Implementing ISO 9001:2015 properly can benefit an organization across the board if executed appropriately. The first steps of an effective implementation process should include determining what the intended results of the program should be.
These quality objectives may include factors beyond meeting customer expectations and ensuring the quality of products and services. For example, a factor for consideration might be employee retention or improvement through training of required skills.
Context of the Organization
Requirements of the standard include that the organization define the environment in which the business operates. This analysis should include both internal and external factors that could affect the intended results of the quality management system (QMS). These factors may include:
- Type of industry
- Company Objectives
- Company Culture
- Degree of Innovation
- Customer Characteristics and Expectations
- Competitors in the Field
- Nature of the Market Sector
To be optimally effective these insights need to be gathered from interested parties inside and outside of the organization. These include people at all levels within the company, customers, and suppliers. Once these expectations have been gathered, an analysis can be made that will determine the scope of the QMS.
As a company grows and evolves these factors can be revised and again used to reshape the manner in which the organization is implementing ISO 9001:2015 to reflect these changes. This allows the company to manage processes instead of the processes managing the company.
Risks and Opportunities
Once the scope of the QMS has been defined, actions can be planned and implemented to address the determined risks and opportunities. These actions should be implemented in defined processes and include methodologies for evaluation of effectiveness.
When planning these actions it is often advantageous to integrate a SMART objectives approach. SMART objectives are Specific, Measurable, Achievable, Relevant, and Time Based. These types of objectives are most likely to achieve desired continuous improvements over time.
ISO 9001:2015 Flexibility
Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.
One of the great strengths of ISO 9001:2015 is the degree of flexibility in implementation. This makes it a valuable and effective Quality Management System for large and small businesses alike for a wide variety of market sectors. The essential task is to define and establish policies, procedures, and actions that are tailored to your organization’s requirements.
Our Exemplar Global Lead Auditor Consultants can help you with implementing ISO 9001:2015 in a manner that reflects the long term goals of your organization. CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in many business sectors.
Our quality strategy allows clients new to Quality Management Systems to rapidly implement a tailored system, because everything we do as consultants is processed based. Our Quality Experts have experience with ISO9001:2015, AS9100D, ISO 13485:2016, ISO 27001:2013 and Association of American Railroads (AAR) M-1003 and can readily deliver compliant procedures and work instructions.
We can provide expertise coupled with an outside perspective to assist you in tailoring a QMS that fits your organization’s specific requirements. We have als assisted organizations in establishing programs for ISO 13485, ISO 14971, and AS9100.
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