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ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP Maintenance Solution

Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP maintenance solution for product system certification


ISO 9000 GMP FDA Maintenance Program Solution

After all the hard work of getting the product certification and management system implemented and registered, the benefits are not just internal. Product certification and registered management system show your customers and other stakeholders that you are in compliance with ISO or GMP FDA International Standards, which have significant benefits on the market. The process of achieving and maintaining the registration helps an organization:
  • Demonstrate to stakeholders that the business is run effectively
  • Ensure that the organization continually improves processes
  • Prove an innovative and forward thinking approach for Quality
Development and Implementation of ISO 9000 or GMP FDA Quality Management System is just the beginning of your journey. System performance, quality management and improvement are on-going requirements of the ISO or GMP FDA International Standards.

ISO 9000 GMP FDA Maintenance Program Compliance

The maintenance and continual improvement program of the quality management system come after getting the system and product certification. The management system is a living thing and needs to be continually updated and improved in order to operate effectively over time. Maintenance and continual improvement throughout the continual assessment process are required in order to maintain registration. Once again, Six Sigma is not specifically required by ISO GMP-FDA International Standards, but Six Sigma is a flexible, systematic problem solving methodology, which proposes continuous improvement tools that can nicely be applied to implement management systems and certify products. The ultimate goal is to achieve near 3.4 defects per million of opportunities (products).

ISO 9000 GMP FDA Maintenance Program Registration

Registration is whereby an accredited 3rd party visits an organization, assesses their management systems, and issues a certificate to show that the organization meets the requirements of the ISO or GMP-FDA International Standard. Once an organization has been issued with a certificate, the ISO or GMP FDA maintenance program enables the organization to stay up-to-date and in compliance with its industry. The maintenance program service, which we offer, allows assess whether the Quality Management System continues to meet the requirements of the International Standards. If not, we work with the organization on implementing corrective actions to adjust the quality management system.

ISO 9000 GMP FDA Maintenance Program Implementation

  • Plan your ISO or GMP-FDA certification maintenance program
  • Define two internal audits per year to assess the management system
  • Get insurance and closure of corrective actions for Quality purpose

ISO GMP FDA Maintenance Program Time Delivery

Maintaining the quality of the management system is typically the most cost effective solution for organizations seeking to maintain ISO or GMP-FDA registration. And, the quality Six Sigma approach is designed to help you put in place statistical process controls so that you control effectively your operations on a daily basis saving you time and money. However, the duration of the project depends on the size and complexity of your organization, as well as the quality of the QA manual and all documents associated to it.

We have partnered with Caliso Consulting to extend our network of experts not only in the USA but also in Canada, Mexico, France, Brazil and North Africa. Check our ISO GMP FDA Certification Maintenance Program Success Stories


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LEARN MORE ABOUT ISO CERTIFICATION

ISO 9001 certification maintenance program process and benefits

Maintain ISO 9001 business system performance

Control ISO quality management system


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