This article explains the key external factors that organizations need to consider while implementing the ISO 9001 quality management system.

Organizations face different challenges, follow distinct workflows, and hence need to consider different factors to get their ISO 9001 Quality Management System implemented. A Quality Management System (QMS) is the most crucial management system today. It helps them to supervise and control their end-to-end processes to ensure each product or service delivered is of superior quality and meets every expectation of the customers. Naturally, while implementing the QMS, organizations should first consider their processes and the quality expectations of their customers. However, organizations also should consider external factors while implementing the QMS.

The reasons why external factors should be considered when implementing a QMS include:

• External factors have equal influence on the quality of products or services like the internal factors such as processes, performance of staff, organizational culture, and financial performance.

• Though most of the external factors cannot be controlled, they have huge impact on stability, performance, and profitability of the business.

• Consideration of the external factors is essential to ensure that your QMS is able to manage any unexpected events or challenges.

4 Key External Factors that You Should Consider when Implementing an ISO 9001 QMS

Market Factors

The ever-evolving scenarios in the market are a challenging situation for the business. They directly have an impact on customer preferences and expectations. Some of the key scenarios that influence customers’ purchase behavior are competition, emerging consumer trends, demographic changes, and supply chain circumstances. A QMS is developed to satisfy whatever customers want, no matter how frequently they change their preferences or expectations. It is therefore essential for a business to consider all market factors while implementing their QMS and working with it. For that, businesses need to consistently keep an eye on their market patterns and make sure their QMS is prepared to satisfy the evolving needs of customers.

Economic Factors

There are numerous economic challenges that businesses must consider for ISO 9001 QMS implementation to ensure that the quality is never compromised due to the influence of any economic factors. The most common economic factor that businesses should first consider is the fluctuations in demand and supply. Changes in demand-supply conditions have a direct impact on an organization’s productivity and performance.

When demand rises, the business needs to immediately manifold its production scale while maintaining quality consistency and vice-versa. There are several other conditions to consider such as inflation, fluctuation in the currency exchange rate, economic slump/growth, and changes in fiscal policies. Since all these have a major impact on demand and supply, they can affect your organizational effectiveness. Therefore, it is necessary for businesses to consider economic uncertainties as well as positive impacts on production.

Technological Factors

These include the technological changes or advancements that happen over time, mostly due to emerging market trends. Major technological influences that have an impact on the quality of output are mechanization/automation, digital technology awareness, and advanced production equipment. With the rapid technological advances taking place, your business needs to adapt to them to survive in the competition. Other organizations might be quickly adapting to them and enhancing their product/service quality. Hence, to make sure you do not fall behind, make your QMS flexible for any technological changes.

Political Factors

This mainly includes the federal government actions or statutory regulations initiated towards businesses to bring certain economical changes. While following them is mandatory, they are also responsible for altering the ways businesses work. You should hence implement the QMS considering the common political factors that can impact your production such as government policies, tax changes, national or global trade policies, etc.

Because most external factors have potential impact on the operations of a business, you need to know how to manage them better. Most importantly, these can have a serious impact on production and simultaneously on the quality of output. Therefore, undoubtedly, the key way for a business to prepare is to make its ISO 9001 quality management system capable of managing the external influences or challenges. Their quality management professionals should be continuously involved in learning the changes in external factors and continuously improving the QMS to take their organization’s productive efficiency and quality compliance to the next level.

Author's Bio: 

Damon Anderson is the owner of a reputed ISO consultancy firm that offers wide-ranging certification services to businesses all over the world to help them get ISO certified cost-effectively. He is also the senior consultant for the ISO 9001 quality management standard and passes on his experience to business owners through his write-ups to help them become successful at the QMS implementation.