In October 2010, iso 13485 consulting decided to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that a minimum of 13 people could possibly have died as a result of problem. Situations such as this emphasize why standards have already been put in place, standards including ISO 13485: 2003, that assist medical device companies maintain quality assurance and manage risk.
Medical devices for example pacemakers and diabetic pumps can help to save countless lives, in addition they pose a huge 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 Usa Department of Commerce’s International Trade Association, the medical devices marketplace is expected to grow to more than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to make certain quality, standardize manufacturing and make certain that their products are safe for the user.
Many standards including ISO 13485: 2003 have grown to be the international standard for people 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 particular standard, and Canada requires device manufacturers marketing their products in Canada to experience a quality system certified to ISO 13485 or 13488. Adoption of the standard remains to be under consideration from the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 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 key word is consistently. Consistency helps you to minimize errors.
How do consistency be accomplished? The short answer is through documentation of processes, incorporating quality control into all the production process and utilizing an automated quality management system.
The key objective of the 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 folks, 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 from your 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 to the process itself. The revised standard focuses on how good the business assesses and manages risk, identification and traceability, and cleanliness from the work place.
The bottom line? ISO 13485: 2003 is actually a tool that reassures consumers that any hazards for them with the medical devices they could come in touch with are being managed via a systematic procedure for making these products safer for use.
The real key to this particular standard is e stewards certification that builds the true secret themes from the standard into its processes from your start. For that reason, medical device manufacturers can realize better product quality, cost-effectiveness and time for you to market.