ISO 9001: 2015 Quality Management System Requirements
Proper documentation is the cornerstone of ISO 9001:2015. Creating a system of documentation that is appropriate to your company’s requirements is crucial. This is because the documentation defines the manner in which it will conduct business. Paying attention to the design of your Quality Management System (QMS) at the offset can provide an efficient system that avoids a cumbersome bureaucratic framework.
Elements that comprise ISO 9001:2015 documentation are:
- Scope Statement
- Quality Policy
- Quality Objectives
- Process Flowchart
- Work Instructions
Fitting the Documentation to a Company’s Requirements
The formation of each of these categories is critical and requires detailed analysis to properly implement. There is no specific requirement as to format or layout. Because each company has a unique business model, “cookie cutter” methods of implementing a QMS can have diminishing returns.
Quality Management System Documentation should be created understanding the needs and expectations of the organization. This requires that all stakeholders. Moreover it should be concise and user oriented. ISO 9001:2015 documentation provides instructions on how your QMS is run and ultimately how your company is run. Therefore, properly structured documentation can actually make your operations easier. This is because well designed program can integrate ISO-14001, Lean methodologies and other business models into your vision and strategy.
As your company grows, so too will its QMS. A program started out on the right path can therefore easily grow to facilitate new aspects and players in your company’s scope, objectives, and goals.
In conclusion, ISO 9001:2015, if well incorporated and conceived in its documentation, is a powerful tool that can enhance a business’s potential by creating intelligent processes, quality products, and a satisfied customer base.
CVG Strategy quality experts focus on processes and process improvement in all our work. Understanding Quality Management System Documentation development is a fundamental aspect of our work as consultants, helping our customers make their business run more efficiently and improving customer satisfaction.