Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.
So, what should your internal auditors be aware of and watch out for? Find the most common issues noted during the years of IMS audits conducted at my clients. Each of these items can and will lead to ISO 45001 findings from your registrar as well.
The role of quality auditors has evolved into that of strategic leaders and data experts, driven by technology and industry demands. This article highlights the key traits and importance of modern quality professionals.
Certification as a supplier boosts reputation and efficiency in the aerospace market by ensuring quality and compliance. This leads to better communication, change management, and higher customer satisfaction.
Our 2025 Quality Professional of the Year has nineteen competences listed on his CV as well as 50 skills listed on LinkedIn. Here Ben Tomic shares his insights from a long career in quality.
Manufacturing companies must document greenhouse gas emissions, energy usage, and hazardous materials handling due to new sustainability regulations. The SEC Climate Disclosure Rules require public companies to report emissions, and private manufacturers may also face pressure to disclose similar information, according to Marcel Minutola of Peritia LLC.
Auditing is a journey that demands a positive attitude, effective planning, and clear goals. Auditors require essential skills to achieve the audit objective, ultimately delivering value by identifying findings that save time and money. While preparation can be challenging, knowing key strategies for successful auditing can make a big difference.
Success is the achievement of goals, but its meaning is subjective and varies among individuals. Influential figures emphasize focus, perseverance, and learning from failure as key components, suggesting that defining success requires personal interpretation.
Keep in mind that standards such as ISO 9001:2015 and ISO 13485:2016 do not require a record for every activity, however, if an activity requires a record, it is stated as such in the standard.
The Opening Meeting is essential for setting a positive tone in the audit process, where the audit team and auditee discuss the audit's purpose, scope, and logistics. By fostering good communication and rapport, this meeting alleviates anxiety and promotes cooperation, ensuring an efficient and productive audit.