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

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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517 views3 pages

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

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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victor
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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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