I work with many companies within many different industries. My primary focus is the implementation and/or remediation of quality management systems. Over the years, I have come to realize that quality management is just good business!
I often hear statements like, “I have to do this because ISO said so” or “it’s an ISO requirement to do it this way.” In reality, ISO is just a standard integrating the value of quality into your business strategy. The standard identifies key business processes and infrastructure with a quality focus to set a foundation for sustainability and growth. So, let’s take a step backwards before we dive into the ISO 9001:2015 standard. (NOTE: While I reference the ISO 9001:2015 standard in this article, the principles discussed are applicable regardless of the standard you select.)
Imagine you are an entrepreneur starting a new business with some friends. What are some key elements you need to consider for your company?
I could go on, but hopefully you get the point.
The structure of ISO 9001:2015 can be used as a model for business structure. Just looking at the high- level outline you can see the following basic business requirements.
As you can see, these considerations should align with the overall strategic plan whether it is a new business or a Fortune 500 organization.
As you can see, each of the elements of the ISO standard is something you should implement for good business practices. The best approach I can recommend is that conformance to the standard is to evaluate your business and what you are doing in relation to the standard requirements. It starts with a requirement to align a quality management system (QMS) with the strategic direction of the organization. In other words, don’t look at quality as being a stand-alone process/activity. A focus on the value of quality should be built into every aspect of the business. After all, quality is just good business!
In subsequent blog posts, I will take on each of the elements in detail, addressing ways you can build your business with the value of quality through ISO.
Christine (Chris) Park is a seasoned quality assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. Using a pragmatic approach to compliance and quality assurance, Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations. Her experience in R&D and general manufacturing for medical devices, IVDs, biotech/pharmaceuticals, chemicals, and other regulated and/or non-regulated products provides a well-balanced background for her work in compliance.
Whether working on a full quality system or on key quality components (CAPA, complaints, audits, supplier quality, management controls), Park provides employees and management not only with adequate direction and tools to maintain compliance, but also with the understanding of why they must comply with specific requirements.