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.

COURSE OUTCOME:

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.

COURSE OBJECTIVES:

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

WHO SHOULD ATTEND ?

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.

COURSE CONTENT:

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