--- title: "ISO 13485:2016 Mandatory Documents and Records" description: "This document provides a complete list of all mandatory documents and records required by ISO 13485:2016 for medical device Quality Management Systems." type: skill canonical_url: https://claudary.paisolsolutions.com/skills/mandatory-documents source: "Claudary" difficulty: intermediate author: "Claude Code Knowledge Pack" date: 2026-07-10T11:30:46.645Z license: CC-BY-4.0 attribution: "ISO 13485:2016 Mandatory Documents and Records — Claudary (https://claudary.paisolsolutions.com/skills/mandatory-documents)" --- # ISO 13485:2016 Mandatory Documents and Records This document provides a complete list of all mandatory documents and records required by ISO 13485:2016 for medical device Quality Management Systems. ## Overview # ISO 13485:2016 Mandatory Documents and Records This document provides a complete list of all mandatory documents and records required by ISO 13485:2016 for medical device Quality Management Systems. ## Overview ISO 13485:2016 requires organizations to establish and maintain **31 documented procedures** along with a **Quality Manual** and **Medical Device Files**. Additionally, numerous **records** must be maintained to provide evidence of conformity. **Important Notes:** - The 31 documented procedures do not need to be 31 separate documents - Multiple procedures can be combined into one document - One procedure can be split across multiple documents - Not all procedures may be applicable to every organization (exclusions must be justified) - Additional documentation may be required by applicable regulatory requirements ## 1. Quality Manual (Required by 4.2.2) **Description:** Foundational QMS document **Must Include:** - Scope of QMS with justified exclusions - Documented procedures or references to them - Description of interaction between QMS processes - Structure of documentation used in QMS **Applicable To:** All organizations --- ## 2. Medical Device File (Required by 4.2.3) **Description:** File for each medical device type or family **Must Include:** - General description and intended use - Label and instructions for use specifications - Product and/or manufacturing specifications - Procedures for purchasing, manufacturing, servicing - Measuring and monitoring procedures - Installation requirements (if applicable) - Risk management file(s) - Verification and validation information - Design and development file(s) when applicable **Applicable To:** All organizations for each device type/family --- ## 3. The 31 Documented Procedures ### Clause 4: Quality Management System #### 1. Risk Management Procedures (4.1.5) **Description:** Requirements for risk management throughout product realization **Must Address:** - Risk management methodology - Risk analysis and evaluation - Risk control measures - Risk acceptability criteria - Risk management review **Referenced Standard:** ISO 14971 #### 2. Software Validation Procedure (4.1.6) **Description:** Validation of computer software applications used in QMS **Must Address:** - Risk assessment of software - Validation approach and activities - Acceptance criteria - User responsibilities - Validation before initial use and after changes - Revalidation criteria #### 3. Control of Documents Procedure (4.2.4) **Description:** Control of all QMS documents **Must Address:** - Document approval before issue - Document review and update - Identification of changes and revision status - Availability of relevant document versions - Document legibility and identification - Control of external documents - Prevention of obsolete document use - Identification of retained obsolete documents #### 4. Control of Records Procedure (4.2.5) **Description:** Control of all QMS records **Must Address:** - Record identification - Storage and security - Integrity protection - Retrieval procedures - Retention time determination - Record disposition - Legibility requirements - Change identification ### Clause 5: Management Responsibility #### 5. Management Review Procedure (5.6.1) **Description:** Systematic review of QMS by top management **Must Address:** - Review frequency (at least annually) - Review agenda and inputs - Review outputs and actions - Attendee requirements - Record-keeping requirements #### 6. Internal Communication Procedure (5.5.3) **Description:** Communication regarding QMS effectiveness **Must Address:** - Communication channels - Communication frequency - Responsible parties - Topics to be communicated - Documentation of communications ### Clause 6: Resource Management #### 7. Human Resources/Competence Procedure (6.2) **Description:** Ensuring personnel competence **Must Address:** - Competence requirements determination - Training needs identification - Training provision and evaluation - Education, training, skills, and experience requirements - Competence records maintenance - Awareness of personnel contributions #### 8. Infrastructure Maintenance Procedure (6.3) **Description:** Maintenance of facilities and equipment (when affecting quality) **Must Address:** - Maintenance activities definition - Maintenance scheduling - Maintenance records - Impact on product quality - Verification after maintenance #### 9. Contamination Control Procedure (6.4.2) **Description:** Control of contaminated or potentially contaminated product (when applicable) **Must Address:** - Contamination identification - Contaminated product handling - Segregation requirements - Decontamination procedures - Special arrangements for control ### Clause 7: Product Realization #### 10. Customer Communication Procedure (7.2.3) **Description:** Communication with customers **Must Address:** - Product information provision - Inquiry, contract, order handling - Customer feedback including complaints - Advisory notices - Communication channels and responsibilities #### 11. Design and Development Procedures (7.3.1 - 7.3.10) **Description:** Control of design and development process **Must Address:** - Design and development planning - Input determination and review - Output provision and approval - Design reviews at suitable stages - Verification against inputs - Validation for intended use - Transfer to manufacturing - Change control - Design file maintenance #### 12. Purchasing Procedures (7.4.1) **Description:** Control of purchasing process **Must Address:** - Supplier evaluation and selection criteria - Supplier monitoring and re-evaluation - Supplier performance tracking - Purchasing controls - Supplier notification of changes - Communication to sub-tier suppliers #### 13. Verification of Purchased Product Procedure (7.4.3) **Description:** Verification that purchased product meets requirements **Must Address:** - Verification activities - Extent of verification - Method of product release - Verification at supplier's premises (if applicable) - Customer verification arrangements (if applicable) #### 14. Production and Service Provision Control Procedures (7.5.1) **Description:** Control of production and service activities **Must Address:** - Work instructions and documented procedures - Use of suitable equipment - Monitoring and measuring activities - Release, delivery, and post-delivery activities - Labelling and packaging operations - Servicing procedures (if applicable) #### 15. Product Cleanliness Procedures (7.5.2) **Description:** Control of product cleanliness (when applicable) **Must Address:** - Cleaning requirements and specifications - Cleaning before sterilization - Uncleanable product handling - Hygiene requirements in manufacturing - Cleaning verification #### 16. Installation and Verification Procedures (7.5.3) **Description:** Installation activities (when applicable) **Must Address:** - Installation requirements - Installation instructions - Verification of installation - Installation records - Responsible parties #### 17. Servicing Procedures (7.5.4) **Description:** Servicing activities (when applicable) **Must Address:** - Servicing requirements - Reference materials and measurements - Feedback analysis from servicing - Servicing records - Servicing notification to regulatory authorities #### 18. Process Validation Procedure (7.5.6) **Description:** Validation of processes where output cannot be verified **Must Address:** - Process validation for manufacturing - Computer software validation for production - Sterilization process validation - Aseptic processing validation - Clean room validation (if applicable) - Criteria for review and approval - Equipment approval and personnel qualification - Revalidation criteria and triggers #### 19. Sterilization and Sterile Barrier System Validation (7.5.7) **Description:** Validation of sterilization processes (when applicable) **Must Address:** - Sterilization method validation - Sterile barrier system validation - Process parameters for each batch - Validation of changes to sterilization - Maintenance of validation records #### 20. Product Identification and Traceability Procedures (7.5.8, 7.5.9) **Description:** Identification and traceability throughout realization **Must Address:** - Identification methods throughout realization - Traceability extent definition - Distribution and location tracking - Consignee identification - Quantity shipped identification - Retention period requirements - Applicable regulatory traceability requirements #### 21. Customer Property Procedure (7.5.10) **Description:** Control of customer-provided property **Must Address:** - Customer property identification - Verification of customer property - Protection and safeguarding - Loss, damage, or unsuitability reporting - Records of customer property #### 22. Preservation of Product Procedure (7.5.11) **Description:** Product preservation during processing and delivery **Must Address:** - Identification requirements - Handling requirements - Packaging requirements - Storage requirements - Protection requirements - Special handling (if applicable) - Application to constituent parts #### 23. Control of Monitoring and Measuring Equipment Procedure (7.6) **Description:** Calibration and control of measuring equipment **Must Address:** - Equipment identification - Calibration or verification intervals - Calibration methods and standards - Adjustment procedures - Identification of calibration status - Protection from invalid adjustments - Protection from damage - Assessment when found non-conforming - Computer software confirmation ### Clause 8: Measurement, Analysis and Improvement #### 24. Feedback Procedure (8.2.1) **Description:** Post-production information system **Must Address:** - Early warning system for quality issues - Post-production information collection - Complaint handling linkage - Reporting to regulatory authorities - Input to risk management - Input to corrective and preventive action - Feedback sources and channels #### 25. Complaint Handling Procedure (8.2.2) **Description:** Timely handling of complaints **Must Address:** - Complaint receipt and recording - Complaint evaluation and investigation - Determination of need for reporting to authorities - Determination of need for advisory notices - Information to customer about actions taken - Transfer of complaint information not directly handled - Complaint trending and analysis #### 26. Reporting to Regulatory Authorities Procedure (8.2.3) **Description:** Notification to regulatory authorities **Must Address:** - Determination of reportable events - Notification timeframes - Notification content requirements - Advisory notice requirements - Applicable regulatory requirements by region - Responsible parties for reporting #### 27. Internal Audit Procedure (8.2.4) **Description:** Conduct of internal audits **Must Address:** - Audit program planning - Audit criteria, scope, frequency, methods - Auditor selection and impartiality - Audit responsibilities and requirements - Audit reporting - Records of audits - Follow-up activities #### 28. Process Monitoring and Measurement Procedures (8.2.5) **Description:** Monitoring and measurement of QMS processes **Must Address:** - Process monitoring methods - Process measurement methods - Demonstration of achieving planned results - Implementation of corrections when needed - Corrective actions when processes fail #### 29. Product Monitoring and Measurement Procedures (8.2.6) **Description:** Monitoring and measurement of product **Must Address:** - Product acceptance criteria - Measurement at appropriate stages - Release authority identification - Release procedures - Records of conformity to criteria - Traceability to measuring authority #### 30. Control of Nonconforming Product Procedure (8.3) **Description:** Identification and control of nonconforming product **Must Address:** - Identification of nonconformity - Documentation requirements - Evaluation of nonconformity - Segregation of nonconforming product - Disposition of nonconforming product - Notification to external parties - Concession process (if applicable) - Rework procedures - Actions for nonconformity detected before delivery - Actions for nonconformity detected after delivery - Reporting requirements #### 31A. Corrective Action Procedure (8.5.2) **Description:** Elimination of causes of nonconformities **Must Address:** - Review of nonconformities including complaints - Cause determination methodology - Evaluation of need for action - Planning and documentation of actions - Implementation of actions - Effectiveness review of actions - Records of investigation and follow-up #### 31B. Preventive Action Procedure (8.5.3) **Description:** Elimination of causes of potential nonconformities **Must Address:** - Determination of potential nonconformities - Evaluation of need for action - Planning and documentation of actions - Implementation of actions - Effectiveness review of actions - Sources of information for preventive action - Records of investigation and follow-up --- ## Additional Required Documentation ### Analysis of Data Procedure (8.4) While not explicitly called out as requiring a "documented procedure," organizations must establish processes for: - Data determination, collection, and analysis - Evaluation of continual improvement opportunities - Statistical techniques (if applicable) - Analysis of: - Customer satisfaction - Conformity to product requirements - Process and product characteristics and trends - Suppliers - Other relevant data including feedback and risk management outputs --- ## Required Records by Clause ### Clause 4 Records - Software validation records (4.1.6) - Risk management records (4.1.5) - All records specified in documented procedures and work instructions - All records required by applicable regulatory requirements ### Clause 5 Records - Management review records (5.6.1) - Evidence of personnel competence (6.2) ### Clause 6 Records - Infrastructure maintenance records (6.3) - Personnel training and competence records (6.2) ### Clause 7 Records - Product requirements review and follow-up actions (7.2.2) - Design and development files (7.3.10) including: - Design and development plans - Design inputs - Design outputs - Design review records - Design verification records - Design validation records - Design change records - Risk management file - Design and development transfer records (7.3.8) - Supplier evaluation, selection, and monitoring (7.4.1) - Verification of purchased product (7.4.3) - Cleanliness of product records (7.5.2) - Installation and verification records (7.5.3) - Servicing activity records (7.5.4) - Sterilization process parameter records for each batch (7.5.5, 7.5.7) - Process validation records (7.5.6) - Product identification and traceability recor --- Source: [Claudary](https://claudary.paisolsolutions.com/skills/mandatory-documents) · https://claudary.paisolsolutions.com