@saibolla/ada 0.1.2

package/skills/iso-13485-certification/references/iso-13485-requirements.md

@@ -0,0 +1,610 @@
+# 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.)