Document Control: ISO 9001 - 2008

  • Course Description
  • Objectives
  • Audience

Document Control – ISO 9001 - 2008: Course Description

In this 2-day workshop designed for technical and non-technical Records & Information Management professionals will provide operatives with a thorough understanding of the role of managing corporate-wide documentation.

Training Overview: Effective Document Control

Documents are supposed to be useful tools. They describe requirements. As such, they are indispensable to an organization's QMS (quality management system). Unfortunately, the challenge of managing documentation has evolved into a burdensome task where maintaining control supersedes actual utilization. This course is designed to assist individuals in identifying documents and appropriately defining the requirements that will make them a positive feature of the organization.

Here is an outline of the primary topics taught in this training program:

What Are Documents

  • Formats Relating to Access, Readability, Timeliness, etc.
  • Distinct Attributes: Content, Context and Interrelationship
  • Various Types of Documents

Different Kinds of Documents

  • The Pyramid Model
  • Traditional Quality Procedures and Documents
    • manuals and policies
    • quality procedures
    • work instructions
  • Other Internal Documents
    • Travelers
    • drawings and specifications
    • schedules
    • contracts
    • strategic plan
    • job descriptions and training guides
    • user manuals and product literature
    • unconventional documents and formats
  • Docuents of External Origin
    • national/international standards
    • customer specifications
    • statutory and regulatory requirements
    • industry and product standards
    • operating and repair manuals
  • Electronic Media
Identifying Owners and Defining Responsibility
  • Authors
  • Documents Coordinators
  • Custodians and Librarians
  • Revisers, Editors, Reviewers, Approvers
  • Users
  • Outsourcing
  • Communicators, Distributors, Trainers, Facilitators

The Relationship between Documents and Records

  • Concept of Process
  • Process and Related Documents
  • Series of Processes
  • Evidence of Compliance
  • Evidence of Process Control
    • Document/control record chart
  • Clarifying the QMS

Tips for Document Writers

  • Bulleted List
  • Illustrations
  • Forms
  • Flowcharts
  • Memos
  • Electronic Forms and Databases
  • General Guidelines
    • purpose
    • scope

Managing and Maintaining Documents

  • Controlled vs. Uncontrolled
    • electronic Media
    • paper documentation
    • training
  • Condition of Old Documents
  • Obsolete Documents
  • Access
  • Documents of External Origin
    • matrix of documents of external origin
  • Tips for Managing Documentation

Handling Revisions and Deviations

  • Review and Approval Process
  • Deviations
    • deviation notice
  • Engineering Change Notices
  • Failure Modes and Effects Analysis (FMEA)
  • Design Plans

Writing Document Control Procedures

  • Focus on the Intended Audience
  • Enlist Process Owners
    • chart of documents and authorized individuals
  • Writing with ISO 9001:2000 in Mind
    • requirements for a documented procedure

Training Course Brochure: Document Control – ISO 9001 - 2008

Document Control – ISO 9001 - 2008: Objectives

This course provides a clear and concise approach to implementing document control within an organization. Training will include exercises and examples to help participants increase efficiency for cost savings and process improvement. The overall training objective will be to learn how to make documents the valuable and meaningful enterprise-wide tools they are meant to be.

Added Bonus

Each participant will receive a copy of the book:
Document Control - A Simple Guide to Managing Documentation, by Course Instructor, Denise Robitaille.

Document Control – ISO 9001 - 2008: Who Should Attend

This course is intended for anyone who is responsible for generating documents, auditing, managing/coordinating documentation, writing QMS procedures or managing various aspects of the organization's QMS, including: quality managers, ISO 9000 coordinators, Internal auditors, production supervisors, quality technicians, and customer service managers.

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