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-# 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 records (7.5.8, 7.5.9)
-  - Including distribution records with consignee name/address and quantity (7.5.9.2)
-- Customer property records (7.5.10)
-- Calibration and verification records (7.6)
-
-### Clause 8 Records
-- Post-production feedback and complaints (8.2.1, 8.2.2)
-- Complaint investigations (8.2.2)
-- Regulatory authority reporting (8.2.3)
-- Internal audit records (8.2.4)
-- Process monitoring and measurement results (8.2.5)
-- Product monitoring and measurement records (8.2.6)
-- Product release authority (8.2.6)
-- Nonconforming product records (8.3.1)
-- Concession records and authority (8.3.2)
-- Nonconforming product actions after delivery (8.3.3)
-- Rework procedures and results (8.3.4)
-- Data analysis results (8.4)
-- Corrective action records including investigation and follow-up (8.5.2)
-- Preventive action records including investigation and follow-up (8.5.3)
-
----
-
-## Documentation Matrix
-
-| Clause | Document Type | Document Name | Mandatory? | Records Required? |
-|--------|--------------|---------------|------------|-------------------|
-| 4.2.2 | Manual | Quality Manual | Yes | No |
-| 4.2.3 | File | Medical Device File | Yes (per device) | Yes |
-| 4.1.5 | Procedure | Risk Management | Yes | Yes |
-| 4.1.6 | Procedure | Software Validation | Yes | Yes |
-| 4.2.4 | Procedure | Control of Documents | Yes | No |
-| 4.2.5 | Procedure | Control of Records | Yes | No |
-| 5.5.3 | Procedure | Internal Communication | Yes | No |
-| 5.6.1 | Procedure | Management Review | Yes | Yes |
-| 6.2 | Procedure | Competence/Training | Yes | Yes |
-| 6.3 | Procedure | Infrastructure Maintenance | When applicable | Yes |
-| 6.4.2 | Procedure | Contamination Control | When applicable | Yes |
-| 7.2.3 | Procedure | Customer Communication | Yes | Yes |
-| 7.3.1-10 | Procedures | Design and Development | When applicable | Yes |
-| 7.4.1 | Procedure | Purchasing | Yes | Yes |
-| 7.4.3 | Procedure | Verification of Purchased Product | Yes | Yes |
-| 7.5.1 | Procedures | Production Control | Yes | Yes |
-| 7.5.2 | Procedure | Product Cleanliness | When applicable | Yes |
-| 7.5.3 | Procedure | Installation | When applicable | Yes |
-| 7.5.4 | Procedure | Servicing | When applicable | Yes |
-| 7.5.6 | Procedure | Process Validation | When applicable | Yes |
-| 7.5.7 | Procedure | Sterilization Validation | When applicable | Yes |
-| 7.5.8 | Procedure | Product Identification | Yes | Yes |
-| 7.5.9 | Procedure | Traceability | Yes | Yes |
-| 7.5.10 | Procedure | Customer Property | When applicable | Yes |
-| 7.5.11 | Procedure | Preservation of Product | Yes | Yes |
-| 7.6 | Procedure | Control of M&M Equipment | Yes | Yes |
-| 8.2.1 | Procedure | Feedback | Yes | Yes |
-| 8.2.2 | Procedure | Complaint Handling | Yes | Yes |
-| 8.2.3 | Procedure | Regulatory Reporting | Yes | Yes |
-| 8.2.4 | Procedure | Internal Audit | Yes | Yes |
-| 8.2.5 | Procedure | Process Monitoring | Yes | Yes |
-| 8.2.6 | Procedure | Product Monitoring | Yes | Yes |
-| 8.3 | Procedure | Control of Nonconforming Product | Yes | Yes |
-| 8.4 | Process | Analysis of Data | Yes | Yes |
-| 8.5.2 | Procedure | Corrective Action | Yes | Yes |
-| 8.5.3 | Procedure | Preventive Action | Yes | Yes |
-
----
-
-## Common Additional Documents (Not Required by ISO 13485 but Often Needed)
-
-While not explicitly required by ISO 13485, the following documents are commonly needed for effective QMS operation and regulatory compliance:
-
-### Work Instructions
-- Manufacturing work instructions
-- Testing work instructions
-- Inspection work instructions
-- Cleaning instructions
-- Equipment operation instructions
-
-### Forms and Templates
-- Training records forms
-- Calibration forms
-- Audit checklists
-- Complaint forms
-- CAPA forms
-- Change request forms
-- Document review forms
-- Supplier evaluation forms
-
-### Additional Plans
-- Quality plan
-- Product realization plan
-- Validation plans
-- Clinical evaluation plans
-- Post-market surveillance plans
-
-### Technical Documentation
-- Product specifications
-- Material specifications
-- Test methods and protocols
-- Packaging specifications
-- Labeling artwork
-- Instructions for use
-
-### Regulatory Documentation
-- Technical files (EU MDR/IVDR)
-- 510(k) submissions (FDA)
-- Clinical evaluation reports
-- Post-market surveillance reports
-- Periodic safety update reports
-
----
-
-## Tips for Document Management
-
-### Combining Procedures
-Multiple procedures can be combined into single documents, such as:
-- "Corrective and Preventive Action (CAPA) Procedure" (combines 8.5.2 and 8.5.3)
-- "Document and Record Control Procedure" (combines 4.2.4 and 4.2.5)
-- "Monitoring and Measurement Procedure" (combines 8.2.5 and 8.2.6)
-- "Product Identification and Traceability Procedure" (combines 7.5.8 and 7.5.9)
-
-### Determining Applicability
-Not all procedures apply to all organizations. Common exclusions include:
-- Design and development (when only manufacturing per customer specifications)
-- Installation (when product doesn't require installation)
-- Servicing (when not offered)
-- Sterilization (when product is non-sterile)
-- Contamination control (when not applicable to product type)
-
-All exclusions must be justified in the Quality Manual.
-
-### Regulatory Requirements
-Remember that applicable regulatory requirements may mandate additional documentation beyond ISO 13485, including:
-- FDA regulations (21 CFR Part 820 / QMSR)
-- EU MDR/IVDR requirements
-- Health Canada requirements
-- Other regional regulatory requirements
-
----
-
-## Record Retention
-
-Per ISO 13485:2016 (4.2.5), records must be retained for:
-- **Minimum:** The lifetime of the medical device as defined by the organization
-- **Additional:** Not less than the retention period of any resulting record
-- **Regulatory:** As specified by applicable regulatory requirements
-
-Organizations must define the "lifetime" of their medical devices and establish retention times that meet or exceed:
-- ISO 13485 minimum requirements
-- Applicable regulatory requirements (often 5-10 years minimum)
-- Any customer contractual requirements
-
----
-
-## Transition to Medical Device File (MDF)
-
-With FDA QMSR harmonization (effective February 2, 2026), organizations should prepare for transitioning from separate files to a unified Medical Device File (MDF) that replaces:
-- **DHF** (Design History File)
-- **DMR** (Device Master Record)
-- **DHR** (Device History Record)
-
-The MDF approach aligns with ISO 13485:2016 requirements and provides a more unified documentation structure.