Quality Management System (QMS) Consulting Services

ISO 13485, ISO 9001, EU MDR, MDSAP & 21 CFR 820

Streamline your quality journey with our QMS Consulting: ISO & regulatory experts helping you achieve excellence

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Quality Management Consulting Services

We offer quality management consulting services tailored to businesses aiming to enhance their quality management system or build one from the ground up. Our expertise spans various domains, and we work closely with clients to pinpoint areas for enhancement and provide comprehensive support throughout the implementation phase.

Areas of Specialization:

  • ISO Standards Compliance: Ensure adherence to ISO 9001, 13485, and 14971 standards.
  • Continuous Improvement: Foster a culture of ongoing enhancement.
  • Process Optimization: Streamline operations for efficiency gains.
  • Quality Documentation Support: Assistance with creating and managing quality documentation.

What are a few of the common quality management systems used in medical device & high-tech manufacturers?

  1. ISO 13485: This system is made for medical devices. It helps companies follow rules and standards for making medical devices.
  2. ISO 9001: This system is used in many industries, including medical devices and high-tech. It helps companies improve quality and make customers happy.
  3. 21 CFR 820: This is a set of rules from the U.S. FDA for making medical devices. It tells companies how to design, make, and sell medical devices in the U.S.
  4. Good Manufacturing Practice (GMP): These are guidelines to make sure products are safe in manufacturing. They’re often used in pharmaceuticals and medical devices.
  5. Lean Six Sigma: This method helps companies reduce waste and improve quality in making products. It’s used a lot in high-tech to make things faster and better.

What are the phases of a typical quality management consulting project?

The phases of a typical quality management system consulting project may vary depending on the specific needs and requirements of a business, but generally, the following phases can be expected:

Planning: Define project scope, set goals, and develop a plan.
Assessment: Analyze existing quality management system.
Design: Develop a customized plan to improve the quality management system.
Implementation: Work with the business to implement the new quality management system.
Monitoring and Review: Monitor performance and review effectiveness.
Continuous Improvement: Work with the business to continuously improve the quality management system.

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