Overview
On March 27th, 2020, the president of the National Institute of Metrology, Quality, and Technology - INMETRO announced actions in response to the coronavirus pandemic, aiming to ensure the continuity of conformity assessment activities for regulated products.
Key Resolutions
Based on SEI process No. 0052600.001384 / 2020-74, the following provisions are established:
Article 1: Alternative Conditions for OCPs
Alternative conditions are set for Product Certification Bodies (OCP) to conduct conformity assessments in manufacturing plants in countries affected by the coronavirus, including Brazil.
Article 2: Risk Analysis Requirement
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The OCP must perform a risk analysis based on:
- Records of the latest internal audits
- Critical analyses from top management
- Complaints handling procedures
- History of non-conformities in testing
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The OCP may choose to postpone maintenance or recertification audits under certain conditions:
- I - Audit postponement by documented OCP decision does not impede the issuance of maintenance confirmation or recertification certificates within the specific RAC deadlines.
- II - If postponed, the audit must occur within 6 months from the decision date, possibly requiring two in-person audits in the same evaluation stage.
- III - Depending on the risk analysis, the OCP may decide to conduct a remote audit.
- IV - During remote auditing, which may include “Complaints Handling” activities, the maintenance or recertification audit may be recognized as conducted, potentially bypassing the requirement for an in-person audit in item II.
- V - If the risk analysis does not support postponement of the audit, or if conditions do not allow for remote auditing, the certificate must be suspended.
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Tests can be executed by the manufacturer in accredited 1st or 3rd party laboratories in Brazil or abroad, under the ILAC Mutual Recognition Arrangement (ILAC MRA).
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If justified, the DCO may issue the “Certification Maintenance Document” or a new “Certificate” without conducting the required tests, but must complete those tests within 6 months of the decision, which may require two rounds of testing in the same evaluation stage.
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The same conditions apply to certifications of new families or new models.
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Conformity assessment schemes published by INMETRO involving OCPs and Forest Audit Bodies under INMETRO Ordinance No. 235 are also encompassed by these established conditions.
Article 3: Compliance with PEFC Guidelines
The Chain of Custody Certification Bodies accredited under INMETRO Ordinance No. 512 must follow the guidelines in the PEFC document, “COVID-19: Guidance for certification bodies and certified companies,” to align the Brazilian Forest Certification Program - Cerflor with the PEFC standards it endorses.
Article 4: Additional Guidelines for Forest Management Certification
Forest Management Certification Bodies accredited under INMETRO Ordinance No. 547 must adhere to the provisions of Circular Letter No. 5/2020 / Dicor / Cgcre-INMETRO.
Article 5: Exceptional Conditions for Initial Certification
- For initial certifications, the OCP may conduct a remote audit and decide the necessity of a subsequent in-person audit.
- Testing may be performed in accredited laboratories as previously outlined.
- If justified, the OCP may issue certificates based on tests not older than 6 months from the start of certification, provided relevant reports are equivalent as stated.
- All initial certifications must comply with specific RAC tests within 6 months post-granting of the certificate, maintaining the testing requirement for the first maintenance assessment.
Article 6: Record Keeping
Records of all activities, analyses, and decisions per this Ordinance must be retained for INMETRO’s review upon request.
Article 7: Postponement of Test Reports
For Product Supplier's Declaration mechanisms, test report submissions are postponed for 6 months during maintenance or renewal, conditional on adherence to timelines previously established.
Article 8: Initial Registration Concession Waiver
Initial registration concessions under Product Supplier Declaration may waive certain test report submissions, with specified compliance within six months post-registration.
Article 9: Ordinance Validity
This Ordinance is effective from January 1, 2020, to June 30, 2020.
Article 10: Compliance with Technical Requirements
All technical requirements in INMETRO regulations remain mandatory for suppliers.
Article 11: Revocation of Previous Ordinance
INMETRO Ordinance No. 79, dated March 4th, 2020, is revoked upon publication of this Ordinance in the Federal Official Gazette.
Article 12: Effectiveness
This Ordinance is effective from the publication date in the Federal Official Gazette.
For more information, please contact info@orbiscompliance.com - mailto:info@orbiscompliance.com or (408) 465-7331.
Based on the Grupo Ibrace website.