ISO 17025 vs ISO 9001 – both standards are for quality management systems, but they have different purposes. The purpose of this article is to explain the difference between these two standards. This article will also explain how you can use them together for greater efficiency. What is ISO 9001? The International Organization for Standardization, […]
21 CFR 211.198, 21 CFR 211.167, 21 CFR 211.180, and 21 CFR 211.194 are four regulations that govern the manufacturing of pharmaceuticals and medical devices in the United States by defining how to store, test and produce them safely. These regulations were established by the Food and Drug Administration (FDA) under the authority given to […]
It’s important to understand that becoming an ISO 9001 consultant can be both challenging and rewarding. It takes hard work and dedication to get this designation, but once you’ve done it and become certified in the field, you may find yourself with a lot more options for your career path. Now you can watch this […]
Now you can watch this blog too! ISO 9001 section 8.4 is related to supplier management and it’s one of the most important sections in the ISO 9001 standard. ISO 9001:2015 has brought in a lot of changes and supplier management is one of them. Gone are those days when it used to be only […]
Introduction How to prepare employees for ISO audit is the most common question we come across. The ISO audit is a critical part of your business’s international standards strategy. It’s an opportunity for your organization to demonstrate that it meets the requirements set by the International Organization for Standardization (ISO) and other regulatory authorities. An audit […]
Introduction When we think of a 21 CFR 820 Nonconforming Product, the first thing that comes to mind is a consumer who has been injured by a defective product. But did you know that many nonconforming products are not defective? The term “nonconformance” refers to any deviation from the requirements of 21 CFR 820. This […]
One of the biggest challenges of running a business is the sheer number of regulations that must be followed to bring your service or product to market. Paperwork and reporting requirements using the wrong QMS can make quality management difficult and costly. Requirements can vary by a multitude of factors, such as region, consumer demands, […]
The Medical Device Single Audit Program (MDSAP), enables auditing organizations recognized by the MDSAP to conduct one regulatory audit or medical device manufacturers that satisfies the requirements associated with the participating authorities of the program.
Companies that are committed to quality are always looking for ways to improve. When a process is running smoothly, they explore new ways of enhancing workflow. When something breaks down, they take extra steps to ensure a clear
Finding ways to optimize quality control is important. In fact, it should be one of the top priorities of all high-performing companies. Even the smallest companies are now competing against big corporations. Therefore, ensuring that one’s products are always of optimal quality is imperative to the overall success of your company. Consumers have to be […]
On May 2016, the US Food and Drug Administration (FDA) decided that electronic nicotine delivery systems (ENDS) companies must follow the same rules as tobacco products. It includes:
GMP stands for Good Manufacturing Practices, it is a compliance standard in production and manufacturing industries. GMP guidelines are aimed at making the production line more consistent and aims to give better control
The burgeoning vape industry is about to transform side by side with its exponential rise. As with any new emerging industry, there are always regulations that need to be updated or created in order to better serve its community and the public.
Quality management is a resource-intensive business activity. When implemented properly, it offers a significant return on investment. Many companies that rely on production equipment to manufacture goods have selected the
How to Implement 5S In The Workplace Your company’s production and efficiency is dependent on the organization of your work spaces. Cluttered spaces create risks for employee mistakes, bottlenecks, worker safety, and worker morale. Leaders look to methods such as 5S in the workplace