Policy: General Terms and Conditions

References

Scope

This policy relates to potential or current customers of Scarlet (see ISO/IEC 17021-1:2015, IAF MD9:2017, Regulation (EU) 2017/745; Annex VII; 4.2a).

Definitions

Appeals Panel

The panel will consist of at least two people. Neither of whom shall have a conflict of interest with the subject of the appeal.

Audit team

Individual or set of individuals who have the responsibility for performing audits, reporting audit findings and making certification decisions.

Appellant

Any person or Client making an appeal.

Certificate

Certificate issued and authorised by the Final Reviewer and Decision Maker. Recognising that the system operated by the company has been assessed against the applicable regulation.

Client

An organisations which has been granted an ISO 13485:2016 certificate.

Final Reviewer and Decision Maker

Individuals within Scarlet who is authorised to grant, refuse, maintain, renew, suspend, restore, or withdraw certification.

Registered Symbol

The symbols shown in Appendix 1.

Suspension

When a certificate is temporarily suspended for a period up to a maximum of 6 months.

Withdrawal

When a certificate and registration is terminated.

Policy

  1. The Final Reviewer and Decision Maker has the authority to review and challenge certification decisions made by the audit team and are the final signatory on all certificates issued.
  2. The Final Reviewer and Decision Maker will base his decisions on findings of the audit team, their conclusions, and any other relevant information.
  3. If the Final Reviewer and Decision Maker decides to grant certification, the Client will be entitled to a Certificate, which shall remain the property of Scarlet. Initial Certificates are valid for 3 years from the date of issue. If the Client does not intend to renew its registration at the end of the 3 year period, they must notify Scarlet within 90 days prior to the expiration.
  4. The Certificate is not transferable without the permission of the Final Reviewer and Decision Maker.
  5. The Client shall:
  6. The Final Reviewer and Decision Maker shall:
  7. The Final Reviewer and Decision Maker may require the Client to discontinue the use of the Registered Symbol, if the Client is unable to comply with the requirements set in this Policy. Under suspension policy(see clause 8), the Client’s quality management system is temporarily invalid and therefore the Client must stop all promotion of its certification immediately.
  8. If the Client fails to comply with the policy (see clause 5), the Final Reviewer and Decision Maker may:
  9. Suspension may occur when the Client’s certified management system has:
  10. The Final Reviewer and Decision Maker may, at his discretion, and subject to the provisions of Regulation 11, refuse to grant or renew (and may withdraw) a Certificate if the Client becomes subject to the bankruptcy laws or enters into liquidation, whether compulsory or voluntary (but not including liquidation for the purpose of reconstruction). Such decisions and the grounds for them shall be communicated to the Client.
  11. In the event of a Client wishing to appeal against any decision of the Audit team, the Client shall do it within 14 days of receiving the decisions. An investigation will be conducted, the results of which will be shared within 30 days of receiving the appeal. If the Client is not happy with the decision of the investigation (conducted by the Final Reviewer and Decision Maker), The Client can forward the appeal to the Scarlet Governing Board. A meeting of the Appeals Panel will be summoned, which shall be held within 30 days of receipt of such notice. The decision of the Decision Maker shall stand pending the meeting of the Appeals Panel. At the meeting both the appellant and Decision Maker shall be entitled to be heard in confidence. The decision of the Appeals Panel shall be final and any associated correction or corrective action shall be carried out by Scarlet or the appellant. Submission, investigation and decision on appeals shall not result in any discriminatory action being taken against the appellant. The panel appointed in respect of each appeal shall consist of a at least two members, none of whom shall have any direct commercial interest in the subject of the appeal.
  12. This Policy may be altered from time to time, at the discretion of the Final Reviewer and Decision Maker. These alterations will not alter the Certificate or use of the Registered Symbol.
  13. Any notice under this Policy shall be communicated electronically.
  14. English is the only language used to interact with Scarlet.

Appendix 1

Registration number:…

Registration number:…