In October 2010, iso 13485 consulting decided to pay $268 million to settle U.S. lawsuits and claims relevant to its Sprint Fidelis group of defibrillation leads recalled 3 years ago because of faulty wires. During 2009, the corporation estimated that at the very least 13 people could possibly have died due to problem. Situations similar to this emphasize why standards have already been set up, standards for example ISO 13485: 2003, that assist medical device companies maintain quality assurance and manage risk.
Medical devices including pacemakers and diabetic pumps can help to save countless lives, in addition they pose a massive threat to human life if proper safety and quality procedures are certainly 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 United states Department of Commerce’s International Trade Association, the medical devices sector is likely to grow to a lot more than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to guarantee quality, standardize manufacturing and be sure that the tools are safe for the end-user.
Many standards for example ISO 13485: 2003 have become the worldwide standard for individuals who manufacture medical devices since they provide a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to employ an excellent 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 in the standard continues to be under consideration from the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where an organization has 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 important thing word is consistently. Consistency helps to minimize errors.
How can consistency be achieved? The short solution is through documentation of processes, incorporating quality control into all the production process and utilizing a computerized quality management system.
The primary objective on this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The typical 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 through the role of quality inspection after production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures in to the process itself. The revised standard focuses on how well the corporation assesses and manages risk, identification and traceability, and cleanliness of the workplace.
The important thing? ISO 13485: 2003 is actually a tool that reassures consumers that any hazards in their mind using the medical devices they can come in contact with are now being managed via a systematic method of making the products safer for usage.
The true secret to this particular standard is e stewards certification that builds the real key themes from the standard into its processes from the start. As a result, medical device manufacturers can realize better product quality, cost-effectiveness and time and energy to market.