This is an important clause 4.4 of ISO9001: 2015 as its intention is for the organisation to plan its quality system and processes and to define the interaction of those processes with other key support functions.
This would include audit activities, inspection regimes and management reviews. Key processes will have inputs and outputs. The outputs should meet customer expectations and hopefully lead to repeat business or indeed satisfied customers.
Process charts should be simple to follow and provide adequate data for staff to easily follow required instructions.
The processes should define the inputs including goods, personnel, and skills. The processesshould define the operations to be taken to ensure suitable controls are deployed which are appropriate to the type and nature of product or service.
Processes should have appropriate inspection regimes and monitors and measures deployed to assess their effectiveness. Some of these monitors and measures may support strategic objectives.
The outputs should be the product or service being released to the customer meeting contractual obligations. The outputs should meet defined requirements.
It is important to clearly define the interaction of processes and the importance of support functions. Without the establishment of interactions of processes, the QA system cannot address the requirements of the Standard and it may be deficient in satisfying outputs.
Detailed work instructions can be linked to high level processes for more information if needed.
Resources should be identified within the interactions of the quality system. The author suggests that this exercise is best done as a high-level diagram.
Processes should have a clearly identified owner. In addition, they should be regularly reviewed and enhanced with results of on-going risk reviews etc.
For further information and to book your ISO9001 survey please contact: Marcus J Allen at Thamer James Ltd. Email: [email protected]
Marcus has twenty years’ experience in delivering Governance, Risk and Compliance solutions to over two hundred organisations within the UK. Including over one hundred ISO9001 programmes.
Marcus holds a BSI ISO9001 lead auditor qualification and is registered on the BSI Associate Consultant Programme.
Marcus holds the respected Diploma in Governance, Risk and Compliance from the International Compliance Association and holds a master’s degree in Management Learning & Change from the University of Bristol. Marcus is a Fellow of the Institute of Consultants and Fellow of the Chartered Management Institute.