FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

BiotechHealthcare22 minutes21 questions

1. Management Responsibility (820.20)

Have you established and documented a quality policy and quality objectives?*

820.20(a): Management with executive responsibility shall establish policy

Is there a designated management representative responsible for quality system requirements?*

820.20(b): Management representative with authority and responsibility

Do you conduct management reviews of the quality system at defined intervals?*

820.20(c): Review adequacy and changes needed

Have you established a quality plan that defines quality practices, resources, and activities?*

820.20(d): Quality planning to meet quality objectives

2. Design Controls (820.30)

Are design and development activities planned, documented, and controlled?*

820.30(a): Design controls required for Class II and III devices

Do design inputs include functional, performance, and regulatory requirements?*

820.30(c): Approved, documented design input requirements

Are design outputs reviewed and approved before release?*

820.30(d): Design output meets input requirements and is adequately reviewed

Do you conduct design reviews at appropriate stages with documented results?*

820.30(e): Formal documented reviews by qualified individuals

Is design verification performed to ensure outputs meet input requirements?*

820.30(f): Verification with documented results and conclusions

Is design validation performed under actual or simulated use conditions?*

820.30(g): Validation including initial production units, lots, or batches

3. Document & Change Controls (820.40)

Are all documents approved prior to issuance and distribution?*

820.40(a): Document control procedures for approval and distribution

Do you have a formal change control process for all design and quality system changes?*

820.40(b): Changes reviewed and approved before implementation

Are obsolete documents removed from all points of use and properly archived?*

820.40: Prevent unintended use of obsolete documents

4. Purchasing & Supplier Controls (820.50)

Do you evaluate and select suppliers based on their ability to meet requirements?*

820.50(a): Supplier evaluation and approval procedures

Do purchasing documents contain specifications and quality requirements?*

820.50(b): Purchasing data approved for adequacy

5. Production & Process Controls (820.70)

Are manufacturing processes validated and performed under controlled conditions?*

820.70(a): Process validation with documented procedures

Are inspection, measuring, and test equipment calibrated and maintained?*

820.72: Equipment calibration with documented procedures and schedules

Is finished device acceptance documented with traceability to manufacturing records?*

820.80: Receiving, in-process, and finished device acceptance activities

6. Corrective & Preventive Action (820.100)

Do you analyze quality data to identify existing and potential nonconformities?*

820.100(a): CAPA procedures for investigating and identifying causes

Are corrective actions implemented and verified for effectiveness?*

820.100(a): Corrective actions to eliminate causes of nonconformities

Do you implement preventive actions to eliminate causes of potential nonconformities?*

820.100(b): Preventive action based on quality data analysis

Please answer all required questions to see your results