Mod6_pt4_MedicalDevices_QSR

Mod6_pt4_MedicalDevices_QSR - 12/2/2009 1 Medical Devices...

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Unformatted text preview: 12/2/2009 1 Medical Devices Quality Systems Regulations (QSR) Regulations (QSR) [21CFR820] David W. Mullis, Jr., Ph.D. RAC PHAR 6010 Quality System Regulation 820.5 Quality System Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical appropriate for the specific medical device(s) designed and manufactured, and that meets the requirements of this part (21CFR820) 2 QSR Key Components Management Responsibility Quality Audit Personnel Design Controls Document Controls Purchasing Controls Identification and Traceability Production and Process Controls Acceptance Activities Nonconforming Products Corrective and Preventive Action Labeling and Packaging Control Handling, Storage, Distribution and Installation Records Servicing Statistical Techniques 3 12/2/2009 2 QSR Key Definitions- Complaint- Management with executive responsibility- Component- Manufacturer- Control Number- Nonconformity- Design History File- Product- Design Input- Quality - Design Output- Quality Audit- Design Review- Quality Policy Quality System- Device History Record- Rework- Device Master Record- Specification- Finished Device- Validation- Lot or Batch- Verification 4 Quality System Requirements 820. 20 Management Responsibility (a) Quality Policy (b) Organization (c) Management Review (d) Quality Planning (e) Quality Systems Procedures 5 Quality System Requirements 820.22 Quality Audit Establish procedures for quality audits Conduct quality audits A dit h ld b i d d Auditors should be independent Conduct reaudits of corrective actions Quality Audit results to be reviewed by management Audits shall be documented 6 12/2/2009 3 Quality System Requirements 820.25 Personnel Sufficient personnel with necessary education, background, training and experience experience Training Documentation of Training 7 Quality System Requirements 820.30 Design Controls Design and development planning Design input Design outpu Design output Design review Design verification Design validation Design transfer Design changes Design history file 8 Quality System Requirements 820.04 Document controls Document approval and distribution Document changes 9 12/2/2009 4 Quality System Requirements 820.50 Purchasing controls Evaluation of suppliers, contractors and consultants Purchasing Data/Documents Purchasing Data/Documents 10 Quality System Requirements 820.60 Identification Identification of product during production Identification of product during distribution distribution 820.65 Traceability For surgical implants, life supporting devicesa control number for each unit, lot or batch of finished devices. When appropriate, component traceability 11 Quality System Requirements 820.7 Production and process controls Assure device conforms to its specifications...
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Mod6_pt4_MedicalDevices_QSR - 12/2/2009 1 Medical Devices...

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