Quality management system certification is performed as follows:
Provision of the information on a client
Client by using the form “Basic information for preparing the price offer for certification of the quality management system according to EN ISO 9001and EN ISO 13485”, which is available in the section Download, provides the information required by the certification body.
Preparation of the price offer
Certification body reviews the information and in case they are comprehensive and the requested certification is in the scope of certification body it prepares price offer without engagement.
Submission of application
Client by using the form “Application for certification of a quality management system according to EN ISO 9001and EN ISO 13485”, which is available in the section Download, formally submits an application on the quality management system certification.
Certification body prepares a contract, which is signed by both sides.
Client submits the documentation specified in the contract.
Certification body prepares the audit program and eventually sampling program for the whole certification cycle.
Certification body prepares a plan of initial audit which is divided into the first and second stage. In the audit plan is defined the scope of activities and responsibilities of particular audit team members as well as locations where will be these actions performed.
Certification body decides on the certification. For the decision in the favor of granting certification is needed that all nonconformities identified during the initial audit were removed.
In regular intervals are performed surveillance audits according to audit program.
Before the end of the certification, cycle is the client provided with the option of recertification. Recertification includes preparation of new contract and recertification audit. In case the certification decision will not be taken until 6 months until the end of the previous certification it is necessary to repeat the audit.
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