ISO Management Systems
ISO 13485 — Medical Device Quality Management
Medical Device Quality Management — consultancy for implementation and certification readiness.
What it addresses
Quality management requirements specific to the design, production and servicing of medical devices.
Who it is relevant to
- Medical device manufacturers
- Component suppliers
- Sterilisation and service providers
Typical consulting scope
- Gap assessment and implementation roadmap
- Policy, objectives, procedures and record formats
- Risk and opportunity assessment
- Awareness and internal auditor training
- Internal audit and management review support
- Coordination with an accredited certification body of your choice
Documents and inputs required
- Organisation profile, sites and headcount
- Products, services and key processes in scope
- Existing policies, procedures and records
- Applicable legal and customer requirements
- Organisation chart and responsibilities
- Any previous audit or certification reports
Implementation stages
- 01
Scoping call and context review
- 02
Gap assessment against the standard's clauses
- 03
Documentation and process design
- 04
Implementation workshops and awareness training
- 05
Internal audit and management review preparation
- 06
Certification-body selection and readiness review
- 07
Support during stage 1 / stage 2 assessment and corrective actions
Certification is granted by an independent certification body after its own audit. Foxwyn provides consultancy and application support only.
Part of ISO & Management Systems.
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