How does a company go from GMP compliance to ISO certification

  • Understand ISO 9000 requirements.

Though the revised GMP and ISO are now closer in influential how a quality system should be implemented, the manners in which both accomplish the task are diverse. Look at the ISO standard and become familiar with it (including each and every paragraph of each section, since the audit covers how your company is complying with this standard down to each paragraph).

  •  See where your GMP quality system complies with the ISO quality.

Once you understand the ISO standard, take your present quality system for GMP compliance and evaluation it to ensure it covers each paragraph of the ISO standards. You will then be able to determine what you will be requisite to write and implement in meeting the ISO standard.

  •  A good mental attitude: GMP to ISO is a lot easier than you think.

A good mental attitude is critical in structure your project to achieve ISO certification. The individuals must be appropriately instructed to assure that responsible time frames are met.

·        If your company has achieved GMP compliance, then you already meet 75% of the ISO requirements.

The side-by-side review of your GMP quality system and the ISO standard may indicate that you are probably already meeting 75% of the ISO standard. If your company has been implementing the revised GMP, raising that to approximately 80% compliant with the ISO standard is a realistic goal.

·        A GMP mentality provides the necessary environment for successful ISO certification.

In a regulated industry, maintaining documents and records requirements has been ingrained in the thought processes of responsible individuals. The ISO standard requires such discipline; therefore, being GMP compliant is an ideal environment for achieving ISO certification without much deviation in your organization’s mindset.

  • The GMPs provide the basis of a quality system.

Having a quality system in place facilitates the achievement of ISO certification. The main basis of the ISO standard is the preparation, acceptance, and implementation of a quality system. Adjusting your system to meet the ISO standard will be much easier than starting from scratch.