Certification and quality management systems

It depends on what you do. If you manufacture medical devices - ISO 13485 and an ISO 14971 risk file for international device registration. If you run a clinic - internal quality control. If you bid in tenders - ISO 9001 for scoring points. We choose the direction during a short brief.

For registering medical devices under international regulations, a quality management system is mandatory and its operation is checked by a production inspection. For clinics, internal quality control is a standing obligation. In tenders, an ISO 9001 certificate is not always mandatory but earns extra points.

Usually 30-60 documents: quality manual, SOPs, policies, record forms, risk management file, audit programmes and checklists. The exact scope depends on device risk classes, site size and whether it is a manufacturing site or a clinic.

Turnkey implementation takes 3-5 months: a readiness audit from 1 week, implementation and documentation roughly 2-12 weeks, then inspection prep before the conformity assessment. We fix the timeline after the gap analysis.

A QMS cannot be implemented once and forgotten. Maintenance means internal audits, document updates and recertification prep. We run this stage on a retainer so the system stays alive rather than going stale before the next inspection.

Passing an inspection cannot be guaranteed on behalf of a third party - and we do not promise it. We guarantee something else: fixing any findings against our documentation at our own expense. The methodology is validated by a specialist expert by device risk class.