ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit
This checklist covers compliance requirements under Medical Devices Rules 2017 and applicable Indian regulations for healthcare operations. Non-compliance can result in cancellation of manufacturing licence and penalties up to ₹10 lakh under Section 27 of the Drugs & Cosmetics Act 1940.
- Industry: Healthcare
- Frequency: Quarterly
- Estimated Time: 25-35 minutes
- Role: Quality Director
- Total Items: 20
- Compliance: Medical Devices Rules 2017, CDSCO MD Guidance, IS 13485, MDR 2017 Schedule 3
CDSCO Licence & GMP Registration
Verify Drugs & Cosmetics Act 1940 manufacturing licence and Schedule M GMP registration.
- Is the manufacturing licence (Form 25 or 28) valid and current for all products manufactured?
- Is a qualified Technical Staff person (B.Pharm or equivalent) appointed and approved by the licencing authority?
- Is the manufacturing site registered with CDSCO for export and does it comply with Schedule M GMP requirements?
- Attach photo of manufacturing licence Form 25/28, Technical Staff appointment, and CDSCO registration:
Premises, Equipment & Utilities Compliance
Verify GMP premises qualification, utilities, and equipment calibration per Schedule M.
- Are all premises, equipment, and utilities qualified per Schedule M GMP and validation master plan?
- Is the water system (Purified Water or WFI) tested per pharmacopoeial limits with records maintained?
- Are all analytical instruments calibrated with valid calibration certificates on file?
- Attach photo of cleanroom qualification, water system test results, and calibration certificates:
Batch Records & OOS Investigation
Verify BMR completeness, OOS investigation compliance, and QA release per Schedule M.
- Is the batch manufacturing record (BMR) complete, reviewed by QA, and available for every batch?
- Is the out-of-specification (OOS) procedure followed and all OOS investigations documented?
- Overall cGMP production and QA compliance status:
- Attach photo of batch manufacturing record, OOS investigation file, and QA release stamp:
CAPA, Complaints & Pharmacovigilance
Verify CAPA system effectiveness and ADR/pharmacovigilance compliance per CDSCO requirements.
- Is the CAPA system effectively identifying, investigating, and preventing recurrence of quality issues?
- Are product complaints investigated and Adverse Drug Reactions (ADRs) reported to CDSCO PvPI portal?
- Number of open CAPAs beyond target closure date:
- Quality Director or Head of Quality certification:
Corrective Actions & Inspector Sign-Off
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- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
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Why Use This ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit?
This iso 13485:2016 & medical devices rules 2017 india qms audit helps healthcare teams maintain compliance and operational excellence. Designed for quality director professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with Medical Devices Rules 2017, CDSCO MD Guidance, IS 13485, MDR 2017 Schedule 3. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What is a ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit?
A ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit is a standardized inspection form used by quality director to ensure consistent healthcare operations. It contains 27 inspection points organized into 5 sections. FREE PDF - ISO 13485:2016 & Medical Devices Rules 2017 India QMS compliance checklist for Indian operations. Covers Medical Devices Rules 2017 requirements. Download FREE template.
How often should I use this healthcare checklist?
This checklist is designed to be completed quarterly. Regular use ensures compliance with Medical Devices Rules 2017 and CDSCO MD Guidance and helps identify issues before they become problems.
Can I download this ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 27 fields across 5 sections and typically takes 25-35 minutes to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with Medical Devices Rules 2017, CDSCO MD Guidance, IS 13485, MDR 2017 Schedule 3. Following these standards protects your organization and ensures best practices.
How do I complete this healthcare inspection checklist?
Begin by completing the header fields for Facility / Unit Name, Inspection Date, Inspector Name & Designation, and Factory/Registration Number. Work through each of the 5 sections, marking items Yes or No as applicable. Add notes for any issues found. Finally, complete the footer fields and add your signature. The entire process takes approximately 25 to 35 minutes.
What are the key sections in this healthcare checklist?
This healthcare checklist is organized into 5 key sections: CDSCO Licence & GMP Registration, Premises, Equipment & Utilities Compliance, Batch Records & OOS Investigation, CAPA, Complaints & Pharmacovigilance, Corrective Actions & Inspector Sign-Off. Each section contains specific inspection points that quality director must verify. The structured layout ensures nothing is missed during healthcare inspections and makes the process efficient, typically taking 25-35 minutes to complete.
Who should use this ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit?
This checklist is primarily designed for quality director working in healthcare operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that healthcare standards are being met. Organizations of all sizes can benefit from using this ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit to maintain consistency and accountability.