Jim Colyn & Associates Quality Consultants, LLC

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Services Quality System Development Quality Documentation Corrective and Preventive
  Action (CA/PA) Root Cause Analysis Training/Training Programs Management Training Audit Management Validation Planning 483 & Warning Letters Joint Commission Tissue
  Compliance Quality Culture Development           Register Here
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We provide expert guidance with your Quality System Documentation.

Establishment and Maintenance of the Quality Manual and Document Control Systems to a number of recognized models, including:

  • Current Good Tissue Practice Regulations (21 CFR 1271)
  • Quality System Regulations for Medical Devices (21 CFR 820)
  • American Association of Tissue Banks – Standards for Tissue Banking
  • Eye Bank Association of America – Procedures Manual and Medical Standards
  • ISO 9001:2000 – Quality Management Systems – Requirements
  • ISO 13485:2003 – Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes

Development of Document and Data Control Systems (Change Control), including installation and configuration of electronic change control systems

Technical Writing and Training, including

  • Quality Manual – Quality Policies
  • Standard Operating Procedures (SOPs)
  • Work Instructions
  • Product Specifications
  • Process Specifications

We provide expert guidance with your Quality System Documentation.

Establishment and Maintenance of the Quality Manual and Document Control Systems to a number of recognized models, including:

  • Current Good Tissue Practice Regulations (21 CFR 1271)
  • Quality System Regulations for Medical Devices (21 CFR 820)
  • American Association of Tissue Banks – Standards for Tissue Banking
  • Eye Bank Association of America – Procedures Manual and Medical Standards
  • ISO 9001:2000 – Quality Management Systems – Requirements
  • ISO 13485:2003 – Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes

Development of Document and Data Control Systems (Change Control), including installation and configuration of electronic change control systems

Technical Writing and Training, including

  • Quality Manual – Quality Policies
  • Standard Operating Procedures (SOPs)
  • Work Instructions
  • Product Specifications
  • Process Specifications