ISO 9001 in the Pharmaceutical industry

Unfortunately, we do not have a specific guide for the Pharmaceutical Industry.
According to my experience in implementing a QMS in three different pharmaceutical companies what is different from other sectors is the number of compliance obligations that must be determined and complied with.

The first step is to perform a Gap analysis, to determine the amount of work to be done.
Then, an important step is to design a model of how your organization works, as a set of interrelated processes: Your organization does any research? Develops new products? Looks for customers, sends proposals, wins orders, prepares, and delivers those orders? Buys products, tests those products, and warehouses them? Trains people, keeps the work environment and equipment?

With this information, you can develop your project plan, listing what needs to be done, by whom, until when.
After implementation, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.

You can find more information below:

• Should you use a gap analysis in your ISO 9001 implementation? -https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
• Free ISO 9001:2015 Gap Analysis Tool -https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
• Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
• ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
• Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
• Free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  If you are in a hurry to implement your QMS, perhaps our ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/ may be useful
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Thank you Carlos