Many of the ISO standards are designed around the process approach to auditing and design of the management system and takes you away from clause based systems.
Organisations who introduce ISO 9001, AS9100, AS9120, AS9110 etc need to ensure their management systems are utilising the Plan Do Check Act definitions and steer away from clause based auditing and system design. This is also relevant to organisations implementing other standards such as ISO 14001.
Within ISO 9000, the definition of a process is: A set of interrelated or interacting activities which transforms inputs into outputs.
Inputs to a process are generally outputs from other processes and a process has a start and an end defined by two limits and must be considered when defining your own processes.
Within ISO 9001 and AS9100, clause 4.1 requires organisations to (e) monitor, measure where applicable, and analyse these processes, and (f) implement actions necessary to achieve planned results and continual improvement of these processes.
The above clause is very important and is commonly overlooked by organisations and auditors. Many organisations applying AS9100, AS9120 or AS9110 will be aware of the the new Process Effectiveness Assessment Report (PEAR) form which auditors shall begin to use during assessments. These Reports are very important and will identify if your processes have been clearly defined and are suitably monitored and measured. Further information on the PEAR shall be included within a separate blog.
Tools can be used to help organisations define their processes, these shall also be detailed within a separate blog but some example tools can be process flowcharts, SIPOCs and Turtle Diagrams.
Taking the above information, organisations need to ensure that their processes have been clearly defined with inputs and outputs and showing the interaction of these processes. Measuring the effectiveness of the process is also vitally important and non-conformance’s shall be raised if these processes are found to be ineffective.
You can be in compliance with a clause of ISO 9001 or the Aerospace Standards but still be non-conforming if you are not monitoring and measuring a defined process and taking corrective actions against any areas which are outside of the defined requirements or targets.
A prime example of this could be late deliveries, if you have a process for delivering products within a defined time frame and you are late or outside of that requirement then a non-conformance’s should be raised internally and corrective actions taken.
Please note that this is a requirement of ISO 9001 not just the aerospace standards. Review clause 4.1 carefully and consider your processes and how you are defining, monitoring and measuring those processes.
If you need to download some process tools or the PEAR form visit the IMS website.