91-QM-9001 Rev B Product Resources Quality Manual ISO 9001

91-QM-13485 Rev D Product Resources Quality Manual ISO 13485

Major Processes

Customer Processes

91-1001 Rev B Repeat and New Business Inquiries
91-1002 Rev C Quotation and Order Acceptance
91-1003 Rev F Customer Communication, Satisfaction and Property
91-1004 Rev C Customer Order Shipping

Design and Development

91-2001 Rev F Design, Development, and Engineering Processes
91-2002 Rev B Management of Design and Development Process
91-2003 Rev A Risk Management in the Design and Development Process

Purchasing Process

91-3001 Rev D Supplier Management
91-3002 Rev D Requirements for Purchased Materials and Services and Order Placement
91-3003 Rev B Verification and Receipt of Purchased Materials

Manufacturing Process

91-4001 Rev F Manufacturing, Inspection and Test of Material and Product
91-4002 Rev E Control of Nonconforming Material
91-4003 Rev B Preservation and Storage of Material and Product
91-4004 Rev B Production Environment


91-5001 Rev D Service and Returns

Control of Information

91-6001 Rev E Control of Documents
91-6002 Rev G Control of Records
91-6003 Rev B Identification and Traceability
91-6004 Rev B Planning for Product Realization and Device Master Records
91-6005 Rev B Device History Records
91-6006 Rev A  Labeling and Marking

Risk Management

91-7001 Rev C Internal Audit
91-7002 Rev E Corrective Action
91-7003 Rev C Preventive Action
91-7004 Rev C Control of Measuring Devices
91-7005 Rev B Business Continuity
91-7006 Rev E Product Process Analysis and Validation

Company Resources

91-8001 Rev D Infrastructure
91-8002 Rev B Competence, Awareness, Knowledge and Training

Organization and Management

91-9001 Rev D Context of Organization
91-9002 Rev D Quality Policy
91-9003 Rev B Processes and Procedures
91-9004 Rev A Objectives and Analysis of Data
91-9005 Rev G Management Review


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