Overall, all these standards share a common goal of providing a framework for organizations to create high-quality products that satisfy their customers. The choice of a specific QMS depends on the organization's industry, regulatory requirements, and specific customer needs.
While all these systems aim to improve product quality and enhance customer satisfaction, their differences are based on the specific requirements of the industries they cater to.
Generic vs. Industry-Specific: ISO 9001 is a generic standard applicable to any organization, while ISO/TS 16949 and AS9100 are industry-specific standards for the automotive and aerospace industries, respectively. ISO 13485 is specific to the medical devices industry.
Focus Areas: While ISO 9001 emphasizes customer satisfaction and continuous improvement, ISO/TS 16949 includes more specific requirements around defect prevention and reduction of variation and waste. AS9100 includes additional requirements related to the safety and reliability of aerospace products. ISO 13485, on the other hand, puts more focus on meeting regulatory as well as customer requirements, and risk management.
Applicability: Each standard has its specific applicability. ISO 9001 can be used by any organization, large or small, regardless of its field of activity. ISO/TS 16949 is suitable for any company within the automotive supply chain, AS9100 is for organizations doing business in the aerospace industry, and ISO 13485 is designed for manufacturers of medical devices.
Total Quality Management (TQM) is a strategic approach focused on maintaining consistent quality across all operations of a business. Emphasizing customer satisfaction and the involvement of all members of an organization, TQM is dedicated to continuous improvement, efficiency, and excellence. The method uses quantitative measurements to evaluate progress, aiming to reduce variation and waste, thereby enhancing overall business performance.
TQM is different from other QMS in the way that it's not a standard or a series of checklists. Instead, it is a philosophy, an approach that puts quality at the forefront of everything that an organization does, from customer service to internal process efficiency. The main difference between TQM and ISO 9001, for instance, is that the latter can be audited against a standard set of requirements, which isn't the case with TQM. This makes TQM more flexible, but it also makes its implementation more dependent on buy-in from all levels of the organization.