Project Description

  • sistema de qualidade

Quality System: ISO 9001, ISO 13485 and GMP

Do you want to ensure the quality of your products and services, meet customer and regulatory requirements, and stand out in the market? Then you need to know Passarini Group, the company that offers the best solutions in Quality Systems: ISO 9001, ISO 13485 and GMP.

Passarini Group helps you implement and maintain ISO 9001, ISO 13485 and Good Manufacturing Practices – GMP (ANVISA) systems in accordance with the new resolution RDC No. 665 of March 30, 2022. These systems are essential to ensure compliance of your processes, products and services with legal and regulatory requirements, as well as continuously improve your performance.

Passarini Group also assists you in handling non-conformities, Corrective Actions and Preventive Actions, so that you can identify and eliminate the causes of problems, prevent their recurrence and avoid their occurrence. In addition, Passarini Group performs a Critical Analysis of the Quality Management System, so that you can evaluate the effectiveness and adequacy of your system, and define opportunities for improvement.

How do we implement ANVISA’s ISO 9001 and GMP Systems?

If you want to know more about how we implement ISO 9001 and ANVISA’S GMP Systems, keep reading this article. We will explain our working method, which is based on:

We believe that team participation and commitment are essential for the successful implementation of quality systems. Therefore, we seek to involve employees from the beginning of the project, clarifying their doubts, listening to their suggestions and motivating them for change.

Making use of lessons learned and exalting the values that will be added. We not only follow the standards but also interpret them according to the reality and needs of each company. We use our previous experiences and best market practices to implement quality systems efficiently and effectively, adding value to the business and customers.

With the main objective of mitigating impacts on the current reality of the company and its work methodology. We know that implementing quality systems can generate some challenges and resistance in the company. Therefore, we hold brainstorming sessions with the team involved in the process to identify possible impacts, risks and opportunities, and define the best strategies to mitigate or take advantage of them.

We do not apply ready-made or generic solutions but rather personalized and exclusive solutions for each company. We standardize actions according to the company’s processes, products and services, respecting its culture and competitive differential. (exclusive procedure for the company)

Training in the process in a way that enables maintenance of tools developed for your Quality Management System. We not only implement quality systems but also train the work team so that it can maintain and continuously improve the Quality Management System. We offer theoretical and practical training on concepts, requirements and tools of quality systems as well as on management techniques leadership and communication.

We form a team of internal auditors for the company who will be responsible for periodically verifying compliance with quality systems’ effectiveness. We also conduct recycling training to update existing internal auditors’ knowledge and skills. (we also conduct recycling training for your audit team).

As you can see, Passarini Group has a complete and efficient working method to implement ISO 9001 and ANVISA’s GMP Systems in your company. If you want to know more about our services or request a quote, please contact us by phone or email.

Don’t waste time and contact Passarini Group to learn more about our Quality Systems services: ISO 9001, ISO 13485 and GMP. Passarini Group has the solution you need to ensure the quality of your business!

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