Documentation in ISO 9001:2015

Course Objectives

• Understanding and addressing the documentation implications embedded in the newly published standards including ISO 9001:2015.
• Using Risk-Based-Thinking as a critical tool in determining the need for documentation.
• Determining the business needs for Documentation given the reduced emphasis within ISO 9001:2015.
• Using documentation as a critical tool for linking your Quality Management System to your day-to-day Business Processes and the Strategic Direction of your organization.
• Using the Process Approach to build a bridge to your organizations bottom line while at the same time reducing the emphasis on documentation.
• De-emphasizing documentation without losing control or the ability to provide evidence to Auditors and other Interested Parties.
• Providing an opportunity to use your completed Quality Management System as a platform for current or future Lean Management activities
• Determining when documentation matters – creating value and getting it right.
• Choosing appropriate and value-added methods for controlling processes and results other than using documentation

Target Audience

Quality Managers, Process Owners and Document Controllers as well as anyone who have been entrusted to administer the Document Control System in the company.

Methodology

• Delivery of the conceptual framework together with a demonstration of how process, components and systems tie up and form a complete whole.
• Once a concept is understood, practical application is applied.
• Once application is made clear, implementation can be executed at work place.
• Spoon-feeding (Delivered in a Take-Back-and-Do Approach).

Course Modules

• Module 1 – Understanding the Documented Information Requirements
• Module 2 – Providing a New Emphasis Rather Than the Traditional Emphasis on Documentation
• Module 3 – Documents and Records – A Critical Distinction.
• Module 4 – Effective Documented Information to Prevent Non-Conformists