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    Requerimentos Regulatorios ISO13485

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    Yer Gomez
    ISO 13485:2016 outlines the requirements for a quality management system for medical device manufacturers. It covers ten sections that address the scope, terms and definitions, documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement. The standard is designed to ensure that medical devices and related services consistently meet customer and regulatory requirements.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Requerimentos Regulatorios ISO13485

    Uploaded by

    Yer Gomez
    7 views2 pages
    ISO 13485:2016 outlines the requirements for a quality management system for medical device manufacturers. It covers ten sections that address the scope, terms and definitions, documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement. The standard is designed to ensure that medical devices and related services consistently meet customer and regulatory requirements.

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    Requerimentos regulatorios ISO13485

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    ISO 13485:2016 outlines the requirements for a quality management system for medical device manufacturers. It covers ten sections that address the scope, terms and definitions, documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement. The standard is designed to ensure that medical devices and related services consistently meet customer and regulatory requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    7 views2 pages

    Requerimentos Regulatorios ISO13485

    Uploaded by

    Yer Gomez
    ISO 13485:2016 outlines the requirements for a quality management system for medical device manufacturers. It covers ten sections that address the scope, terms and definitions, documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement. The standard is designed to ensure that medical devices and related services consistently meet customer and regulatory requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    ISO 13485:2016

    Medical devices—Quality management systems—


    Requirements for regulatory purposes
    0 Introduction
    0.1 General
    0.2 Clarification of concepts
    0.3 Process approach 7 Product realization
    0.4 Relationship with ISO 9001 7.1 Planning of product realization
    0.5 Compatibility with other management 7.1.1 General
    systems 7.2 Customer-related processes
    7.2.1 Determination of requirements related to
    1 Scope the product
    7.2.2 Review of requirements related to the
    2 Normative references
    product
    3 Terms and definitions 7.2.3 Communication
    7.3 Design and development
    4 Quality management system 7.3.1 General
    4.1 General requirements 7.3.2 Design and development planning
    4.2 Documentation requirements 7.3.3 Design and development inputs
    4.2.1 General 7.3.4 Design and development outputs
    4.2.2 Quality manual 7.3.5 Design and development review
    4.2.3 Medical device file 7.3.6 Design and development verification
    4.2.4 Control of documents 7.3.7 Design and development validation
    4.2.5 Control of records 7.3.8 Design and development transfer
    5 Management responsibility 7.3.9 Control of design and development
    5.1 Management commitment changes
    5.2 Customer focus 7.3.10 Design and development files
    5.3 Quality policy 7.4 Purchasing
    5.4 Planning 7.4.1 Purchasing process
    5.4.1 Quality objectives 7.4.2 Purchasing information
    5.4.2 Quality management system planning 7.4.3 Verification of purchased product
    5.5 Responsibility, authority, and 7.5 Production and service provision
    communication 7.5.1 Control of production and service
    5.5.1 Responsibility and authority provision
    5.5.2 Management representative 7.5.2 Cleanliness of product
    5.5.3 Internal communication 7.5.3 Installation activities
    5.6 Management review 7.5.4 Servicing activities
    5.6.1 General 7.5.5 Particular requirements for sterile
    5.6.2 Review input medical devices
    5.6.3 Review output 7.5.6 Validation of processes for production
    and service provision
    6 Resource management 7.5.7 Particular requirements for validation of
    6.1 Provision of resources processes for sterilization and sterile
    6.2 Human resources barrier systems
    6.3 Infrastructure 7.5.8 Identification
    6.4 Work environment and contamination 7.5.9 Traceability
    control 7.5.10 Customer property
    6.4.1 Work environment 7.5.11 Preservation of product
    6.4.2 Contamination control 7.6 Control of monitoring and measuring
    equipment

    DT.119 Rev. A QMS Associates 121


    8 Measurement, analysis, and
    improvement
    8.1 General
    8.2 Monitoring and measurement.
    8.2.1 Feedback
    8.2.2 Complaint handling
    8.2.3 Reporting to regulatory authorities
    8.2.4 Internal audit
    8.2.5 Monitoring and measurement of
    processes
    8.2.6 Monitoring and measurement of product
    8.3 Control of nonconforming product
    8.3.1 General
    8.3.2 Actions in response to nonconforming
    product detected before delivery
    8.3.3 Actions in response to nonconforming
    product detected after delivery
    8.3.4 Rework
    8.4 Analysis of data.
    8.5 Improvement
    8.5.1 General
    8.5.2 Corrective action
    8.5.3 Preventive action

    DT.119 Rev. A QMS Associates 122

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