For those of you who just need a brief overview of the requirements of the ISO 9001:2015 standard, we have prepared a short guide:
- You need to PLAN the work to be undertaken.
This entails being familiar with what you can supply, knowing what your customers want and then taking steps to make sure that you have the relevant resources needed to provide it.
- You need to CONTROL the production and/or supply of your products and/or services.
This entails provision of a suitable environment and any equipment needed, also control of the work practices used to provide the products or services, and testing the products and/or services.
- You need to MONITOR the manner in which your products and/or services are produced and supplied.
This requires an examination of the effectiveness of the processes involved. It will necessitate analysis of data in order to monitor the efficiency, failure rates, etc of your processes.
- You need to TAKE ACTIONS to manage any faulty or inaccurate products or services, and to rectify the problems.
This covers actions taken when a customer complaint is received, or when your checking or test processes find faulty or inaccurate goods or services, as well as descriptions of how you record these events, and the actions that you have taken to rectify the problems.
- You need to carry out PREVENTION PLANNING.
This might involve preliminary work on a system to decrease the number of problems, a review of customer needs to ensure that possible problems are identified and reduced, as well as broad- spectrum consideration of operational activities (such as Environmental Risk Assessments or Health and Safety).
There are also a number of overall system requirements that mean that you have to:
- KEEP RECORDS of particular events defined by the standard
This includes any problems that occur, customer complaints, checking over customer orders etc.
- DEVELOP PROCEDURES that describe how you carry out specific activities
- Clearly DEFINE certain operational policies and objectives