Waiting for the new version of ISO 9001 we can try to compare the current version (2015) with GMP for a better understanding of their requirements and applicability.
One of the main problems of comparing GMP and ISO 9001 is that the two standards are not the same and are not really trying to do the same thing.
Difference between GMP and ISO 9001
The difference between ISO 9001 and GMP is that ISO 9001 is a quality management system standard, while GMP is a set of Good Manufacturing Practices.
ISO 9001 is applicable to all types of businesses, while GMP is specifically for companies involved in the manufacture of food, drugs, cosmetics, and medical devices.
ISO 9001 can be used by any organization to improve its overall management, while GMP is more focused on the specific needs of companies in the manufacturing industry.
Whilst GMP focuses on Manufacturing and Quality Control – ISO focuses on the all departments and processes of an organisation.
- ISO 9001:2015 | Quality Management Systems Reuirements
- GMP Audit Checklist for Pharmaceutical Industry
