BRAZILIAN CERTIFICATION SYSTEM

Transcription

1 BRAZILIAN CERTIFICATION SYSTEM By: Giovanni Hummel (IEx) and Denise Ferreira (UL do Brasil) BRAZIL has a new Regulation Page 1

2 GENERAL INFORMATION November, Brazil submits the Application Form to become an IECEx Country Member ; Page 2

3 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, 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. Page 3

4 HAZARDOUS LOCATION INMETRO MARK Inmetro National Institute of Metrology, Standardization and Industrial Quality Page 4

5 Who sets the Rules? INMETRO (National Institute of Metrology, Standardization and Industrial Quality) Governmental Accreditation Organization for: Certification Organizations (CO) 1. Product Certification Organism (OCP) 2. Quality System Certification Organism (OCS) Test Organizations (TO) Page 5

6 Conformity Assessment Rule: What are the Rules? Portaria (Regulation) 83 as of April 03, 2006 (Expiration date: May 17, 2011) 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). Page 6

7 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: 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) - Submission to External Certification Commission Page 7

8 Portaria 83 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 accreditation, with the applicable HazLoc standards 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. Surveillance: Annually (12 months) an audit is performed at manufacturer Page 8

9 Portaria 83 Model 2: Lot Certification model (no limit of units): This type of certification model is used for lots of products. - 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 - Submission to External Commission Page 9

10 Portaria 83 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 by an ILAC full member, under the same or equivalent scope of standards. The original test reports can be used as reference. Page 10

11 Portaria 83 Small Quantity Process (DIPQ) This special situation is applicable for the importation of: - Electrical equipment or component that are part of machines, equipment or installation Skid mounted - Lots up to 25 units covered at same certificate Page 11

12 Portaria 83 For the Small Quantity, certification is not required. Instead of the certification two Declarations are issued: - The Customs Clearance Declaration - Product inspection after customs clearance - The Definitive Declaration - Submission to External Commission Page 12

13 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 Certification Organization - Manufacturer quality system ISO 9001 registration - Purchase Order, Invoice or Proforma Invoice listing 25 units maximum Portaria 83 - All components must have a unique identification, such as a serial number Page 13

14 It is not allowed to issue Declarations for the following products: - Installation accessories - Luminaires - Handlamps - Floodlights - Empty enclosures - Junction boxes - Solenoid valves - Signaling and command components Portaria 83 - Motors (except those marked Ex d for use with frequency inverters) Page 14

15 Portaria 83 Summary: Certification Models Special Situation Type Test, Quality System and Surveillance Lot Certification Small Quantity Documentation analysis Yes Yes Yes Type Test Yes Yes, 6% of lot plus the routine test to remaining lot Product must be certified by a third party organization abroad Pre-Certification Audit Yes No No Annual audit Yes No No External Commission Yes Yes Yes Page 15

16 Portaria 179 as of May 18, 2010 What are the Rules? INMETRO issue the new Regulation with support of the Brazilian society: Brazilian COs: : 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) PETROBRAS Petróleo Brasileiro S.A. Page 16

17 Portaria 179 as of May 18, 2010 Main Changes (improvements): What are the Rules? Dust Atmospheres product certification become mandatory; 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 / IECEx OD 005/V2 for Manufacturer Quality System audits; Changes in the DIPQ (new certification model); New criteria for the use of test laboratories. Page 17

18 Who sets the Standards? ABNT: Associação Brasileira para Normas Técnicas (Brazilian Association for Technical Standards) HazLoc Standards: COBEI Comitê Brasileiro de Eletricidade (Brazilian Committee of Electricity) Subcomitê SC-31 COBEI CB 03 ABNT Page 18

19 Who sets the Standards? Portaria : 16 standards (some of them IEC) Portaria : 40 standards (mainly Brazilian standards) Note: Including installations, quality system and terminology Page 19

20 Title What are the Standards (New Regulation)? IEC (Reference) ABNT NBR IEC (No deviation) General requirement : :2008 Flameproof enclosures 'd' : :2009 Electrical apparatus-type of Protection p : :2009 Powder filling "q" :2007 IEC Applies Page 20 (Previous Version Available) Oil-immersion o : :2009 Increased safety e : :2008 Intrinsic safety i : :2009 Electrical apparatus with type of protection n Construction, test and marking of type of protection encapsulation "m electrical apparatus : : : :2007

21 What are the Standards (New Regulation)? Title IEC (Reference) ABNT NBR IEC (No deviation) Equipment repair, overhaul and reclamation Intrinsically safe electrical systems Equipment with equipment protection level (EPL) Ga Fieldbus intrinsically safe concept (FISCO) Protection of equipment and transmission systems using optical radiation Gas detectors - Performance requirements of detectors for flammable gases Page : : :2010 IEC Applies (Previous Version Available) : : : : : : : :2008

22 What are the Standards (New Regulation)? Title IEC (Reference) ABNT NBR IEC (No deviation) Electrical resistance trace heating: General and testing requirements Equipment dust ignition protection by enclosure "t" :2007 IEC Applies :2008 IEC Applies Electrical apparatus for use in : :2009 the presence of combustible dust: Type of protection "pd" Electrical apparatus for use in the presence of combustible dust: Protection by intrinsic safety "id" :2006 IEC Applies ABNT NBR 15456:2007 Liquid Combustible Dispensers Page 22

23 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 / 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. Page 23

24 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); CO Inspection; There is no Quality System Assessment; Not applicable for all type of products and limited to 20 units at every 6 months; The product cannot be installed. Page 24

25 Certification Models Special Situation for Imported Products Restriction List: - Installation accessories - Luminaires - Electronic ballasts - Handlamps - Floodlights - Empty enclosures - Junction boxes - Solenoid valves - Signaling and command components - Motors Page 25

26 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); 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; Certificate Validity: Three years. Page 26

27 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 Control of documents; o Control of records; o Planning of product realization; o Verification of purchased product; o Control of production and service provision; o Identification and traceability; o Preservation of product; o Control of monitoring and measuring equipment; o Customer satisfaction; o Monitoring and measurement of processes; o Monitoring and measurement of product; o Control of nonconforming product; o Corrective action; o Preventive action. Page 27

28 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 and 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 observed during the audits (or other reasons defined in the Regulation, such: changes, complaints, etc.). Page 28

29 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. Page 29

30 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 identified one of the following criteria: No test laboratory accredited for the specific scope; Price issues; Time frame issues; Note: Qualified CO expert in ISO/IEC must perform the test lab assessment. Page 30

31 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 for other scope; Third part test laboratory not accredited; Manufacturer test laboratory. Page 31

32 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 Recognition Agreement : a) Interamerican Accreditation Cooperation - IAAC b) European Cooperation for Accreditation - EA c) International Laboratory Accreditation Cooperation - ILAC Page 32

33 Test Results Conducted Abroad Brazilian OCPs are authorized to accept IECEx results: 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; Page 33

34 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 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; c) INMETRO must approve the MOU. Page 34

35 Marking on the Product PRODUCT MARKING PACKING MARK Ex d IIC T5 Gb CO Certificate Number Page 35

36 Enforcement dates? 1- In 2 years, Electrical Equipment for Explosive Atmospheres, under Combustible Dust conditions, shall be manufactured and imported according to Portaria 179; 2- In 3 years, Electrical Equipment for Explosive Atmospheres, under Combustible Dust conditions, shall be commercialized within the Brazilian marked according to Portaria 179; 3- In 1 year, Electrical Equipment for Explosive Atmospheres, under flammable Gases and Vapors conditions, shall be manufactured and imported according to Portaria 179; 4- In 2 years, Electrical Equipment for Explosive Atmospheres, under flammable Gases and Vapors conditions, shall be commercialized within the Brazilian marked according to Portaria 179; 5- Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions, which need maintenance and/or repair to be commercialized shall be suitable to Portaria 179 in 3 years; Page 36

37 Continues: Enforcement dates? 6- After 1 year of timeframes of items 1 to 5 above established, the Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions shall be manufactured and imported according to updates which occur in the listed Standards on 179; 7- Establishes that after 2 years, of timeframes of items 1 to 5 above established, Electrical Equipment for Explosive Atmospheres under flammable Gases and Vapors and Combustible Dust conditions shall be 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

38 Enforcement dates? 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 COMMERCIALIZATION 3 YEARS 2 YEARS + 2 YEARS MAINTENANCE AND REPAIR 3 YEARS 3 YEARS Page 38

39 QUESTIONS? THANK YOU! Page 39