What is Certification?
In order to ensure long-term effectiveness of an implemented management system and continuously bring advantages to a company, a certification is not only helpful but reasonable. Here, a certification audit is always part of a permanent assessment process. This process always includes a comprehensive system review and monitoring, which comprises at least three years. The graph "How does a certification take place?" helps demonstrating this process. In the actual certification audit compliance with certain standards or regulations is being assessed. Following the determination of compliance and approval by the Certification body, this is officially confirmed by a document - the certificate. An essential prerequisite for certification is an independent, impartial and objective assessment by a third, competent body.
The certification of a management system by an independent third party has many benefits that go far beyond the mere acknowledgment of conformity of a system in accordance with the requirements of a standard or a set of rules. In today's ever faster and increasing competition, companies have to deal with significant challenges. Globalization, increasingly faster change- / Innovation processes, steadily increasing demands on companies and products, as well as increasing cost pressure should not be disregarded factors. A certified management system helps your competitiveness and ultimately improving your operational performance. With certification you display to your customers, competitors, suppliers, employees and investors that you are applying accepted standardized methods and demonstrate to stakeholders that your business is run efficiently. Through the regular audit process, from the initial audit and subsequent annual assessment, the sense of responsibility, commitment and motivation of the employees is being promoted, which naturally leads to an overall increase of performance in the company.
Who is concerned by certifications in the healthcare system?
Companies such as: medical device manufacturers, suppliers, hospitals and practices - which have to comply with legal requirements, but not mandatory certification according to the Medical Device Directive - a certification according to ISO 13485 and or ISO 9001 provides a good basis for verification of the performance towards the customer demands and stakeholders. It should be noted that service providers in the social and health care sector cannot be certified according to ISO13485.
Suppliers of health aids must be properly qualified to professionally exercise of their profession and to fulfil the requirements for technical and personal suitability or rather capability. This needs to be checked by the health insurances before signing the contract. The prequalification procedure can be used as evidence.
The implementation and certification of a quality management system based on other national and international standards (e.g. ISO 15378 GMP standard for primary packaging materials for medicinal products, ISO 15224 for services in health care) should be a strategic decision of an organization to meet long-term the ever increasing market requirements.
How does a certification take place?
DQS MED audits are highly individual discussions, in which an auditor inserts his personality, his expertise and full integrity. A DQS MED-Audit is a dialogue between equal partners, in a working atmosphere, which allays any fears and opens up people.
We do not play either prosecutors or judges, neither schoolmaster nor examiner. We are interested in providing our findings fairly and cooperatively to companies. We want to understand why a company has chosen this and no other way of implementation. It is also important to us that our customers can understand and use our feedback.
Compliance with process specifications we do not take as granted. We strongly recognize the achievements of employees and managers. We do not beat around the bush if there are errors happening. In order to promote a culture of learning, we help you to direct your attention to development potentials and strengths. Our clients particularly appreciate the practical relevance, which a DQS MED Auditor introduces through his/her expertise and experience to the organization. An audit by DQS MED supports those responsible in their commitment to align the entire organization towards success – so that your customers will appreciate you as a reliable partner in future
We support and guide you at every important step - see the following process - from the initial information to the successful certification of your management system.
What benefit has a certification?
Health Workshop, industrial concern, businesses and organizations of all kinds can use audits for themselves. Therefore, audits by DQS MED provide the management and the driving forces in your organizations with certainty about the effectiveness of leadership and change processes. In addition, DQS MED audits provide the management with expert and clear impulses in order to use the company’s products or services strengths optimally. Such audits are investments into the future.
A good audit also protects against blind spots. We take into account the individual situation of each organization: the special procedures, the varying levels of maturity and needs, and in particular, the specific objectives. If an audit is associated with a certificate, it paves the way for supplier relationships. Customers of the audited company receive confirmation of conformity with established rules. Furthermore, the certified management system offers other advantages. It
- contributes that the company achieves set objectives through numerous strategies,
- forms a good basis for continuous improvement of procedures and processes,
- increases the performance of the company,
- creates transparency of the processes,
- weakens the risks and liability from obligations in the to be supplied markets,
- enhances the brand image and supports the access to international as well as new markets.