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-# 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](#clause-4-quality-management-system)
-2. [Clause 5: Management Responsibility](#clause-5-management-responsibility)
-3. [Clause 6: Resource Management](#clause-6-resource-management)
-4. [Clause 7: Product Realization](#clause-7-product-realization)
-5. [Clause 8: Measurement, Analysis and Improvement](#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.)