STRUCTURED QUALITY MANAGEMENT SYSTEMS FOR STERILE SERVICES

CSSD STANDARDS
Sterile Services Departments in both New Zealand and Australia have worked closely with Standards AUS & NZ to develop AS/NZS 4187:2014. The standards exist to identify the systems and processes required to monitor and control the environments in which Reusable Medical Devices are reprocessed Iwashed, packed and sterilised.

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.

WHAT DO WE OFFER?

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.

COMPLETE COMPLIANCE TO ISO 13485 & AS/NZS 4187

 
Ph: 09 276 3271
Email: qms@crknz.co.nz
CRKQMS ™ is a Trademark of C. R. Kennedy NZ Ltd
© 2019 C. R. Kennedy NZ Ltd
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Questions & Answers

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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.

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