The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation. It is known as the base of a quality system. ISO 9001 is a management system that can be used to provide a solid foundation for a business. It can have a positive impact on productivity and ISO 9001 offers good quality products and services.
All medical device manufacturers are required under the Medical Device Regulation to have a quality management system in place. Once this has been attained, it must be managed by an accredited body.
Here are some of the main benefits –
- Less waste – ISO 9001 helps to meet specific requirements and optimise the production process.
- More efficiency in the workplace – staff are in a routine that allows them to feel more organised.
- Recognised globally – meaning that it can help to improve business globally, which can open up a lot more opportunities for you.
- Increase in profits – with more structure in the workplace, everyone is on top form and working to the best of their ability.
- Improved communication skills – teaching can be provided in order to achieve better communication within different teams of an organisation.
- Improved risk management – structure offers staff to be more clear on procedures and how to reduce risks in the workplace.
- More quality products and services – having clear goals means that staff can focus on how to provide products with higher quality levels than before.
- High customer satisfaction – customers can easily recognise when a workplace has a good working structure, with higher quality products, customers are more satisfied.
- Suitable for any organisation regardless of size – iso 9000 caters for any business, it can work anywhere.
- Reduced errors – goals are more clear and therefore staff are less likely to make errors within their work.
If you’d like any more information regarding a quality management system, please get in touch with us at Patient Guard today.