Preparing for your ISO 9001:2015 audits? Don’t overlook strategic changes!

mcphersonqualityma
Jan 25
2 min read

As organization prepare for their ISO 9001:2015 audits, it is crucial to consider how changes in strategic direction can impact the scope of your Quality Management System (QMS). One key area that auditors will focus on is clause 4.2, which emphasizes understanding of external factors that may influence your organization.

These are critical external factors to consider:

Political Factors: Keep up-to-date with government policies and regulations that could affect your operations. For example, in Trinidad and Tobago, West Indies an Office of Procurement Regulation (OPR) has been established. The OPR has been established to regulate public procurement, retention and disposal of public property. This change does not affect private institutions.

However, in territories such as the United States of America (USA), organizations need to pay close attention to the executive orders that the 47th president of the US is signing. For example, his desire to lay claim to the Gulf of Mexico. Any disruptions there can affect shipping routes and cause delays and increased expenses if alternative routes need to be used. Evidence can come from environmental scanning done by the marketing department.

Economic Factors: Organizations should examine current economic conditions, such as inflation rates and market trends, that could influence financial performance and procurement tactics. One tactic that I use is to mark the price of an item on the box and compare it to same item when I go to replenish my stock. Presently, the price is usually more – never less. Evidence can be generated by the Purchasing Officer.

Social Factors: Organizations need to understand shifts in societal expectations and demographics. At present there is a shift to localism. Consumers want to support local over foreign products. There is also the situation where as health care improves persons are living longer and organizations should pivot to products and services tailored to older adults. The organization can purchase or create market studies internally that analyze societal changes and their impact on the organization.

Technological Factors: Future-focused companies should keep abreast of technological advancements that can enhance or disrupt their processes. Are you leveraging new technologies to improve efficiency to improve your quality. For example, embracing AI.

Legal and Environmental Factors: I am happy to see that some local food handlers in Trinidad and Tobago are abiding by section 2.04 f) in the Solid Waste section of the National Environmental Policy of Trinidad and Tobago (2018). They have stopped using non-biodegradable materials such as polystyrene and plastics. Organizations can retain evidence of purchases made of environmentally friendly materials.

By proactively identifying and addressing these external factors, you not only prepare for a successful audit but also strengthen your QMS as a strategic asset that drives continuous improvement.

Remember, a well-prepared organization is one that not only meets compliance but also positions itself for future success.

#ISO9001 #QualityManagement #AuditPreparation #ContinuousImprovement #StrategicPlanning #StakeholderEngagement