In October 2010, iso 13485 consulting consented to pay $268 million to settle U.S. lawsuits and claims linked to its Sprint Fidelis family of defibrillation leads recalled 36 months ago due to faulty wires. During 2009, the corporation estimated that no less than 13 people may have died due to the problem. Situations similar to this emphasize why standards happen to be put in place, standards like ISO 13485: 2003, which help medical device companies maintain quality assurance and manage risk.
Medical devices for example pacemakers and diabetic pumps can help to save countless lives, but they also pose a massive 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 marketplace is supposed to grow to greater than $285 billion by the end of 2012. Medical device manufacturers need quality management systems to make certain quality, standardize manufacturing and make sure their tools are safe for your user.
Many standards like ISO 13485: 2003 are becoming the worldwide standard for individuals who manufacture medical devices simply because they give a proven guideline for maintaining assurance and managing risk. The EU device directives require medical device companies to use a top quality system consistent using this type of standard, and Canada requires device manufacturers marketing their products in Canada to have a quality system certified to ISO 13485 or 13488. Adoption of your standard remains under consideration from the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a corporation needs to 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 true secret word is consistently. Consistency helps you to minimize errors.
Just how can consistency be achieved? The short response is through documentation of processes, incorporating quality control into every step of the production process and utilizing a computerized quality management system.
The main objective with this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The typical 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 value in 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 to the process itself. The revised standard concentrates on how good the group assesses and manages risk, identification and traceability, and cleanliness of your work place.
The important thing? ISO 13485: 2003 can be a tool that reassures consumers that any hazards for them with all the medical devices they could come in touch with are managed via a systematic approach to making the products safer for use.
The real key to this particular standard is e stewards certification that builds the true secret themes in the standard into its processes from the start. Consequently, medical device manufacturers can realize better product quality, cost-effectiveness and time and energy to market.