ISO 13485 Medical devices
Quality management systems
Requirements for regulatory purposes
Başvuru Formlarının Doldurulması ve Gözden Geçirilmesi
– The application form is filled out by the organization requesting certification and sent to firstname.lastname@example.org or email@example.com.
– MEDCER examines the scope applied for and sends the certification offer to the organization requesting certification.
ISO 13485 Certification Application Form
– The Audit Plan Form is sent to the organization requesting certification. The plan is finalized upon the acceptance of the plan.
– The audit is carried out at the place and time determined in accordance with the plan.
– If nonconformities are detected during the audit, they are recorded in the audit reports.
– The MEDCER certification committee takes the certification decision in the light of application review records, stage 1 and 2 audit reports, nonconformity reports, and objective evidence.
– MEDCER certification committee may request additional documents from the organization requesting certification when necessary.
– The MEDCER certification committee makes the certification decision independent of the opinions and recommendations of the field audit team.
Surveillance Audits are the examination of the certified firm’s management system twice in total, at least once a year, based on the stage 2 audit date.
Postponement requests from customers for surveillance audits are evaluated by the Technical Manager and a postponement of a maximum of 6 months can be made for special cases. In case of delay, the date of the surveillance audit performed does not bind the next audit date.
In the event that major nonconformities are detected after the surveillance audit and the certificate is suspended due to the nonconformity in the report of the lead auditor, the Certification Committee puts the issue on the agenda, makes its examination, requests additional documents if necessary, and in the light of all this information, it decides to continue the certification or cancel, suspend or narrow the scope of the certificate.
The re-certification audit is planned and carried out in order to evaluate that all of the requirements of the relevant management system standard and other decisive document are consistently fulfilled. Re-certification audit is planned and performed like the first audit.
When there is a significant change in the recertification audit activities, the management system, the client or the scope of the management system (such as changes in legislation), a separate Stage 1 audit can be performed.
In cases where multi-site or multi-management system certification is provided by MEDCER®, it is ensured that an appropriate site audit is included in the audit planning to ensure the confidence in certification. The company is warned with a letter 3 months before the expiry of the certificate. Necessary plans are made for the re-certification audit upon request.
MEDCER® makes its decisions about renewal of certification based on the results of the recertification audit, the review of the system during the certification period and the complaints received from certification users.
The MEDCER may make unannounced visits to the manufacturer. If these visits are deemed necessary, they can make or have a test to check that the quality system works well and the product is in compliance with the relevant requirements of this Regulation. 25.09.2013 Recommendations of the European Commission were taken as basis in the unannounced inspection application.
SCOPE EXTENSION – NARROWING
The company may request to expand or narrow the scope of the document it owns. In scope change audits, documents are reviewed. As a result of the scope change inspection; If it is decided to expand or narrow the scope in line with the decision of the Certification Committee, the old document is requested back from the company and a new document is prepared.
MEDCER® may suspend the use of the customer’s certificate for a certain period of time according to the decision of the Certification Committee. The reasons for the suspension can be:
The company’s voluntary temporary suspension request,
As a result of major nonconformities in the audits performed,
Minor – major nonconformities detected during the inspections are not resolved within the specified periods,
The company’s violation of the obligations in the contract text to the extent that it does not require the cancellation of the document,
Determination of non-fulfillment of legal sanctions regarding the product / service within the scope of certification, which should be applied other than the relevant standard,
At the request of the company, the company stops its production / service due to strikes, lockouts, reorganization, natural disasters, shortage of raw materials, inability to receive orders, interruption of operations due to change in the facility address or similar reasons,
The firm’s request to postpone the surveillance audit date continuously,
Failure to comply with the certification rules,
Misuse of the document and logo,
Failure to pay document or audit fees.
At the request of the company as a result of the suspension of operations due to the change in the documented facility address
With the decision of the Certification Committee as a result of the firm’s request to postpone the surveillance audit date based on the certificate date,
The customer’s certificate is temporarily invalid if the customer’s certified management system fails to meet the certification requirements, including the requirements for the management system to be effective.
WITHDRAWAL of THE CERTIFICATE
The customer’s contract for the use of the document issued by MEDCER® may be terminated according to the decision of the Certification Committee. The reasons for the termination of the contract and the withdrawal of the document may be:
The firm does not allow the inspection to be carried out until the end of the suspension period given,
The company does not close its nonconformities within the prescribed time during the activities carried out to remove the suspension (inspection, document review, etc.),
Bankruptcy of the company or ceasing its activities within the scope of the document
Using the company in areas other than the product or service specified in the Management System Certificate,
If the company gives incomplete and misleading information during the examinations,
Misleading and unfair use of the document,
Failure to pay the fees accrued by MEDCER® within 30 days following the invoice,
Within the validity period of the certificate, it is determined that the Company’s management system has completely lost its conformity during the audits,
The firm does not accept the terms of suspension,
The company does not remove the reasons for suspension,
The company does not give confirmation at the end of the suspension period in order to perform a follow-up audit,