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ISO 9001 – Process Approach

What is a Process Approach?


A “process” is the interaction of activities within an organization.  Most processes are continual loops within an organization with defined input requirements and a resulting output.  ISO 9001 promotes the use of the process approach when developing, implementing and improving the effectiveness of a Quality Management System.  As always, it is Managements responsibility to oversee the effectiveness of the Quality Management System with the goal to enhance customer satisfaction by meeting the customer’s requirements.process approach


What are the Benefits of a Process Approach?


The easiest way to understand any organization is to understand the processes used to run the business.  By using a process approach, the core processes and activities are identified.  Once there is an understanding of the core processes, the sequence of activities and interactions can be determined. 


Each organization is somewhat unique and will only require documentation for the applicable Quality Management System requirements which apply to the organizations business practices.  Define the scope of the Quality Management System in the Quality Manual.  Documentation is created around the organizations processes as well as the ISO 9001 requirements for procedures.  Defining the control measures necessary for each process within each procedure will result in consistent outputs.   These day to day control measures will drive a successful business.


Management Responsibility is not the responsibility of the Quality Manager alone.  It is the responsibility of the entire Executive Management Team to ensure the effectiveness of a Quality Management System.  The employees will buy into the Quality Management System as well as the control measures when the Management Team is committed to the continual improvement of the processes and systems.


Resource Management is a key to success.  Implement the necessary resources and training to support the processes operation using the procedures and control measures documented.  The availability of resources will improve quality, performance as well as dollars to the bottom line.

Product realization is the core of a process approach.  Product Realization begins with a concept or idea with is developed for manufacturing and results in a product shipped to a customer which meets the customer’s needs. 

Measurement analysis will ensure the product and processes are in control so that any the necessary improvements are addressed in a timely manner.  Implementing corrective and preventive action to achieve the planned results will result in continuous improvements that will help the organization succeed at delivering a product that will satisfy the customer.  Using Internal Auditing, Management Review, Analysis of Data and control of non-conforming materials are good techniques to use for evaluating the product and processes.


Steps to implement a Quality System based on a Process Approach


  1. Executive Management Team defines the organizations quality policy, purpose and the requirements for the Quality Management System based on the organizations requirements.
  2. Document the processes (ie:  Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis and Improvement) needed to achieve the intended outputs.
  3. Determine the process flow, sequence of interactions and timing. 
  4. Create flow charts to map each process.  (Flow Charts will help when its time to write methods and procedures.)
  5. Assign responsibilities or process ownership for each step to ensure implementation of each process.
  6. Write a Quality Manual outlining the Quality Management System requirements for the organization.
  7. Create documentation as required by the ISO 9001 standard. 
  8. Planning for the activities needed to achieve outputs.
  9. Determine where and how to implement monitoring and measuring of processes and product.
  10. Define the required resources necessary to achieve planned results at each operation.
  11. Verify the processes and activities against the plan.
  12. Implement the processes and monitoring and measuring activities.
  13. Analyze the process to determine performance.
  14. Determine if Corrective and Preventive Actions are required to improve the outputs.
  15. Conduct effective Management Reviews.

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