We can fully manage the introduction, implementation and certification of ISO 13485 in your company. This service entails the presence of one of our consultants on-site for one to three days per week, depending on the timescales involved, for the duration of the project. A typical timeframe is six to twelve months, depending on the resources available and the level of documentation already in place.
During this time the consultant will act as an interim quality manager, thus providing continuity throughout the project. The following activities are included in this service:
- Project planning (a detailed map of the activities to the completion of the project)
- Document preparation (including industry specific templates, customised to your business)
- Delivery and co-ordination of the required training throughout the project
- Document and change control administration
- Liaising with external bodies on quality and regulatory matters
- Co-coordinating the external audits and ensuring that the company is adequately prepared prior to the audits
- Support the preparation of formal responses to the external audits
Please contact us and we will provide you with a quote based on the extent of your current documentation and the relevant ISO standard.
If you are interested in our ISO program management service, please contact us and we can arrange a free consultation at your premises.
Please click here for further detail on the initial consultation.