [sic] of this document. 5.2 Certification Model Stages Each model comprises a series of stages described in Table 1.

Table 1: Certification Model Stages

MODELS STAGES IN THE PRODUCT CERTIFICATION PROCESS 1 2 3 4 5 5* 6 7 8 9

Application for Commencement of the Certification Process X X X X X X X X X X

Analysis of Application and Documentation

X X X X X X X X X X

Initial Audit of Quality Management System

X X X X

Initial Testing Schedule (types of tests, laboratory, sampling and acceptance and rejection criteria)

X X X X X X X X X

Initial Assessment

Issue of Certificate of Conformity X X X X X X X X X X

Analysis of Documentation X X X X X X X

Maintenance Audit X X X

Maintenance Audit at varying intervals X

Maintenance Testing Schedule (types of tests, laboratory, sampling and acceptance and rejection criteria)

X X X X X X

Maintenance Assessment

Maintenance Confirmation X X X X X X X

Application for Renewal Process X X X X X X X

Analysis of Application and Documentation X X X X X X X

Renewal Audit of Quality Management System

X X X X

Renewal Testing Schedule (types of tests, laboratory, sampling and acceptance and rejection criteria)

X X X X X X

Renewal Assessment (see NB)

Renewal Confirmation X X X X X X X

NB: Renewal assessment is applicable only when the object submitted for Certification is liable to registration pursuant to Conmetro Resolution No 5/2008. 5.2.1 Initial Assessment The initial stages in the conformity assessment process are described in this section, culminating in certification of the object’s conformity. They include: 5.2.1.1 Application for Commencement of the Certification Process Commencement of the Certification Process is subject to a formal statement by the applicant, which must be submitted directly to one of the Conformity Assessment Bodies – CABs accredited and/or appointed by Inmetro for the purpose of the object to be assessed, having regard to the following matters: a) option relating to the model or family of the object in question, indicating its technical description; b) option in respect of the Certification Model, as mentioned in the CARs for the object in question; c) in the case of imported objects to be certified on the basis of Model 7, the Import Licence and the description and identification of the batch subject to Certification must be attached to the application; d) other documents needed for the application process as described in the CARs.

5.2.1.1.1 The application must abide by the provisions of these GCRs and the CARs of the object to be assessed. 5.2.1.1.2 In the case of Model 7 or when requested in the CARs, the description and identification of the batch subject to Certification must be attached to the application. 5.2.1.1.3 In the case of Model 5, the documents referring to the Quality Management System – QMS applicable to the production process of the model or family must be submitted to the CAB. 5.2.1.1.4 In the case of Model 9, the documents referring to the Environmental Management System – EMS applicable to the production process of the model or family must be submitted to the CAB. 5.2.1.2 Analysis of Application and Documentation On receipt of the specified documentation, the CAB must initiate the process for granting the Certificate of Conformity and must carry out an analysis of the relevance of the application within 15 (fifteen) days, as well as assessing the documentation submitted by the applicant. NB: If any non-conformity is identified in the documentation received, this must be formally returned to the applicant who shall correct it and then re-submit it to the CAB, indicating the corrective action(s) adopted, with a view to re-analysis. 5.2.1.3 Initial Audit of Quality and Environmental Management Systems The purpose of this audit is to check that the Quality Management System – QMS and Environmental Management System – EMS for the production process of the object covered by the CARs have actually been established. The CAB must assess the QMS or EMS for the production process of the object assessed, in accordance with the model adopted, as well as carry out an audit in the factory, with the aim of verifying conformity of the production process with the documentation submitted, using Table 2 in subsection 5.2.1.3.1 and [Table 3 in] subsection 5.2.1.3.2 of these GCRs as a reference for the QMS and EMS respectively. 5.2.1.3.1 The QMS for the production process of the object must be assessed by the CAB on the basis of the scope of the Certification Process and in accordance with the requirements of standard ABNT NBR ISO 9001:2008, as defined below:

Table 2: Items to be checked according to standard ABNT NBR ISO 9001:2008

ITEMS ABNT NBR ISO 9001:2008 Control of documents 4.2.3 Control of records 4.2.4 Customer communication 7.2.3 Verification of purchased product 7.4.3 Control of production and service provision 7.5.1 Identification and traceability 7.5.3 Preservation of product 7.5.5 Control of monitoring and measuring equipment 7.6 Customer satisfaction 8.2.1 Monitoring and measuring of product 8.2.4

Control of non-conforming product 8.3 Corrective action 8.5.2 Preventive action 8.5.3 NB: If the QMS is based on another standard, this must be mentioned in the CARs. 5.2.1.3.2 The EMS for the production process of the object must be assessed by the CAB on the basis of the scope of the Certification Process and in accordance with the requirements of standard ABNT NBR ISO 14001:2004, as defined below:

Table 3: Items to be checked according to standard ABNT NBR ISO 14001:2004

EMS requirements ABNT NBR ISO 14001:2004 Environmental aspects 4.3.1 Legal and other requirements 4.3.2 Objectives, targets and programmes 4.3.3 Operational control 4.4.6 Emergency preparedness and response 4.4.7 Monitoring and measurement 4.5.1 Evaluation of legal and other compliance 4.5.2 Non-conformity, corrective action and preventive action 4.5.3 NB: If the EMS is based on another standard, this must be mentioned in the CARs. 5.2.1.3.3 Submission of a manufacturer’s current QMS or EMS Certificate, which has been issued by an SCB accredited by Inmetro or recognised by the IAF, according to ISO 9001:2008 or ISO 14001:2004, for Models 5 and 9 respectively, where that certificate is valid for the production line of the product subject to certification, may exempt the applicant undertaking, subject to analysis and under the responsibility of the CAB, from assessment of the QMS or EMS provided in these GCRs during initial audit. In this case, the applicant undertaking must make all the records corresponding to that certification available to the CAB. The CAB must analyse the relevant documentation to ensure that the requirements described in Table 2 in subsection 5.2.1.3.1 have been met in respect of the QMS and that the requirements described in Table 3 in subsection 5.2.1.3.2 have been met in respect of the EMS. NB: If non-conforming items are identified during initial audit, the CAB must ask the manufacturer to implement the necessary actions to remedy the non-conformity, with a deadline being set for this purpose. The need for a further audit to verify implementation of the actions taken to remedy the identified non-conformity shall be a matter for the CAB to decide. 5.2.1.3.4 QMS and EMS Certificates issued by a foreign CAB must be accompanied by a sworn translation into Portuguese, if the certificate is issued in a language other than English or Spanish. 5.2.1.3.5 During the audit, the CAB must issue a report recording its result, using the object’s CARs as the reference.

5.2.1.3.6 The audit report must be signed by the manufacturer and the CAB. A copy must be made available to the manufacturer. 5.2.1.4 Initial Testing Schedule The initial tests must establish that the object covered by the conformity assessment meets the regulatory requirements, with the PCB taking responsibility for preparing the Testing Schedule. These tests must be carried out and recorded according to the following stages: 5.2.1.4.1 Definition of Tests to be carried out The tests are defined in the object’s CARs and must be conducted in accordance with the reference standards. 5.2.1.4.2 Definition of Sampling The CAB is responsible for selecting and collecting samples of the object covered by the application for Certification. The sampling schedule, sampling acceptance criteria and exceptional cases are detailed in the CARs for the object in question. Table 4 shows the sampling distribution model.

Table 4: Sample Distribution Model for Tests

SAMPLING TESTS STANDARD

ITEM TEST SAMPLE

COUNTER SAMPLE CONTROL ACCEPTANCE

CRITERIA (Definition of each type of

test)

(Number of the standard item)

(Size of the test sample)

(Size of the counter sample)

(Size of the control sample)

(Criteria for acceptance of the

sample) 5.2.14.3 Definition of the Laboratory The CAB must use laboratories accredited by Inmetro for the purpose of the tests specified in the CARs. The CAB must record, on the basis of supporting documents, the reasons that led it to select the laboratory. The following items must be considered when defining the laboratories to be used: a) The selected laboratories must be third-party and accredited by Inmetro;. b) On an exceptional and temporary basis and subject to assessment and approval by the CAB, a laboratory that is not accredited for the specific purpose may be used if one of the circumstances described below arises:

I – when there is no laboratory accredited for the specific purpose relating to the CAP; II – when there is only one accredited laboratory and the CAB can show that the price of the tests carried out by the non-accredited laboratory, plus the costs arising from the assessment by the CAB, is at least 50% lower in comparison with the accredited laboratory; III – when the accredited laboratory or laboratories do not proceed within a maximum of two months to start the analyses or tests required by the Conformity Assessment Requirements – CARs; IV – when the accredited laboratory or laboratories are located far from the applicant, to the extent of creating difficulty in the transport of samples, including breakage or damage to the latter, or jeopardising the deadline for delivery to the laboratory.

c) Where there are no laboratories accredited for the required purpose, the CAB must adopt the following order of priority in selecting a laboratory that is not accredited by Inmetro for the specific purpose:

- third-party laboratory accredited for (an)other testing purpose(s); - first-party laboratory accredited for (an)other testing purpose(s); - non-accredited third-party laboratory; - non-accredited first-party laboratory. d) If a non-accredited laboratory is appointed, it shall have a period of 12 months to obtain accreditation; otherwise, it may not participate further in the conformity assessment programme in question. This deadline may be extended if it is proven that the time between the laboratory’s application for accreditation and the assessment carried out by the Cgcre has been in excess of six months. e) The assessment made by the CAB of the non-accredited laboratory must be carried out by a CAB professional who has a record of training in standard ABNT NBR ISO/IEC 17025:2005. f) If a non-accredited first-party laboratory is contracted, the CAB must monitor the performance of all tests whenever the laboratory performs that service. g) If a non-accredited laboratory or a third-party laboratory accredited for other testing purpose(s) is contracted, the CAB must assess the requirements appearing in Annex A to this document. h) For tests carried out by foreign laboratories, if agreed by the regulator, equivalence in the testing method and sampling methodology established must be observed. Apart from this, such laboratories must be accredited by Inmetro or by an Accreditation Body – AB which is a signatory to the mutual recognition agreement to which Inmetro is also party, i.e.: - InterAmerican Accreditation Cooperation – IAAC; - International Laboratory Accreditation Cooperation – ILAC. 5.2.1.5 Issue of Certificate of Conformity Having met the requirements set out in these GCRs or the CARs specific to the product, the CAB must take a decision on whether or not to issue the Certificate of Conformity. NB 1: The validity of the Certificate of Conformity is defined in the specific CARs. The certificate must contain the following wording in the case of certification according to Models 2, 3, 4, 5, 5*, 6 and 9. ‘The validity of this certificate is subject to maintenance assessments being carried out and any non-conformity being dealt with according to the CAB’s guidelines’. NB 2: The formal instrument – the Certificate of Conformity issued by the CAB – must contain at least:

a) company name and CNPJ (Brazilian register of legal entities) number and fancy name where applicable;

b) full address; c) date of issue and validity of the Certificate of Conformity; d) identification of the models covered by the Certificate of Conformity; e) name, registration number and signature of the CAB; f) identification of the batch, compulsory in the case of batch conformity assessment.

NB 3: Any additional items required for the issue of the Certificate of Conformity must be described in the CARs. 5.2.2 Maintenance Assessment The maintenance assessment must be scheduled by the CAB according to the criteria established in the CARs specific to the object in question, according to the following stages:

5.2.2.1 Planning the Maintenance Assessment The maintenance assessment schedule must provide for all the activities described below, establishing the frequency of the activities and sampling: a) periodic assessments (audits, tests, technical inspections, etc.) to be carried out, indicating their characteristics and respective frequencies; b) periodic tests – sampling and frequency must be indicated in accordance with the CARs, taking into consideration the process control established in manufacturing, tests carried out by the manufacturer, technical standards, etc.; c) acceptance and rejection criteria for analysing the test results; d) conditions (test sample, counter sample, control sample, etc.) for delivery of the assessor’s judgement as to the conformity of the products, processes, services, persons or quality management systems assessed by him. 5.2.2.2 Maintenance Audit Periodic maintenance audits must be scheduled, with the aim of confirming that the producer of the object liable to conformity assessment is still meeting the regulatory requirements. This item must include the following stages as a minimum: a) analysis of the (original) documentation previously sent, particularly as regards its availability, organisation and recovery; b) analysis of records, especially Quality Control results; c) treatment of non-conformity in the maintenance assessment NB: Following the audit or verification of maintenance follow-up and after the maintenance tests, if any non-conformity is found, the assessor and assessed party must discuss the possible lines of action to be adopted to eliminate such non-conformity. 5.2.2.2.1 Maintenance Audit at varying intervals After the Certificate of Conformity has been granted, the CAB must monitor Certification, by scheduling further audits to check whether the technical and organisational conditions that gave rise to the initial granting of the certificate are still being met. The steps for the progressive maintenance audit are as follows: a) The first maintenance audit must take place 6 (six) months after the initial audit. The CAB must assess the manufacturer’s QMS in accordance with Table 2 in subsection 5.2.1.3.1. If, during the maintenance audit, any non-conformity on the part of the certificate holder is found with regard to the QMS, the next maintenance audit will again take place after 6 (six) months, provided that evidence is produced that adequate corrective actions have been adopted in respect of the non-conformity found previously. b) If there is no non-conformity on the part of the certificate holder, the next maintenance audit will take place 12 (twelve) months after the first maintenance audit. c) The interval of 12 (twelve) months is the maximum interval between maintenance audits that may be achieved by the certificate holder. NB: The interval between maintenance audits is 6 (six) months or 12 (twelve) months. The interval will be increased solely where no non-conformity is found during the QMS maintenance audit. In this case, the interval will be increased to the next highest interval. However, if a non-conformity is found during subsequent maintenance audits, the interval will be reduced to 6 (six) months, with a new cycle then beginning. The intervals of 6 (six)

months or 12 (twelve) months respectively represent the minimum and maximum periods allowed between audits. d) If the non-conformity in the QMS has not been resolved within the time-limit, the certification process of the certificate holder will be cancelled. e) A QMS certificate issued by an SCB accredited by a body that is party to the IAF for the purpose of the CARs of the object in question may be accepted provided that it meets the criteria set out in these GCRs. NB: Submission of a manufacturer’s current QMS Certificate, which has been issued by an SCB accredited by Inmetro, according to ISO 9001:2008, where that certificate is valid for the production line of the object in question, may exempt the certificate holder, subject to analysis and under the responsibility of the CAB, from maintenance assessment of the QMS. In this case, the certificate holder must make all the records corresponding to that certification available to the CAB. f) QMS Certificates issued by a foreign SCB must be accompanied by a sworn translation into Portuguese, if the certificate is issued in a language other than English or Spanish. g) During the audit, the CAB must issue a report recording its result, using these GCRs or the CARs specific to the object as the reference. h) The audit report must be signed by the certificate holder and the CAB. A copy must be made available to the manufacturer. i) All the above steps also apply to Environmental Management System – EMS Certification under ISO 14001:2004. 5.2.2.3 Maintenance Testing These tests must prove maintenance of conformity, following the initial assessment, with the requirements appearing in the CARs. These tests must be conducted and recorded according to the following stages: 5.2.2.3.1 Definition of tests to be carried out The tests must comply with the guidelines set out in subsection 5.2.1.4.1 of this document. NB: When prescribed in the CARs, the tests may be divided up and conducted in more than one maintenance assessment so that, at the end of the period of time set in the CARs, the entire standard has been covered. 5.2.2.3.2 Definition of maintenance sampling The guidelines set out in subsection 5.2.1.4.2 of this document must be followed. Table 5 shows the maintenance sampling distribution model.

Table 5: Sample Distribution Model for Maintenance Testing

SAMPLING SIZE OF BATCH

OR ITEMS FROM SAME

FAMILY

TESTS STANDARD ITEM TEST

SAMPLECOUNTER SAMPLE

CONTROL SAMPLE

ACCEPTANCE CRITERIA

(Number of items from the batch

or from the same

family in test

sample)

(Definition of each type of

test)

(Number of standard item)

(Size of test

sample)

(Size of counter sample)

(Size of control sample)

(Criteria for acceptance of

sample)

NB 1: During the phase of collection/purchase of samples for the maintenance tests, it is compulsory for the CAB to collect/purchase these on the market. The samples for each new round of tests must be collected/purchased in different states of the Brazilian federation. If the undertaking can prove, by means of a sales receipt, that the product subject to maintenance [assessment] is sold in only one federal state, collection/purchase of samples shall take place only in that state, but at different points of sale. NB 2: Definition of sample size and frequency of collection/purchase of samples must be described in the CARs. NB 3: Considering the history of non-conformity of the undertaking under assessment, the CAB may decide to carry out a further test. 5.2.2.3.3 Definition of the laboratory The guidelines set out in subsection 5.2.1.4.3 of this document must be followed. 5.2.2.4 Maintenance Confirmation Issue of a statement based on a decision taken after critical analysis by the CAB that fulfilment of the maintenance requirements has been demonstrated. NB 1: If the undertaking presents any non-conformity during the maintenance assessment with regard to the QMS (in the case of Model 5) and/or during the tests, the next maintenance assessment must take place within the period stipulated in the CARs for the object in question. NB 2: If the undertaking presents any non-conformity during the maintenance assessment with regard to the EMS (in the case of Model 9) and/or during the tests, the next maintenance assessment must take place within the period stipulated in the CARs for the object in question. NB 3: Failure in the test for maintenance of Certification shall entail the immediate suspension of the Authorisation to Use the Conformity Identification Seal for the family or batch corresponding to the failure, until the non-conformity has been remedied.

NB 4: Any additional items required for the issue of the Certificate of Conformity must be described in the CARs. 5.2.3 Renewal Assessment The renewal assessment must be scheduled by the CAB in accordance with the criteria set out in section 5.2.1 of this document. 5.2.3.1 [sic] The period of validity for renewal and its stages, indicated in Table 1, must be described in the CARs specific to the object in question. 5.2.3.1 Renewal Confirmation Issue of a statement based on a decision taken after critical analysis by the CAB that fulfilment of the renewal requirements has been demonstrated. NB 1: If the undertaking presents any non-conformity during the renewal assessment with regard to the QMS (in the case of Model 5) and/or during the tests, the next renewal assessment must take place within the period stipulated in the CARs for the object in question. NB 2: If the undertaking presents any non-conformity during the renewal assessment with regard to the EMS (in the case of Model 9) and/or during the tests, the next renewal assessment must take place within the period stipulated in the CARs for the object in question. NB 3: Failure in the test for renewal of Certification shall entail the immediate suspension of the Certificate of Conformity for the family or batch corresponding to the failure, until the non-conformity has been remedied. NB 4: Any additional items required for the issue of the Certificate of Conformity must be described in the CARs. 6 CLAIMS HANDLING The applicant’s analysed claims handling process must include: a) a policy on handling claims, signed by the chief executive, showing that the undertaking:

• values and deals effectively with claims submitted by its customers; • is familiar with and undertakes to fulfil and submit to the penalties provided by law,

specifically Law No 8078/1990; • undertakes critical analysis of the results and adopts the appropriate measures in

accordance with the statistics on claims received; • determines responsibilities with regard to claims handling; • undertakes to respond to any claim forwarded by Inmetro within the established

deadline; b) an information system for handling claims from its customers, which contains a record of each claim, the action taken and current status; c) the formal identification of a person or team that is duly empowered and free to handle claims; d) a telephone number for dealing with claims and a form for recording claims.

6.1 Authorised undertakings must also carry out a six-monthly critical analysis of the statistics on claims received and evidence of implementation of the corresponding corrective actions, as well as opportunities for improvement. 7 REGISTRATION The registration of conformity-assessed products is the responsibility of Inmetro, for which a prerequisite is the Certificate of Conformity issued for the product in question, in compliance with the specific regulations in this regard. Inmetro must arrange publication in the DOU of summary information on the product’s registration. 7.1 Application for Registration The undertaking must formally apply to Inmetro for Registration through the system available on the website: http://www.inmetro.gov.br/qualidade/regobjetos.asp. 7.1.1 The documents for the product Registration application that must be sent to the system are as follows: a) the Certificate of Conformity complying with the provisions set out in these GCRs, demonstrating the conformity of the object; b) the undertaking’s articles of association and suitable document proving that the applicant is legally invested with powers to represent the undertaking; c) conformity assessment agreement signed by the legal representative responsible for marketing the product in that country; d) other documents if relevant, in which case the documents must be specified in the CARs. 7.2 Granting of Registration Authorisation to use the Conformity Identification Seal is given through product Registration by Inmetro, which is a pre-requisite for marketing products (liable to compulsory Certification) in the country, pursuant to the requirements set out in Conmetro Resolution No 05 of 6 May 2008 and complemented by these GCRs and the CARs applicable to the object. 7.2.1 Inmetro must assess the application and, if all the documents are in accordance with the provisions of these GCRs, grant the Registration under a number that will identify the product. This number, together with the Inmetro mark will form the Registration, according to Annex B to this document. 7.2.2 The validity of Registration is linked to the period of validity of the Certificate of Conformity. 7.3 Maintenance of Registration (not applicable to Certification Models 7 and 8) Maintenance of Registration is subject to there being no non-conformity during the Maintenance Assessment as defined in subsection 5.2.2 and Conmetro Resolution No 05 of 6 May 2008. 7.3.1 Applications to maintain Registration must be made to Inmetro by the undertaking, through the website: http://www.inmetro.gov.br/qualidade/regobjetos.asp, at least

20 (twenty) days prior to expiry of the validity of the Registration, according to the procedures established in Conmetro Resolution No 05 of 6 May 2008. 7.3.2 Undertakings holding Registration must forward to Inmetro, together with their applications, a formal document from the CAB declaring that Certification has been maintained. 7.4 Renewal of Registration (not applicable to Certification Models 7 and 8) Renewal of Registration is subject to there being no non-conformity in the procedures established in these GCRs, the CARs and Conmetro Resolution No 05 of 6 May 2008. 7.4.1 Applications to renew authorisation or Registration must be made to Inmetro by the undertaking, through the website: http://www.inmetro.gov.br/qualidade/regobjetos.asp, at least 45 (forty-five) days prior to expiry of their validity, according to the established procedures. 7.5 Alteration of the Scope of Registration (not applicable to Certification Models 7 and 8 and in cases where assessment is made on the basis of the family concept) Undertakings holding Registration that wish to include or exclude models in or from a family that is already registered must formally apply to Inmetro on the website: http://www.inmetro.gov.br/qualidade/regobjetos.asp. 7.5.1 Inclusion of a model in a registered family requires the CAB to assess the compatibility of the new model with the characteristics of the registered family, in accordance with these GCRs and the CARs, and to include the reports on the initial tests required by the object’s CARs. 7.5.2 New Registration with Inmetro in accordance with these GCRs and the CARs is available for models making up a new family that is not yet registered. 7.6 Suspension or Cancellation of Registration Registration must be suspended or cancelled if any of the requirements laid down in these GCRs, the CARs and/or Chapter III of Conmetro Resolution No 05 of 6 May 2008 are not met. 7.6.1 In the event of suspension or cancellation of the Certificate of Conformity due to non-fulfilment of any of the requirements established here and in the CARs, the Registration of the product liable to Certification shall also be suspended or cancelled. In these cases, the undertaking that holds the Registration must cease the use of, and any advertising relating to, certification of its conformity. 7.6.2 While Registration is suspended or cancelled, the manufacture and marketing of the product or products considered as non-conforming must be halted immediately. 7.6.3 The undertaking that holds Registration must also arrange withdrawal of non-conforming products from the market. 7.6.4 Halting the partial or full suspension of Registration is subject to the undertaking that holds Registration providing evidence of correction of the non-conformity that gave rise to the suspension.

7.6.5 An undertaking that holds Registration which has been cancelled may only return to the scheme when a new complete process of conformity assessment has been carried out and a new application for Registration has been submitted to Inmetro. 8 CONFORMITY IDENTIFICATION SEAL The purpose of the Conformity Identification Seal is to prove that the object covered by Certification has undergone the assessment process and met the requirements contained in these GCRs and its respective CARs. 8.1 The model, characteristics, traceability and manner of affixing the Conformity Identification Seal must be determined in the CARs for the object, in compliance with the provisions of Inmetro Act No 179 of 16 June 2009 and the Conformity Identification Seal User Manual. 8.2 The Conformity Identification Seal may be printed on the certificate, marked or affixed on the product and printed or affixed on the packaging. 8.3 When the CARs establish that the Conformity Identification Seal is to be obtained through a graphic designer, the authorised undertaking must adopt the following procedures:

• choose and assess the graphic designer who will produce the Conformity Identification Seal, in terms of fulfilment with the requirements laid down in the CARs;

• obtain approval from Inmetro of the layout of the Conformity Identification Seal to be produced by the graphic designer;

• provide Inmetro, at any time, with samples of the seals produced, for verification that the requirements of the CARs have been fulfilled, with the undertaking assuming the burden of this verification.

9 ACTIVITIES CARRIED OUT BY FOREIGN CABs Conformity assessment activities carried out by a foreign CAB may be accepted provided that all the following conditions are met: a) the Brazilian CAB has an MoU with the foreign CAB; b) the foreign CAB is accredited through the same international rules adopted by Inmetro, for the same or equivalent purpose; c) the activities carried out abroad are equivalent to those regulated by Inmetro; d) the body accredited by Inmetro issues the certificate of conformity with Brazilian regulations and accepts all responsibility for the activities carried out abroad and deriving from such issue, as if it had itself carried out all the activities; e) the CAB is responsible for the assessment and granting of certificates of conformity; f) Inmetro approves the MoU.

10 DEALING WITH THE RESULTS OF MARKET MONITORING 10.1 Penalties Failure to comply with the instructions contained in the Ministerial Acts, this document and the CARs shall result in the penalties involving warnings and suspension and cancellation of Certification being imposed on offenders. In the case of compulsory CAPs, the penalties provided in Law No 9933 of 20 December 1999 shall also apply. 10.2 Verification of Conformity Certified objects are subject to market monitoring by Inmetro through, inter alia, verification of conformity. 10.2.1 Authorised undertakings are responsible for replacing the samples of the certified object withdrawn from the market by Inmetro or its delegated bodies for the purposes of analysing verification of conformity. 10.2.2 An authorised undertaking whose certified object has been verified must undertake to provide Inmetro, on request, with all information on the Certification process. 10.2.3 Any intentional non-conformity identified through verification of conformity may result in the imposition of the penalties provided in Chapter 10 of these GCRs. 11 RESPONSIBILITIES AND OBLIGATIONS 11.1 Obligations of the Authorised Undertaking 11.1.1 Fulfil all the conditions laid down in this document, the CARs, legal provisions and contractual provisions referring to authorisation, whether or not written down. 11.1.2 Apply the Conformity Identification Seal to all certified products, in accordance with the criteria laid down in this document and the CARs. 11.1.3 In the case of Certification of services, systems or professionals, use of the Conformity Identification Seal is confined to the certificate. 11.1.4 Comply with decisions on Certification taken by the CAB, appealing to Inmetro as a last resort in cases of claims and appeals. 11.1.5 Facilitate the audit and monitoring work of the CAB or its contractor, subject to proof of this status, as well as the carrying out of tests and other Certification activities provided in this document and the CARs. 11.1.6 Maintain the technical and organisational conditions that served as a basis for obtaining authorisation to use the Conformity Identification Seal, informing the CAB in advance of any amendment it is planning to make to the product for which authorisation was granted. 11.1.7 Notify the CAB immediately in the event of permanent cessation of the manufacture or import of the certified object.

11.1.8 Not use the same coding for a certified product and a non-certified product (code and model). Furthermore, products can only be identified with one of the standards laying down the technical requirements against which they were certified. 11.1.9 Submit all the publication material on which the Conformity Identification Seal appears to Inmetro for authorisation. 11.1.10 Authorised undertakings are technically, civilly and criminally liable for the certified objects, as well as all the documents referring to the Certification. There is no possibility of transferring this liability. 11.2 Obligations of the CAB 11.2.1 Implement the CAP in accordance with the requirements laid down in this document and the CARs, being obliged to resolve any doubts with Inmetro. 11.2.2 Use the database system provided by Inmetro to keep the information about certified products up to date within 72 hours from the issue of the Certificate of Conformity or alteration of its status. 11.2.3 Notify the Inmetro Quality Directorate within 24 hours in the event of suspension, extension, reduction or cancellation of Certification, in hard copy, as well as entering the information within the same period in the database system provided by Inmetro. 11.2.4 Submit Memoranda of Understanding established with other Certification bodies pursuant to this document and the CARs to Inmetro for analysis and approval. 11.2.5 Choose, by mutual agreement with the applicant, the laboratory to be used in the Certification process. 11.2.6 Possess a Claims Handling System according to the model provided in Chapter 6 of these GCRs. 12 TERMINATION OF CERTIFICATION Authorised undertakings must apply to terminate Certification and the CAB must ensure that objects certified prior to that decision are in conformity with the CARs. 12.1 The CAB must schedule an extraordinary audit to verify and record the following details:

a) when the last batches of the certified object were manufactured and their sizes; b) material available in stock for new productions; c) quantity of finished products in stock and the authorised undertaking’s forecast of

when that batch will be consumed; d) whether the requirements laid down in the CARs have been fulfilled since the last

monitoring audit; and e) routine tests conducted on the last batches produced.

12.2 When deemed necessary, the CAB must also schedule the collection of samples and the carrying out of tests to assess the conformity of products in stock at the factory and/or on the market. 12.3 If the result of these tests reveals any non-conformity, the CAB must, prior to considering the process terminated, request the undertaking to adopt the relevant measures, laying down the conditions and time-limits for implementation. 12.4 Once the above stages have been concluded, the CAB must notify Inmetro of the termination.

ANNEX A – REQUIREMENTS FOR THE ASSESSMENT OF NON-ACCREDITED LABORATORIES OR THIRD-PARTY LABORATORIES ACCREDITED FOR (AN)OTHER TESTING PURPOSE(S) BY PRODUCT CERTIFICATION BODIES A.1 CONFIDENTIALITY The laboratory must have documented procedures that are implemented to ensure protection of the confidentiality and integrity of information, taking account as a minimum of: a) access to archives, including computerised archives; b) restricted access to the laboratory; c) awareness among the laboratory staff of the need to ensure confidentiality of information. A.2 ORGANISATION A.2.1 The laboratory must name the signatories who will sign the test reports and take full technical responsibility for their content. A.2.2 The laboratory must have a technical manager and a replacement (whatever his title) with overall responsibility for its technical operations. A.2.3 In the case of a first-party laboratory, the responsibilities of the organisation’s key staff who have involvement in or influence on laboratory tests must be determined, so as to identify any potential conflicts of interest. A.2.3.1 It is also important that organisational arrangements should be such that any departments which have potential conflicts of interest, such as production, marketing or finance, do not have a negative influence on the laboratory’s compliance with the requirements of this Annex. A.3 MANAGEMENT SYSTEM A.3.1 All the documents needed for the proper performance of the laboratory’s activities must be unambiguously identified and include their date of issue, revision number and authorisation for their issue. A.3.2 All the documents needed for the proper performance of the laboratory’s activities must be up-to-date and available to its staff. A.3.3 The laboratory must document the duties and responsibilities of the technical manager and technical staff involved in the tests, taking account as a minimum of responsibilities for: a) conducting the tests; b) scheduling the tests, assessing the results and issuing the test reports; c) modification, development, characterisation and validation of new testing methods; d) managerial activities. A.3.4 The laboratory must have the identification details of the authorised signatories (where this concept is appropriate). A.3.5 The laboratory must have documented procedures that are implemented to ensure traceability of measurements. A.3.6 The laboratory must have formal records of the scope of its services and provisions to ensure that it possesses appropriate installations and resources. A.3.7 The laboratory must have documented procedures that are implemented in terms of handling the test items. A.3.8 The laboratory must have a list of the reference equipment and standards used, including the respective identification details. A.3.9 The laboratory must have documented procedures that are implemented for feedback and corrective action, whenever non-conformity is detected in the tests.

A.4 STAFF A.4.1 The laboratory must have sufficient staff, with the necessary education, training, technical skills and experience for the designated functions. A.4.2 The laboratory must have procedures for the use of technicians undergoing training, establishing records of their supervision in this regard and creating mechanisms to ensure that their use does not prejudice the results of the tests. A.4.3 The laboratory must have and maintain up-to-date records of all its technical staff involved in the tests. These records must include the authorisation date for, as a minimum: a) carrying out the different types of sampling, where applicable; b) carrying out the different types of tests; c) signing the test reports; and d) operating the different types of equipment. A.5 FACILITIES AND ENVIRONMENTAL CONDITIONS A.5.1 The laboratory facilities, test areas, energy sources, lighting and ventilation must enable appropriate performance of the tests. A.5.2 The laboratory must have installations ensuring effective monitoring, control and recording of environmental conditions, whenever necessary. A.5.3 The laboratory must maintain effective separation between neighbouring areas, where there are incompatible activities. A.6 EQUIPMENT AND REFERENCE MATERIALS A.6.1 The laboratory must have all the equipment, including reference materials, needed to conduct the tests correctly. A.6.2 Before conducting the test, the laboratory must check whether any item of equipment is giving suspect results. When this happens, the equipment must be taken out of service, identified as being out of service, repaired and shown through calibration, checking or testing to have resumed satisfactory operation before being brought back into use. A.6.3 Each item of equipment must be labelled, marked or identified to indicate its calibration status. This calibration status must visually indicate the last and next calibrations. A.6.4 Each item of equipment must have a record that indicates, as a minimum: a) name of the equipment; b) name of the manufacturer, type identification, serial number or other specific identification; c) acceptance status, where appropriate; d) copy of the manufacturer’s instructions, where appropriate; e) dates and results of the calibrations and/or checks and date of the next calibration and/or check; f) details of maintenance operations carried out and planned for the future; g) details of each instance of damage, modification or repair. A.6.5 Each item of reference material must be labelled or identified to indicate certification or standardisation. The label must contain, as a minimum: a) name of the reference material; b) party responsible for certification or standardisation (company or person); c) composition, where appropriate; d) validity date. A.6.5.1 For long-lasting reference materials, the laboratory must have a record containing the information indicated in item A.4.

A.7 TRACEABILITY OF MEASUREMENTS AND CALIBRATIONS A.7.1 The laboratory must have an established programme for calibrating and checking its equipment, in order to ensure the use of calibrated and/or checked equipment on the date of conducting the tests. A.7.2 The calibration certificates of the reference standards must be issued by: a) national metrology laboratories listed in C.7.2; b) calibration laboratories accredited by Cgcre/Inmetro; c) laboratories belonging to the National Metrology Institutes of other countries, in the following cases:

- when traceability has been obtained directly from an institution that holds the primary measurement standard; - when the institution takes part in inter-laboratory comparison programmes together with Cgcre/Inmetro, obtaining compatible results; - laboratories accredited by other countries’ Accreditation Bodies, when there is a mutual recognition or cooperation agreement between Cgcre/Inmetro and those bodies.

A.7.3 The certificates for the measuring and testing equipment of a test laboratory must comply with the requirements of the previous section. A.7.4 The reference standards maintained by the laboratory must be used only for calibrations, unless it can be demonstrated that their performance as reference standards is not invalidated. A.8 CALIBRATION AND TESTING METHOD A.8.1 All instructions, standards and reference data relevant to the laboratory work must be documented and kept up to date and readily available to the laboratory staff. A.8.2 The laboratory must use documented procedures and appropriate statistical techniques for sample selection when sampling is carried out as part of the test. A.8.3 The laboratory must submit calculations and data transfers to appropriate checks. A.8.4 The laboratory must have procedures to protect the security of data in computerised records. A.9 HANDLING OF ITEMS A.9.1 The laboratory must unambiguously identify the items to be tested, so that there is no mistake at any time regarding their identification. A.9.2 The laboratory must have documented procedures and adequate facilities to avoid deterioration of or damage to the test item during storage, handling and preparation of the test item. A.10 RECORDS A.10.1 The laboratory must maintain a record-keeping system adequate for its particular circumstances and must comply with applicable regulations, as well as keeping all original observations, calculations and respective data, records and a copy of the test reports for a period of at least four years. A.10.2 Alterations to and/or errors in records must be struck out without removing the previous wording or annotation or making it illegible, and the new annotation must be recorded alongside the earlier struck-out annotation, in a legible manner that does not permit any doubts in interpretation and that bears the signature or initials of the person responsible. A.10.3 Records of test data must contain, as a minimum: a) identification of the laboratory; b) identification of the sample;

c) identification of the equipment used; d) relevant environmental conditions; e) results of the measurement and its uncertainties, where appropriate; f) date and signature of the staff who carried out the work. A.10.4 All records printed by computer or calculator, graphics and other records must be dated, initialled and attached to the measurement records. A.10.5 All (technical and quality) records must be kept by the laboratory ensuring security and confidentiality. A.11 TEST CERTIFICATES AND REPORTS A.11.1 The results of each test or series of tests conducted by the laboratory must be recorded in a precise, clear and objective manner, without ambiguity, in a test report and must include all the information needed to interpret the test results, as required by the method used. A.11.2 The laboratory must record all the information needed to repeat the test and these records must be available to the customer. A.11.3 Every test report must include at least the following information: a) title; b) name and address of the laboratory; c) unique identification of the report; d) name and address of the customer; e) description and unambiguous identification of the tested item; f) characterisation and condition of the tested item; g) date of receipt of the item and date of conducting the test; h) reference to the sampling procedures where relevant; i) any deviations from, additions to or exclusions from the test method and any other information relevant to a specific test, such as environmental conditions; j) measurements, verifications and respective results, supported by tables, graphics, diagrams and photographs; k) a statement of the estimated uncertainty of the test result (where relevant); l) signature, title or equivalent identification of the staff responsible for the content of the report and date of issue; m) where relevant, statement that the results refer only to the tested items; n) statement that the report may only be reproduced in full and with the customer’s approval; o) identification of the item; p) reference to the standard specification used. A.12 EXTERNAL SUPPORT SERVICES AND SUPPLIES A.12.1 The laboratory must keep records referring to the purchase of equipment, materials and services, including: a) purchasing specification; b) acceptance inspection; c) calibration or verification.

ANNEX B – CONFORMITY IDENTIFICATION SEAL AND PRODUCT TRACEABILITY The identification of the Conformity Identification Seal illustrated below must be embossed in high or low relief on the [product to be certified]. Typical Layout Scheme: Certification Objective of CA: Security Field: Compulsory Minimum size of the Inmetro logo: 5 mm NB: (if space allows)

[Graphic]

Non-interference area

[Inmetro logo]

5 mm [[logo] OCP 00 REG 0000] 4 mm

Minimum size

Important: any alterations must be in proportion

Real size

5 mm [[logo] OCP 00 REG 0000] 4 mm

FIGURE A

[logo]

OCP 00 REG 0000