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    Medical Device Standard: Documented Requirements by Section

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    yusranarif
    This document outlines the ISO 13485:2003 standard for medical devices. It lists the clauses in the standard and the type of documented requirements needed for each clause, whether it requires a quality manual, procedure, or record. Key documented requirements include procedures for design and development, purchasing, servicing, validation, identification, handling nonconforming products, customer feedback and corrective actions. Records are required for management reviews, training, risk management, design controls, supplier evaluation, calibration, audits, complaints and corrective/preventive actions.

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    Medical Device Standard: Documented Requirements by Section

    Uploaded by

    yusranarif
    51 views2 pages
    This document outlines the ISO 13485:2003 standard for medical devices. It lists the clauses in the standard and the type of documented requirements needed for each clause, whether it requires a quality manual, procedure, or record. Key documented requirements include procedures for design and development, purchasing, servicing, validation, identification, handling nonconforming products, customer feedback and corrective actions. Records are required for management reviews, training, risk management, design controls, supplier evaluation, calibration, audits, complaints and corrective/preventive actions.

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    ISO_13485-2003_Blacksheet

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    This document outlines the ISO 13485:2003 standard for medical devices. It lists the clauses in the standard and the type of documented requirements needed for each clause, whether it requires a quality manual, procedure, or record. Key documented requirements include procedures for design and development, purchasing, servicing, validation, identification, handling nonconforming products, customer feedback and corrective actions. Records are required for management reviews, training, risk management, design controls, supplier evaluation, calibration, audits, complaints and corrective/preventive actions.

    Copyright:

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

    Medical Device Standard: Documented Requirements by Section

    Uploaded by

    yusranarif
    This document outlines the ISO 13485:2003 standard for medical devices. It lists the clauses in the standard and the type of documented requirements needed for each clause, whether it requires a quality manual, procedure, or record. Key documented requirements include procedures for design and development, purchasing, servicing, validation, identification, handling nonconforming products, customer feedback and corrective actions. Records are required for management reviews, training, risk management, design controls, supplier evaluation, calibration, audits, complaints and corrective/preventive actions.

    Copyright:

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

    ISO 13485:2003

    Medical Device Standard


    Documented Requirements by Section
    (1:20:37)

    Clause Description Document Type


    4.2.2 Quality manual Manual

    4.2.3 Control of documents Procedure


    4.2.4 Control of records Procedure
    7.3.1 Design & development planning Procedure
    7.4.1 Purchasing process Procedure
    7.5.1.2.3 Servicing activities Procedure
    7.5.2.1 Validation of computer software Procedure
    7.5.2.2 Validation of sterile processes Procedure
    7.5.3.1 Product identification Procedure
    7.5.3.1 Returned product identification Procedure
    7.5.3.2.1 Product traceability Procedure
    7.5.5 Preservation of product (processing) Procedure
    7.5.5 Preservation of product (shelf-life) Procedure
    7.6 Control of monitoring & measuring devices Procedure
    8.2.1 Feedback system Procedure
    8.2.2 Internal audits Procedure
    8.3 Control of nonconforming product Procedure
    8.4 Analysis of data Procedure
    8.5.1 Issue & implementation of advisory notices Procedure
    8.5.2 Corrective action Procedure
    8.5.3 Preventive action Procedure

    Legend: M = manual / P = procedure / R = record


    ISO 13485:2003
    Medical Device Standard
    Documented Requirements by Section
    (1:20:37)

    Clause Description Document Type


    5.6.1 Management review Record
    6.2.2 (e) Competence, awareness & training Record
    6.3 Maintenance Record
    7.1 (d) Planning of product realization Record
    7.1 Risk management Record
    7.2.2 Review of requirements related to product Record
    7.3.2 Design & development inputs Record
    7.3.3 Design & development outputs Record
    7.3.4 Design & development review Record
    7.3.5 Design & development verification Record
    7.3.6 Design & development validation Record
    7.3.7 Control of design & development changes Record
    7.4.1 Supplier evaluations Record
    7.4.2 Purchasing information Record
    7.4.3 Verification of purchased product Record
    7.5.1.1 Batch records Record
    7.5.1.2.2 Installation activities Record
    7.5.1.2.3 Servicing activities Record
    7.5.1.3 Sterilization parameters Record
    7.5.2.1 Validation (process) Record
    7.5.2.2 Validation (sterilization) Record
    7.5.3.2.1 Product traceability Record
    7.5.3.2.2 Consignee name & address Record
    7.5.4 Customer property Record
    7.5.5 Preservation of product Record
    7.6 Calibration (as found) Record
    7.6 Calibration (corrected) Record
    8.2.2 Internal audits Record
    8.2.4.1 Product release Record
    8.2.4.2 Product inspection & testing Record
    8.3 Nonconformances (authorization) Record
    8.3 Nonconformances (nature) Record
    8.4 Analysis of data Record
    8.5.1 Customer complaints (investigations) Record
    8.5.1 Customer complaints (no action) Record
    8.5.2 Corrective action Record
    8.5.3 Preventive action Record

    Legend: M = manual / P = procedure / R = record

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