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:

1. Assess current status
2. Identify existing documentation
3. Note gaps or deficiencies
4. Prioritize actions needed
5. Assign responsibility and target dates

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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

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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

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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

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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 available
7.5.1.c	Monitoring and measuring equipment available
7.5.1.d	Monitoring and measuring activities available and used
7.5.1.e	Product release, delivery, post-delivery activities implemented
7.5.1.f	Operations for labelling and packaging defined
7.5.1.g	Procedures for servicing documented (if applicable)
7.5.1	Requirements for product cleanliness documented
7.5.1	Requirements for installation and verification documented
7.5.2	Cleanliness requirements documented (if applicable)
7.5.2	Hygiene requirements in manufacturing documented
7.5.3	Installation requirements documented (if applicable)
7.5.3	Verification of installation conducted
7.5.3	Records of installation and verification maintained
7.5.4	Servicing procedures documented (if applicable)
7.5.4	Servicing records analyzed for feedback
7.5.4	Records of servicing maintained
7.5.5	Records of sterilization process parameters maintained (if applicable)
7.5.6	Processes validated where output cannot be verified
7.5.6	Defined criteria for review and approval
7.5.6	Equipment approval and personnel qualification
7.5.6	Specific methods, procedures, and acceptance criteria used
7.5.6	Requirements for records defined
7.5.6	Revalidation criteria defined
7.5.6	Software validation for production documented
7.5.6	Sterilization process validation documented (if applicable)
7.5.6	Aseptic processing validation documented (if applicable)
7.5.6	Clean room validation documented (if applicable)
7.5.7	Sterilization process validation records maintained (if applicable)
7.5.7	Sterile barrier system validation records maintained (if applicable)
7.5.8	Product identification procedures documented
7.5.8	Product identified by suitable means throughout realization
7.5.8	Records of identification maintained where traceability required
7.5.9.1	Traceability extent defined and documented
7.5.9.1	Distribution and location documented
7.5.9.2	Consignee name and address recorded
7.5.9.2	Quantity shipped recorded
7.5.9.2	Regulatory traceability requirements included
7.5.9.2	Traceability records maintained for defined period
7.5.10	Customer property identified, verified, protected (if applicable)
7.5.10	Loss, damage, unsuitability reported to customer
7.5.10	Records of customer property maintained
7.5.11	Product preservation during processing and delivery
7.5.11	Identification, handling, packaging, storage, protection included
7.5.11	Preservation applies to constituent parts
7.5.11	Special handling requirements documented (if applicable)

7.6 Control of Monitoring and Measuring Equipment

#	Requirement	Status	Evidence	Gaps	Action Required
7.6	Monitoring and measurement to be undertaken determined
7.6	Monitoring and measuring equipment needed determined
7.6.a	Calibration or verification at specified intervals
7.6.b	Adjustment or re-adjustment as necessary
7.6.c	Identification to determine calibration status
7.6.d	Safeguarding from adjustments invalidating calibration
7.6.e	Protection from damage and deterioration
7.6	Validity of previous results assessed when non-conforming
7.6	Records of calibration and verification maintained
7.6	Computer software confirmed for intended application
7.6	Software confirmation before initial use and reconfirmation

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Clause 8: Measurement, Analysis and Improvement

8.1 General

#	Requirement	Status	Evidence	Gaps	Action Required
8.1	Monitoring, measurement, analysis, improvement processes planned
8.1	Product conformity demonstrated
8.1	QMS conformity ensured
8.1	QMS effectiveness maintained
8.1	Applicable methods including statistical techniques determined

8.2 Monitoring and Measurement

#	Requirement	Status	Evidence	Gaps	Action Required
8.2.1	Feedback procedure established
8.2.1	Early warning system for quality issues established
8.2.1	Post-production information collected
8.2.1	Requirements for regulatory reporting included
8.2.1	Feedback used as input to risk management
8.2.1	Feedback used as input to corrective/preventive action
8.2.2	Complaint handling procedure established
8.2.2	Requirements for receiving, recording, evaluating complaints
8.2.2	Requirements for handling, investigating complaints
8.2.2	Requirements for reporting to regulatory authorities
8.2.2	Requirements for informing customer of actions
8.2.2	Complaint information transferred to organization
8.2.2	Records of complaints and investigations maintained
8.2.3	Regulatory reporting procedure established
8.2.3	Notification to regulatory authorities per requirements
8.2.3	Advisory notices per applicable requirements
8.2.3	Records of reporting maintained
8.2.4	Internal audits conducted at planned intervals
8.2.4	QMS conformity to ISO 13485 and requirements determined
8.2.4	QMS effective implementation and maintenance determined
8.2.4	Audit program considers importance, changes, previous results
8.2.4	Audit criteria, scope, frequency, methods defined
8.2.4	Audit procedure includes responsibilities and reporting
8.2.4	Objective and impartial auditors selected
8.2.4	Records of audits and results maintained
8.2.4	Need for corrections or corrective actions identified
8.2.4	Follow-up activities conducted
8.2.5	Suitable methods for process monitoring and measurement
8.2.5	Ability to achieve planned results demonstrated
8.2.5	Corrections and corrective actions implemented when needed
8.2.5	Records maintained
8.2.6	Product characteristics monitored and measured
8.2.6	Conducted at appropriate stages per planned arrangements
8.2.6	Records show conformity to acceptance criteria
8.2.6	Authority responsible for release recorded
8.2.6	Release and delivery not proceed until arrangements completed

8.3 Control of Nonconforming Product

#	Requirement	Status	Evidence	Gaps	Action Required
8.3.1	Nonconforming product identified and controlled
8.3.1	Procedure for identification, documentation established
8.3.1	Procedure for evaluation, segregation, disposition established
8.3.1	Procedure for notification to external parties established
8.3.1	Review of nonconforming product conducted
8.3.1	Records of nonconformities and actions maintained
8.3.2	Action taken to eliminate detected nonconformity
8.3.2	Use under concession authorized (if applicable)
8.3.2	Action taken to preclude original intended use
8.3.2	Records of concessions maintained
8.3.2	Authority making concession identified
8.3.3	Appropriate action for nonconformity after delivery
8.3.3	Procedure includes regulatory notification requirements
8.3.3	Records maintained
8.3.4	Rework procedures documented
8.3.4	Potential effects on medical device evaluated
8.3.4	Approval before rework implementation
8.3.4	Records of results and actions maintained
8.3.4	Re-verification after rework
8.3.4	Rework procedure documented before beginning

8.4 Analysis of Data

#	Requirement	Status	Evidence	Gaps	Action Required
8.4	Appropriate data determined, collected, and analyzed
8.4	Continual improvement opportunities evaluated
8.4	Procedures for data analysis established
8.4.a	Analysis provides information on customer satisfaction
8.4.b	Analysis of conformity to product requirements
8.4.c	Analysis of process and product characteristics and trends
8.4.d	Analysis of suppliers
8.4.e	Analysis of feedback and risk management outputs
8.4	Statistical techniques used if necessary
8.4	Records of analysis results maintained

8.5 Improvement

#	Requirement	Status	Evidence	Gaps	Action Required
8.5.1	Changes identified and implemented to ensure effectiveness
8.5.1	Quality policy, objectives, audits, data, CAPA, reviews used
8.5.2	Corrective action procedure established
8.5.2.a	Nonconformities including complaints reviewed
8.5.2.b	Causes of nonconformities determined
8.5.2.c	Need for actions to prevent recurrence evaluated
8.5.2.d	Actions needed planned, documented, and implemented
8.5.2.e	Results of actions documented
8.5.2.f	Effectiveness of corrective actions reviewed
8.5.2	Records of investigation and follow-up maintained
8.5.3	Preventive action procedure established
8.5.3.a	Potential nonconformities and causes determined
8.5.3.b	Need for action to prevent occurrence evaluated
8.5.3.c	Actions needed planned, documented, and implemented
8.5.3.d	Results of actions documented
8.5.3.e	Effectiveness of preventive actions reviewed
8.5.3	Appropriate information sources used
8.5.3	Records of investigation and follow-up maintained

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Summary and Prioritization

Gap Summary by Clause

Clause	Total Items	Compliant	Partial	Non-Compliant	N/A	Compliance %
4. QMS
5. Management
6. Resources
7. Product Realization
8. Measurement & Improvement
TOTAL

Priority Actions

Critical (Immediate Action Required): 1. 2. 3.

High Priority (Within 30 days): 1. 2. 3.

Medium Priority (Within 90 days): 1. 2. 3.

Low Priority (Within 180 days): 1. 2. 3.

Resource Requirements

Personnel:

Training:

Tools/Systems:

External Support:

Timeline and Milestones

Milestone	Target Date	Responsible	Status
Gap analysis completion
Priority 1 items complete
Priority 2 items complete
Priority 3 items complete
Internal audit readiness
Certification audit

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Notes and Additional Considerations

Regulatory Requirements

Document any additional requirements beyond ISO 13485:

• FDA QMSR requirements
• EU MDR/IVDR requirements
• Health Canada requirements
• Other regional requirements

Exclusions

Document and justify any clause exclusions:

Clause	Exclusion	Justification

Additional Documentation Needed

List any additional documents identified during gap analysis:

Lessons Learned and Best Practices

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Revision History

Version	Date	Author	Changes
1.0			Initial gap analysis