Quality Blog

Find articles, case studies, videos and other insightful resources related to quality assurance, quality control, supply chain, and manufacturing.

How to combine an MDR 2017/745 and an ISO 13485 Supplier Audit

Factory Audits

MDR (EU) 2017/745 is a set of regulations that govern the European medical device market. It was created to ensure the safety and efficacy of medical devices, as well as to improve patient care and treatment options. The regulation includes strict rules for manufacturers of medical devices and in vitro diagnostic medical devices, such as […]

What is Medical Device Single Audit Program (MDSAP)?

Factory Audits

Medical Device Single Audit Program (MDSAP) An MDSAP is a type of audit that focuses on the medical device industry. It is a voluntary program that helps companies to improve their quality management systems and comply with international standards. The program is based on ISO 13485. What is MDSAP? The Medical Device Single Audit Program […]

A Guide to Sourcing in China: Advantages, Challenges, Supplier Selection and Product Quality

Manufacturing

Sourcing in China can be a daunting task, but it doesn’t have to be. There are many benefits to sourcing products in China, including lower labor costs, lower production costs, and easier access to raw materials. However, there are also some challenges to sourcing in China, such as language barriers, cultural differences, and quality control […]

Manufacturing in Colombia

Manufacturing

Advantages and challenges of manufacturing in Colombia With a rapidly growing economy and advantageous geographical location for access to the South American markets, Colombia has many benefits for anyone looking to set up a manufacturing base in the country. Colombia has several key advantages for industries seeking a strategic manufacturing location to export throughout the […]

All You Need to Know About Process Failure Mode Effects Analysis (PFMEA)

Supplier Management

Introduction – Process Failure Mode Effects Analysis (PFMEA) What if you could systematically prevent manufacturing failures from occurring? What if you could fix the highest-risk processes before they cause a problem? This is the promise of Process Failure Mode Effects Analysis (PFMEA). The following article will describe this powerful analytical method and introduce you to […]

How do Supplier Verification Audits Aid Buyers During Current Chip Crisis?

Supplier Management

Chips Disrupting the World Supply chain disruptions caused by a mix of geopolitical issues, factory fires at large plants in Japan, and the Covid-19 pandemic have led to severe semiconductor shortages around the world. The drop in air flights to carry chips around the world has not helped the situation. And while all this drama […]

Evaluating potential suppliers with Supplier Quality Audits

Factory Audits

What is a Supplier Quality Audit? A supplier quality audit is a general assessment of the supplier’s operation and quality capability. It is more in depth than an initial supplier verification. It is broader in scope that a manufacturing process audit as it covers many aspects of the quality management system, but still less exhaustive […]

A Guide to Motorcycle Quality Control Inspections

Quality Control

Motorcycle inspections: quality control method and checklist God didn’t create metal so that man could make paper clips, says the old Harley Davidson quote. It’s enough to tell you that motorcycles are one of those quintessentially evergreen products, with a need for a solid supply chain to provide the parts required to put these hefty […]

Pro QC Attendance – 5th Annual European Medical Device & Diagnostic Quality Assurance Conference

Medical Devices

The modern medical device industry has transformed global healthcare for one single reason: new technologies enable more accurate diagnoses. However, to be effective, every part that goes into a medical device must be of the highest, fully functional, quality to help ensure patients ultimately receive the right treatment for their concerns. To participate in the […]

5 things to know about Pre-Shipment Inspections

Quality Control

An integral part of the supply chain management process are Pre-Shipment Inspections (PSI), which ensure newly manufactured products are checked for quantity and quality before being shipped out from the factory. So, what are the top five things you need to know about this important quality control process? Pre-Shipment Inspection is a systematic random inspection […]

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