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 INDU STRIAL QUALITY - INMETRO, in the exercise of his powers 
granted by Article 4 (§3) of Law No 5966 of 11 Decem ber 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 Minister ial 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 publi cation 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, Standard isation 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 disc ussions aimed at conso lidating the final text. 
 
Article 5 Publish this Public Consultation Act in the Br azilian Official Journa l, 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 INST ITUTE OF METROLOGY, STANDARDISATION 
AND INDUSTRIAL QUALITY - INMETRO, in the exerci se of his powers grante d by Article 4 (§3) of 
Law No 5966 of 11 December 1973, Article 3 (i ndent I) of Law No 9933 of 20 December 1999 and 
Article 18 (indent V) of the Regulatory Framewor k 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 Br azilian 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 a nd there is a need to review a nd 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 standa rdisation, conciseness and streamlining in setting up 
Conformity Assessment Programmes – CAPs; 
 
Whereas the General Certification Requirements – GCRs are designed to es tablish 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, Standardis ation 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 Journa l 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 Requi rements – GCRs now approved. 
 
Article 4  Make known that the Conf ormity Assessment Requirements – CARs must include 
specific information complementary to the Genera l 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 th e 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 cer tification model used; 
VI – Specific stages in the certification proce ss (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, sa mpling 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 test s, sampling and acceptance and rejection 
criteria); 
• Renewal Assessment; 
• Renewal Audit (where applicable); 
• Renewal Testing Schedule (types of test s, sampling and acceptance and rejection 
criteria); 
VII – Conformity Identification Seal. 
 
§2 Exceptionally, the Conformity Assessment Re quirements – CARs may not, depending on the 
specific features of the object to be assessed, adopt all the provisi ons 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 th e terms of the precedi ng paragraph, it is 
necessary to make changes, ad justments or additions to th e 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 Asse ssment Requirements – CARs approved 
prior to the entry into force of this Minister ial Act shall be adjust ed 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 Certif ication Requirements – GCRs common to all 
Conformity Assessment Programmes – CAPs wh ich use the Product Certification scheme.  
The specific features of each CAP must be se t out in Conformity Assessment Requirements – 
CARs, which must give details of the subject ma tter, having regard to th e 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 Organi zation 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 Providi ng for consumer protection and other 
measures 
Law No 9933 of 20 December 1999 Provi ding 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 Envi ronmental 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 adapta tions 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 attestat ion concerning a conformity assessment body, 
confirming that its competence to carry out sp ecific conformity assessment tasks has been 
formally demonstrated. 
 
4.2 Sample 
Consists of one or more product units taken at random from and re presentative of the 
universe to be inspected.  
4.3 Audit 
A systematic, independent and documented proce ss for obtaining records, statements of fact 
or other relevant information and assessing them in an objectiv e manner to determine to what 
extent the specific requirements have been met.  
4.4 Authorisation to use the Conf ormity 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 ri ght to use the Conformity Id entification Seal on products, 
processes, services and systems regulated by Inmetro.  Pursuant to Act No 179/2009, use of 
the seal is restricted to ob jects that have been assessed on the basis of Conformity 
Assessment Programmes set up by Inmetro.  
4.5 Authorisation to use the Conformity Iden tification Seal on advertising material 
A document issued by Dqual that gives authoris ation to use the Conf ormity Identification 
Seal on advertising material re ferring 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 serv ice, 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 co ncerning the conformity of an object. 
 
4.8 Conformity Certificate 
Issue of a statement based on a decision taken afte r critical analysis of whether fulfilment of 
the specified requirements has been demonstrated.  
4.9 Consumer 
Consumer means any individual or legal entity th at 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 en tity, legally establishe d in the country, which 
carries out product manufacture, creation, construction, processing, import, export, 
distribution or mark eting 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 gr anting 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 characte ristics in common: dimensions, mass, raw 
material, configuration, use, etc.  
4.15 Control 
Activity involving administrative policing pow ers, which has the purpose of checking that 
regulated objects and objects subj ect to compulsory conformity  assessment available on the 
national market comply with the requirements  established in laws, resolutions, technical 
regulations and conformity as sessment regulations, making th em liable to the penalties 
provided in Article 8 of Law No 9933/99. 
 
4.16 Inmetro Statutory Instruction – ISI 
Document defining the technical requirements th at the product, process, service, person or 
Quality Management System must meet in voluntary assessments. The requirements are 
established by means of Ministerial Act a nd 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 prin ciples and policies a dopted 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 succinct ly 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, producti on process, dimensions and other regulatory 
requirements.  
4.21 Certification Model 
The model adopted in consideration of the na ture of the product, production process, raw 
material characteristics, economic aspects and level of confiden ce required (source: 
Conformity Assessment – 5th edition,  2007, with the excep tion 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 follow ed 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 conf ormity.  It includes tests on samples taken from the market. 
 
4.21.3 Certification Model 3 – Type test with fu rther action to test  samples taken from 
the factory  
This is a model based on type testing, but co mbined with further acti on to check whether the 
production continues to be in conf ormity.  It includes tests on samples taken from the factory.  
This model provides for permanent supervisi on of the manufacture r’s production and may 
trigger corrective actions wh en non-conformity is shown. 
 
4.21.4 Certification Model 4 – Type test follow ed 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 test ed, this model can combine the advantages 
of Models 2 and 3, although it is more costly.  4.21.5 Certification Model 5 – Type test, assess ment and approval of the manufacturer’s 
Quality Management System, monitoring by me ans 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 re spect of the Quality Management System for 
his production, followed by regular monitoring by means of audits of factory qua lity control 
and verification tests on samples taken from the market and factory.  Th is model is the most 
commonly used in the BCAS and provides a fu ll 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 Ma intenance 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 th e ability of an industry to ma nufacture a product conforming to 
a given specification is assessed.  This model is  not adequate for Produc t Certification, as it 
does not assess the conformity of the end product  but rather the abilit y of the undertaking to 
produce a particular product in conform ity 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 assessm ent 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 test ed 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, asse ssment 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 aud its, of the factory’s environmental control 
and verification tests on samples taken from th e market and factory.  This model must be 
applied whenever there is environmental legisla tion applicable to the product to be certified 
and/or whenever it is deemed necessary to  ensure environmenta l control due to the 
significance of the impact on the environment cau sed by the process.  This model increases 
the environmental security of the conform ity assessment process.  The frequency of 
maintenance audits may be altered in accordance with the results of the previous audit and 
progressive audit cycle cr iteria 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 th e national territory of objec ts liable to compulsory 
conformity assessment, generally associat ed with their peak consumption period. 
 
4.24 Accreditation Body 
Body authorised to perfor m accreditation activities. 
 
4.25 Conformity Assessment Body – CAB 
Body that provides conformity assessment services. 
 
4.26 Product Certification Body – PCB  
Body that conducts the Certificat ion procedure and awards the Ce rtificate 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 na tional, regional and international standards. 
 
4.28 Delegated Body 
National, federal, state or muni cipal public institution, which be longs 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 c onformity 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 re gulatory basis (Technical Sta ndard or Technical Quality 
Requirements – TQRs) and the document now a pproved, General Certification Requirements 
– GCRs, for both compulsory and voluntary assessments.  
4.30 Object Registration  
Act whereby Inmetro, in compulsory assessmen ts and in the form and cases provided in 
Conmetro Resolution No 05/2008, authorises use of the Conformity Id entification Seal and 
marketing of the object, subjec t 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 obj ect, in accordance with the requirements laid 
down in the Technical Standard or Technica l 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, C onformity 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 st andard 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 undert akings, Conformity Asse ssment Bodies – CABs 
and other relevant parties.  
4.33 General Certificatio n Requirements – GCRs  
Document defining the general requirements applicable to all C onformity 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, capab le of taking technical resp onsibility 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 Identific ation 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 veri fy 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 Ce rtification 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 Chap ter 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 Comm encement 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 c onformity assessment process ar e 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 s ubject 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 qu estion, indicating its technical 
description; b) option in respect of the Cer tification Model, as mentioned in the CARs for the object in 
question; c) in the case of imported obj ects to be certified on the basi s 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 applic ation process as desc ribed in the CARs.  
5.2.1.1.1 The application must abide by the provisi ons 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 request ed in the CARs, the description and 
identification of the batch subj ect 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 releva nce 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 En vironmental 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 b een 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 fact ory, 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 refe rence for the QMS and EMS respectively. 
 5.2.1.3.1 The QMS for the production process of th e object must be assessed by the CAB on 
the basis of the scope of the Certification Pr ocess and in accordance with the requirements of 
standard ABNT NBR ISO 9001:2008, as defined below: 
 
Table 2: Items to be checked accordi ng 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 standar d, this must be mentioned in the CARs. 
 5.2.1.3.2 The EMS for the production process of th e object must be assessed by the CAB on 
the basis of the scope of the Certification Pr ocess and in accordance with the requirements of 
standard ABNT NBR ISO 14001:2004, as defined below: 
 
Table 3: Items to be checked accordi ng 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 ac tion and preventive action 4.5.3 
 
NB: If the EMS is based on another standar d, this must be mentioned in the CARs. 
 5.2.1.3.3 Submission of a manufacturer’s current QM S 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 resp ectively, 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 thes e GCRs during initial audit.  In this case, the applicant 
undertaking must make all the r ecords corresponding to  that certification available to the 
CAB.  The CAB must analyse th e relevant documentation to en sure that the requirements 
described in Table 2 in subsection 5.2.1.3.1 have b een met in respect of the QMS and that the 
requirements described in Table 3 in subsect ion 5.2.1.3.2 have been met in respect of the 
EMS.  NB: If non-conforming items are identified dur ing initial audit, th e CAB must ask the 
manufacturer to implement the necessary ac tions to remedy the non-conformity, with a 
deadline being set for this purpose. The need fo r a further audit to verify implementation of 
the actions taken to remedy th e identified non-c onformity 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 repor t recording its result,  using the object’s 
CARs as the reference.  5.2.1.3.6 The audit report must be signed by the manuf acturer 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 objec t covered by the conformity assessment meets the 
regulatory requirements, with the PCB taki ng responsibility for pr eparing the Testing 
Schedule.  These tests must be carried out a nd 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 co llecting samples of the object covered by the 
application for Certification.  The sampli ng schedule, sampling acceptance criteria and 
exceptional cases are detailed in the CARs fo r 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 Inme tro for the purpose of th e tests specified in 
the CARs.  The CAB must record, on the basi s 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 a nd subject to assessment and approval by the 
CAB, a laboratory that is not accredited for th e 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 labor atory 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 labor atories 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 laborat ories 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 th e deadline for delivery to the laboratory. 
c) Where there are no laborator ies 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 tes ting purpose(s); 
 - first-party laboratory accredited  for (an)other testing purpose(s); 
 - non-accredited thir d-party laboratory; 
 - non-accredited firs t-party laboratory. 
d) If a non-accredited la boratory is appointed, it shall have a period of 12 months to obtain 
accreditation; otherwise, it may not particip ate further in the conformity assessment 
programme in question.  This deadline may be ex tended if it is proven that the time between 
the laboratory’s application for accreditation a nd 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 mu st be carried out by 
a CAB professional who has a record of training in st andard 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 th e laboratory performs that service. 
g) If a non-accredited laboratory or a third- party laboratory accred ited for other testing 
purpose(s) is contracted, the CA B must assess the requirements a ppearing in Annex A to this 
document. h) For tests carried out by foreign laboratories , if agreed by the regulat or, equivalence in the 
testing method and sampling methodology establis hed must be observed.  Apart from this, 
such laboratories must be accred ited by Inmetro or by an Accred itation Body – AB which is a 
signatory to the mutual recognition agreemen t to which Inmetro is also party, i.e.: 
 - InterAmerican Accredit ation Cooperation – IAAC; 
 - International Laboratory A ccreditation Cooperation – ILAC. 
 
5.2.1.5 Issue of Certificate of Conformity 
Having met the requirements set out in these G CRs 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 Conf ormity is defined in the specific CARs. The 
certificate must contain the following wordi ng in the case of certi fication according to 
Models 2, 3, 4, 5, 5*, 6 and 9.  ‘The validity of  this certificate is s ubject to maintenance 
assessments being carried out and any non-conf ormity being dealt wi th according to the 
CAB’s guidelines’.  NB 2: The formal instrument – the Certific ate 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 covere d by the Certificat e of Conformity; 
e) name, registration number and signature of the CAB; 
f) identification of the batch, compulsory in the case of batch conf ormity assessment. 
 NB 3: Any additional items required for the issu e of the Certificate of Conformity must be 
described in the CARs.  
5.2.2 Maintenance Assessment 
The maintenance assessment must be sche duled by the CAB according to the criteria 
established in the CARs specifi c to the object in question, acco rding to the following stages:  
5.2.2.1 Planning the Maintenance Assessment 
The maintenance assessment schedule must provi de for all the activities described below, 
establishing the frequency of the activities and sampling: 
a) periodic assessments (audits, te sts, 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 pr ocess control established in ma nufacturing, tests carried out 
by the manufacturer, tec hnical standards, etc.; 
c) acceptance and rejection criteria  for analysing the test results; 
d) conditions (test sample, counter sample, cont rol sample, etc.) for de livery of the assessor’s 
judgement as to the conformity of the produc ts, 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 pr eviously sent, particul arly 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 veri fication of maintenance follow- up and after the maintenance 
tests, if any non-conformity is found, the a ssessor 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 ch eck whether the technical and organisational conditions that 
gave rise to the initial granting of the certi ficate 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 accord ance with Table 2 in subsection 5.2.1.3.1.  If, 
during the maintenance audit, any non-conform ity on the part of the certificate holder is 
found with regard to the QMS, the next mainte nance audit will again ta ke place after 6 (six) 
months, provided that evidence is produced th at 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 th e 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 in creased solely where no non-conf ormity is found during the QMS 
maintenance audit.  In this case, the interval wi ll be increased to the next highest interval.  
However, if a non-conformity is found during su bsequent 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 certif icate 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 questi on 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 responsibil ity of the CAB, from maintena nce assessment of the QMS.  
In this case, the certificat e holder must make all the records corresponding to that 
certification available to the CAB.  f) QMS Certificates issued by a foreign S CB 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 re sult, using these GCRs or the 
CARs specific to the object as the reference.  h) The audit report must be signed by the cer tificate holder and the CAB.  A copy must be 
made available to the manufacturer.  i) All the above steps also apply to Environm ental Management System – EMS Certification 
under ISO 14001:2004.  
5.2.2.3 Maintenance Testing 
These tests must prove maintenance of conformi ty, following the initial assessment, with the 
requirements appearing in the CARs.  These test s 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 e nd of the period of tim e set in the CARs, the 
entire standard has been covered.  
5.2.2.3.2 Definition of maintenance sampling 
The guidelines set out in subs ection 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 th ese on the market. The samples for each new 
round of tests must be collected/purchased in di fferent states of the Br azilian federation.  If 
the undertaking can prove, by means of a sa les receipt, that th e product subject to 
maintenance [assessment] is sold in only one federal state, collecti on/purchase of samples 
shall take place only in that state,  but at different points of sale. 
 NB 2: Definition of sample si ze and frequency of collection/pu rchase of samples must be 
described in the CARs.  NB 3: Considering the history of non-confor mity 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 take n after critical analysis by the CAB that 
fulfilment of the maintenance requirements has been demonstrated. 
 
NB 1: If the undertaking presents any non-c onformity 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-c onformity 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 Conf ormity 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 issu e 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 specifi c to the object in question. 
 
5.2.3.1 Renewal Confirmation 
Issue of a statement based on a decision take n after critical analysis by the CAB that 
fulfilment of the renewal requirements has been demonstrated.  NB 1: If the undertaking presents any non-c onformity 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-c onformity 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 Cer tification 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 issu e 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 ch ief executive, showing that the undertaking: 
• values and deals effectively with claims submitted by its customers; 
• is familiar with and undertakes to fulfil a nd 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 statisti cs on claims received; 
• determines responsibilities with regard to claims handling; 
• undertakes to respond to any claim forwar ded by Inmetro within the established 
deadline; 
b) an information system for handling claims fr om its customers, which contains a record of 
each claim, the action taken and current status; 
c) the formal identification of a person or t eam that is duly empowered and free to handle 
claims; d) a telephone number for dealing with cl aims and a form for recording claims. 
 6.1 Authorised undertakings must also carry ou t 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 pr oduct in question, in compliance 
with the specific regulations in this regar d. 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 In metro 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 applic ation that must be sent to the system 
are as follows: a) the Certificate of Confor mity complying with the provi sions 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 th e undertaking; 
c) conformity assessment agreement signed by the legal representa tive 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 th e Conformity Identification Seal is given through product Registration 
by Inmetro, which is a pre-requisite for ma rketing products (liable to compulsory 
Certification) in the country, pursuant to th e requirements set out in  Conmetro Resolution 
No 05 of 6 May 2008 and complemented by thes e GCRs and the CARs applicable to the 
object.  7.2.1 Inmetro must assess the application and, if a ll the documents are in accordance with the 
provisions of these GCRs, grant the Regist ration under a number th at will identify the 
product. This number, together with the Inme tro 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 applic able to Certification Models 7 and 8) 
Maintenance of Registration is subject to  there being no non-conformity during the 
Maintenance Assessment as defined in subs ection 5.2.2 and Conmetro Resolution No 05 of 
6 May 2008.  
7.3.1 Applications to maintain Registration mu st 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 e xpiry of the validity  of the Registration, according to the 
procedures established in Conmet ro Resolution No 05 of 6 May 2008. 
 
7.3.2 Undertakings holding Registration must fo rward to Inmetro, together with their 
applications, a formal document from the CA B declaring that Certification has been 
maintained.  
7.4 Renewal of Registration (not applicab le to Certification Models 7 and 8) 
Renewal of Registration is subject to ther e 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 Re gistration must be made to Inmetro by the 
undertaking, thr ough the website: http://www.inmetro.gov.br/qualidade/regobjetos.asp
, at 
least 45 (forty-five) days prio r to expiry of their validity, according to the established 
procedures.  
7.5 Alteration of the Scope of Registration (n ot applicable to Certification Models 7 and 
8 and in cases where assessment is made on the basis of the family concept) 
Undertakings holding Registration th at wish to include or exclude models in or from a family 
that is already registered must form ally apply to Inmetro on the website: 
http://www.inmetro.gov.br/ qualidade/regobjetos.asp
. 
 7.5.1 Inclusion of a model in a regi stered family requires the CAB to assess the compatibility 
of the new model with the characteristics of th e registered family, in accordance with these 
GCRs and the CARs, and to include the report s 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 fa mily that is not yet registered. 
 
7.6 Suspension or Cancella tion 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 Conm etro 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 establishe d here and in the CARs, the Registration of 
the product liable to Certificati on shall also be suspended or ca ncelled.  In these cases, the 
undertaking that holds the Registration must ceas e the use of, and any a dvertising relating to, 
certification of its conformity.  7.6.2 While Registration is suspended or cance lled, the manufacture and marketing of the 
product or products considered as non-c onforming 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 Regi stration 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 Regi stration which has been cancelled may only return to the 
scheme when a new complete process of conf ormity 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 Se al is to prove that the object covered by 
Certification has undergone the assessment pr ocess 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 th e 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 cer tificate, marked or affixed 
on the product and printed or affixed on the packaging.  8.3 When the CARs establish that the Conform ity Identification Seal is to be obtained 
through a graphic designer, the authorised undert aking must adopt the following procedures: 
• choose and assess the graphic design er who will produce the Conformity 
Identification Seal, in terms of fulfilmen t 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 sa me 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 ce rtificate of conformity with Brazilian 
regulations and accepts all res ponsibility for the activities carried out abroad and deriving 
from such issue, as if it had its elf 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 contai ned in the Ministerial Acts, this document and 
the CARs shall result in the penalties invol ving 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 monito ring by Inmetro through, in ter 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 w hose certified object has been verified must undertake to 
provide Inmetro, on request, with all in formation on the Certification process. 
 10.2.3 Any intentional non-conformi ty identified through verifi cation 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 referri ng to authorisation, whet her 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, syst ems or professionals, use of the Conformity 
Identification Seal is conf ined to the certificate. 
 11.1.4 Comply with decisions on Cer tification 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 th e CAB or its contractor, subject to proof 
of this status, as well as the car rying out of tests and other Cer tification 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 ma ke 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 pr oduct and a non-certif ied product (code and 
model). Furthermore, products can only be iden tified with one of th e standards laying down 
the technical requirements agai nst which they were certified. 
 11.1.9 Submit all the publication material on whic h the Conformity Identification Seal 
appears to Inmetro for authorisation.  11.1.10 Authorised undertakings are technically, civi lly and criminally liable for the certified 
objects, as well as all the documen ts referring to the Certifica tion. 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 Inmetr o to keep the information about certified 
products up to date within 72 hours from the i ssue of the Certificate of Conformity or 
alteration of its status.  11.2.3 Notify the Inmetro Quality Directorate wi thin 24 hours in the event of suspension, 
extension, reduction or cancellati on of Certification, in hard c opy, as well as entering the 
information within the same period in the database system provided by Inmetro. 
 11.2.4 Submit Memoranda of Understanding estab lished 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 appli cant, 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 terminat e Certification and the CAB must ensure that 
objects certified prior to that decision are in c onformity with the CARs. 
 12.1 The CAB must schedule an extraordinary a udit to verify and record the following 
details: 
a) when the last batches of the certified obj ect were manufactured and their sizes; 
b) material available in stock for new productions; 
c) quantity of finished products in stock a nd the authorised under taking’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 a ny 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 conclude d, the CAB must no tify Inmetro of the 
termination.  ANNEX A – REQUIREMENTS FOR THE ASSESSMENT OF NON-
ACCREDITED LABORATORIES OR THIRD-PARTY LABORATORIES 
ACCREDITED FOR (AN)OTHER TESTI NG 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 in formation, 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 n eed to ensure confiden tiality 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 ma nager and a replacement (whatever his title) 
with overall responsib ility for its tech nical operations. 
A.2.3 In the case of a first-part y laboratory, the responsibilities of the organisation’s key staff 
who have involvement in or influence on labor atory tests must be determined, so as to 
identify any potential conflicts of interest. A.2.3.1 It is also important th at organisational arrangement s should be such that any 
departments which have potential  conflicts of interest, such  as production, marketing or 
finance, do not have a negative influen ce 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 la boratory’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 la boratory’s activities 
must be up-to-date and av ailable to its staff. 
A.3.3 The laboratory must document the duties an d responsibilities of the technical manager 
and technical staff involved in the tests, taki ng account as a minimum of responsibilities for: 
a) conducting the tests; b) scheduling the tests, assessing the results and i ssuing the test reports; 
c) modification, development, characterisat ion and validation of new testing methods; 
d) managerial activities. A.3.4 The laboratory must have the identification details of the authoris ed signatories (where 
this concept is appropriate). A.3.5 The laboratory must have documented pro cedures 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 appropria te installations and resources. 
A.3.7 The laboratory must have documented pro cedures that are implemented in terms of 
handling the test items. A.3.8 The laboratory must have a list of th e reference equipment and standards used, 
including the respective identification details. A.3.9 The laboratory must have documented pro cedures that are implemented for feedback 
and corrective action, whenever non-confor mity is detected in the tests. 
 A.4 STAFF 
A.4.1 The laboratory must have sufficient sta ff, with the necessary education, training, 
technical skills and experien ce for the designated functions. 
A.4.2 The laboratory must have procedures fo r the use of technici ans 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 incl ude the authorisation date for, as a minimum: 
a) carrying out the different types of sampling, where applicable; b) carrying out the diffe rent 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, en ergy sources, lighting a nd ventilation must 
enable appropriate performance of the tests. A.5.2 The laboratory must have installations  ensuring effective m onitoring, control and 
recording of environmental c onditions, whenever necessary. 
A.5.3 The laboratory must maintain effectiv e 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, th e equipment must be taken out of service, 
identified as being out of service, repaired  and shown through calibra tion, checking or testing 
to have resumed satisfactory operation before being brought back into use. 
A.6.3 Each item of equipment must be labe lled, marked or identif ied 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 iden tification, 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 calib rations and/or checks and date of the next calibration and/or 
check; f) details of maintenance operations ca rried 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 MEAS UREMENTS AND CALIBRATIONS 
A.7.1 The laboratory must have an establishe d programme for calibra ting and checking its 
equipment, in order to ensure the use of calib rated and/or checked equipment on the date of 
conducting the tests. A.7.2 The calibration certificat es of the reference standa rds must be issued by: 
a) national metrology laborat ories listed in C.7.2; 
b) calibration laboratories accr edited by Cgcre/Inmetro; 
c) laboratories belonging to the National Metr ology Institutes of other countries, in the 
following cases: 
- when traceability has been obtained dire ctly 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 ot her countries’ Accreditation Bodies, when there is a 
mutual recognition or cooperation agreem ent between Cgcre/Inmetro and those 
bodies. 
A.7.3 The certificates for the measuring and te sting 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 refe rence standards is not 
invalidated.  
A.8 CALIBRATION AND TESTING METHOD 
A.8.1 All instructions, standards a nd reference data relevant to the laboratory work must be 
documented and kept up to date and read ily available to th e laboratory staff. 
A.8.2 The laboratory must use documented proce dures 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 an d data transfers to appropriate checks. 
A.8.4 The laboratory must have procedures to pr otect the security of data in computerised 
records.  
A.9 HANDLING OF ITEMS 
A.9.1 The laboratory must unambiguously identify th e items to be tested, so that there is no 
mistake at any time regarding their identification. A.9.2 The laboratory must have documented pro cedures 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-k eeping system adequate for its particular 
circumstances and must comply with applicable  regulations, as well as keeping all original 
observations, calculations and re spective data, records and a c opy of the test reports for a 
period of at least four years. A.10.2 Alterations to and/or errors in record s 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 legi ble manner that does not permit 
any doubts in interpretation and that bears the sign ature 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 comp uter 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 CERTIFICA TES AND REPORTS 
A.11.1 The results of each test or series of test s conducted by the laborato ry must be recorded 
in a precise, clear and objectiv e 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 inform ation 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 identifica tion of the report; 
d) name and address of the customer; e) description and unambiguous iden tification of the tested item; 
f) characterisation and cond ition 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 ex clusions from the test method and any other 
information relevant to a specific te st, such as environmental conditions; 
j) measurements, verifications and respective re sults, supported by tables, graphics, diagrams 
and photographs; k) a statement of the estimated uncertainty  of the test result (where relevant); 
l) signature, title or equivale nt identification of the staff re sponsible for the content of the 
report and date of issue; m) where relevant, statement that the re sults refer only to the tested items; 
n) statement that the report may only be reprodu ced in full and with the customer’s approval; 
o) identification of the item; p) reference to the sta ndard specification used. 
 
A.12 EXTERNAL SUPPORT SE RVICES AND SUPPLIES 
A.12.1 The laboratory must keep records referrin g to the purchase of equipment, materials 
and services, including: a) purchasing specification; b) acceptance inspection; c) calibration or verification.  ANNEX B – CONFORMITY IDENTI FICATION SEAL AND PRODUCT 
TRACEABILITY 
 
The identification of the Conformity Identifica tion 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