Policy: General Terms and Conditions

References

• ISO/IEC 17021-1:2015;
• IAF MD9:2017;
• Regulation (EU) 2017/745; Annex VII; 4.2a
• Regulation (EU) 2017/745; Annex IX;
• Regulation (EU) 2017/745; Annex V;
• ISO 13485:2016;

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 organisation which has been granted certification for ISO 13485:2016 or Regulation (EU) 2017/745; Annex IX.

Final Reviewer and Decision Maker

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

Registered Symbol

• For ISO 13485:2016 certification, the symbols shown in Appendix 1.
• For Regulation (EU) 2017/745; Annex IX certification, the symbols shown in Appendix 2. Use of the symbol must be compliant with Regulation (EU) 2017/745; Annex V.

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 for ISO 13485:2016 certificates and 5 years for Regulation (EU) 2017/745; Annex IX from the date of issue. If the Client does not intend to renew its registration, 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:
   • comply with this policy;
   • ensure that corrective action plans are provided to Scarlet within 30 days.
   • not make or permit an misleading statements regarding the Certificate or use of the Certificate;
   • allow for follow up assessments (which may include on-site assessments) when necessary;
   • not use the Registered Symbol on packaging;
   • not use the Registered Symbol in a misleading way or for a product that is not in the scope of good or services provided;
   • not use the Registered Symbol in any form other than how it’s shown in Appendix 1.
   • amend its website and any other advertising material, to accurately reflect the scope of certification granted;
   • maintain a quality management system according to requirements of the applicable certificate and make available to Scarlet all the data required for certification activities;
   • inform Scarlet if any of the following information changes:
     • legal, commercial, organisational status or ownership;
     • organisation and management;
     • contact address and sites;
     • scope of operations under the certified management system; and
     • major changes to the management system and processes.
   • give access to Scarlet representatives (and observers, whether they are part of Scarlet or the authorities) during normal working hours to the registered premises for the purpose of auditing.
   • plan for an annual surveillance visit;
   • allow audit reports, certificates, and any certification decisions to be shared with the authorities at their request;
   • upon the termination of the Certificate, however determined, discontinue the use of the Registered Symbol and all advertising matters that contains any reference to the Registered Symbol; and
   • when transferring certification to Scarlet, provide all necessary data and previous certification reports and certificates.
   • pay:
     • fees as defined by the customer agreement;
     • any additional costs incurred by Scarlet due to the Client’s non-compliance with this Policy
6. The Final Reviewer and Decision Maker shall:
   • notify the client, by giving due notice, of any change to its processes or version of the standard used;
   • notify the client, 14 days in advance, if it’s going to place any information in the public domain;
   • appoint a member of the audit team to perform the audit, and follow the scheduled visits defined by the audit programme;
   • notify the Client of any complaints received with regards to the compliance of the product.
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:
   • suspend or withdraw the Certificate;
   • refuse to grant the Certificate; or
   • reduce the scope of the Certificate;
   • The decision and the rationale will be communicated to the Client.
9. Suspension may occur when the Client’s certified management system has:
   • persistently or seriously failed to meet the relevant requirements;
   • is ineffective.
   • Or the Client does not allow for audits to be conducted according to the audit programme
10. The Final Reviewer and Decision Maker may, at his discretion, 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.
15. Scarlet is committed to remaining free of discrimination in the submission, investigation, and decision on appeals and complaints.

Appendix 1

Registration number:…

Registration number:…

Appendix 2