Quality Management System

Quality Management System

A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction

When you think of the word quality, what is the first thing that comes to mind? The word quality has more than one definition. Quality could be defined as a feature or characteristic as in the following statement: They are people of integrity, which is a good quality to possess. It can also be thought as how well something is made, if it meets all required specifications or if there are any apparent defects or non-conformances in the product. Therefore, quality is also defined as a determination of how good or bad something is, or how well it meets customer expectations.

The QMS outlines how an organization will produce, document, control and deliver a product or service possessing customer perceived value.

Regulators in most markets require device companies to maintain a quality management system to obtain device approvals and registrations. Some markets recognize certification to international standards like ISO 13485 or ISO 9001; other markets require compliance with a local quality management regulation like MDSAP, 21 CFR or so. Failure to comply with quality system requirements can be a hurdle for approvals and registration as well as jeopardize your standing with regulators post-market and disrupt product sales.

Development and implementation of a Quality Management System is no small task. Proper implementation of the QMS will require commitment, time and resources. If done properly, the organization can reap enormous benefits.  At Maven Profcon service LLP, our team can provide a customized approach for development and implementation of a robust Quality Management System within your organization. We can provide QMS Consulting to assist in the development of your Quality Management System as well as QMS Training to bring your team up to speed with the new processes and related tools.  We also provide QMS Support, where one or more of our Subject Matter Experts work directly with your teams to build and implement your Quality Management System effectively and efficiently.

As part of your QMS implementation, we will set up procedures for the following:

  • Document and records control
  • Training on regulatory requirements and internal procedures
  • Design and development
  • Risk management
  • Software development (if applicable)
  • Supplier evaluation
  • Control of measurement of Product and Equipment 
  • Internal Audits & MRM
  • Continual Improvement
  • Data Analysis
  • Post market activities (Complaints, Feedbacks, PMS, PMCF [if applicable])

We offer Quality and Reliability Support for Product and Process Development through Consulting, Training and Project Support.

What We Do

Understand our customer’s business and mission. Continuously innovate and improve our customer’s QMS, technology and business processes. Use advanced data analytics to enhance business operations and draw continual improvements in the system.

It is our mission to build transparent, fully integrated and compliant systems that help support all aspects of business function

We have a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies. The Consultants provide valuable input into optimizing systems to ensure a high quality output.

We can also perform Third party internal quality system audits if you do not have the staff or resources to do so.

We understand that becoming conversant with CDSCO, European Regulations and US FDA Regulations can be very challenging.

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