MDSAP Audit Approach (MDSAP AU P0002) C1-T3: Set a quality policy and measurable quality objectives at relevant functions and levels, consistent with the policy, and act to achieve them

What does C1-T3 require?

The organisation must have a quality policy and quality objectives set at the relevant functions and levels, with objectives that can be measured and that line up with the policy, and must take suitable action to meet them. Clauses: ISO 13485:2016 5.3 and 5.4.1; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(a); RDC 665/2022 Arts 5 to 7; MO169 Arts 12 and 13.

Maintained by Gerard Blokdyk

Other controls in Chapter 1: Management – 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
C1-T10 Distribute or offer devices only into markets where they hold the required marketing authorization, and license and label private-label devices for Canada correctly
C1-T11 Top management demonstrates commitment to an effective QMS and communicates its effectiveness, as judged across management, measurement and improvement, design, production and purchasing
C1-T2 Appoint and document a management representative responsible for QMS effectiveness, reporting to top management and promoting regulatory awareness
C1-T4 Define the organisational structure, responsibilities and authorities, and provide the people, infrastructure, competence and training needed to design and make devices as planned
C1-T5 Document the extent of outsourcing and the controls over outsourced processes, keep the supplier list current, and divide regulatory duties correctly with sponsors, importers and correspondents
C1-T6 Determine competence needs for work affecting quality, close gaps, check effectiveness in proportion to risk, keep competence records and qualify consultants
C1-T7 Top management commits to and owns risk management planning across the product life cycle, with documented methods, acceptability criteria and post-market updating of risk files

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All MDSAP Audit Approach (MDSAP AU P0002) controls