In October 2010, iso 13485 consulting agreed to pay $268 million to settle United states lawsuits and claims relevant to its Sprint Fidelis group of defibrillation leads recalled 3 years ago due to faulty wires. During 2009, the organization estimated that a minimum of 13 people might have died due to problem. Situations such as this emphasize why standards have already been set up, standards including ISO 13485: 2003, that assist medical device companies maintain quality assurance and manage risk.
Medical devices such as pacemakers and diabetic pumps could save countless lives, but they also 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 United states Department of Commerce’s International Trade Association, the medical devices market is supposed to grow to a lot more than $285 billion at the end of 2012. Medical device manufacturers need quality management systems to make sure quality, standardize manufacturing and ensure that their items are safe for your user.
Many standards including ISO 13485: 2003 are getting to be the worldwide standard for people who manufacture medical devices simply because they provide a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to hire a high quality system consistent with this standard, and Canada requires device manufacturers marketing their products in Canada to get a quality system certified to ISO 13485 or 13488. Adoption in the standard remains under consideration with the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a corporation 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 really helps to minimize errors.
How can consistency be achieved? The short answer is through documentation of processes, incorporating quality control into all the production process and utilizing a computerized quality management system.
The key objective of 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 folks, process approach, system method of management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
Revised in 2003, ISO 13485: 2003 shifts the benefit from your role of quality inspection at the conclusion of production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures into the process itself. The revised standard focuses on how good the business assesses and manages risk, identification and traceability, and cleanliness of your workplace.
The conclusion? ISO 13485: 2003 can be a tool that reassures consumers that any hazards to them together with the medical devices they could come in touch with are increasingly being managed through a systematic procedure for making the merchandise safer for usage.
The important thing to the standard is e stewards certification that builds the important thing themes in the standard into its processes in the beginning. For that reason, medical device manufacturers can realize better product quality, cost-effectiveness and a chance to market.