defines the scope of the QMS, key processes, and regulatory references, including 21 CFR 820.
– Include procedures for document control, record keeping, and regulatory compliance.

4.1.2 Quality Policy and Objectives
– Establish a quality policy demonstrating the organization’s commitment to product quality, safety, and compliance with regulatory requirements.
– Define measurable quality objectives aligned with QSR requirements.

4.1.3 Organizational Structure
– Define the organizational structure, roles, and responsibilities related to QMS activities.
– Assign a Management Representative to oversee compliance with QSR and liaise with the FDA.

4.2 Design and Development Controls
4.2.1 Design Planning
– Develop a Design and Development Plan outlining design inputs, outputs, and review stages.
– Ensure the plan includes risk management activities as per ISO 14971.

4.2.2 Design Documentation
– Maintain a Design History File (DHF) containing:
– Design and development plans.
– Design inputs and outputs.
– Verification and validation records.
– Design review minutes and approvals.

4.2.3 Design Transfer
– Document and validate the transfer of design to manufacturing to ensure reproducibility and compliance.

4.3 Document and Data Control
4.3.1 Document Management
– Implement a document control system to ensure that:
– Only approved versions of documents are accessible.
– Obsolete documents are removed or archived to prevent misuse.
– All changes are documented with version history and approvals.

4.3.2 Record Retention
– Retain records for the duration specified by FDA regulations or as defined in internal policies.
– Maintain a secure electronic or physical storage system to ensure records are accessible during FDA inspections.

4.4 Production and Process Controls
4.4.1 Process Validation
– Validate all production processes that affect product quality, including sterilization, packaging, and assembly.
– Maintain records of validation activities in Process Validation Reports.

4.4.2 Work Instructions and Specifications
– Provide clear and accessible work instructions, including process parameters and inspection criteria.
– Ensure operators are trained on these instructions.

4.4.3 Monitoring and Control
– Implement controls to monitor production processes, including environmental conditions and equipment calibration.
– Document any deviations and corrective actions taken.

4.5 Corrective and Preventive Actions (CAPA)
4.5.1 Non-Conformance Reporting
– Establish a system for identifying, documenting, and addressing non-conformities.
– Use Non-Conformance Reports (NCRs) to document deviations and initiate corrective actions.

4.5.2 Root Cause Analysis
– Conduct root cause analysis for non-conformities using tools such as the 5 Whys or Fishbone Diagram.
– Document findings and actions taken in the CAPA report.

4.5.3 Preventive Actions
– Implement preventive actions based on trends and audit findings.
– Record preventive measures and monitor their effectiveness.

4.6 Device Master Record (DMR)
4.6.1 Contents of the DMR
– Include the following in the DMR:
– Device specifications
– Production and process specifications
– Quality assurance procedures
– Packaging and labeling specifications

4.6.2 Maintenance
– Update the DMR whenever changes are made to processes, specifications, or materials.
– Ensure DMRs are accessible for FDA inspections.

4.7 Internal Audits and Management Reviews
4.7.1 Internal Audits
– Develop an annual audit schedule to assess compliance with 21 CFR 820.
– Use audit findings to identify gaps and improve processes.

4.7.2 Management Reviews
– Conduct management reviews at least annually to evaluate the effectiveness of the QMS.
– Include inputs such as audit results, CAPA effectiveness, and quality objectives.

4.8 Preparing for FDA Inspections
4.8.1 Inspection Readiness
– Maintain inspection-ready documentation, including training records, CAPA logs, and device master records.
– Conduct mock inspections to identify and address potential gaps.

4.8.2 Responding to FDA Observations
– Address FDA observations promptly with documented corrective actions.
– Submit a response to the FDA detailing actions taken to resolve issues.

5) Abbreviations

– QSR: Quality System Regulation
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– DHF: Design History File
– DMR: Device Master Record
– FDA: Food and Drug Administration
– NCR: Non-Conformance Report
– SOP: Standard Operating Procedure

6) Documents

– Quality Manual
– Design History File (DHF)
– Device Master Record (DMR)
– Non-Conformance Reports (NCR)
– CAPA Logs
– Process Validation Reports

7) Reference

– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 13485: Medical devices – Quality management systems
– ISO 14971: Application of Risk Management to Medical Devices

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Internal Audit Checklist Template

Section	Requirement	Compliance Status	Remarks
Document Control	Are documents controlled and up-to-date?	Compliant	All documents reviewed

Annexure 2: CAPA Log Template

CAPA ID	Description	Root Cause	Corrective Action	Status	Completion Date
CAPA-001	Deviation in sterilization process	Equipment malfunction	Equipment repair and recalibration	Completed	DD/MM/YYYY