MDSAP Audit Approach (MDSAP AU P0002) C1-T1: Plan, document and maintain the QMS with a risk-based approach to process control, manage QMS changes and keep a quality manual

What does C1-T1 require?

The organisation must plan its quality management system so that every process it needs is identified, documented, implemented, monitored and maintained to meet ISO 13485:2016 and the regulatory requirements of each MDSAP jurisdiction it supplies, and the objectives it sets, applying a risk-based approach to how tightly each process is controlled (for example giving installation more control than servicing where installation drives safety). QMS planning inputs (policy, objectives, standards, regulations, product requirements, required changes) and outputs (process descriptions and interactions, the quality manual, gap analyses, resource and competence needs, action plans) should be recorded, and planning repeated whenever the QMS changes. Changes to the QMS must be controlled so that the system and the devices stay conforming, and a quality manual must describe the documentation structure and process interactions. Clauses: ISO 13485:2016 4.1.1 to 4.1.4, 4.2.1, 4.2.2, 5.4.2; TG(MD)R Sch 3 Pt 1 cl 1.4(4); RDC 665/2022 Arts 4 and 106; MO169 Arts 5 to 7 and 14.