Implementing a Quality Management System - ISO 9001
James O. Hill, P.E.

Audience

This seminar is for those who are responsible for designing and implementing a quality management system (QMS) in accordance with the requirements of ISO 9001:2000, or for evaluating the effectiveness of the QMS.

Learning Outcomes

Upon completion of this seminar, one will be able to:

·  Understand the eight underlying principles of ISO 9001:2008;

·  Understand the requirements of ISO 9001:2008;

·  Understand the organization as a process-based enterprise;

·  Understand how quality improvement tools (Lean, Six Sigma, etc.) apply in the context of a QMS;

·  Basically understand some of the processes necessary for the design and implementation of an ISO 9001:2008 QMS.

Outline

1.  Foundation

·    Scope and objectives of the quality function

·    Description of the ISO 9000 series

2.  Principles

The language of each principle is analyzed to gain a full understanding of the principle and its universal applicability. The technical and economic bases for the principle are discussed. Examples of the application of the principle are provided for various phases of enterprise activity, such as: design; procurement; construction, fabrication, assembly and installation; inspection and test; handling, storage, packaging and shipping; and field service. Examples of misapplications or non-applications of the principle are provided. The benefits of appropriate application, and the consequences of mis-application or inappropriate non-application are discussed.

The principle topics are:

·    Principle 1 – Customer focus;

·    Principle 2 – Leadership;

·    Principle 3 – Involvement of people;

·    Principle 4 – Process approach;

·    Principle 5 – System approach to management;

·    Principle 6 – Continual improvement;

·    Principle 7 – Factual approach to decision-making;

·    Principle 8 – Mutually beneficial supplier relationships.

3.  Understanding a process-based enterprise; understanding the relationship between a process and a system

4.   QMS applied to business phases

·  Design phase activities – e.g.,

·    Design “abilities”

·    Environmental considerations in design

·    Design change management

·    Procurement phase activities – e.g.,

·    Quality requirements for the procure of design & construction services, equipment, components, parts and materials

·    Supplier controls

·    Fabrication, assembly, construction, and installation activities – e.g.,

·    Integrated fabrication / assembly and inspection plans; integrated construction / installation and inspection plans

·    Measurement control

·    Operations & maintenance activities – e.g.,

·    Operating procedures

·    Maintenance planning

·    All phases – e.g.,

·    Document management

·    Problem reporting & corrective action

Handouts

·        Copy of the visual aids

·        Extensive references to other learning tools

·        Copy of ISO 9001:2008

·        Certificate of Completion, with Continuing Education Units