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 because of faulty wires. During 2009, the company estimated that at least 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, which help medical device companies maintain quality assurance and manage risk.
Medical devices including pacemakers and diabetic pumps could save countless lives, in addition they pose a tremendous threat to human life if proper safety and quality procedures will not be followed. ISO 13485: 2003 solves two concerns for medical device manufacturers:
Supplying customers and end-users with safe medical products and superior patient outcomes
Based on the United states Department of Commerce’s International Trade Association, the medical devices sector is anticipated to grow to greater than $285 billion in the end of 2012. Medical device manufacturers need quality management systems to guarantee quality, standardize manufacturing and be sure that the items are safe for your user.
Many standards like ISO 13485: 2003 have grown to be the global standard for people 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 hire a high quality system consistent with this particular standard, and Canada requires device manufacturers marketing their items in Canada to get a quality system certified to ISO 13485 or 13488. Adoption in the standard continues to be under consideration with 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 true secret word is consistently. Consistency helps to minimize errors.
How do consistency be accomplished? The short solution is through documentation of processes, incorporating quality control into every step of the production process and utilizing an automated quality management system.
The key objective of this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The typical is founded on eight quality management principles: customer focus, leadership, involvement of men and women, 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 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 to the process itself. The revised standard is focused on how good the organization assesses and manages risk, identification and traceability, and cleanliness in the workplace.
The important thing? ISO 13485: 2003 is really a tool that reassures consumers that any hazards for them using the medical devices they can come in contact with are managed through a systematic strategy to making the items safer to be used.
The real key for this standard is e-stewards certification that builds the key themes of the standard into its processes from the start. As a result, medical device manufacturers can realize better product quality, cost-effectiveness and time for you to market.