isoTracker Solutions Ltd. articles
Is your CAPA process solving problems, or just documenting them?
A CAPA approach that’s too reactive, ill-defined, or focused on ticking boxes is unlikely to drive real improvements. In a regulated industry, it can also lead to serious compliance issues.
We summarize the most common issues and associated audit findings and offer practical ways to strengthen your CAPA system.
IsoTracker’s affordable document management software is popular with small to medium businesses across countries and industries.
It’s been trusted for several years, is regularly updated and has transparent pricing.
Here’s what you need to know about the cost, key features and recent upgrades to our DMS.
We may only be a few months into 2025 but already there’s been a seismic shift in global trade. Protectionism and tariff wars are realigning trading partners and supply chains.
With higher prices knocking consumer confidence, and the global economy heading for a recession, quality management is more critical than ever if businesses are to survive.
Quality management tools and methods are usually applied to organizations to maintain standardized procedures for better quality outcomes – especially where legal standards are required.
But these methods can have a positive effect on all areas of life – including at home and in your personal work environment.
The same principles that organize documents or help you perform audits at work can also do wonders for other parts of your life.
Not convinced? Keep
A comprehensive complaints management system is essential for identifying product or service shortfalls and resolving them efficiently.
As part of an overall quality management system (QMS), complaints management offers vital feedback and data about both current and potential future quality or service weaknesses.
Not only is effective complaints
Newer versions of this standard have simplified the requirements and group documents and records under one term – documented information.
The ISO 9001 quality standard requires that documented information be maintained, retained, or both.
In this article, we offer seven audit tips and tricks. Share these dos and don’ts with your team to help them prepare for the audit and ensure it goes smoothly.
Audit tips and tricks key takeaways:
Version control is an often-overlooked aspect of overall document management. It ensures changes to vital documents are stored and saved in a central repository, so everyone has access to the latest, correct version.
Some organizations don’t approach version control with consistency and structure. They simply rename each version using numbers or dates or s
In this article, we look at how risk-based thinking should affect internal auditing processes and how to perform a risk-based internal audit (RBIA).
Over recent years, there has been a move to risk-based thinking across quality standards, including ISO 9001: 2015.
Incorporating this approach in internal adits al
The difference between major and minor non-conformances lies in the potential severity of their impact.
In this article, we offer advice on defining what constitutes minor versus major non-conformances as part of your organization’s quality management system (QMS).
We also offer several examples of minor and major non-conformances, to help illustrate the differences.