In October 2010, iso 13485 consulting agreed to pay $268 million to settle United states lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled 3 years ago on account of faulty wires. In 2009, the business estimated that a minimum of 13 people could have died as a result of problem. Situations like this emphasize why standards happen to be put in place, standards such as ISO 13485: 2003, which help medical device companies maintain quality assurance and manage risk.
Medical devices like pacemakers and diabetic pumps can save countless lives, they also pose a tremendous 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
Based on the Usa Department of Commerce’s International Trade Association, the medical devices market is anticipated to grow to over $285 billion at the end of 2012. Medical device manufacturers need quality management systems to ensure quality, standardize manufacturing and make certain that the tools are safe to the end-user.
Many standards for example ISO 13485: 2003 are getting to be the international standard for many who manufacture medical devices because 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 using this type of standard, and Canada requires device manufacturers marketing their items in Canada to get a quality system certified to ISO 13485 or 13488. Adoption of your standard is still under consideration through the FDA.
ISO 13485: 2003, “specifies requirements for ohsas 18001 where a company 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 key word is consistently. Consistency really helps to minimize errors.
How do consistency be achieved? The short answer is through documentation of processes, incorporating quality control into every step of the production process and utilizing a computerized quality management system.
The key objective of the international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The conventional is dependant 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 importance 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 in the process itself. The revised standard focuses on how well the organization assesses and manages risk, identification and traceability, and cleanliness of the work environment.
The bottom line? ISO 13485: 2003 is a tool that reassures consumers that any hazards for them with the medical devices they might come in touch with are now being managed by way of a systematic strategy to making the merchandise safer for use.
The true secret for this standard is e stewards certification that builds the true secret themes in the standard into its processes through the start. For that reason, medical device manufacturers can realize better product quality, cost-effectiveness and time for you to market.