MDSAP Audit Approach (MDSAP AU P0002)

Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C3-T11: Feed nonconforming product, QMS nonconformity, correction, corrective and preventive action information into management review

What does C3-T11 require?

Management review inputs must include relevant information on nonconforming product, QMS nonconformities and the corrections, corrective and preventive actions taken. Clauses: ISO 13485:2016 5.6.2; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(b)(iii); RDC 665/2022 Arts 12 and 120 VII; MO169 Art 19.

Maintained by Gerard Blokdyk

Other controls in Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

C3-T1 Establish documented measurement, analysis and improvement procedures covering monitoring of product conformity, early-warning feedback, CAPA and dissemination of quality problem information
C3-T10 Run planned internal audits under a documented procedure with trained, independent auditors, and follow up findings with corrections, corrective actions and verification
C3-T12 Gather and evaluate post-production experience, including complaints and post-market surveillance, feed it into improvement and risk management, and (for Australia) pass serious problem and proposed recall information to the TGA or sponsor as soon as practicable
C3-T12-BR-US Keep complaint handling procedures and records that meet ANVISA and FDA rules: a designated unit, documented decisions not to investigate, mandatory investigation of failures and reportable events, and complete investigation records
C3-T12-CA For Canada, keep problem and complaint records, run effective investigation and recall procedures, prepare periodic summary reports with critical benefit-risk analysis and notify the Minister within 72 hours of a changed benefit-risk conclusion
C3-T12-CYBER For devices with software or programmable logic, collect cybersecurity feedback (vulnerability reports, incidents, threat intelligence) after release and feed it into risk management, improvement and design change
C3-T13 Exchange relevant information with external organisations whose activities contributed to a complaint, and keep records of it
C3-T14-T15 Evaluate every complaint for adverse event reportability and every quality problem in distributed product for an advisory notice, under documented procedures with recorded rationale for decisions not to report or not to act

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