ISO 13485 Certification - Medical Devices
ISO 13485 Medical Devices –Quality Management Systems-Requirements for regulatory purposes. Is your organisation concerned about threats to patients from your products?
ISO 13585 is the recognised medical device standard developed from ISO 9001 specifically for this particular sector. However, it must be emphasised that the standard only complements the technical requirements for medical device supply chain products and services. All organisations EFFECTIVELY implementing the requirements of ISO 13485 must take a risk to process-based approach to products used or produced thereby ensuring that they are safe and effective, whether these be raw materials, intermediates or finished goods.
A related standard, ISO 14969 acts as a complementary standard to ISO 13485 and provides guidance on the application of the requirements of the latter. It also provides approaches to the establishment of quality targets as well as the monitoring and measurement of process performance inthis particular industry sector. The effectiveness of the standard relies heavily on each supplier and/or producer taking a risk-based approach to the products and or services provided in the sector.
The ISO 13485 standard concerns producers and suppliers of medical devices.
A certificate issued by an independent, accredited certification body guarantees that a quality management system has been implemented, documented, used, maintained and improved by the supplier or producer of medical devices.
Benefits of 13485 certification:
- guarantees high quality of provided services and products
- reduces production loss rate
- reduces operational costs
- increases effectiveness across the whole organisation
- increases your customers‘ trust in you as a safe supplier or producer
Certified organisations can include URS and UKAS logos in their promotional activities.
"Realtime Technologies have found URS a very well organised certification body with very educated auditors in all of the standards we currently have (ISO 9001 and ISO 13485) and the standard we are currently implementing (AS 9100). All of the auditors were very clear in what they were looking for when raising an issue. All of the auditors Realtime Technologies have had the pleasure of dealing with were very approachable when they had a query on anything raised from the audit.
All the standards are very focused on Risk Assessment and URS drive this point across very effectively. Realtime Technologies created a Work Instruction to focus our attention to when an FMEA should be carried out so that all the relevant areas are covered from request for quotation stage to approving a new supplier etc.
Realtime Technologies have benefited hugely in KPI review and the requirement to collect data for various different KPI’s. These requirements allow Realtime Technologies to view the areas that need to be improved thus allowing Realtime Technologies to continually improve."
- Realtime Technologies Ltd, Dublin, Ireland (Client Testimonial)