Refine by
Internal Audit Articles & Analysis
105 articles found
The FDA’s new Quality Management System Regulation (QMSR) Final Rule aligns U.S. medical device quality requirements with ISO 13485. This checklist highlights key compliance areas to help manufacturers prepare for the February 2026 enforcement ...
How Artificial Intelligence Is Reshaping Emissions Monitoring and Reporting Introduction: Why EPA AI Is Becoming a Regulatory Turning Point The integration of EPA AI into environmental regulation marks a significant shift in how methane emissions are monitored, analyzed, and reported across the energy and industrial sectors. As methane regulations grow more complex and enforcement becomes more ...
ByOPGAL
Ensuring product reliability, operational safety, and compliance with international standards requires a comprehensive quality assurance system that spans the entire lifecycle of crane production - from raw material inspection to final commissioning.This article delves into the critical quality control measures employed in the production of double girder overhead cranes, ...
Precision in heat treatment processes is essential for ensuring product quality, operational safety, and compliance with global standards. Whether applied in metal hardening, sintering, or brazing, the ability to monitor and control gas composition is a critical factor. This is particularly true in industries such as aerospace, automotive, and manufacturing, where the integrity of treated ...
Astra Zeneca Canada partnered with 360 Energy to implement comprehensive energy management solutions at their Mississauga facility, resulting in significant reductions in energy consumption and costs. ...
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 ...
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: Be positive, courteous and cooperative with the auditor. ...
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). ...
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 ...
For your business to comply with the ISO 9001 standard, it needs a quality management system (QMS) that includes adequate CAPA processes. These processes must be properly defined, in accordance with the CAPA requirements in ISO ...
Businesses often overlook the benefits of internal quality audits as they can be viewed as an unwelcome disruption. Internal audits are powerful tools. They can help businesses prepare for external audits and find out if they are meeting their self-declared objectives. To get the most out of the process, ...
If you’re aware of the common causes of nonconformance with ISO 9001:2015, you can help your organization take steps to avoid them. A nonconformance is the nonfulfillment of a specified requirement. Here are the six nonconformances most commonly uncovered in ...
Internal audits are an important part of any organization’s quality management strategy. Your organization must meet ISO 9001 internal audit requirements to be compliant with the standard. Internal audits are used to assess the compliance of your systems, processes, and ...
Having a quality management system (QMS) is essential for compliance with the ISO 9001 standard. It’s also important to audit this system to make sure the system is having the desired effect. An internal quality audit evaluates the QMS to ensure its objectives are being achieved and that the business is compliant with ISO 9001. In this ...
An internal audit is an essential component of a quality management system (QMS). ...
Preparing a small business for ISO 9001 certification might appear an expensive, complex and daunting undertaking. You may think that certification is only for large enterprises. In reality, ISO 9001 uses what an organization already has in place for quality practices, makes improvements and documents them effectively. When applied practically, it’s easier to implement than it at first ...
It is an environmental management and audit tool created by the European Commission, which any type of organisation can use to improve its environmental performance. ...
This past week, Harmony Enterprises successfully completed its 2021 ISO 9001:2015 surveillance audit. According to iso.org, ISO 9001 “sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). This standard is based on a number of quality management principles including a strong customer focus, ...
Forced farm labor is one of the most significant human rights issues in the agriculture sector in India, for example, so this is one aspect that we look into more intentionally there. Our internal audit team tracks and manages instances of human rights abuse, and there is a redress mechanism in place. If there are any instances of our policy not being heeded, it ...
This plant has an annual capacity of more than 550,000 engines and 600,000 automatic transmissions and regularly participates in Toyota’s internal water audits. The ultimate goal is to reduce, reuse and recycle virtually all water within their reach. ...