claude-scientific-skills/scientific-skills/iso-13485-certification/references/iso-13485-requirements.md

ISO 13485:2016 Requirements Breakdown

This document provides a comprehensive breakdown of ISO 13485:2016 requirements for medical device Quality Management Systems (QMS).

Table of Contents

1. Clause 4: Quality Management System
2. Clause 5: Management Responsibility
3. Clause 6: Resource Management
4. Clause 7: Product Realization
5. Clause 8: Measurement, Analysis and Improvement

Clause 4: Quality Management System

4.1 General Requirements

4.1.1 QMS Requirements

• Establish, document, implement, and maintain a QMS
• Maintain its effectiveness in accordance with ISO 13485
• Document the QMS processes and their interactions

4.1.2 Process Approach

• Identify processes needed for the QMS
• Determine sequence and interaction of these processes
• Determine criteria and methods for effective operation and control
• Ensure availability of resources and information
• Monitor, measure, and analyze processes
• Implement actions to achieve planned results and maintain effectiveness

4.1.3 Outsourced Processes

• Control any QMS process that is outsourced
• Ensure control is documented in the QMS
• Outsourcing does not relieve the organization of responsibility

4.1.4 General QMS Requirements

• Establish, document, implement, and maintain QMS requirements per ISO 13485
• Include requirements for medical devices and applicable regulatory requirements
• Establish documented procedures for QMS activities

4.1.5 Risk Management

• Establish documented requirements for risk management in product realization
• Maintain risk management records
• Ensure risk management is conducted according to documented requirements

4.1.6 Software Validation

• Validate computer software applications used in QMS
• Validation must be conducted prior to initial use and after changes
• Establish documented approach including:
  • Risk associated with the software application
  • Validation activities
  • Acceptance criteria
  • User responsibilities
  • Validation records

4.2 Documentation Requirements

4.2.1 General Documentation

QMS documentation must include:

• Quality policy and quality objectives
• Quality manual
• Documented procedures and records required by ISO 13485
• Documents required by organization for effective processes
• Records required by ISO 13485
• Medical device files as required by applicable regulatory requirements

4.2.2 Quality Manual

Establish and maintain a quality manual that includes:

• Scope of the QMS with details and justification for exclusions
• Documented procedures or reference to them
• Description of interaction between QMS processes
• Structure of documentation used in the QMS

4.2.3 Medical Device File

Establish and maintain a medical device file for each type or family that includes:

• General description, intended use/purpose
• Label and instructions for use specifications
• Specifications for product and/or manufacturing
• Specifications for procedures for purchasing, manufacturing, servicing
• Procedures for measuring and monitoring
• Installation requirements (if applicable)
• Risk management file(s)
• Verification and validation information
• Design and development file(s) when applicable

4.2.4 Control of Documents

Establish documented procedure to:

• Approve documents before issue
• Review, update, and re-approve documents
• Ensure changes and current revision status are identified
• Ensure relevant versions are available at points of use
• Ensure documents remain legible and readily identifiable
• Control distribution of documents
• Prevent unintended use of obsolete documents
• Apply suitable identification if retained for any purpose

Document changes must:

• Be reviewed and approved by original function unless otherwise designated
• Have access to pertinent background information
• Be identified in the document or appropriate attachments

4.2.5 Control of Records

Establish documented procedure for:

• Identification, storage, security, integrity, retrieval, retention time, and disposition
• Records must remain legible, readily identifiable, and retrievable
• Changes to records must remain identifiable
• Retention time must be at least the lifetime of the medical device
• Records may be stored on any media but must remain retrievable

Clause 5: Management Responsibility

5.1 Management Commitment

Top management must provide evidence of commitment by:

• Communicating importance of meeting regulatory and customer requirements
• Establishing quality policy
• Establishing quality objectives
• Conducting management reviews
• Ensuring availability of resources

5.2 Customer Focus

• Determine customer requirements and regulatory requirements
• Ensure customer requirements are met to enhance satisfaction
• Maintain documented requirements related to the medical device

5.3 Quality Policy

• Appropriate to the organization
• Includes commitment to meet requirements and maintain QMS effectiveness
• Provides framework for quality objectives
• Communicated and understood within organization
• Reviewed for continuing suitability

5.4 Planning

5.4.1 Quality Objectives

• Establish quality objectives at relevant functions and levels
• Must be measurable and consistent with quality policy
• Objectives must support conformity to product requirements

5.4.2 QMS Planning

• Plan to meet general requirements and quality objectives
• Maintain QMS integrity when changes are planned and implemented
• Document planning

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

• Define and communicate responsibilities and authorities
• Document roles that manage, perform, verify QMS work
• Identify interrelation of all personnel

5.5.2 Management Representative

Appoint a member of management who:

• Ensures QMS processes are established, implemented, and maintained
• Reports to top management on QMS performance and improvement needs
• Ensures promotion of awareness of regulatory and customer requirements

5.5.3 Internal Communication

• Ensure communication processes are established
• Ensure communication occurs regarding QMS effectiveness

5.6 Management Review

5.6.1 General

• Review QMS at planned intervals (at least annually)
• Review to ensure continuing suitability, adequacy, and effectiveness
• Include assessment of opportunities for improvement
• Maintain records of management reviews

5.6.2 Review Input

Include:

• Results of audits
• Customer feedback
• Process performance and product conformity
• Status of preventive and corrective actions
• Follow-up actions from previous reviews
• Changes affecting QMS
• Recommendations for improvement
• Applicable new or revised regulatory requirements

5.6.3 Review Output

Include decisions and actions related to:

• Improvements to QMS effectiveness and processes
• Product improvements related to customer requirements
• Resource needs
• Changes necessary to maintain QMS effectiveness

Clause 6: Resource Management

6.1 Provision of Resources

Determine and provide resources needed to:

• Implement and maintain QMS and its effectiveness
• Meet regulatory and customer requirements

6.2 Human Resources

6.2 General

Personnel performing work affecting product quality must be competent based on:

• Education, training, skills, and experience
• Documented evidence of competence

6.3 Infrastructure

Determine, provide, and maintain infrastructure including:

• Buildings, workspace, and associated utilities
• Process equipment (hardware and software)
• Supporting services

Infrastructure maintenance requirements:

• Document requirements including maintenance activities
• Document requirements when maintenance can affect product quality
• Maintain records of maintenance activities

6.4 Work Environment and Contamination Control

6.4.1 Work Environment

• Determine and manage work environment needed for product conformity
• Document requirements for work environment
• Document requirements if work environment can adversely affect product quality

6.4.2 Contamination Control

• When applicable to medical device, document requirements for control of contaminated or potentially contaminated product
• Establish special arrangements for control of contaminated product

Clause 7: Product Realization

7.1 Planning of Product Realization

Plan and develop processes needed for product realization including:

• Quality objectives and requirements for the product
• Need to establish processes, documentation, and resources
• Required verification, validation, monitoring, measurement, inspection, handling, storage, distribution, and traceability
• Records to provide evidence of conformity

Risk management requirements:

• Establish documented requirements for risk management throughout product realization
• Maintain risk management records

7.2 Customer-Related Processes

7.2.1 Determination of Requirements

Determine:

• Requirements specified by customer including delivery and post-delivery
• Requirements not stated but necessary for specified or intended use
• Applicable regulatory requirements
• Any additional requirements determined by organization

7.2.2 Review of Requirements

• Review product requirements before commitment
• Ensure requirements are defined and documented
• Ensure differences are resolved
• Ensure ability to meet requirements
• Maintain records of review results and follow-up actions

7.2.3 Communication

Establish and document effective arrangements for communication with customers concerning:

• Product information
• Inquiry, contract or order handling, amendments
• Customer feedback including complaints
• Advisory notices

7.3 Design and Development

7.3.1 General

• Establish, document, and maintain design and development procedures
• Document design and development plan for each medical device
• Maintain design and development files

7.3.2 Design and Development Planning

Plan and control design and development including:

• Stages of design and development
• Required review, verification, and validation activities
• Responsibilities and authorities
• Resources and interfaces
• Update plans as design progresses
• Document plans

7.3.3 Design and Development Inputs

• Determine inputs relating to product requirements
• Include functional, performance, usability, and safety requirements
• Include applicable regulatory requirements and standards
• Include applicable outputs of risk management
• Include appropriate information from previous similar designs
• Review inputs for adequacy and completeness
• Resolve incomplete, ambiguous, or conflicting requirements
• Maintain records

7.3.4 Design and Development Outputs

Provide outputs that:

• Meet design input requirements
• Provide appropriate information for purchasing, production, and service
• Contain or reference product acceptance criteria
• Specify characteristics essential for safe and proper use
• Document outputs and maintain as records

7.3.5 Design and Development Review

• Conduct systematic reviews at suitable stages
• Evaluate ability to meet requirements
• Identify problems and propose actions
• Include representatives of functions concerned
• Maintain records including results and follow-up actions

7.3.6 Design and Development Verification

• Perform verification per planned arrangements
• Ensure outputs meet input requirements
• Maintain records of verification results and follow-up actions

7.3.7 Design and Development Validation

• Perform validation per planned arrangements
• Ensure product meets specified application or intended use
• Conduct validation before delivery or implementation
• Include validation under defined operating conditions
• Maintain records of validation results and follow-up actions

7.3.8 Design and Development Transfer

• Document procedures for transfer to manufacturing
• Verify manufacturing output meets design output
• Ensure specification for materials, production, QC, servicing are appropriate
• Maintain records

7.3.9 Control of Design and Development Changes

• Identify, document, and control changes
• Review, verify, validate, and approve changes before implementation
• Evaluate effects on constituent parts, in-process product, and delivered product
• Maintain records of changes, review results, and follow-up actions

7.3.10 Design and Development Files

Establish and maintain design and development files for each type or family including:

• Design and development plan
• Design inputs
• Design outputs
• Design review, verification, validation records
• Design change records
• Risk management file

7.4 Purchasing

7.4.1 Purchasing Process

• Ensure purchased product conforms to purchase information
• Establish documented processes for purchasing activities
• Establish criteria for evaluation and selection of suppliers
• Base criteria on ability to supply per organization's requirements
• Monitor supplier performance
• Maintain records of evaluations and follow-up actions
• Establish process for notifying suppliers of changed product requirements

7.4.2 Purchasing Information

Purchasing information must include:

• Requirements for approval of product, procedures, processes, equipment
• Requirements for qualification of personnel
• Quality management system requirements
• Requirements for notification to organization of nonconforming product
• Agreement that suppliers provide notification of changes to purchased product
• Agreement that purchase information be communicated to sub-tier suppliers

7.4.3 Verification of Purchased Product

• Establish and implement inspection or other activities to ensure conformity
• Document extent of verification
• Verify at supplier's premises when customer intends to perform verification at supplier
• Document verification arrangements and method of product release

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

Plan and carry out production under controlled conditions including:

• Availability of documented procedures and work instructions
• Availability of suitable infrastructure and work environment
• Availability of monitoring and measuring equipment
• Availability and use of suitable monitoring and measuring activities
• Implementation of product release, delivery, and post-delivery activities
• Implementation of defined operations for labelling and packaging
• Procedures for servicing if applicable

Document requirements for:

• Control of product cleanliness if applicable
• Control during installation and verification if applicable

7.5.2 Cleanliness of Product

Document requirements if:

• Product is cleaned per specified requirements before sterilization and/or use
• Product cannot be cleaned before sterilization
• Product is supplied non-sterile to be cleaned and then sterilized

Establish requirements for product hygiene in manufacturing, handling, and storage.

7.5.3 Installation Activities

If applicable:

• Document requirements for installation and verification
• Maintain records of installation and verification

7.5.4 Servicing Activities

If servicing is specified requirement:

• Establish documented procedures, reference materials, and measurements for servicing
• Analyze records of servicing for feedback into post-production phase
• Maintain records of servicing activities

7.5.5 Particular Requirements for Sterile Medical Devices

Maintain records of process parameters for sterilization of each batch.

7.5.6 Validation of Processes

Validate processes where resulting output cannot be verified by subsequent monitoring or measurement, including:

• Defined criteria for review and approval
• Approval of equipment and qualification of personnel
• Use of specific methods, procedures, and acceptance criteria
• Requirements for records
• Revalidation including criteria for revalidation
• Approval of changes to process

Document requirements for validation of:

• Computer software used in production and service provision
• Sterilization processes
• Aseptic processing
• Clean room requirements if applicable

7.5.7 Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems

Maintain records of validation of:

• Sterilization processes for each batch
• Sterile barrier systems

7.5.8 Identification

• Establish documented procedures for product identification throughout realization
• Identify product by suitable means
• Maintain records of identification where traceability is a requirement

7.5.9 Traceability

7.5.9.1 General

Establish documented procedures defining extent of traceability including:

• Distribution and location of medical device

7.5.9.2 Particular Requirements

Document procedures to maintain records of:

• Name and address of shipping package consignee
• Identification of quantity shipped
• Include requirements of applicable regulatory requirements
• Maintain traceability records for defined period

7.5.10 Customer Property

• Exercise care with customer property while under organization's control
• Identify, verify, protect, and safeguard customer property
• Record and report to customer if lost, damaged, or unsuitable
• Maintain records

7.5.11 Preservation of Product

• Preserve product during internal processing and delivery
• Include identification, handling, packaging, storage, and protection
• Apply to constituent parts of product
• Document requirements for special handling if applicable

7.6 Control of Monitoring and Measuring Equipment

• Determine monitoring and measurement to be undertaken
• Determine monitoring and measuring equipment needed
• Establish documented procedures for:
  • Calibration or verification at specified intervals before use
  • Adjustment or re-adjustment as necessary
  • Identification to enable determination of calibration status
  • Safeguarding from adjustments that would invalidate calibration
  • Protection from damage and deterioration
• Assess and record validity of previous results when found not to conform
• Maintain records of calibration and verification
• Confirm ability of computer software to satisfy intended application when used
• Undertake confirmation before initial use and reconfirm as necessary

Clause 8: Measurement, Analysis and Improvement

8.1 General

• Plan and implement monitoring, measurement, analysis, and improvement processes
• Demonstrate product conformity
• Ensure QMS conformity
• Maintain QMS effectiveness
• Include determination of applicable methods including statistical techniques

8.2 Monitoring and Measurement

8.2.1 Feedback

Establish documented procedure for feedback including early warning system for:

• Post-production information including complaints
• Requirements for reporting to regulatory authorities
• Use as potential input to risk management for monitoring and maintaining product requirements
• Use as potential input for corrective and preventive action

8.2.2 Complaint Handling

Establish documented procedures for timely complaint handling including:

• Requirements and responsibilities for receiving, recording, and evaluating complaints
• Requirements and responsibilities for handling, investigating, and evaluating complaints
• Requirements and responsibilities for reporting complaint information to regulatory authorities
• Requirements for informing customer of organization's actions
• Requirements to ensure complaint information not handled by organization is transferred to organization
• Maintain records of complaints and investigations

8.2.3 Reporting to Regulatory Authorities

Establish documented procedures to:

• Provide notification to regulatory authorities per applicable requirements
• Provide advisory notices per applicable requirements
• Maintain records of reporting

8.2.4 Internal Audit

• Conduct internal audits at planned intervals
• Determine if QMS conforms to ISO 13485 and organization's requirements
• Determine if QMS is effectively implemented and maintained
• Plan audit program considering importance of processes, changes, and previous results
• Define audit criteria, scope, frequency, and methods
• Establish documented procedure for audits including responsibilities, requirements, and reporting
• Select objective and impartial auditors
• Maintain records of audits and results
• Identify need for corrections or corrective actions
• Conduct follow-up activities to verify implementation and effectiveness

8.2.5 Monitoring and Measurement of Processes

• Apply suitable methods for monitoring and measurement of QMS processes
• Demonstrate ability to achieve planned results
• Implement corrections and corrective actions when planned results not achieved
• Maintain records

8.2.6 Monitoring and Measurement of Product

• Monitor and measure product characteristics to verify conformity
• Conduct at appropriate stages per planned arrangements
• Maintain records showing conformity to acceptance criteria
• Record authority responsible for release
• Ensure product release and delivery not proceed until planned arrangements completed
• Allow release by relevant authority and customer when applicable

8.3 Control of Nonconforming Product

8.3.1 General

• Ensure nonconforming product is identified and controlled
• Establish documented procedures for:
  • Identification, documentation, evaluation, segregation, and disposition
  • Notification to external parties
  • Review of nonconforming product
• Maintain records of nonconformities and subsequent actions including concessions

8.3.2 Actions in Response to Nonconforming Product Detected Before Delivery

Deal with nonconforming product by:

• Taking action to eliminate detected nonconformity
• Authorizing use, release, or acceptance under concession per applicable regulatory requirements
• Taking action to preclude original intended use or application
• Taking action appropriate to effects of nonconformity when detected after delivery or use

Maintain records of concessions and identify authority making concession.

8.3.3 Actions in Response to Nonconforming Product Detected After Delivery

When nonconforming product detected after delivery or use:

• Take action appropriate to effects of nonconformity
• Establish documented procedure including notification requirements to regulatory authorities
• Maintain records

8.3.4 Rework

Establish documented procedures for rework including:

• Requirements to evaluate potential effects on medical device
• Approval before implementation
• Records of results and actions including nonconformities and rework
• Re-verification after rework
• Documentation of rework procedure before rework begins

8.4 Analysis of Data

• Determine, collect, and analyze appropriate data from monitoring and measurement
• Evaluate where continual improvement of QMS effectiveness can be made
• Establish documented procedures for:
  • Analysis of data to provide information on customer satisfaction
  • Analysis of conformity to product requirements
  • Analysis of characteristics and trends of processes and products including preventive action opportunities
  • Analysis of suppliers
  • Analysis of other relevant data including feedback and output from risk management
• Include use of statistical techniques if necessary
• Maintain records of analysis results

8.5 Improvement

8.5.1 General

• Identify and implement changes to ensure and maintain QMS effectiveness
• Include use of quality policy, objectives, audit results, data analysis, corrective and preventive actions, and management review

8.5.2 Corrective Action

• Establish documented procedures to:
  • Review nonconformities including complaints
  • Determine causes of nonconformities
  • Evaluate need for actions to ensure nonconformities do not recur
  • Plan and document actions needed and implement
  • Document results of actions taken
  • Review effectiveness of corrective actions taken
• Maintain records including investigation results and follow-up

8.5.3 Preventive Action

• Establish documented procedures to:
  • Determine potential nonconformities and their causes
  • Evaluate need for action to prevent occurrence
  • Plan and document actions needed and implement
  • Document results of actions taken
  • Review effectiveness of preventive actions taken
• Use appropriate sources of information including:
  • Work processes and operations affecting product quality
  • Concessions
  • Analysis of data and risk management outputs
  • Medical device performance data
  • Records of nonconformities
• Maintain records including investigation results and follow-up

Key Regulatory Updates

FDA QMSR Harmonization (Effective February 2, 2026)

• FDA 21 CFR Part 820 has been harmonized with ISO 13485:2016
• Renamed to QMSR (Quality Management System Regulation)
• Medical Device File (MDF) replaces separate DHF, DMR, and DHR
• Organizations should prepare for transition to unified documentation approach

References and Resources

This requirements breakdown is based on ISO 13485:2016, which was last reviewed and confirmed in 2025.

For additional guidance, refer to:

• ISO 13485:2016 standard document
• FDA Quality Management System Regulation (QMSR)
• Applicable regional regulatory requirements (EU MDR, Health Canada, etc.)