ISO 9001:2008: Quality Management System

It specifies requirements displaying the ability of an organization in producing products meeting customer and applicable statutory and regulatory requirements. In fact, its core aim is boosting customer satisfaction through the effective application of the system, including processes for continual improvement of the system as well as the assurance of conformity to customer and applicable regulatory requirements.

Some associated benefits of this standard would include increased marketability, reduced operational expenses, Better management control, increased customer satisfaction, improved internal communication, improved customer service, Reduction of product-liability risks, Attractiveness to investors. Each benefit is briefly explained as follows:

increased marketability: this standard has proven that the company is dedicated to providing quality to its customers, which is no small advantage whether the company is negotiating with a long-time customer or endeavoring to pry a potentially lucrative customer away from a competitor Reduced operational expense: the rigorous registration process often exposes significant shortcomings in various operational areas. When these problems are brought to light, the company can take the appropriate steps to improve its processes.

Increased customer satisfaction: as ISO 9000 certification process leads to the improvement of the quality of products, it brings about higher levels of customer satisfaction.

Improved internal communication: The ISO 9000 certification process encourages various internal areas or departments of companies to interact with one another in hopes of gaining a more complete understanding of the needs and desires of their internal customers.

Reduction of product-liability risks: it is commonly believed that companies succeeding in being granted the ISO 9000 certifications are less likely to be hit with product liability lawsuits, etc., because of the quality of their processes.

ISO 10002:2014

ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

ISO 10002:2014 addresses the following aspects of complaints handling:

enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization’s ability to improve its product and customer service;

top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;

recognizing and addressing the needs and expectations of complainants;

providing complainants with an open, effective, and easy-to-use complaints process;

analyzing and evaluating complaints in order to improve the product and customer service quality;

auditing of the complaints-handling process;

reviewing the effectiveness and efficiency of the complaints-handling process.

ISO 13485:2003

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.