In October 2010, iso 13485 consulting decided to pay $268 million to settle United states lawsuits and claims linked to its Sprint Fidelis group of defibrillation leads recalled 36 months ago because of faulty wires. During 2009, the company estimated that a minimum of 13 people might have died because of the problem. Situations similar to this emphasize why standards are already put in place, standards including ISO 13485: 2003, that will help medical device companies maintain quality assurance and manage risk.
Medical devices for example pacemakers and diabetic pumps can save countless lives, they also pose an enormous 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 accordance with the United states Department of Commerce’s International Trade Association, the medical devices industry is anticipated to grow to over $285 billion by the end of 2012. Medical device manufacturers need quality management systems to ensure quality, standardize manufacturing and make certain their items are safe to the user.
Many standards like ISO 13485: 2003 are getting to be the international standard for people who manufacture medical devices since they supply a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to employ a high 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 in the standard is still under consideration through the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a company must 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 real key word is consistently. Consistency helps you to minimize errors.
How can consistency be achieved? The short fact is through documentation of processes, incorporating quality control into all the production process and utilizing an automated quality management system.
The key objective with this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The conventional is based on eight quality management principles: customer focus, leadership, involvement of individuals, 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 at the conclusion of production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures in the process itself. The revised standard focuses on how well the group assesses and manages risk, identification and traceability, and cleanliness of the work environment.
Tha harsh truth? ISO 13485: 2003 can be a tool that reassures consumers that any hazards directly to them with all the medical devices they may come in contact with are increasingly being managed by way of a systematic procedure for making the merchandise safer for usage.
The important thing to the standard is e-stewards certification that builds the true secret themes in the standard into its processes from the very beginning. As a result, medical device manufacturers can realize better product quality, cost-effectiveness and a chance to market.