Pressure Equipment Directive Consistency Assessment Procedure
时间:2023-08-10 访问量:366

1. Mode A (Internal Production Control)

According to this procedure, the manufacturer or its authorized representative in the European Community guarantees and declares that the pressure device meets the requirements of the applicable directive. Manufacturers or their authorized representatives in the European Community shall affix the CE mark to each pressure device and prepare a declaration of conformity.

2. Mode A1 (internal production inspection+final evaluation monitoring)

In addition to the requirements of Mode A, there are also the following requirements: the final evaluation should be conducted by the manufacturer and monitored by a consistency assessment agency selected by the manufacturer through surprise visits.

3. Mode B (EC type test)

-This mode is part of the entire evaluation process for consistency assessment to determine and demonstrate that the extracted samples meet the instructions

-The EC type test must be applied for by the manufacturer or its authorized representative within the European Community to a notified body selected by it.

-The technical documentation should be able to meet the requirements for conformity assessment of pressure devices according to the directive requirements.

-The notified body shall notify the members of the European Community of the revoked EC type test certificate, including relevant information on the EC type test certificate issued by it, if necessary.

-The manufacturer or its authorized representative within the European Community shall keep the technical documentation of the EC type test certificate and its supplementary certificates for a period of ten years from the date of production of the last pressure device.

4. Mode B1 (EC Design Review)

-This mode is part of the consistency assessment procedure, through which the notified body confirms and confirms that the design of a pressure device complies with the provisions of the directive applicable to it.

-The EC type test must be applied for by the manufacturer or its authorized representative within the European Community to a notified body selected by it.

-The technical documentation should be able to meet the requirements for conformity assessment of pressure devices according to the directive requirements.

-The notified body shall notify the members of the European Community of the revoked EC type test certificate, including relevant information on the EC type test certificate issued by it, if necessary.

-The manufacturer or its authorized representative within the European Community shall keep the technical documentation of the EC type test certificate and its supplementary certificates for a period of ten years from the date of production of the last pressure device.

5. Mode C1 (type compliant)

-According to this procedure, the manufacturer or its authorized representative in the European Community guarantees and declares that the pressure device meets the requirements of the applicable directive. Manufacturers or their authorized representatives in the European Community shall affix the CE mark to each pressure device and prepare a declaration of conformity.

-The manufacturer or its authorized representative within the European Community shall keep a copy of the declaration of conformity for a period of ten years from the date of production of the last pressure device.

-The final assessment should be monitored by the notified body chosen by the manufacturer. Monitoring is achieved through surprise inspections by notified bodies.

6. Mode D (Production Quality Assurance)

-Manufacturers should submit an application to a designated notified body for an audit of their quality system.

-The quality system shall ensure that the pressure device complies with the type specified in the EC type test certificate or EC design review certificate and the requirements applicable to it under this Directive.

-The notified body shall conduct regular audits of the quality system to ensure that the manufacturer maintains and applies the quality system, and provide audit reports to the manufacturer.

-The notified body may conduct surprise inspections of manufacturers.

-Manufacturers should keep relevant documents for ten years from the date of production of the last pressure device, for reference by the competent national authorities.

7. Mode D1 (Production Quality Assurance)

-Manufacturers operate recognized quality systems in production, final inspection, and testing.

-Manufacturers should submit an application to a designated notified body for an audit of their quality system.

-The notified body may conduct surprise inspections of manufacturers.

-Manufacturers should keep relevant documents for ten years from the date of production of the last pressure device, for reference by the competent national authorities.

-Each notified body shall notify the members of the European Community of its revocation of accreditation of the quality system, and shall notify the members of the European Community of its accreditation of the quality system upon request.

8. Mode E (Product Quality Assurance)

-Manufacturers should take responsibility for fulfilling the requirements of recognized quality systems and ensuring the suitability and effectiveness of the quality system.

-The notified body may conduct surprise inspections of manufacturers.

-Manufacturers should keep relevant documents for ten years from the date of production of the last pressure device, for reference by the competent national authorities.

-Each notified body shall notify the members of the European Community of its revocation of accreditation of the quality system, and shall notify the members of the European Community of its accreditation of the quality system upon request.

9. Mode E1 (Product Quality Assurance)

-Manufacturers should submit an application to a designated notified body for an audit of their quality system.

-The notified body may conduct surprise inspections of manufacturers.

-Manufacturers should keep relevant documents for ten years from the date of production of the last pressure device, for reference by the competent national authorities.

-Each notified body shall notify the members of the European Community of its revocation of accreditation of the quality system, and shall notify the members of the European Community of its accreditation of the quality system upon request.

10. Mode F (Product Validation)

-Verify through review and testing of each pressure device

-The notified body shall attach or have the manufacturer attach its identification number to each pressure device and issue a declaration of conformity stating that it has been tested.

-Manufacturers or their authorized representatives in the European Community shall ensure that they can provide a declaration of conformity issued by a notified body upon request.

11. Mode G (EC single item verification)

-Manufacturers should apply for single item verification to the notified body they have selected.

-The notified body shall attach or have the manufacturer attach its identification number to each pressure device and prepare a declaration of conformity for the tests conducted. This certificate should be guaranteed for ten years.

-Manufacturers or their authorized representatives in the European Community shall ensure that they can provide a declaration of conformity upon request and a declaration of conformity issued by a notified body.

   

12. Mode H (Total Quality Assurance)

-Manufacturers should submit an application to a designated notified body for an audit of their quality system.

-The notified body may conduct surprise inspections of manufacturers.

-Manufacturers should keep relevant documents for ten years from the date of production of the last pressure device, for reference by the competent national authorities.

-Each notified body shall notify the members of the European Community of its revocation of accreditation of the quality system, and shall notify the members of the European Community of its accreditation of the quality system upon request.

-Each notified body shall also inform other notified bodies of its information regarding the revocation or refusal of quality system accreditation.

13. Mode H1 (Total Quality Assurance+Special Supervision for Design Review and Final Evaluation)

-Manufacturers should apply to the notified body for design review.

-The application should enable the design, production, and operation of the pressure device to be understood, and its compliance with the relevant requirements of this directive to be evaluated.

-The notified body shall review this application and issue an "EC Design Examination Certificate" to the applicant when the design complies with the provisions applicable to it under this Directive.

-The applicant shall notify the notified body that issues the "EC Design Review Certificate" of any changes made to the approved design.

-The notified body shall also notify other notified bodies of the relevant information regarding the revoked or refused EC design review certificate.