Leveraging the Value of Quality in Your Business Through ISO


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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?

  • A company plan or focus. What is your business all about?
  • What market influencers do you need to consider? Competition, politics, regulations, culture, target customers and industry are just a few examples.
  • Employees – Competent to make or do whatever your business needs.
  • Facilities – Equipment, warehouse, packaging – an area to work in.
  • Qualified suppliers to provide materials or services for your products.
  • Processes to define how to do whatever you need for the business – manufacturing, sales, customer service – and consistency in the product – documentation and records
  • Customer service – Order processing and feedback from customers.
  • Review business performance – How do you know you are successful?

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.

  • Context of the organization – This clause is focused on the importance of understanding your organization and aligning it to the strategic business plan.
    • Define external and internal influencers.
    • Who are the interested parties and what are they interested in?
    • What are the key processes in your organization and how are they interrelated?

    As you can see, these considerations should align with the overall strategic plan whether it is a new business or a Fortune 500 organization.

  • Leadership – When you evaluate clause 5.1.1, there are 10 elements defining the expectations of top management/leadership. Again, these expectations are not just something that ISO expects. These are expectations you would have for anyone in a leadership position within any organization. Consider looking at these requirements as skillsets for leadership and measure how your business rates today.

  • Risk management and planning – This clause is all about making changes in a controlled manner with the appropriate levels of risk. This was one of the early lessons I learned in MBA school. Every business executive I know makes decisions based on evidence and the appropriate levels of risk. Additionally, this is where the business objectives are set to achieve the intended results.

  • Support – Another basic business concept. Every company/organization needs a strong infrastructure for support. This includes resources, facilities, equipment, training, communication and documentation. Think of your business as a house under construction. There must be a strong foundation to support the structure of the home. If you put the right processes in place, the business can grow with great efficiency and speed.

  • Operations – Having set a strong foundation, it’s time to look at the processes necessary to produce product and support customers. This will vary from business to business. Whether you are manufacturing product, providing services or both, there should be processes in place to ensure a high level of quality and consistency in the product. In this section of the standard, you get guidance on design/development, purchasing and supplier management, actual production and release of product. Essentially, these are all the activities necessary to provide products and/or services to meet customer requirements.

  • Performance and Evaluation – This area of the standard focuses on how to measure your business performance. Having defined your business goals and objectives, it is important to identify meaningful metrics that demonstrate how the key processes are performing. As you work through this area, remember to address the meaningful few rather than the trivial many.Don’t define data or metrics for data sake.

  • Improvement – The leadership of every company/organization should focus on improvements and how to make things better. Nothing is ever perfect, so there will always be things that don’t go the way you expect. Understanding root cause and implementing corrective action facilitates greater opportunities for growth and reduction in the cost of poor quality.

This article is related to the White Paper:
ISO 9001:2000 Standards: Automating Quality Systems
To view the full details, please  download  your free White Paper.

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.


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