If executed properly, a business plan can help increase profits and the likelihood of your organization’s long-term success. Do you know that your Quality Management System (QMS) was designed to work in conjunction with your business plan? It’s true. ISO 9001 expects top management to take an active role throughout the entire process, otherwise the results will be less than stellar. Below are some helpful tips to enable your organization to reach its QMS goals:
• Business plan: There are several areas where the ISO 9001 standard refers to “the purpose and strategic direction of the organization.” The intent is that the QMS is aligned with (or better yet, integrated into) the organizational business plan. The QMS is the desired tool to achieve strategic goals.
• SWOT: SWOT is an acronym for Strengths, Weaknesses, Opportunities and Threats. It is not required for ISO 9001, but it is a great way to look at your organization and the business environment in which it operates. Periodically performing a SWOT analysis could meet several requirements in the standard and will be beneficial for the organization as well as its long-range goals.
• Quality Policy deployment: ISO 9001 has always required a Quality Policy. ISO 9001:2015 looks to the Quality Policy to be the bridge between the business plan and the shop floor. How the Quality Policy is deployed is critical to the success of the organization.
• Cascading of leadership: Senior management has to ensure that their commitment to the QMS is cascaded down the management chain. Each lower level is expected to demonstrate their leadership in regards to the QMS. It is senior management’s responsibility to ensure that lower management does in fact exhibit leadership.
• Risk-based thinking: We have always considered risks when dealing with jobs. ISO 9001 takes this thinking to a deeper level. The consideration of risks is carried throughout the entire business and operations.
• Interested parties: This has been part of ISO 14001 for years. An interested party is a person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity. Interested parties can be either internal or external.
• Employee knowledge: ISO has a new requirement for maintaining organizational knowledge. Top management needs to understand what knowledge is necessary throughout the organization, how to keep from losing that knowledge and acquire new knowledge.
• Employee awareness: Management needs to ensure that employees are aware of requirements, the benefits of improved performance and the consequences of deviation from requirements. These consequences could be either to the product, to the organization, to the customer, to the end user or even to the employee.
• Documentation: ISO 9001 no longer separates documents from records. This can cause confusion within the organization. Management must make sure that the organizational methods for dealing with documented information is clear and lacks uncertainty.
• Change management: The intent is that companies implement change in a controlled fashion. Change introduces a risk of unwanted variation that puts the product at risk. Top management is expected to have plans and programs in place to reduce unwanted variation of change in both planned changes as well as unplanned changes (think contingency plans).
By mastering these areas, management can accomplish much of what ISO 9001 is striving to achieve. Along the way, the organization will be in a better position to reach both short- and long-term goals and do what the business was created for—generating revenue.
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