Part 7 – Conducting Internal Audits within your organisation Regular internal audits of the quality management system (QMS) will make sure it does what it is intended to do for your organisation. How often you want to do internal…
Part 6 – How to achieve continual improvement of your QMS It is important to look at the QMS regularly to make sure it does what you need it to do for your organisation. If you measure, analyse and evaluate processes…
Part 5 – Planning your QMS You can identify the risks and opportunities that could affect your organisation by thinking about interested parties within and outside your organisation, and in the context of your organisation what might they expect and…
Part 4 – Engagement Getting every member of staff involved with your organisation’s QMS really adds to its success. The staff are the people best placed to know about the processes of your organisation as they are actively involved in…
Part 3 – Leadership Strong Leadership is critical in the effective running of a Quality Management System (QMS). An individual or small team can be appointed as responsible for the QMS. Their main task would be to ensure the QMS…
Part 2 – Core principle number 1 – Customer Focus Customer focus is a very important part of a Quality Management System (QMS), as it is at the heart of providing a high quality service. Customer satisfaction results in repeat business…
Part 1 –Introduction to Implementing a Quality Management System An effective and well maintained Quality Management System (QMS) can really help an organisation to run more effectively. It is particularly helpful to new businesses and growing businesses when they need…
When ISO13485, the quality management standard for medical devices, received its last update and re-issue in 2016 it took the notable departure from using the current ISO9001 standard as its baseline. Divergence of ISO13485 from ISO 9001 The previous version…
In our blog “How Much does ISO Certification Cost?” we discussed some of the factors that influence the cost of achieving ISO Certification, but with the very specific requirements of the standard for Quality Management, how much does ISO 9001 Certification Cost?…
