As I said last week, ISO calls for your company to have written procedures. You need to follow those procedures and you need to be able to show that you are following them. It does not tell you what those procedures need to look like. It doesn’t tell you how to do your job. It just tells you to do it.
Your quality manual will include documentation of all of your procedures. The international standards organization [ISO] understands that in order to improve quality, you must have procedures [processes] in place.
Analyze & Improve
In order to improve how your company works, you must know how things work. Even if you don’t have written procedures, workers know what their job requires and where they fit into the bigger picture.
If you haven’t already documented your procedures, you will need to. Once documented, you can measure it – how much time is spent on each step.
Some analysis questions:
- Are there some activities taken that don’t add value to your end product?
- Are there some steps that can be done by a computer rather than a human?
- Are there some steps that can be taken to improve your product?
- Do you pay attention to product safety?
- Do your procedures take into account the needs of your customer?
- How do you interact with your customers?
These questions are just the beginning of your analysis. The idea behind the ISO requirements is that process improvements will lead to efficiency and quality improvements.
Looking for Software?
A company’s process approach will help them achieve their goals and objectives in accordance with their quality policy and the strategic direction of their company. Managing their processes will increase their efficiency. It will help them make improvements based on an ongoing analysis of their processes.
At a minimum the software that you select will need the following capabilities:
- Secure file storage [document management]
- Electronic signatures
- Access controls
- Email management
- Workflow [business process management]
- Version controls
Most of the PLM [product lifecycle management] software packages have all of the tools listed above and more that are needed to help you be ISO9001 compliant. Start with a good requirements document.
Selecting the right software for your company is not a simple task. Contact me if you would like some help…