ISO 9001 Overview

An ISO 9001 overview follows. It is an overview. For a comprehensive review, I suggest you get a copy of the "Introduction to ISO 9001:2008" from QPA Quality Training and Consulting. The book explains the standard in plain English. This is the best book I've read on what the standard and its requirements mean.

The original 2000 and the 2008 revision focuses on enhancing customer satisfaction through continual improvement.

Although ISO 9001-2008 requires an organization to create an quality manual and six documented procedures it does not have as heavy a focus on documentation as the 1994 revision.

In fact, documentation is not mentioned as one of the eight goals of ISO 9000. The eight goals include things such as: the process approach, system approach to management, data analysis and use, employee involvement and empowerment, continual improvement and measuring customer satisfaction, defect prevention and supply chain management.

The Process Approach

This is probably the most significant changes from previous revisions. The standard promotes the use of the process approach for developing, implementing and improving the effectiveness of the system, and to improve customer satisfaction.

The process approach requires an organization to identify the linked activities in the organization and then manage and improve those processes.

What is a process?

A process is any activity that transforms input into output. That could be as simple as one operation or activity. Or, it could be an entire department. It is the responsibility of each organization to define and identify the processes in their organization. The standard does not callout any specific processes.

When you put the processes together, including their interactions and management, this is called the "process approach".

What is the purpose of the "Process Approach"?

The idea to this process approach is that it provides ongoing control over the linkage between the individual processes and their combinations and interactions. The idea is you cannot manage by individual parts and expect the whole to turnout perfect.

The process approach focuses on:

• understanding and meeting all requirements 

• adding value to the processes by removing waste 

• measuring process performance and effectiveness, and 

• continually improving the processes based on data.

The authors of the standard used the Plan, Do, Check and Act (PDCA) cycle to illustrate the linkages and interactions of the processes. They define the four phases as follows:

Plan: establish the objectives and processes required to meet the customer and organizational needs

Do: implement the processes according to the plan

Check: monitor and measure the processes and products against the policies, objectives and requirements and then report the results

Act: continually improve the processes.

What needs to be included in the ISO 9001 quality system?

The simple answer is everything. In fact, you cannot exclude anything if it can affect customer or regulatory requirements. And, since all processes interact to form the system it literally covers everything.

What is covered in ISO 9001?

The standard has five sections that are used to generically describe a quality management system.

Section 4: Quality Management System

Section 5: Management Responsibility

Section 6: Resource Management

Section 7: Product Realization, and

Section 8: Measurement, Analysis and Improvement