Procedure For Issue and Control, Suspension and Withdrawal of Certificate
Purpose
This procedure outlines the steps and requirements for the issuance, suspension, and withdrawal of management system certifications.
Scope:
This procedure covers all types of product certifications services and all management system certification services.
Procedure:-
Receipt and review of Audit report
- The Team Leader is responsible for submission of audit report to the Quality manager within 10 days of completion of the stage-2 audit. This contains at least client signed audit report, corrective action plan for non-conformances. All audit reports (Stage 1, Stage 2, routine surveillances, follow-up, special audit, recertification etc.) are reviewed by the Report reviewing authority at appropriate stages.
- PRNS ensures that certificate of conformity is issued only on the basis of evidence-based recommendation received from a competent audit team.
- The certificate issued is valid for three years as described. However, PRNS has the right to suspend this certificate for violation of various requirements. Also, certified client/organization may request for self- suspension and withdraw of their certification with valid reasons.
Approval for Certification.
- Certification committee decides on granting or refusing of certification. In cases of any non-compliance or requirement of additional information or clarification, report shall be sent back to audit team leader for necessary actions / submission. In cases of audit report meeting the requirements, certificate is granted based on the approval of approving authority i.e. Director, Certification committee may refuse certification, in case of non fulfilment of audit criteria, non submission of corrective action / documentation to meet the requirements within stipulated time frame. In cases of re-certification, certification committee shall make decisions on renewing certification based on the results of the recertification audit, as well as the results of the review of the system over the period of certification and complaints received from users of certification.
Detail for issuing of certification
The issued certificate to client identifies the following:
- The date of granting, extending or renewing certification.
- The name of the certified client and geographic location (such as the geographic location of the headquarters and any sites)
- The expiry date or recertification due date
- A unique identification code/revision number, Certification standards, normative document and the scope of certification.
- Details and certification mark of PRNS certification
- In the event of issuing any revised certification documents, a means to distinguish the revised documents from any prior obsolete documents.
Criteria for Refusing Certification
PRNS will refuse client Certification under following circumstances-
- Customer do not have a documented management system that meets applicable standard or other normative documents.
- One internal Audit and management review cycle has not been completed and non- conformity’s, if any have not been corrected.
- The applicant does not meet the criteria of certification and all major non-conformities, if any found during assessment have not been closed. For minor NC’s corrective action has not been taken or planned has not been received.
- There are adverse reports/information/complaints with the PRNS about the applicant regarding the quality and effectiveness of implementation of system as per PRNS Contract terms and schemes for registration.
- The applicant has not paid all the fees dues.
Maintaining the Certification
The Certification is maintained for a period as per specific to the scheme under the following conditions.
- The Surveillance Audits are conducted as required/planned and the client has demonstrated that it continues to satisfy the requirements of the standard as confirmed by PRNS.
- All the non-conformance raised during previous audits are closed within the time frame agreed and correction and corrective actions for the non-conformities raised during the current audit are identified and accepted by PRNS as described in Procedure for Initial Audit.
- The client shall maintain suitable records of customer complaints and keep the records of investigation and remedial actions taken with respect to such complaints for verification by auditors.
- All outstanding dues to PRNS are paid
- The certification panel approves the audit
- The continuation of certification is held up on the ground that the team leaders report for any nonconformity which may lead to suspension or withdrawal of certification as per specific certification scheme requirement.
- PRNS has a system that requires the audit team leader to report to PRNS initiates a review by competent personnel, different from those who carried out the audit, to determine whether certification can be maintained;
- Competent personnel of PRNS monitor its surveillance activities, including monitoring the reporting by its auditors/ evaluators, to confirm that the certification activity is operating effectively
Extending the Certification
- Any request by the client for extending the scope is dealt as per specific requirements of the scheme
- The decision for granting extension is taken as described in sections 4.1 and 4.2 of this procedure.
- PRNS shall issue a fresh certificate with amended scope without any change in the certification period as identified in the previous certification document. The fresh certificate shall contain revision number and date.
Restoring of Certification.
PRNS shall restore the suspended certification if the issue that has resulted in the suspension has been resolved. Failure to resolve the issues that have resulted in the suspension within six months shall result in withdrawal or reduction of the scope of certification.
Reducing the scope of Certification
- PRNS shall decide to reduce the client’s scope of certification by excluding the parts not meeting the requirements, when the client has persistently and seriously failed to meet the certification requirements for those parts of the scope of certification or if the reduction in scope is requested by the client. Such exclusions shall be consistent with the certification standard.
- The decision for reducing the scope is taken as described in section 4.2 of the procedure.
- PRNS shall issue a fresh certificate with amended scope without any change in the certification period as identified in the previous certification document. The fresh certificate shall contain revision number and date.
Renewing the certification or re-certification
- PRNS shall renew the certification as per procedure for Auditing and Reporting of Management System Audits as Initial certification and process of re-certification shall start 3 months before of expiry of certificate.
- PRNS shall make decisions on renewing certification based on the following,
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- The results of the re-certification audit
- The results of the review of the system over the period of certification
- Complaints received from customers of certified clients.
- The decision for re-certification is taken as described in section 4.2 of this procedure.
- PRNS shall issue a fresh certificate as described in sections 4.2.8 and 4.2.9 of this procedure.
Suspending and Withdrawing Certification
- When a non-conformity with certification requirements is substantiated, as a result of evaluation, PRNS shall consider and decide upon the appropriate action i.e.
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- Continuation of certification under conditions specified by PRNS
- Reduction in scope of the certification to remove the Nonconforming variant
- Suspension of the certification
- Withdrawal of the certification
- When appropriate actions means evaluation, review or certification decision done, are complied with.
- If the certification is terminated (upon client’s request), reduction of scope, suspension or withdrawn, PRNS shall take necessary action as required by the scheme and shall initiate the process required as detailed in the respective scheme procedure.
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- If PRNS is required to suspend the certificate the Certification In-charge shall be responsible to formulate and communicate the following to the client
a) Actions required to end the suspension and restore certification for the product(s), process (es) or service(s) as per the requirements of the specific scheme
- Any other action that might be required to fulfil the requirements of the specific scheme
- The Certification in-charge shall be competent in their knowledge & understanding to handle all aspects of suspended certifications as defined in the competency matrix.
- PRNS complies with the requirements of compliance of procedure for Auditing and Reporting of Management System Audits to carry out the evaluation, review or certification decision in order to resolve the suspension.
- PRNS restores the suspended certification if the issue that has resulted in the suspension has been resolved. Failure to resolve the issues that have resulted in the suspension in a time established by PRNS shall result in withdrawal or reduction of the scope of certification. The suspension shall be as per the requirements of the applicable scheme.
- If certification is reinstated after suspension or scope is reduced or extended the PRNS shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, Logos, etc., in order to ensure all appropriate indications exist that the product continues to be certified and exiting scope.
- PRNS shall withdraw the certificate at the request of the certified plant, if the operation(s) in the certified plant premises can no longer be carried due to reasons of natural calamities such as flood, fire, earthquake etc., lock out declared by the management, or closure of business operations etc.
- If certification is terminated (by request of the client), suspended or withdrawn, scope of certification is reduced the PRNS takes actions make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure it provides no indication that the product continues to be certified. Reduced scope of certification or termination, as the case maybe is clearly communicated to the client and clearly specified in certification documentation and public information.
- Upon request from any interested party PRNS shall correctly state the status of certification of a client’s management system as being suspended, withdrawn or reduced.
- If in case , Any adverse events, Advisory Notices and Recalls are found by side of Client, then PRNS shall take immediate action by doing surveillance programme include a thorough review of the actions taken by the client for the notification of any event that cause which include client's process for identifying, documenting, investigating, and reporting adverse events related to their Product to relevant regulatory authorities, as required by law (e.g., vigilance reporting), records for issuing advisory notices
Reporting to Regulatory Authorities
- The Management Representative or Legal & Compliance Officer shall maintain an up-to-date register of all regulatory authorities and relevant laws/schemes that mandate the reporting of certification information (granted, suspended, or withdrawn) for specific sectors or types of certifications (e.g., Medical Devices under EU MDR, Canadian CMDCAS)
- Where it is required by law or by a relevant Regulatory Authority PRNS shall provide the specified information about certifications granted, suspended, or withdrawn to the respective Regulatory Authority.
- The reporting shall occur within the timelines specified by the relevant law or Regulatory Authority.
- The information provided shall typically include:
- Client identification (name, address, PRCN Number).
- Details of the certification (standard, scope, certificate number).
- Date of certification decision (grant, suspension, withdrawal).
- Reason for suspension or withdrawal, if applicable.
- All communication with Regulatory Authorities regarding certification status shall be documented and retained as a record.
Doc. No.: PRNS-P-019
Rev No.:01
Effective Dt: 10-05-2025