Policy: Public information on quality management certification

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).

This information is publicly available at the the following link.

Policy

Scarlet provides ISO 13485 certification services. This document sets out relevant information regarding some of the processes related to Scarlet’s ISO 13485 certification services.

Quality Management System Certification Process and Conditions Guidelines

Geography

Scarlet operates in the European Union and in the United Kingdom.

Certification cycle

The following diagram sets out the audit processes for a full ISO 13485 certification cycle at Scarlet. Explanations for the different types of audits are provided below the figure.

procedure
Stage 1 audit

Once a contract for ISO 13485 certification services has been agreed between Scarlet and an customer, a stage 1 audit is performed. A stage 1 audit is an initial assessment of the state of the customer’s quality management system and the customer’s readiness for a stage 2 audit. Following a stage 1 audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either recommend that the customer proceeds to a stage 2 audit (subject to identified non-conformities being addressed appropriately), or that the customer repeats the stage 1 audit once further progress has been made.

Stage 2 audit

A stage 2 audit is a further assessment of the customer’s quality management system and its alignment with the applicable standard and regulations. During a stage 2 audit, Scarlet’s auditors will evaluate the quality management system’s adequacy and effectiveness. Following a stage 2 audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either grant certification of the quality management system (subject to identified non-conformities being addressed appropriately), or refuse to grant certification. If certification is granted, the customer will be issued a certificate from Scarlet. If certification is refused, the justification for refusal will be explained to the customer.

Surveillance audits

Once the customer’s quality management system has been certified after a successful stage 2 audit, the customer enters a 3-year certification cycle. During the cycle, two surveillance audits will be carried out in 11 - 13 month intervals. Surveillance audits are similar in nature and scope to stage 2 audits. Following each surveillance audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either recommend continuation of the certification cycle (subject to identified non-conformities being addressed appropriately), or suspend the customer’s certificate. Further information regarding suspension of certificates is provided below.

Recertification audit

As the customer’s certificate nears expiry, a recertification audit is carried out. Recertification audits are similar in nature and scope to stage 2 audits. Following a recertification audit, Scarlet will prepare an audit report summarising the findings. Based on the findings throughout the audit cycle, Scarlet may either recommend renewal of the certificate (subject to identified non-conformities being addressed appropriately), or refuse to renew the customer’s certificate.

Suspension, amendment, restoration and withdrawal of certificates

Scarlet suspends certification in such circumstances as:

Under suspension, the customer’s certificate is temporarily invalid.

Scarlet will 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 in a time established by Scarlet will result in withdrawal or reduction of the scope of certification.

In cases where the customer has persistently or seriously failed to meet the certification requirements for certain parts of the scope of certification, Scarlet will reduce the customer’s scope of certification to exclude the parts not meeting the requirements. Any such reduction shall be in line with the requirements of the applicable regulation or standard.

Scarlet will notify any applicable recognising competent authorities of the action taken against the certificate.

Requests for information, complaints and appeals

Requests for information, complaints and appeals can be submitted via the following link.

In the event of a client wishing to appeal against any decision Scarlet, the client shall do so within 14 days of receiving the decision. 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, 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 original decision of Scarlet shall stand pending the meeting of the Appeals Panel. At the meeting both the appellant and Scarlet 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.

Impartiality

Scarlet is committed to maintaining the highest levels of impartiality. Scarlet follows the requirements set out in applicable standards, regulation and guidance, and has appointed an impartiality panel intended to safeguard Scarlet’s impartiality.

Conditions for Promoting Certification and Usage of Marks

Scarlet’s marks (as shown in Appendix 1) are only permitted for use by customers whose quality management system has a valid certificate issued by Scarlet. The use of the marks is subject to the below conditions and further conditions specified in the contract for certification services agreed between Scarlet and the customer.

Appendix 1

Registration number:…

Registration number:…