CAPA: Corrective Action – Preventive Action
“CAPA” … this term is used frequently in the Medical, Aerospace and Automotive sectors and is a fundamental principle of a Quality Management…
Internal auditor in the automotive industry – competences
The automotive industry is one of the most dynamic and demanding industries in the world. The supply chain must meet increasingly higher standards…
Quality policy – how to write it effectively?
The quality policy is the most important document in the quality management system of every organization. Organizations certifying their quality management systems for…
Documented information – requirements in quality management system
Organizations certified for compliance with ISO 9001 certainly know very well the requirements of clause 7.5 “Documented information”. It is the essence of…
Statutory and regulatory requirements in IATF 16949:2016
Recently, I have devoted a little more attention to statutory and regulatory requirements as part of ensuring compliance with legal requirements and product…
Top 10 minor nonconformities in IATF 16949 audit in 2021
In the previous article, I presented “Top 10 major nonconformities in the IATF 16949 audit in 2021”. But as we know, according to…
Quality objectives – results to achieve in the quality management system
Entering the New Year for many organizations means a summary of activities in QMS for the previous year. At the same time, it…
Audit – do not look for nonconformities!
Have you ever felt a feeling of insecurity and stress hearing that an audit is coming? Moreover, you must take part in it…
IATF 16949 – what can your organization gain with this standard?
When I was a student of Management and Production Engineering, I went on an exchange program at the Fachhochschule Darmstadt near Frankfurt am…
Process Monitoring – Process Management with Use of Indicators
Process-managed organizations are required to use process monitoring (process-oriented management approach is discussed here and monitoring basics here ). For this purpose, they use…
Risk management framework – how to understand it
Qualitywise’s mission is to respond to the needs of its readers and followers of my profile in various social media. That’s why I…
Processes – what is not discussed and is extremely important
When designing a process, we usually think about specific requirements set for it, for example, under the ISO 9001: 2015 standard. It defines…
