QM certification
for medical devices
Certification according to QM standards in industry, trade and services
According the standards
EN ISO 9001
EN ISO 13485
QM CERTIFICATION
A well-considered and practised quality management system offers confidence in daily actions and activities and thus represents a stable principle of corporate caution.
The aim of quality management is to ensure and continuously improvement of performance and quality development of a company/organisation. Implemented accordingly, a QM system brings many advantages, such as increased product and service reliability and thus the expansion of a company’s own competitive position. Optimised processes and thus increasing effectiveness and efficiency are combined with the improvement of quality in the company. Properly understood and implemented, it represents a guideline for effective corporate management that takes current legal requirements (which cannot be ignored) into account.
Certification according to QM standards is an added value for all protagonists in the medical device environment. Regardless of whether you are a service provider, distributor, manufacturer (series and customised production) or contract manufacturer – you will receive an objective assessment of your QM system and the underlying company processes.
Our certifications in the area of quality management
The QM certifications we offer cover different QM standards. In addition to the industry-specific EN ISO 13485 standard, we also offer certification in accordance with the universally applicable EN ISO 9001 standard.
By combining audits within the framework of CE and QM certification, we can also optimize the use of resources.
QM certification according to
EN ISO 13485
EN ISO 13485 provides the guidelines for a quality management system (QMS) that is used in the entire medical device market.
The foreword to the current edition clearly emphasises this fact by not only addressing all manufacturers, but also explicitly including service providers (trade, service, installation, contract manufacturing…). In contrast to EN ISO 9001, which addresses the broadest possible user clientele, EN ISO 13485 specifically addresses companies and organisations that deal with medical devices and services in their market.
Nevertheless, ISO 13485 remains a process-orientated standard. It continues to offer an industry-orientated opportunity to align one’s own processes and regulations with the requirements of medical device legislation and thus provide evidence of systematic compliance with the rules applicable to the handling of medical devices.
Certification in accordance with this “gold standard” of the medical device market provides an objective proof that your QM system fulfils the standards applicable to your activities.
ISO 13485 is also the normative basis for the Medical Device Single Audit Programme (MDSAP) and the recognition in Taiwan as part of the Technical Cooperation Programme (TCP).
mdc is one of the few certification bodies in Europe recognised by the Taiwanese government. The proof of an established quality management system in accordance with ISO 13485 can make it considerably easier for our customers to obtain product authorisation in certain regions.
Audits within the framework of MDSAP can be carried out with our auditors via a cooperation partner recognised under MDSAP and offer the possibility of proving compliance with the regulatory requirements for QM systems of up to five participating countries in the course of a certification procedure: Australia, Brazil, Japan, Canada and the USA. This also can significantly simplify product authorisation in the countries covered.
QM certification according to
EN ISO 9001
The commonly known, the rather general Standard EN ISO 9001:2015 contains widely applicable and interpretable statements and requirements for a QM system. It takes the need to comply with relevant regulations into account, but requires more creativity and personal responsibility with regard to determining the necessary requirements. The focus here is on the management’s responsibility towards external and internal interested parties and the systematic handling of risks and opportunities.
Even if EN ISO 9001 is not harmonised with either the MDR or the IVDR, certification in accordance with ISO 9001 may be helpful or even necessary for your company if your organisation operates in other sectors in addition to the medical device sector:
- is active in other markets in addition to the medical device sector
- is active in the field of medical devices, but your activities are not exclusively within the scope of ISO 13485
- considers certain aspects of QM that are only addressed in EN ISO 9001 to be of value to your organisation
With certification to this widely known and general QM standard, you can also demonstrate your expertise in quality and standardisation outside the world of medical devices.
Contact
Contact us for more information on QM certification
EN ISO 13485
Here you can find further information on product EN ISO 13485
EN ISO 9001
Here you can find further information on product EN ISO 9001
Requirements for quality management
The aim of a quality management system is to ensure and continuously improve process and product quality in companies. The standard provides a framework with subject areas for the implementation of this:
a) Handling documents and records
- How do I manage information (internally and externally)?
- How do I avoid document chaos?
- How do I find my records again?
- Which regulatory requirements need to be taken into account?
b) Management tasks
- How do I regulate responsibilities and authorisations in my company?
- Who is authorised to do what and why?
- How do I implement the QM system in practice?
- What tools do I have at my disposal?
c) Dealing with operational resources
- What equipment and infrastructure do I need?
- What personnel expenditure is necessary?
- Which training and further education programmes are required and how effective are they?
d) Core process(es):
- How do I plan the processes?
- What (supply / product / process) risks do I need to take into account?
- What are the customer requirements (patient, payer…)?
- How do I implement these appropriately?
- How do I manage the procurement of the necessary resources and any external services?
- How do I manage my (value-adding) processes?
- Are there processes that cannot be measured by their results?
- How are these to be validated and thus safeguarded in the result?
e) Review:
- How do I check my processes and their results?
- What information, data and tools do I use for this?
- Have any reportable incidents been identified – is communication with the authorities necessary?
- What do my customers say?
- What conclusions do I draw from the above information and
Do you have any questions?
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FAQ
What is a quality management system?
A quality management system (QMS) is a systematic and organised set of processes, procedures and responsibilities that an organisation uses to improve and control its products, services and processes in compliance with standards. The aim of a QMS is to ensure and improve the quality of results, increase customer satisfaction and reduce costs. In order to be able to react to changing market and customer requirements, a QMS must be constantly adapted and is therefore referred to as a “living system”.
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