Quality Management
Medical device manufacturers need to be able to rely upon a robust Quality Management System (QMS) that works for them. We have experience of implementing EN ISO 13485 QMS to achieve certification. However, the story does not end at certification. Through our approach to implementation and the training and support we are able to provide, our clients have found that maintaining their system has not been an undue burden, as demonstrated by subsequent positive surveillance audits. If you are at the beginning of this process, or have a mature QMS that you consider could be optimised, consider using our experience and fresh pair of eyes to take a look. Or should you be struggling to find enough trained people to conduct all your internal audits, let us assist you. Be warned, we don't see audits as a tick-box exercise, but as a chance to take stock and find opportunities for improvement to the QMS and the business. We can also help address any issues found.
An effective QMS provides a solid foundation to the business and requires control of suppliers. We have an experienced purchasing department and can offer an outsourcing solution that is EN ISO 13485 compliant. As with internal audits, in our experience, a simple but closely adhered to supplier approval (and re-approval) programme can save time and money.
If you are interested in speaking to us about Quality Management Systems, please contact us.
Medical device manufacturers need to be able to rely upon a robust Quality Management System (QMS) that works for them. We have experience of implementing EN ISO 13485 QMS to achieve certification. However, the story does not end at certification. Through our approach to implementation and the training and support we are able to provide, our clients have found that maintaining their system has not been an undue burden, as demonstrated by subsequent positive surveillance audits. If you are at the beginning of this process, or have a mature QMS that you consider could be optimised, consider using our experience and fresh pair of eyes to take a look. Or should you be struggling to find enough trained people to conduct all your internal audits, let us assist you. Be warned, we don't see audits as a tick-box exercise, but as a chance to take stock and find opportunities for improvement to the QMS and the business. We can also help address any issues found.
An effective QMS provides a solid foundation to the business and requires control of suppliers. We have an experienced purchasing department and can offer an outsourcing solution that is EN ISO 13485 compliant. As with internal audits, in our experience, a simple but closely adhered to supplier approval (and re-approval) programme can save time and money.
If you are interested in speaking to us about Quality Management Systems, please contact us.