GMP & ISO

Comparing and Contrast How ISO and GMP Stack Up.

Meeting the needs and requirements of our valued customers.

                Quality Management Systems aren’t technology to improve business; they’re not new pieces for the puzzle. They are a guidebook to help you put the puzzle pieces together faster and more efficiently.

                Here at K.L. Security and www.safeandvault.com; we operate as an ISO9001:2008 certified company and we’ve recently made a push to work with all good manufacturing practices in mind. So what is all the fuss about? Why do we concern ourselves with them? As consultants and advisors to our customers and liaisons to safe and vault manufacturers we look to quality management systems to make our products and businesses more efficient, adhere to higher quality standards and safer. As a consumer you should look at such systems as guideposts for what products and companies to invest in. ISO helps us fulfill many of those goals and the GMPs can help other businesses fulfill their goals. For example, data and document retention and storage policies are avital concern for any business in this day and age. In this article we will compare and contrast ISO vs. GMP and their respective data/document retention policies. We hope you find it helpful and enlightening.

                What is ISO? The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. ISO promulgates worldwide commercial, industrial and proprietary standards by crafting the standards themselves, publishing technical reports, specifications and guides to other standards. K.L. Security has achieved certification in the ISO9001:2008 Standards (we were the first in our field to accomplish that); the 9000 series of standards are a grouping of formal international standards, technical specifications and reports, handbooks and web-based guides on Quality Management. It is a good example of what ISO (and other similar organizations) do; the goals of the standards are to increase a company’s effectiveness, increase the value of their activities and improve their performance by focusing their major processes. For us, this means better advice, better consulting, better products and a better experience for our customers.  Basically we take an in-depth look at the way they do things and use the ISO standards to revamp them into something better – it’s all about continual improvement. The ISO stamp carries a lot of weight and we are proud to have the ISO stamp of approval for K.L. Security Enterprises, Inc.   

                What are the GMPs and how are they different from ISO? A Good Manufacturing Practice is similar to the ISO standards but they differ in several key ways. First off, the ISO is an organization, with members, goals and all that come with them. The GMPs are production and testing practices that help ensure quality products. There are no GMP offices or employees and no goals beyond that which has already been stated. Also, the GMP has a narrow field of application; while ISO standards are used in a wide variety of fields and industries, the GMPs are only concerned with the manufacture of devices and products.  As such, they are employed by companies that produce these items and enforced by such organizations as the FDA in the United States and by various governmental institutions across the globe.

                ISO and GMP do sync up with many of their goals though. Good manufacturing processes, safe products, efficient workplaces and efficient employees. Another way they are similar is the attention that is paid to record keeping and storage. One of the basic principles of the GMP is that records must be made of the manufacturing process, of the product itself and all entities must keep complete histories of all aspects of their devices. In the medical field, this is vital because the health and well-being of human beings is often at stake. GMP encourages multiple levels of record keeping; product master records, batch/manufacturing records, material/component control records, personnel records, training records and equipment and cleaning logs. Going with the GMP practices will allow you to cover all your bases.

                ISO is similar; they have a standard devoted to the security of documents called ISO 27001. It is understood that records and histories are vital so matter what you manufacture and their standard is very extensive. It covers setting up internal security, classification standards, access to systems, processing information, archiving, emails, internet use, commercial software, securing hardware and other equipment, training personnel and much more.

                No matter what quality management system a company employs, they need safe and secure places to store all of that data and all of those records. That is where K.L. Security and www.safeandvault.com come in. Data security and storage is one of our primary specialties and we have products that will protect that information in the field, factory and office or at home. We have a huge range of options for data/IT storage. We have rugged hard drives, data fire safes that have been rated for 1 Hour, 2 Hour or 3 Hours, fireproof data safes from ioSafe, FireKing and SentrySafe. We have the latest in fireproof computer data protection and media storage. Paper records are covered as well; with our media storage cabinets and medical records storage cabinets. We can even provide class 5 modular vaults for the storage of important documents.

                We want to offer the most comprehensive security on the market. That is why we pay very close attention to the ISO and the GMPs. They can help us protect our customers better and they can allow you to run a business better. Use them to make your company safer and more efficient and then use us to protect the new systems you’ve built.