QUALITY STANDARDS FOR THE REPROCESSING OF MEDICAL DEVICES
AS/NZS 4187:2014 identified a requirement to have a Quality Management System (QMS) developed and implemented to meet the elements of the standard.
ISO 13485:2016, Medical devices – Quality Management Systems; is the adopted standard throughout Europe and the UK to control the process requirements for Reusable Medical Devices. This standard requires documented evidence to validate the elements of the standard to ensure compliance.
Having an externally certified QMS significantly reduces the risk in the processing of reusable medical devices. Implementation of such a system provides confidence and assurances that processes are in place to dramatically improve overall patient safety.
Developing a QMS to meet these standards requires valuable time and resources; C. R. Kennedy (CRK) have therefore simplified this process for you.
CRK now have a tried and tested QMS, which has shown to be compliant by external certification bodies in New Zealand, Australia and the UK. CRK have developed this QMS to not only meet, and exceed, all the elements of AS/NZS 4187:2014, but also meet the full requirements of ISO 13485:2016.
The CRK QMS can also be externally validated by JASANZ accredited certification bodies.CRK's QMS has been produced specifically to ease the process and save your department valuable time on its pathway to compliance. Additionally, the CRK QMS facilitates standardisation on the implementation of standards throughout the country.
Quality is not just about making things right, it has to be a documented process that ensures practices and policies are being implemented in a suitable, safe and effective manner. A QMS allows for the prompt identification of issues, ideally before they arise; and certainly, before they have any impact on the patient or organisation.
No matter what your business, quality is an organisation wide responsibility. It is an organic process that goes beyond merely getting the certificate on the wall. The CRK QMS provides a platform to ensure that we all work together to achieve our goals and reduce risk as much as is feasibly possible.
Access to a compliant QMS to meet the requirements of external audit bodies to ISO 13485:2016 - meeting and exceeding the requirements of AS/NZS 4187:2014.
A standardised pathway to compliance and certification.
An easy to follow process for implementation.
Expert knowledge and support during the implementation process.
A full Quality Manual, Procedures, Forms, Work Instruction Templates and Technical File. Undertaking of Risk Analysis to ISO 14971:2007.
Undertaking of the initial Gap Analysis Audit prior to external certification.
Ongoing support once the QMS is implemented.