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ISO 13485:2016 Gap Analysis Checklist
This comprehensive checklist helps identify gaps between your current Quality Management System and ISO 13485:2016 requirements.
Claude Code Knowledge Pack7/10/2026
Overview
ISO 13485:2016 Gap Analysis Checklist
This comprehensive checklist helps identify gaps between your current Quality Management System and ISO 13485:2016 requirements.
How to Use This Checklist
Status Indicators:
- ✅ Compliant: Requirement fully implemented and documented
- ⚠️ Partial: Requirement partially implemented, needs improvement
- ❌ Non-compliant: Requirement not implemented or documented
- N/A Not Applicable: Requirement doesn't apply (must be justified)
For Each Item:
- Assess current status
- Identify existing documentation
- Note gaps or deficiencies
- Prioritize actions needed
- Assign responsibility and target dates
Clause 4: Quality Management System
4.1 General Requirements
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 4.1.1 | QMS established, documented, implemented, and maintained | ||||
| 4.1.2 | QMS processes identified with sequence and interaction | ||||
| 4.1.3 | Outsourced processes controlled and documented | ||||
| 4.1.4 | QMS requirements and applicable regulatory requirements met | ||||
| 4.1.5 | Risk management requirements documented and maintained | ||||
| 4.1.6 | Computer software applications validated before use |
4.2 Documentation Requirements
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 4.2.1 | QMS documentation includes policy, manual, procedures, records | ||||
| 4.2.2 | Quality Manual established with required content | ||||
| 4.2.2.a | Scope of QMS with justified exclusions | ||||
| 4.2.2.b | Documented procedures or references | ||||
| 4.2.2.c | Description of process interactions | ||||
| 4.2.2.d | Structure of documentation described | ||||
| 4.2.3 | Medical Device File established for each device type/family | ||||
| 4.2.3.a | General description and intended use documented | ||||
| 4.2.3.b | Label and IFU specifications | ||||
| 4.2.3.c | Product specifications | ||||
| 4.2.3.d | Manufacturing specifications | ||||
| 4.2.3.e | Purchasing, manufacturing, servicing procedures | ||||
| 4.2.3.f | Measurement and monitoring procedures | ||||
| 4.2.3.g | Installation requirements (if applicable) | ||||
| 4.2.3.h | Risk management file(s) | ||||
| 4.2.3.i | Verification and validation information | ||||
| 4.2.3.j | Design and development file(s) when applicable | ||||
| 4.2.4 | Control of Documents procedure established | ||||
| 4.2.4.a | Documents approved before issue | ||||
| 4.2.4.b | Documents reviewed, updated, and re-approved | ||||
| 4.2.4.c | Changes and current revision status identified | ||||
| 4.2.4.d | Relevant versions available at point of use | ||||
| 4.2.4.e | Documents remain legible and identifiable | ||||
| 4.2.4.f | External documents controlled | ||||
| 4.2.4.g | Obsolete documents prevented from unintended use | ||||
| 4.2.4.h | Obsolete documents identified if retained | ||||
| 4.2.5 | Control of Records procedure established | ||||
| 4.2.5.a | Records remain legible, identifiable, and retrievable | ||||
| 4.2.5.b | Changes to records remain identifiable | ||||
| 4.2.5.c | Retention time at least device lifetime | ||||
| 4.2.5.d | Storage, security, integrity, retrieval, disposition defined |
Clause 5: Management Responsibility
5.1 Management Commitment
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.1.a | Importance of meeting requirements communicated | ||||
| 5.1.b | Quality policy established | ||||
| 5.1.c | Quality objectives established | ||||
| 5.1.d | Management reviews conducted | ||||
| 5.1.e | Resource availability ensured |
5.2 Customer Focus
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.2 | Customer and regulatory requirements determined and met |
5.3 Quality Policy
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.3.a | Policy appropriate to organization | ||||
| 5.3.b | Includes commitment to meet requirements and maintain effectiveness | ||||
| 5.3.c | Provides framework for quality objectives | ||||
| 5.3.d | Communicated and understood within organization | ||||
| 5.3.e | Reviewed for continuing suitability |
5.4 Planning
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.4.1 | Quality objectives established at relevant functions/levels | ||||
| 5.4.1 | Objectives measurable and consistent with policy | ||||
| 5.4.2 | QMS planning meets general requirements and objectives | ||||
| 5.4.2 | QMS integrity maintained when changes occur |
5.5 Responsibility, Authority and Communication
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.5.1 | Responsibilities and authorities defined and communicated | ||||
| 5.5.1 | Roles for QMS management, performance, verification documented | ||||
| 5.5.1 | Interrelation of personnel identified | ||||
| 5.5.2 | Management representative appointed | ||||
| 5.5.2.a | Representative ensures QMS processes established and maintained | ||||
| 5.5.2.b | Representative reports to top management on performance | ||||
| 5.5.2.c | Representative ensures awareness of requirements | ||||
| 5.5.3 | Internal communication processes established |
5.6 Management Review
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 5.6.1 | QMS reviewed at planned intervals (at least annually) | ||||
| 5.6.1 | Review ensures suitability, adequacy, effectiveness | ||||
| 5.6.1 | Review includes improvement opportunities | ||||
| 5.6.1 | Records of reviews maintained | ||||
| 5.6.2 | Review includes audit results | ||||
| 5.6.2 | Review includes customer feedback | ||||
| 5.6.2 | Review includes process performance and product conformity | ||||
| 5.6.2 | Review includes status of corrective and preventive actions | ||||
| 5.6.2 | Review includes follow-up from previous reviews | ||||
| 5.6.2 | Review includes changes affecting QMS | ||||
| 5.6.2 | Review includes recommendations for improvement | ||||
| 5.6.2 | Review includes new/revised regulatory requirements | ||||
| 5.6.3 | Review output includes QMS improvements | ||||
| 5.6.3 | Review output includes product improvements | ||||
| 5.6.3 | Review output includes resource needs | ||||
| 5.6.3 | Review output includes changes to maintain effectiveness |
Clause 6: Resource Management
6.1 Provision of Resources
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 6.1 | Resources determined and provided for QMS | ||||
| 6.1 | Resources provided to meet regulatory and customer requirements |
6.2 Human Resources
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 6.2 | Personnel competent based on education, training, skills, experience | ||||
| 6.2 | Documented evidence of competence maintained |
6.3 Infrastructure
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 6.3 | Infrastructure determined, provided, and maintained | ||||
| 6.3.a | Buildings, workspace, and utilities provided | ||||
| 6.3.b | Process equipment (hardware and software) provided | ||||
| 6.3.c | Supporting services provided | ||||
| 6.3 | Maintenance requirements documented (when affecting quality) | ||||
| 6.3 | Maintenance activity records maintained |
6.4 Work Environment and Contamination Control
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 6.4.1 | Work environment determined and managed | ||||
| 6.4.1 | Work environment requirements documented | ||||
| 6.4.2 | Contamination control requirements documented (if applicable) | ||||
| 6.4.2 | Special arrangements for contaminated product established |
Clause 7: Product Realization
7.1 Planning of Product Realization
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 7.1.a | Quality objectives and requirements determined | ||||
| 7.1.b | Need for processes, documentation, and resources determined | ||||
| 7.1.c | Verification, validation, monitoring, measurement activities determined | ||||
| 7.1.c | Handling, storage, distribution, traceability determined | ||||
| 7.1.d | Records to provide evidence of conformity determined | ||||
| 7.1 | Risk management requirements documented | ||||
| 7.1 | Risk management records maintained |
7.2 Customer-Related Processes
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 7.2.1.a | Requirements specified by customer determined | ||||
| 7.2.1.b | Requirements not stated but necessary determined | ||||
| 7.2.1.c | Applicable regulatory requirements determined | ||||
| 7.2.1.d | Additional requirements determined by organization | ||||
| 7.2.2 | Product requirements reviewed before commitment | ||||
| 7.2.2 | Requirements defined and documented | ||||
| 7.2.2 | Differences resolved | ||||
| 7.2.2 | Ability to meet requirements ensured | ||||
| 7.2.2 | Records of review and follow-up maintained | ||||
| 7.2.3 | Arrangements for communication with customers documented | ||||
| 7.2.3.a | Communication on product information | ||||
| 7.2.3.b | Communication on inquiry, contract, order handling | ||||
| 7.2.3.c | Communication on customer feedback including complaints | ||||
| 7.2.3.d | Communication on advisory notices |
7.3 Design and Development
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 7.3.1 | Design and development procedures documented | ||||
| 7.3.1 | Design and development plan documented for each device | ||||
| 7.3.1 | Design and development files maintained | ||||
| 7.3.2 | Design and development stages determined | ||||
| 7.3.2 | Required review, verification, validation determined | ||||
| 7.3.2 | Responsibilities and authorities defined | ||||
| 7.3.2 | Resources and interfaces managed | ||||
| 7.3.2 | Plans updated as design progresses | ||||
| 7.3.3 | Design inputs determined and recorded | ||||
| 7.3.3 | Functional, performance, usability, safety requirements included | ||||
| 7.3.3 | Regulatory requirements and standards included | ||||
| 7.3.3 | Risk management outputs included | ||||
| 7.3.3 | Previous similar design information included | ||||
| 7.3.3 | Inputs reviewed for adequacy | ||||
| 7.3.4 | Design outputs meet input requirements | ||||
| 7.3.4 | Outputs provide information for purchasing, production, service | ||||
| 7.3.4 | Outputs contain acceptance criteria | ||||
| 7.3.4 | Outputs specify characteristics for safe and proper use | ||||
| 7.3.4 | Outputs documented and maintained as records | ||||
| 7.3.5 | Systematic reviews conducted at suitable stages | ||||
| 7.3.5 | Review evaluates ability to meet requirements | ||||
| 7.3.5 | Review identifies problems and proposes actions | ||||
| 7.3.5 | Representatives of functions concerned included | ||||
| 7.3.5 | Records of reviews and follow-up maintained | ||||
| 7.3.6 | Verification performed per planned arrangements | ||||
| 7.3.6 | Verification ensures outputs meet inputs | ||||
| 7.3.6 | Records of verification and follow-up maintained | ||||
| 7.3.7 | Validation performed per planned arrangements | ||||
| 7.3.7 | Validation ensures product meets specified application | ||||
| 7.3.7 | Validation conducted before delivery or implementation | ||||
| 7.3.7 | Validation includes defined operating conditions | ||||
| 7.3.7 | Records of validation and follow-up maintained | ||||
| 7.3.8 | Transfer procedures documented | ||||
| 7.3.8 | Manufacturing output verified against design output | ||||
| 7.3.8 | Specifications appropriate for manufacturing | ||||
| 7.3.8 | Transfer records maintained | ||||
| 7.3.9 | Design changes identified, documented, and controlled | ||||
| 7.3.9 | Changes reviewed, verified, validated, and approved | ||||
| 7.3.9 | Effects on constituent parts and delivered product evaluated | ||||
| 7.3.9 | Records of changes and review maintained | ||||
| 7.3.10 | Design and development files maintained including all required content |
7.4 Purchasing
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 7.4.1 | Purchased product conforms to purchase information | ||||
| 7.4.1 | Purchasing activities documented | ||||
| 7.4.1 | Criteria for supplier evaluation and selection established | ||||
| 7.4.1 | Criteria based on supplier ability to supply per requirements | ||||
| 7.4.1 | Supplier performance monitored | ||||
| 7.4.1 | Records of supplier evaluations and follow-up maintained | ||||
| 7.4.1 | Process for notifying suppliers of changes established | ||||
| 7.4.2 | Purchasing information includes product approval requirements | ||||
| 7.4.2 | Purchasing information includes qualification of personnel | ||||
| 7.4.2 | Purchasing information includes QMS requirements | ||||
| 7.4.2 | Purchasing information includes notification requirements | ||||
| 7.4.2 | Purchasing information includes supplier change notification | ||||
| 7.4.2 | Purchasing information communicated to sub-tier suppliers | ||||
| 7.4.3 | Verification activities to ensure purchased product conformity | ||||
| 7.4.3 | Extent of verification documented | ||||
| 7.4.3 | Verification at supplier's premises documented (if applicable) |
7.5 Production and Service Provision
| # | Requirement | Status | Evidence | Gaps | Action Required |
|---|---|---|---|---|---|
| 7.5.1.a | Documented procedures and work instructions available | ||||
| 7.5.1.b | Suitable infrastructure and work environment availa |