ISO9001 and the Operational, Planning & Control Requirements
If you think about the first 7 clauses of the ISO9001:2015 as building the framework of your Quality Management System then section 8 - Operation is very much about putting some substance on that framework.
Section 8.1 - Operational Planning and Control, that we will discuss here, gives the requirements for the organsiation to put into place the processes, procedures and controls needed to ensure their products and services meets the requirements of their quality management system (see our post in section 4.4) and also to address the risks and change management elements that they have previously identified in section 6.
Determining the Requirements for Products & Services
Meeting the requirements for part (a) of this section should be pretty simple for most
- Your customers want from your products and services
- You understand what shape, size,
colouror functional requirements there are for your product
- You understand any legal or safety requirements
- You know about the statutory requirements of you
When you are setting out your documented information about your processes, procedures and controls ensure it reflects what you actually do, not what you dreamed you wish you would be doing. Any audit, internal or external will find the gaps quickly and create improvement notices and audit fails.
If you want to change from what you are doing to a better process that's great, that's the continuous improvement loop at work! work through the right process of carrying out a change to your system and document the final real outcome when you get there.
While there is no requirement of within ISO9001:2015 to document the processes or procedures you need to create your product or service lets face it you really have to, it would be madness not to do it. How, for example, would you ensure consistency or quality or functionality, carry out training new people or even market what you have? By actually documenting the steps and processes required to produce your products or services you not only make it simple to determine that you are complying to the standard but you create the groundwork for your continuous improvement processes as well.
The other element is to determine the acceptance criteria of your products or service, i.e. how will you know that it works as intended and meets the applicable standards and expectations of your clients. This may require simple go / no testing,
Implement Your Controls
In the standard this section is actually listed after determining your resources, my view is how do you determine your resources if you don't know what your controls are going to be? So here is my tip, figure out first what your controls are then figure out the resources needed. As mentioned it doesn't matter if your
Also, think about the fact you have opted to document this process or procedure, this would pull it into the requirement for say version control and change control documentation.
Determine Your Resources
Just as you did previously you need to ensure that you have the resources required to implement your processes, procedures, and controls, after all, whats the point of coming up with a process that needs 100 people to comply with it when you have only 12 people in your
Maintaining and Retaining Documented Information
Again the organisations needs to ensure that changes to their processes is controlled. This is especially important for the operational planning and control of your products and services. These changes, intentional or unintentional need to be adequately controlled and reviewed to ensure that they don't have any unintended consequences to your delivered product or service with respect to your earlier defined criteria.
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