Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug Administration regulates current good manufacturing processes (CGMP’s) also known as FDA 21 CFR Part 820.  FDA’s Quality System Regulation Part 820 is harmonized with ISO 13485:1996, which is based on ISO 9001:1994. According to the FDA, “The QS regulation applies to finished device manufacturers who intend to commercially distribute medical …

Engineers Week – Making a Difference

This week recognizes engineers, and in support we are encouraging our partners and teams to share their experience, knowledge and passion with others. Engineers are changing the world all of the time. They dream up creative, practical solutions and work with other smart, inspiring people to invent, design, and create things that matter. At Pro QC, our quality engineers are at the heart of our organization.  Mechanical, electrical, environmental and a host of other specialities are all necessary to sustain our successful global team of quality experts. The Discover Engineering website describes engineers as people who…

Supply Chain Management – Webinar Review

Our Tampa office worked with the local ASQ section and Hillsborough Community College’s Institute for Corporate and Continuing Education and coordinated and instructed a series of webinars that will run through this month.  The webinar scheduled for today discusses Supply Chain Management, which many in our industry recognize is a broad topic. As a brief introduction, the following components are discussed: Supplier Selection Conduct a needs analysis (brainstorm and consider long-term growth expectations). Conduct preliminary interviews and/or surveys. Evaluate samples. Perform on-site audits (general quality systems management, ISO based, social responsibility, security, etc.). Use a grid analysis for objective decision …

Leading Teams Effectively

Managing teams is a core leadership subject within the CMQ/OE certification body of knowledge.  As a CMQ/OE and Education Chair of the local ASQ section in Tampa, Pro QC’s Communications Director recently instructed a webinar related to Leading Teams Effectively.  Similar training was also recently conducted for our team in China.  At Pro QC, we understand the benefits of effective teams as it relates to the delivery of value-added quality services that reduce our clients’ risks and cost. With experience managing teams across 38 countries, our takeaways for managing effectively include: The Right People – Selecting team members that have the …

What is APQP?

Advanced Product Quality Planning, APQP, exists to ensure suppliers and manufacturers produce products that meet or exceed customer expectations. It is considered a structured approach to the design and development of new products and manufacturing processes. As part of Pro QC’s Supplier Development services, APQP incorporates the Deming Cycle, or PDCA. Plan – Technology & Concept Development Do – Product/Process Development & Prototype Development Check – Confirmation Product & Validation Process Act – Continuous Improvement With APQP, upfront planning and output review work together to support continuous improvement. Suppliers understand the requirements of all parties, and an approved product design reflects …