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    F D A O R A: ORA Laboratory Manual Volume I

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    victor
    This document outlines the quality policies and management system for laboratories within the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). It describes the laboratory's quality policy statement to protect consumers and public health by ensuring compliance and minimizing risks of FDA-regulated products. It also addresses the distribution and review of the quality manual, structural and resource requirements including personnel, facilities, equipment and methods. Additionally, it covers processes for requests, sampling, reporting results, handling nonconforming work and controlling records and information management in accordance with ISO/IEC 17025 standards for accreditation.

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    F D A O R A: ORA Laboratory Manual Volume I

    Uploaded by

    victor
    373 views3 pages
    This document outlines the quality policies and management system for laboratories within the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). It describes the laboratory's quality policy statement to protect consumers and public health by ensuring compliance and minimizing risks of FDA-regulated products. It also addresses the distribution and review of the quality manual, structural and resource requirements including personnel, facilities, equipment and methods. Additionally, it covers processes for requests, sampling, reporting results, handling nonconforming work and controlling records and information management in accordance with ISO/IEC 17025 standards for accreditation.

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    ISO Manual

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    This document outlines the quality policies and management system for laboratories within the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). It describes the laboratory's quality policy statement to protect consumers and public health by ensuring compliance and minimizing risks of FDA-regulated products. It also addresses the distribution and review of the quality manual, structural and resource requirements including personnel, facilities, equipment and methods. Additionally, it covers processes for requests, sampling, reporting results, handling nonconforming work and controlling records and information management in accordance with ISO/IEC 17025 standards for accreditation.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    373 views3 pages

    F D A O R A: ORA Laboratory Manual Volume I

    Uploaded by

    victor
    This document outlines the quality policies and management system for laboratories within the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). It describes the laboratory's quality policy statement to protect consumers and public health by ensuring compliance and minimizing risks of FDA-regulated products. It also addresses the distribution and review of the quality manual, structural and resource requirements including personnel, facilities, equipment and methods. Additionally, it covers processes for requests, sampling, reporting results, handling nonconforming work and controlling records and information management in accordance with ISO/IEC 17025 standards for accreditation.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    The key takeaways are that the manual outlines the quality policies and procedures for ORA regulatory laboratories to meet ISO/IEC 17025 accreditation requirements.

    The ORA Laboratory Manual is prepared to meet the requirements for laboratory accreditation of the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC 17025:2017). It consists of volumes covering management requirements, procedures, and training.

    The main sections covered in the manual include quality policy statement, resource requirements, process requirements, and management system requirements.

    FOOD AND DRUG ADMINISTRATION Document Number:

    Revision #: 03
    OFFICE OF REGULATORY AFFAIRS Revision Date:
    ORA-LAB-QM
    ORA Laboratory Manual Volume I 08/13/2019

    Title:
    Manual of Quality Policies for ORA Regulatory Laboratories Page 1 of 47

    Sections in This Document

    1. Introduction............................................................................................................................. 2
    2. Controlled Distribution of the Quality Manual..........................................................................2
    3. Quality Policy Statement......................................................................................................... 2
    3.1. Management System Objectives..................................................................................3
    3.2. Management System Awareness and Implementation.................................................3
    4. General Requirements............................................................................................................3
    4.1. Impartiality.................................................................................................................... 3
    4.2. Confidentiality............................................................................................................... 4
    5. Structural Requirements..........................................................................................................5
    5.1. Laboratory as Legal Entity............................................................................................5
    5.2. Management Responsible for Laboratory.....................................................................5
    5.3. Scope of Accredited Laboratory Activities.....................................................................6
    5.4. Laboratory Requirements.............................................................................................6
    5.5. Laboratory Organizational Structure and Procedures...................................................6
    5.6. Personnel Responsibilities and Authority......................................................................7
    5.7. Communication and Integrity of the Management System............................................8
    6. Resource Requirements.......................................................................................................... 9
    6.1. General......................................................................................................................... 9
    6.2. Personnel..................................................................................................................... 9
    6.3. Facilities and Environmental Conditions.....................................................................12
    6.4. Equipment..................................................................................................................14
    6.5. Metrological Traceability.............................................................................................17
    6.6. Externally Provided Products and Services................................................................18
    7. Process Requirements..........................................................................................................20
    7.1. Review of Requests, Tenders, and Contracts.............................................................20
    7.2. Selection, Verification and Validation of Methods.......................................................23
    7.3. Sampling..................................................................................................................... 26
    7.4. Handling of Test or Calibration Items..........................................................................27
    7.5. Technical Records......................................................................................................28
    7.6. Evaluation of Measurement Uncertainty.....................................................................29
    7.7. Ensuring the Validity of Results..................................................................................29
    7.8. Reporting Results.......................................................................................................30

    For the most current and official copy, check QMiS.


    7.9. Complaints..................................................................................................................33
    7.10. Nonconforming Work..................................................................................................34
    7.11. Control of Data and Information Management............................................................35
    8. Management System Requirements.....................................................................................36
    8.1. Options....................................................................................................................... 36
    8.2. Management System Documentation (Option A)........................................................36
    8.3. Control of Management System Documents (Option A).............................................39
    8.4. Control of Records......................................................................................................40
    8.5. Actions to Address Risks and Opportunities...............................................................40
    8.6. Improvement...............................................................................................................41
    8.7. Corrective Actions.......................................................................................................41
    8.8. Internal Audits.............................................................................................................42
    8.9. Management Reviews................................................................................................43
    9. Document History.................................................................................................................. 43
    10. Change History..................................................................................................................... 44

    1. Introduction
    This Office of Regulatory Affairs (ORA) Laboratory Manual of Quality Policies
    (hereafter referred to as Volume I) has been prepared to meet the
    requirements for laboratory accreditation of the International Organization for
    Standardization/International Electrotechnical Commission (ISO/IEC
    17025:2017).
    2. Controlled Distribution of the Quality Manual
    The Office of Regulatory Science (ORS) is responsible for maintaining the
    official master copy of the ORA Laboratory Manual which contains the ORA
    Laboratory Quality Manual. This Manual consists of Volume I, ORA Laboratory
    Manual of Management Requirements and Volume II, ISO 17025:2017 ORS
    Laboratory Procedures. The ORA Laboratory Manual also includes operational
    procedures and training in Vol III and Vol IV respectively. General distribution
    of this manual is accomplished using a computer network. Biennial review is
    coordinated by the Office of Regulatory Science.
    3. Quality Policy Statement
    ORA’s mission statement states “ORA protects consumers and enhances
    public health by maximizing compliance of FDA regulated products and
    minimizing risk associated with those products”. ORS laboratories are
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