--- title: "ISO 13485:2016 Requirements Breakdown" description: "This document provides a comprehensive breakdown of ISO 13485:2016 requirements for medical device Quality Management Systems (QMS)." type: skill canonical_url: https://claudary.paisolsolutions.com/skills/iso-13485-requirements source: "Claudary" difficulty: intermediate author: "Claude Code Knowledge Pack" date: 2026-07-10T11:30:19.177Z license: CC-BY-4.0 attribution: "ISO 13485:2016 Requirements Breakdown — Claudary (https://claudary.paisolsolutions.com/skills/iso-13485-requirements)" --- # ISO 13485:2016 Requirements Breakdown This document provides a comprehensive breakdown of ISO 13485:2016 requirements for medical device Quality Management Systems (QMS). ## Overview # 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 req --- Source: [Claudary](https://claudary.paisolsolutions.com/skills/iso-13485-requirements) · https://claudary.paisolsolutions.com