ISO 9001 is a Quality management standard that drives businesses to implement and maintain a process approach to all activities within the company. A process is essential a sequence of steps that can be replicated time after time. At the heart of ISO 9001 is customer satisfaction and continuous improvement. These are well recognized elements in growing and maintaining a strong business.
The latest edition of ISO 9001, has recently been published.This brings together over three years of revision work by experts from almost 100 participating countries.
ISO Secretary, General Kevin McKinley explains: “ISO 9001 allows organizations to adapt to a changing world. It enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.”
With well over 1.1 million certificates issued worldwide, ISO 9001 works to help organizations provide products and services of consistently good quality.
Having a process approach also helps to optimize processes and identify where the issue lie
The earlier versions of ISO 9001 were very prescriptive, with many requirements for documented and controlled procedures and records. The 2008 edition, the establishment of processes and managing processes became the mantra.
The 2015 edition puts greater focus on performance, risk based thinking and the Plan-Do-Check-Act methodology.
If you interested in Medical Devices,you will find ISO 13485, the Quality Management System for Medical Devices a useful reference also.
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Comments
So, the most critical thing is that you act upon what ever
your technician tells you to do. This will assist you to attain the desired results in the
time allocated by your technician.