BRAZILIAN
CERTIFICATION SYSTEM
BRAZIL
BRAZIL
has a new
has a new
Regulation
Regulation
By:Giovanni Hummel (IEx) and
GENERAL INFORMATION
• November, 2008 - Brazil submits the Application Form to become an IECEx Country Member ;
GENERAL INFORMATION
•
In 2009 INMETRO and its Ex Technical Committee worked to update the
Portaria (Regulation) 83:2006;
•
In March, 2009 – The seventh Brazilian CO for HazLoc Products is
accredited by INMETRO (IEx);
•
Some services facilities got their voluntary certification to repair motors;
•
May, 2010 - The Brazilian IECEx Subcommittee conducts the 19th
•
May, 2010 - The Brazilian IECEx Subcommittee conducts the 19th
Ordinary Meeting, deciding the Brazilian representatives for the IECEx
annual meetings;
•
Some Certification Bodies (UL do Brasil, CEPEL and NCC) and one
Laboratory (CEPEL) are preparing themselves to be audited by IECEx
Scheme in 2010;
•
May 18th, 2010 – It is published the new INMETRO Regulation for
hazardous locations products.
INMETRO MARK
HAZARDOUS LOCATION
Governmental Accreditation Organization for:
INMETRO
(National Institute of Metrology,
Standardization and Industrial Quality)
Who sets the Rules?
Governmental Accreditation Organization for:
•
Certification Organizations (CO)
1. Product Certification Organism (OCP)
2. Quality System Certification Organism (OCS)
•
Test Organizations (TO)
What are the Rules?
•
Conformity Assessment Rule:
– Portaria (Regulation) 83 as of April 03, 2006
(Expiration date: May 17, 2011)
– Portaria (Regulation) 179 as of May 18, 2010
– Portaria (Regulation) 179 as of May 18, 2010
(Replacing Portaria 83)
Note: If Portaria 83 is requested after May 18, 2010 for new certificates, it is still valid up to May 17, 2011 (transitory period for accreditations updates).
Portaria 83
•
Portaria 83 as of April 03, 2006
The Portaria 83 has two evaluation Models:
Model 1:
Type Test, Quality System Evaluation and Surveillance: Type Test, Quality System Evaluation and Surveillance:
This type of certification model is used for production line certification and is based on:
- Documentation analysis (similar to Scheduled/Related drawings + User Manual in Portuguese language and INMETRO Label Drawing) - Type tests under IEC standards
- Quality System Evaluation (Pre-Certification Audit, before issue CoC) based on NBR ISO 9001:2000 (focus on the product)
Type Test:
It can be waived if the client provides test reports issued by a third party laboratory accredited by an ILAC full member. The test lab must have a valid ISO/IEC 17025 accreditation, with the applicable HazLoc standards
Pre-Certification Audit:
Portaria 83
Pre-Certification Audit:
• It can be performed the audit focusing only the product if the manufacturer has the ISO 9001 Registration by a Certification Organization under SBAC (Brazilian Conformity Evaluation System); or
• The Brazilian CO can accept audit reports issued by foreigner COs if these Agencies were contracted and oriented by the Brazilian CO.
Model 2
:
Lot Certification model (no limit of units):
This type of certification model is used for lots of products.
Portaria 83
- Documentation analysis (similar to Scheduled/Related drawings + User Manual in Portuguese language and INMETRO Label Drawing) - Type test in 6% of lot, and routine test in the remaining lot
Type Test:
The tests must be conducted, even if the product is
already certified abroad. The tests in 6% of the lot can be
performed outside Brazil if the test laboratory is accredited
Portaria 83
performed outside Brazil if the test laboratory is accredited
by an ILAC full member, under the same or equivalent
scope of standards.
Small Quantity Process (DIPQ)
This special situation is applicable for the importation of:
Portaria 83
- Electrical equipment or component that are part of
machines, equipment or installation “Skid mounted”
For the Small Quantity, certification is not required.
Instead of the certification
two
Declarations are
issued:
-
The Customs Clearance Declaration
Portaria 83
- Product inspection after customs clearance
- The Definitive Declaration
The Small Quantity Process for a single model
can only be repeated
every three months
In this process, it is necessary to provide:
- Product certificate issued abroad by a third party
Portaria 83
- Product certificate issued abroad by a third party
Certification Organization
- Manufacturer quality system ISO 9001 registration
- Purchase Order, Invoice or Proforma Invoice listing
25 units maximum
- All components must have a unique identification, such
as a serial number
It is not allowed to issue Declarations for the following
products:
- Installation accessories - Luminaires - HandlampsPortaria 83
- Floodlights - Empty enclosures - Junction boxes - Solenoid valves- Signaling and command components
Summary:
Certification Models Special Situation Type Test, Quality System
and Surveillance Lot Certification Small Quantity Documentation analysis Yes Yes Yes
Portaria 83
Type Test Yes routine test to remaining lotYes, 6% of lot plus the
Product must be certified by a third party organization
abroad
Pre-Certification Audit Yes No No Annual audit Yes No No
What are the Rules?
•
Portaria 179 as of May 18, 2010
INMETRO issue the new Regulation with support of the
Brazilian society:
– Brazilian COs: Bureau Veritas Certification, CEPEL, CERTUSP, – : Bureau Veritas Certification, CEPEL, CERTUSP,
NCC Certificações, IEx – Instituto de Certificação and TÜV Rheinland do Brasil and UL do Brasil
– Brazilian Laboratories: CEPEL, IEE/USP and LABELO
– Brazilian Trade Associations: ABIEPS, ABIMAQ, ABINEE and ABIQUIM
– Neutral Organizations: APAEST and COBEI (Brazilian National Committee)
What are the Rules?
•
Portaria 179 as of May 18, 2010
Main Changes (improvements):
• Dust Atmospheres product certification become
mandatory;
• EPL must be considered in markings;
• EPL must be considered in markings;
• COs are authorized to accept the IECEx test results;
• Use of the newest IEC standards, already translated;
• Adoption of items based on EN 13980 / IECEx OD 005/V2
for Manufacturer Quality System audits;
• Changes in the DIPQ (new certification model);
• New criteria for the use of test laboratories.
Who sets the Standards?
•
ABNT:
– Associação Brasileira para Normas Técnicas
(Brazilian Association for Technical Standards)
•
HazLoc Standards: COBEI
•
HazLoc Standards: COBEI
– Comitê Brasileiro de Eletricidade
(Brazilian Committee of Electricity)
Who sets the Standards?
•
Portaria 83 - 2006:
16 standards (some
of them IEC)
•
Portaria 179- 2010:
40 standards
•
Portaria 179- 2010:
40 standards
(mainly Brazilian standards)
What are the Standards (New Regulation)?
Title IEC (Reference) ABNT NBR IEC (No deviation) General requirement 60079-0:2007 60079-0:2008 Flameproof enclosures 'd' 60079-1:2007 60079-1:2009 Electrical apparatus-Type of Protection “p” 60079-2:2007 60079-2:2009Powder filling "q" 60079-5:2007 IEC Applies
Powder filling "q" 60079-5:2007 IEC Applies
(Previous Version Available)
Oil-immersion “o” 60079-6:2007 60079-6:2009
Increased safety ”e” 60079-7:2006 60079-7:2008
Intrinsic safety ”i” 60079-11:2006 60079-11:2009
Electrical apparatus with type of protection “n”
60079-15:2005 60079-15:2007
What are the Standards (New Regulation)?
Title IEC (Reference) ABNT NBR IEC (No deviation)
Equipment repair, overhaul and reclamation
60079-19:2006 60079-19:2008
Intrinsically safe electrical systems
60079-25:2010 IEC Applies
(Previous Version Available)
Equipment with equipment protection level (EPL) Ga
60079-26:2006 60079-26:2008
Equipment with equipment protection level (EPL) Ga
60079-26:2006 60079-26:2008
Fieldbus intrinsically safe concept (FISCO)
60079-27:2008 60079-27:2010
Protection of equipment and transmission systems using optical radiation
60079-28:2006 60079-28:2010
Gas detectors - Performance requirements of detectors for flammable gases
What are the Standards (New Regulation)?
Title IEC (Reference) ABNT NBR IEC (No deviation)
Electrical resistance trace heating: General and testing requirements
60079-30-1:2007 IEC Applies
Equipment dust ignition protection by enclosure "t"
60079-31:2008 IEC Applies
Electrical apparatus for use in 61241-4:2001 61241-4:2009
Electrical apparatus for use in the presence of combustible dust: Type of protection "pD"
61241-4:2001 61241-4:2009
Electrical apparatus for use in the presence of combustible dust: Protection by intrinsic safety "iD"
Certification Models
Three Certification Models
Type tests, Quality System Evaluation and Surveillance:
- Tests based on NBR IEC Standards (or IEC when NBR IEC is not published);
- Quality System (Initial Audit) – Emphasis in the product (based on EN 13980 / IECEx OD 005/V2);
(based on EN 13980 / IECEx OD 005/V2); - Surveillance (Periodic Audits)
Batch (Lot) Certification:
- Common for small lots (the product sold is the product tested); - Based on tests on 6% of the samples collected from the lot; - There is no Quality System Assessment.
Certification Models
Special Situation for Imported Products (Called previously by DIPQ – Declaration to Import Small Quantities) :
─ Evaluation of the technical documentation provided (basically
product certificate and quality system registration or equivalent, product description, manuals and the legal documents for
importation); importation);
─ CO Inspection;
─ There is no Quality System Assessment;
─ Not applicable for all type of products and limited to 20 units at
Certification Models
Special Situation for Imported Products – Restriction List: - Installation accessories - Luminaires - Electronic ballasts - Handlamps - Floodlights - Floodlights - Empty enclosures - Junction boxes - Solenoid valves
- Signaling and command components - Motors
Type tests, Quality System Evaluation
and Surveillance
• Technical Evaluation of the Product - by the Brazilian CO; • Definition of the Test Lab - by the Brazilian CO;
• Test plan - prepared by the CO and submitted to the Test Laboratory; • Initial Audit - performed by the Brazilian CO (if the manufacturer is ISO
9001:2008 Registered, only the additional requirements are performed);
performed);
• For products not certified by the IECEx Scheme – Test Results from Test Lab accredited by an ILAC Full Member (same INMETRO
accreditation scope, can still be considered according to the new Regulation);
• For products already certified by the IECEx Scheme - ExTR and QAR can be considered according to the new Regulation;
Quality System Evaluation
• MANUFACTURERS NOT ISO 9001 REGISTERED – Must be
audited the following items (complemented by the items listed in the Annex B of the Regulation INMETRO 179:2010):
o 4.2.3 - Control of documents; o 4.2.4 - Control of records;
o 7.1 - Planning of product realization;
o 7.4.3 - Verification of purchased product;
o 7.5.1 – Control of production and service provision; o 7.5.1 – Control of production and service provision; o 7.5.3 - Identification and traceability;
o 7.5.5 – Preservation of product;
o 7.6 - Control of monitoring and measuring equipment; o 8.2.1 - Customer satisfaction;
o 8.2.3 - Monitoring and measurement of processes; o 8.2.4 - Monitoring and measurement of product; o 8.3 - Control of nonconforming product;
o 8.5.2 - Corrective action; o 8.5.3 - Preventive action.
Quality System Evaluation
•
MANUFACTURERS ISO 9001:2008 REGISTERED
Registration must be recognized by INMETRO;
Additional requirements must be audited – Annex B of the
INMETRO Regulation 179:2010 (Based on EN 13980 and
IECEx OD 005-V2);
IECEx OD 005-V2);
Surveillance
frequency
(announced):
18
months
(if
necessary, additional surveillance can be conducted without
announcement);
Additional tests can be required if non-conformities were
Quality System Evaluation
– Before Portaria INMETRO 179:2010 there was
no harmonized procedure adopted by the
Brazilian COs to perform the Quality System
audits (and surveillances);
– Brazilian COs didn’t recognize results from each
other;
– Based on the harmonization of the audit criteria,
any CO are able to accept the audits performed
by another one.
Criteria to use Test Labs
Brazilian COs must choose the laboratory
•
Priority
- Third Part Test Laboratories accredited by
INMETRO for the HazLoc scope;
•
Exceptionally
– Third Part Test Lab not accredited for
HazLoc scope under CO evaluation (assessment) if
HazLoc scope under CO evaluation (assessment) if
identified one of the following criteria:
– No test laboratory accredited for the specific scope; – Price issues;
– Time frame issues;
Criteria to use Test Labs
Must be followed the following order:
• Third part test laboratory accredited by INMETRO
for HazLoc scope (general rule);
• Third part test laboratory accredited by INMETRO
• Third part test laboratory accredited by INMETRO
for other scope;
• Third part test laboratory not accredited;
• Manufacturer test laboratory.
Test Results Conducted Abroad
For products already certified abroad, the tests
performed by laboratories outside Brazil can be
accepted if these laboratories are accredited by
INMETRO or by some Accreditation Body that is
recognized by INMETRO under a Mutual
recognized by INMETRO under a Mutual
Recognition Agreement :
a) Interamerican Accreditation Cooperation - IAAC
b) European Cooperation for Accreditation - EA
Test Results Conducted Abroad
Brazilian OCPs are authorized to accept IECEx
results:
a) ExTRs issued by an ExTL, based on the IEC standards
a) ExTRs issued by an ExTL, based on the IEC standards
equivalent to the Brazilian standards editions;
b) QAR covering the types of protection related to the
product under evaluation;
Certificate Activities Conducted Abroad
The conformity assessment activities performed
by a foreign body can be accepted, provided
that:
a) The Brazilian CO (OCP) must have a Memorandum of
a) The Brazilian CO (OCP) must have a Memorandum of
Understanding (MOU) with foreign body;
b) The foreign body must be accredited by the same
international rules adopted by INMETRO and for the same
scope or equivalent;
Marking on the Product
PRODUCT MARKING PACKING MARK
Ex d IIC T5 Gb
Enforcement dates?
1- InIn 22 years,years, Electrical Equipment for Explosive Atmospheres, under Combustible Dust conditions, shall be manufacturedmanufactured andand importedimported according to Portaria 179;
2- InIn 33 yearsyears, Electrical Equipment for Explosive Atmospheres, under Combustible Dust conditions, shall be commercializedcommercialized within the Brazilian marked according to Portaria 179;
3- InIn 11 yearyear, Electrical Equipment for Explosive Atmospheres, under flammable 3- InIn 11 yearyear, Electrical Equipment for Explosive Atmospheres, under flammable Gases and Vapors conditions, shall be manufacturedmanufactured andand importedimported according to Portaria 179;
4- InIn 22 yearsyears, Electrical Equipment for Explosive Atmospheres, under flammable Gases and Vapors conditions, shall be commercializedcommercialized within the Brazilian marked according to Portaria 179;
5- Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions, whichwhich needneed maintenancemaintenance and/or
Continues:
6- AfterAfter 11 yearyear of timeframes of items 1 to 5 above established, the Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions shallshall bebe manufacturedmanufactured andand imported
imported according to updates which occur in the listed Standards on 179;
7- Establishes that after 22 yearsyears, of timeframes of items 1 to 5 above
Enforcement dates?
7- Establishes that after 22 yearsyears, of timeframes of items 1 to 5 above established, Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions shallshall bebe commercialized
commercialized within Brazilian market according to Portaria 179;
8- Determines that the tool defined by the old Regulation (Portaria 83) as DIPQ will be not accepted after 6 months of the publication of Portaria 179. The DIPQ will be totally replaced by the Special Situation for Imported Products Model according to Portaria 179.
Summary:
COMBUSTIBLE DUST GAS AND VAPORS
ADOPTION OF NEW STANDARDS EDITIONS AFTER EFECTIVE IMPLEMENTATION OF THE REGULATION MANUFACTURING AND
IMPORTATION 2 YEARS 1 YEAR + 1 YEAR
Enforcement dates?
COMMERCIALIZATION 3 YEARS 2 YEARS + 2 YEARS
MAINTENANCE AND
QUESTIONS?
THANK YOU !
THANK YOU !
