In October 2010, iso 13485 consulting decided to pay $268 million to settle U.S. lawsuits and claims relevant to its Sprint Fidelis family of defibrillation leads recalled three years ago as a result of faulty wires. During 2009, the business estimated that a minimum of 13 people might have died because of the problem. Situations such as this emphasize why standards happen to be 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 could save countless lives, in addition they pose an enormous threat to human life if proper safety and quality procedures usually 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 Usa Department of Commerce’s International Trade Association, the medical devices industry is anticipated to grow to greater than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to ensure quality, standardize manufacturing and make certain their products are safe to the end-user.
Many standards like ISO 13485: 2003 have grown to be the worldwide standard for those who manufacture medical devices simply because they supply a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to use an excellent system consistent with this standard, and Canada requires device manufacturers marketing their goods in Canada to have a quality system certified to ISO 13485 or 13488. Adoption from the standard is still under consideration by the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a company 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 could consistency be accomplished? The short response is through documentation of processes, incorporating quality control into all the production process and utilizing an automated quality management system.
The main objective on this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The regular will depend on eight quality management principles: customer focus, leadership, involvement of individuals, process approach, system procedure for management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
Revised in 2003, ISO 13485: 2003 shifts the significance in 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 in the process itself. The revised standard is focused on how well the group assesses and manages risk, identification and traceability, and cleanliness from the work environment.
The bottom line? ISO 13485: 2003 is actually a tool that reassures consumers that any hazards for them with all the medical devices they can come in contact with are increasingly being managed using a systematic procedure for making the items safer for use.
The true secret for this standard is e stewards certification that builds the true secret themes of the standard into its processes in the start. As a result, medical device manufacturers can realize better product quality, cost-effectiveness and time and energy to market.