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AS/NZS 4187:2014 Identified a requirement for a HCO’s (Health Care Organisations) to implement a QMS to meet the elements of the standard. HCO’s are defined as any organisation that provides medical/surgical care to the public. This also includes GP Surgeries, Dental Services and any other clinics that reprocess medical devices for reuse on multiple patients.
AS/NZS 4187:2014 is specifically designed for department who reprocess reusable instruments. This is therefore directed at Sterile Services departments, endoscope reprocessing facilities, etc.
Consideration should be given on the implementation of this standards where a product, or medical device is used on multiple individuals, ie Body piercing studios, Tattoo Studios, etc.
C R Kennedy manage all your document control in relation to the standard. Tis allows the customer to concentrate on the operational elements of the standards. In addition to this C R Kennedy also monitor the standard to ensure any updates or changes are controlled as required.
Yes. The external certification period of the standard is 3 years. Therefore, the commitment from the customer is for this period.
Access to your QMS documentation is via an online portal. If payment is not received, C R Kennedy may block your access rights to your account.
This is dependent on the resource available from the customer. Documentation will be provided to the customer within 1 Month of sign up. Assistance will be provided by C R Kennedy for the initial implementation meeting. This is included in the maintenance fee. Providing the resource is made available, there is no reason why your QMS will not be ready for external certification within the first 12 Months.
External compliance is the responsibility of the customer. C R Kennedy have provided a QMS which meets the requirements of the standards. The external auditor is there to review the effectiveness of a working QMS in the customers environment.
No. At this stage there is no mandatory requirement from the MoH to gain external certification. However, it is important from a customer’s perspective to ensure they have effectively implemented an effective QMS, which in turn, shows compliance, and has a positive impact on patient safety.
There are approximately 30 elements to fully comply with the standards. Tracking and Traceability is only one element of the standards. Therefore, you do need to implement a full QMS to meet such requirements.