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 ISO 13485 & 21 CFR 820 TEMPLATE DOCUMENTATION
Quality Manual, 34 Operational Procedures and 26 Forms
Buy the Template Documentation List of Documents Quality Manual SECTION 0 - INDEX AND REVISION STATUS
SECTION 1 - SCOPE
1.1 Quality Policy
1.2 Introduction
1.3 Application
1.4 Exclusions
SECTION 2 - REFERENCE DOCUMENTS
SECTION 3 - TERMS AND DEFINITIONS
SECTION 4 - QUALITY MANAGEMENT SYSTEM
4.1 Quality System Processes
4.2 Documentation and Records
SECTION 5 - MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Quality System Planning
5.5 Organization and Communication
5.6 Management Review
SECTION 6 - RESOURCE MANAGEMENT
6.1 Provision of Resources
6.2 Competence, Awareness and Training
6.3 Infrastructure
6.4 Work Environment
SECTION 7 - PRODUCT REALIZATION
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design Control
7.4 Purchasing
7.5 Production Control
7.6 Monitoring and Measuring Equipment
SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 Planning of Monitoring and Measurement
8.2 Monitoring and Measurement
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Continual Improvement
Operational Procedures QOP-42-01 Control of Documents
QOP-42-02 Device Master Record
QOP-42-03 Control of Records
QOP-56-01 Management Review
QOP-62-01 Competence, Awareness and Training
QOP-63-01 Equipment Maintenance
QOP-64-01 Production and Work Environment
QOP-71-01 Production Planning
QOP-71-02 Process Risk Management
QOP-72-01 Order Processing and Review
QOP-73-01 Design Control
QOP-73-02 Design Risk Management
QOP-73-03 Control of Design and Process Changes
QOP-74-01 Supplier Evaluation and Monitoring
QOP-74-02 Purchasing
QOP-74-03 Verification of Purchased Product
QOP-75-01 Production Work Order and History Record
QOP-75-02 Cleanliness and Contamination of Product
QOP-75-03 Validation of Processes and Software
QOP-75-04 Installation and Servicing
QOP-75-05 Product Identification and Traceability
QOP-75-06 Labeling and Packaging
QOP-75-07 Storage and Distribution
QOP-76-01 Measuring and Monitoring Equipment
QOP-82-01 Feedback and Customer Satisfaction
QOP-82-02 Internal Quality Audits
QOP-82-03 In-process Inspections
QOP-82-04 Final Acceptance Inspection
QOP-83-01 Control of Nonconforming Product
QOP-84-01 Analysis of Data
QOP-85-01 Continual Improvement
QOP-85-02 Device Recall and Advisory Notices
QOP-85-03 Customer Complaints
QOP-85-04 Corrective and Preventive Action Manual Forms (printable, manual forms) QF-42-02-1 Device Master Record Index
QF-73-01-1 Design Project Plan and Schedule
QF-73-01-2 Design Review Report
QF-73-02-1 Design Risk Analysis
QF-73-03-1 Engineering Change Notice (ECN)
QF-75-01-1 Production Work Order
QF-75-04-1 Service Report
QF-82-02-1 Internal Audit Checklist
Electronic Forms (data entry forms in ISOXpress software) ER-42-01-1 Document Control Record (ISOXpress Document Control module)
ER-56-01-1 Management Review Record (ISOXpress Management Review module)
ER-56-01-2 Quality Objective/Target Record (ISOXpress Management Review smodule)
ER-62-01-1 Training Program Record (ISOXpress Training module)
ER-62-01-2 Training Event Record (ISOXpress Training module)
ER-62-01-3 Competency Certification Program Record (ISOXpress Training module)
ER-62-01-4 Competency Certification Record (ISOXpress Training module)
ER-62-01-5 Personnel Training/Competency Record (ISOXpress Training module)
ER-74-01-1 Supplier Control Record (ISOXpress Supplier Control module)
ER-74-01-2 Supplier Nonconformity Record (ISOXpress Supplier Control module)
ER-74-01-3 Supplier Corrective Action Request Record (ISOXpress Supplier Control module)
ER-76-01-1 Measuring Equipment Record (ISOXpress Measuring Equipment module)
ER-82-02-1 Internal Audit Record (ISOXpress Internal Audit module)
ER-82-02-2 Internal Audit Plan Record (ISOXpress Internal Audit module)
ER-82-02-3 Internal Audit Finding Record (ISOXpress Internal Audit module)
ER-83-01-1 Nonconforming (NC) Product Record (ISOXpress Nonconforming Product module)
ER-85-02-1 Customer Complaint Record (ISOXpress Customer Complaints module)
ER-85-03-1 Corrective/Preventive Action Record (ISOXpress Corrective Action module) Learn More and buy the ISO 13485 & 21 CFR 820 TEMPLATE DOCUMENTATION
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