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The ISO 9001: 2000 Transition Process Part III
By Neal D. Stiemert



By now, I am sure that you have heard of the "process approach" to ISO 9000. In my consulting, training and auditing activities, I have found that there is a great deal of misunderstanding regarding the process approach.

The process approach requires you to define the processes and interactions that are linked together to make your company function. Most companies may have many procedures and instructions that define how individual activities are performed. If we do not define how those individual activities work together and the order which the activities are perfomed, we cannot get a quality product out the door in a minimum amount of time.

The ISO 9001: 2000 standard defines the process approach as follows:

An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach".

When defining you process, use the following model:

 Input   →   Activity   →   Output 

As an example, let us consider the Purchasing Process:

Input Activities/Interactions
(Purchasing) 		Output
  • Receive purchasing requirement
    •      		Activities:
  • Select approved supplier
  • Prepare purchase order

    • Interactions:
  • Supplier
  • Receiving
  • Engineering
  • Quality Assurance
    •
  • Release purchase order to supplier
    •

    1. The Input to the Purchasing process is a requirement to purchase materials, components or services.

    2. The Purchasing Activity involves selecting a supplier from our approved supplier list and preparing a purchase order.

    We will interact with
    - The supplier: to place the order.
    - Receiving: to notify them of the material ordered.

    We may interact with
    - Engineering: if Purchasing specifications are needed.
    - Quality Assurance: if Receiving inspection is needed and to disposition the product if it is nonconforming when received.

    3. The Output of the purchasing process is an approved purchase order released to the supplier.

    A typical manufacturing company will have the following product realization processes:

    Customer Inquiry → Review and Quote → Receive Order → Prepare Process Control Documentation → Purchase Materials → Receive Materials → Production → Pack, Label and Ship

    In addition, we have the following support processes:

    4. Management Review
    5. Training
    6. Document Control
    7. Internal Auditing
    8. Corrective and Preventive Action

    Summary:

    As you develop your quality system, you must define the sequence and interaction of your processes in your quality manual as required in Section 4.2.2 of the new standard. As you define your processes and prepare the accompanying documentation, be sure that the inputs, activities, interactions and outputs are fully defined so your quality system is effective. I hope that this information helps you with your transition. Feel free to contact me with any questions at (763) 441-7912.


    Neal Steimert
    President
    Independent Quality Consultants, Inc.

    About The Author
    Neal StiemertNeal D. Steimert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science Degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a Certified Quality Auditor and has over 23 years of management, auditing, consulting and training experience in the quality profession.

    Neal has served as an examiner for the Minnesota Quality Award, an SPC Indstructor at Purdue University and an Office and Committee Member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments, an RVA and RAB accredited registrar.

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