Quality Manual for Medical Devices
If you are searching for a quality manual for medical devices, look no further. Implementation of our documented, quality manual for medical devices will enable you to meet the FDA's CFR 21 Part 820: Quality System Regulation at a reasonable price. You will receive sensible/flexible procedures which, when implemented, will reduce paperwork to a minimum and will enable you to significantly improve the quality of your products/services. Our quality manual for medical devices is designed for small organizations and includes 27 procedures and 34 forms/checklists, which you customize specifically for your needs. As an added bonus, we will also send you free software download links for document management and calibration management (small business). Testimonial: "The Quality Manual for Medical Devices is exactly what we needed and then some. It is very well written and virtually bug-free so we have been able to make immediate use of the material. Thank you very much." Peter Brownhill, President & CEO, Nexma Technologies
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QUALITY MANUAL TABLE OF
CONTENTS
Approvals Revision and Approval Record 1 General 1.1 Introduction 1.2 Exclusions 1.3 Quality Policy Statement 2 Company History 3 Company Contact Information 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Quality Records 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output 6 Resources 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness, and Training 6.3 Infrastructure 6.4 Work Environment 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring Devices 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
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Order Quality Manual for Medical Devices If you are seeking a quality manual for medical devices that complies with ISO 13485:2003, click here: ISO 13485 Quality Manual for Medical Devices If you are seeking to improve your new product development process, click here: New Product Development and Introduction |