mdc Specific Steps in the
Certification Procedure
mdc divides the steps to
obtain a certification in the following four phases:
Phase 1: Information /
Preparation
Every project can only be
as good as it is prepared. Therefore an exchange of information between the manufacturer
and the notified body at an early stage is required. mdc always asks manufacturers to fill
a short questionnaire, which asks for data about the company and
products. On the basis of this questionnaire and some accompanying information mdc is
usually enabled to provide a detailed tailored proposal with respect to time and costs for
the whole process. In addition mdc considers a personal meeting always as useful. In such
a meeting questions like classification, selection of a suitable conformity assessment
procedure can be treated and discussions about involved organizational and technical
issues may facilitate a smooth further certification process. After an application is
launched, mdc issues a contract.
Phase 2: Assessment
To initiate the
assessment phase mdc proposes the audit team (MDD Annex II, V, and VI) and/or qualified
subcontracted laboratories to perform necessary product test(s) (MDD Annexes III and IV)
to the applicant. The documentation is assessed by the proposed auditors and/or experts.
EC Type Examinations in form of a document review by mdc are made only for products with
already existing EC Type Examination Certificate. In cases of quality system
certifications an audit is always performed at the manufacturer's premises and if required
at the premises of his subcontractors. The audit follows an audit schedule, which is
agreed upon in advance with the manufacturer. The results of the assessment activities are
reported in writing and the performance of necessary corrective actions is verified
through a follow-up assessment.
Phase 3:
Certification
After completion of the
assessment the reports are handed over to mdc´s certification board. This board reviews
the results and verifies that the certification process so far meets the requirements. If
the certification board can confirm compliance with the requirements a written
certification decision and the certificate are issued. In case of a rejection, mdc informs
the applicant about the conditions for getting the certificate. The validity of
certificates according to the MDD is usually for a period of 5 years.
Phase 4: Surveillance
To maintain certification
for the full period of the validity, the manufacturer is subject to regular and to
extraordinary surveillances if necessary. Manufacturers, which hold a quality system
certificate, usually undergo one surveillance audit per year. Planned changes in the
organizational structure, processes or products have to be reported and may cause
additional activities and approval.
Before expiry of a
certification mdc starts again the process with the exchange of information for the
renewal of the certification, which includes all aforementioned stages. The fact that mdc
is already familiar with the company and products is taken into consideration when
proposing the required assessment activities for the re-certification.
Certification of
Quality Systems
The above procedure applies
as well to the certifications according to the voluntary standards ISO 9001/2/3,
ISO 13485/8. These certifications can be provided through mdc and
accredited co-operation partners; they are fully incorporated into the assessment process
according to the MDD.
|
