Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, ...

Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...

All firms that perform accounting or attest engagements must have their new quality management system in place by Dec. 15, 2025. These new standards require firms to develop quality objectives around ...

Firms will need to learn from mistakes, fine-tune systems, and adapt to new ways of thinking about quality. Right-size your quality management documentation for SQMS No. 1 Optimize quality management ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...

An important aspect of a pharmaceutical company is a robust quality management system (QMS) because it shows the company’s commitment to quality. This idea was introduced by the International ...

What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.