CQI & IRCA Certified QMS (ISO 9001:2015) DOCUMENT AND RECORD CONTROL MANAGEMENT

This 2 days program provides participants with the skills and tools needed for quality improvement and compliance within their organization as related to the handling of documents and records.  Course content utilizes real life scenarios with a variety of situations and case studies for analysis toward practical resolutions.  Discussions with participants from other companies and instructors will allow attendees to benchmark their documentation processes and practices within their quality management systems (QMS).  The focus of this course is on how documents and records are controlled, the objective evidence required for compliance, and the linkages between documents and records to the various processes and activities within a QMS.

Upon completion of the program, delegates should be able to:

  • Understand the rationale supporting QMS Implementation and accurately interpreting the requirements of ISO 9001-2008 standard and their scope and fields of applicat
  • Techniques available, process and principles of Quality Management System aspect and impact assessment and emergency response and preparedness and their significance in self – regulating all QMS requirements.
  • How to plan, prepare, perform and report QMS audits including ability to collect and analyze evidence, exercise objectivity and make decisions on the significance of observation made in accordance to relevant audit criteria.
  • Participants will be able to use documents and records as tools to facilitate compliance with the Quality System regulation and as well as make decisions using the appropriate documentation and objective evidence.
  • Ability to use documentation as a tool to facilitate compliance with the Quality System regulation and the ISO 13485:2003 standard
  • Implementation of your quality management system using classic systems to establish appropriate links between core processes
  • Ability to make decisions and use documentation and objective evidence for implementing change

This course is for professionals that have responsibility for making decisions related to the use of documents and records in the areas of change control, quality assurance, design, manufacturing, purchasing, regulatory affairs, FDA inspections, and ISO audits. This course is also meant for Lead Auditor’s, consultants, librarians and secretaries.

  • Introduction to document control
  • The basics of document control
  • Managing deliverables
  • Document identification
  • Document lifecycle
  • Templates
  • Ensuring Quality
  • Transmittals
  • Procedures & Specifications
  • Document distribution
  • Filing & classifying
  • As-built & Final documentation
  • Information security
  • Electronic document management systems
  • Provide information about document
  • The end of the document lifecycle
  • Scanning, copying, binding, formatting
  • How to handle correspondences (letters, emails)
  • Interactions with project teams, engineering team, manager
  • Introduction to EDMS System Implementation

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