Excellence for QM systems
QM systems and good manufacturing practice are global requirements for marketing medical devices. Typically, QM systems that span every stage of the product life cycle are required: From design and development to manufacturing all the way to post-market surveillance.
Schrack & Partner is on-hand with expert advice at every stage.
QM systems for manufacturers, suppliers and distributors – setup and maintenance
International standard ISO 13485 is the key set of rules for medical technology in Europe and many countries around the world. In addition, medical device manufacturers, suppliers and distributors must integrate the applicable legal requirements into their QM systems. Developing, implementing and refining QM systems are some of our core skills. We ensure that they continually comply with current standards, as well as all applicable legal requirements.
Typical projects involve helping businesses to plan and strategically align their QM systems, during initial setup and expansion:
Do you need to adapt your QM system after expanding or restructuring your business?
We will accompany you as you design and plan the strategic (re-)alignment of your QM system. Whether this involves developing viable process structures, expanding across sites or countries, or introducing new products and technologies, we will work closely with you to establish your potential courses of action, or to check whether your concepts comply with the requirements set out in laws and standards.
Are you looking to build a QM system from scratch?
We can provide you with targeted guidance during this process, working with you to implement a QM system that not only meets all regulatory requirements, but also features a cutting-edge structure that ensures your entire organisation is ready for whatever the future holds. Our systems also offer fast-growing businesses a solid, scalable foundation.
Do you need to develop your QM system further?
If you already have an established QM system, the prospect of incorporating new requirements or generally updating your QM system can seem daunting. We can review your processes and collaborate with you to analyse your improvement and further development options.
- Upgrading a QM system to comply with the new EU regulations on medical devices and in-vitro diagnostics
Maintaining and auditing QM systems for manufacturers, suppliers and distributors
Our qualified, experienced auditors will help you prepare for external audits or perform scheduled internal audits and supplier audits for you.
The benefits we offer as an audit partner:
- We can hold audit discussions with employees and suppliers objectively and neutrally.
- We don't have "company blinkers" on – instead, we bring in fresh ideas and allow potential improvements to emerge.
- Thanks to our experience working with a range of customers, certifiers and authorities, we know the current interpretation of the requirements inside and out, and can review your system with any current questions in mind.
Planning and performing internal audits
Internal audits are not only required by standards. They also make a practical contribution to improving and continually developing your company processes. We would be more than happy to plan your internal audits according to your scope- and content-related specifications. Our lead auditors will perform the audit and produce an informative audit report.
If requested, we will continue to support you by working together with you to develop solutions for correcting any deviations or improving your processes.
Supplier qualification and auditing
Benefit from our lead auditors' extensive experience: We take a weight off your employees' shoulders when it comes to quality management and purchasing by planning and performing supplier audits with you. We tailor the process of planning and performing the audit to the customer-supplier relationship in question, as well as the products and/or services you receive. Audit documentation and reports are created in line with international requirements, which allows you to present our audit reports as proof of your supplier monitoring and qualification processes as part of an external audit.
We help you to improve the quality of your products and to gain an insight into your suppliers' processes through the auditing and analysis processes.
Identifying any weak points is the first step in this procedure, which will optimise how you collaborate with your suppliers.
Enhance your knowledge and skills
A QM system can only be maintained by staff who know what they are doing. Our range of training seminars offer you the opportunity to improve understanding and develop skills within your company.
Training programmes tailored to meet your needs complement your processes perfectly.