In October 2010, iso 13485 consulting consented to pay $268 million to settle Usa lawsuits and claims linked to its Sprint Fidelis family of defibrillation leads recalled 3 years ago due to faulty wires. In 2009, the company estimated that no less than 13 people might have died due to the problem. Situations similar to this emphasize why standards are already set up, standards like ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk.
Medical devices such as pacemakers and diabetic pumps can save countless lives, in addition they pose a tremendous threat to human life if proper safety and quality procedures are not followed. ISO 13485: 2003 solves two concerns for medical device manufacturers:
Supplying customers and end-users with safe medical products and superior patient outcomes
In line with the U.S. Department of Commerce’s International Trade Association, the medical devices market is supposed to grow to a lot more than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to make certain quality, standardize manufacturing and ensure that their items are safe to the end-user.
Many standards like ISO 13485: 2003 have grown to be the international standard for individuals who manufacture medical devices since they offer a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to employ a quality system consistent with this standard, and Canada requires device manufacturers marketing their products and services in Canada to experience a quality system certified to ISO 13485 or 13488. Adoption of your standard remains to be under consideration by the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a corporation should demonstrate its capability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
The important thing word is consistently. Consistency helps to minimize errors.
How can consistency be achieved? The short response is through documentation of processes, incorporating quality control into all the production process and utilizing a computerized quality management system.
The key objective of the international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The conventional will depend on eight quality management principles: customer focus, leadership, involvement of folks, process approach, system strategy to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
Revised in 2003, ISO 13485: 2003 shifts the benefit from the role of quality inspection at the end of production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures to the process itself. The revised standard targets how good the business assesses and manages risk, identification and traceability, and cleanliness in the work environment.
The important thing? ISO 13485: 2003 is a tool that reassures consumers that any hazards directly to them using the medical devices they may come in contact with are now being managed through a systematic method of making the products safer for use.
The real key to this standard is e-stewards certification that builds the real key themes in the standard into its processes in the very beginning. For that reason, medical device manufacturers can realize better product quality, cost-effectiveness and time and energy to market.