PREPARING AND DOCUMENTING A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 9001:2000 STANDARD

Description. ISO 9001 specifies requirements for a quality management system that can be used by an organization to address customer satisfaction, by meeting customer and applicable regulatory requirements. It also can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

QMS is a structured business management system that is put in place to prevent errors and provide better structure for an organization. It provides companies with a broadly accepted method for managing their business using proven logistical business practices. By implementing a QMS, you can reduce risks, lower costs, and minimize waste while also making fewer mistakes and complying with improvement requirements.

Objective. At the end of the 16-hour seminar-workshop, the participants shall be able to establish a QMS meeting the requirements of ISO 9001:2000 Standard, and develop the appropriate documentation needed by their organization.

Who should attend. Quality Assurance Managers, General Managers, ISO Implementation Team Members, Management Representatives, and ISO Internal Auditors should attend this course.

Course Outline.
• Introduction
  - What is ISO 9000 about?
  - How does ISO 9000 work?
  - The ISO 9000:2000 series
  - Background of Changes to the ISO 9000 Standards

• The 8 Quality Management Principles

• Highlights of the ISO 9001:2000
  - Main Grouping of QMS Requirements
  - The Quality Management System
  - Management Responsibility
  - Resource Management
  - Product Realization
  - Measurement, Analysis and Improvement

• Documenting the QMS
    - Why is there a need to document the QMS?
    - What should be documented?
          * ISO 9001:2000 Documentation Requirements
          * Documentation Requirements of the Organization

• Process Approach to QMS
    - What is the Process Approach?
    - Basis for Determining Processes to be Documented
    - Model of a Process-Based QMS

• Documenting the Quality Manual

• Documentation of Processes
    - Considerations in Writing a Procedure
    - Process Mapping
    - Other Documents
         * Quality Plan
         * Work instructions
         * Forms
         * References
         * Others

• Linking QMS Documentation
    - Coding of Documents
    - Formatting of Documents

• The Steps to Certification


Duration. 24 hours