Primary product labeling companies have a duty of care. An Institute of Medicine (IOM) report in July 2006 concluded that labeling and packaging mistakes were the cause of 33% of medication errors and 30% of deaths due to medication mistakes. Even though the IOM might not be the most objective source for a statistic of this nature, labeling companies took heed. Quality assurance guidelines were adopted by primary product labeling companies to prevent deaths due to medication errors.

ISO 9001:2008 was created by the International Organisation for Standardisation to improve customer satisfaction and efficiency through a large scale implementation of a standardized quality management system. The only issue was that other systems aiming to achieve the same end were incompatible with cross-platform usage.

ISO 9001:2015

From 2008 to 2015, nothing changed about the processes for quality management. Then, in 2015 came the latest standard, ISO 9001:2015.  While there are many subtle changes between ISO 9001:2008 and ISO 9001:2015, the two principal differences are raising risk aversion and universalizing the standard method.

Additionally, a few stark differences appeared in the newest version of ISO 9001.  They are as follows.

Actualized Standardization

In 2008, this management system was using different language from other sectors’ management systems. Standardizing the language makes collaborative efforts more possible. Additionally, the ten clause structure implemented in 2015 follows the same unambiguous High Level Structure (HLS) as all standardized management systems.

Plan-Do-Check-Act Methodology

Businesses which abide by ISO 9001:2015 must follow a Plan-Do-Check-Act (PDCA) cycle. This assures that processes are thoroughly thought out, executed, meticulously reviewed, then acted upon according to the results.

Risk Analysis

The previous ISO 9001 was insistent on risk analysis as well, but 2015 brought new levels of importance to avert risks. This can be seen in the PDCA loop methodology, which ensures product safety, reliability, and quality.

 

Why Luminer Chose to Become ISO 9001:2015 Certified

Today, producing high quality commercial labels and ensuring compliance across many industries and regulatory restrictions requires more precision, quality and accuracy than ever before.

International standards were created so that specifications in one country would be the same around the world. So if a consumer products company in the United States needs to have labels printed in China, USA, and Latin America, it can choose printers that are ISO certified, thereby assuring that all processes use the same standardization.  For example, paper brightness would be measured the same way, color would be measured the same way, and so on.

At Luminer, we take the greatest care in the quality and compliance of our label manufacturing and converting services. That’s why we chose to be proactive in becoming certified in ISO 9001:2015. Achieving this certification confirms our commitment to continually attaining the highest level of effectiveness within our quality management systems to ensure we provide products and accountability that comply with stringent standards.

If you would like to learn more about our custom label manufacturing process or our quality management systems, please contact us today.