and Objectives
– Define a quality policy that reflects the organization’s commitment to compliance, customer satisfaction, and continuous improvement.
– Establish measurable quality objectives, such as defect rates, on-time delivery, and customer complaint resolution times.

4.1.3 Documentation Requirements
– Develop and maintain required QMS documents, including:
– Standard Operating Procedures (SOPs)
– Work Instructions (WIs)
– Forms and Templates
– Records (e.g., training logs, calibration certificates)
– Ensure document control processes prevent unauthorized changes and ensure accessibility to authorized personnel.

4.2 Implementation of ISO 13485 Processes
4.2.1 Risk Management
– Implement risk management practices as per ISO 14971 to identify, evaluate, and mitigate risks associated with medical devices.
– Maintain a Risk Management File (RMF) for each device.

4.2.2 Design and Development
– Follow controlled processes for design and development, including design inputs, outputs, reviews, and validations.
– Document each stage of the design process in the Design History File (DHF).

4.2.3 Supplier Management
– Qualify and monitor suppliers to ensure the quality of materials and components.
– Maintain supplier approval records and conduct periodic audits.

4.2.4 Process Validation
– Validate manufacturing processes that impact product quality, such as sterilization, assembly, and packaging.
– Document validation activities in Process Validation Reports.

4.3 Monitoring and Measurement
4.3.1 Internal Audits
– Develop an internal audit schedule to assess compliance with ISO 13485 requirements.
– Use audit findings to implement corrective and preventive actions (CAPA).

4.3.2 Customer Feedback
– Establish a system for collecting and analyzing customer feedback, including complaints and returns.
– Use feedback to improve products and processes.

4.3.3 Performance Metrics
– Monitor key performance indicators (KPIs) such as defect rates, delivery times, and audit results.
– Regularly review metrics during management review meetings.

4.4 Management Review
4.4.1 Frequency
– Conduct management reviews at least annually to evaluate the effectiveness of the QMS.
– Include inputs such as audit findings, customer feedback, and performance metrics.

4.4.2 Agenda
– Review the following during management reviews:
– Status of quality objectives
– Results of audits and CAPA activities
– Changes in regulatory requirements
– Resource needs and process improvement opportunities

4.4.3 Documentation
– Document management review minutes, including decisions, action items, and responsible personnel.

4.5 Regulatory Compliance
4.5.1 Global Market Requirements
– Align the QMS with regulatory requirements for key markets, such as FDA CFR Title 21, Part 820 (U.S.) and EU MDR (European Union).
– Maintain documentation to demonstrate compliance during regulatory inspections.

4.5.2 Traceability
– Ensure traceability of materials, components, and finished products through batch/lot numbers and records.
– Maintain a Device Master Record (DMR) for each product.

4.5.3 Records Retention
– Retain QMS records for the duration required by regulatory agencies or product lifecycle requirements.
– Securely store records to prevent loss or unauthorized access.

4.6 Training and Continuous Improvement
4.6.1 Training
– Provide ISO 13485 training to all relevant personnel, including new hires and existing employees.
– Maintain training records to demonstrate compliance during audits.

4.6.2 Continuous Improvement
– Use tools such as root cause analysis, process mapping, and Six Sigma to identify and implement improvements.
– Regularly update QMS documents to reflect changes in processes or regulations.

5) Abbreviations

– QMS: Quality Management System
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– DHF: Design History File
– RMF: Risk Management File
– SOP: Standard Operating Procedure

6) Documents

– Quality Manual
– Risk Management File (RMF)
– Design History File (DHF)
– Internal Audit Reports
– Management Review Minutes
– Training Records

7) Reference

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

8) SOP Version

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

Annexure

Annexure 1: Internal Audit Report Template

Audit Date	Department	Findings	Classification	Corrective Actions	Auditor
DD/MM/YYYY	Department Name	Details of Findings	Major/Minor	Proposed Actions	Auditor Name

Annexure 2: Quality Objective Tracker Template

Objective	Target	Current Status	Responsible Team	Review Date
Reduce defect rate	< 1%	0.8%	Quality Control	DD/MM/YYYY