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IATF 16949 ISO 9001 Quality management Quality Management System

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 safety. This is related to the provision of the so-called automotive product integrity. Probably, if I mention the PSCR function – Product Safety and Conformity Representative, people working with OEMs such as […]

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IATF 16949 ISO 9001 Quality management Quality Management System

Quality objectives – results to achieve in the quality management system

Entering the New Year for many organizations means a summary of activities in the quality management system for the previous year. At the same time, it is the moment to prepare the organization to meet the requirements of ISO 9001, IATF 16949 (more about this standard here) or another standard in the coming months. In […]

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IATF 16949 ISO 9001 Quality management Quality Management System

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 as an auditee? Unfortunately, it is not well remarked because it means a verification/control. Consequently, it may reveal a non-compliance with the requirements against which it is carried out. But is it […]

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IATF 16949 ISO 9001 Quality Management System

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 Main. While being in Germany, I had the unique opportunity to work in the quality department at the Adam Opel GmbH factory in Rüsselsheim. The enormous pleasure of working with various quality […]

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IATF 16949 ISO 9001 Quality management Quality Management System

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 indicators that provide guidance to continual improvement and effective use of resources. Thanks to them, organizations gain information on whether they are moving in the chosen direction in order to implement their […]

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ISO 9001 Management Quality management

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 recently asked you a question, what should the next article be about. Risk management framework was your answer: The clear advantage of risk management indicates that it is a very important aspect […]

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IATF 16949 ISO 9001 Quality management Quality Management System

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 in section 4.4. requirements for the quality management system and its processes. Probably if I had not examined the process approach as part of my dissertation, I would have concluded that what […]

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IATF 16949 ISO 9001 Quality management Quality Management System

Process – how to design it to manage it effectively

The essence of processes presented in the article on the process approach largely relates to the requirements for processes. In this article, I’ll explain what a well-designed process needs to have. Components of the process When describing the process approach, I have already mentioned that the most popular description of the process is presented in […]