In October 2010, iso 13485 consulting decided to pay $268 million to settle United states lawsuits and claims linked to its Sprint Fidelis group of defibrillation leads recalled 36 months ago on account of faulty wires. During 2009, the corporation estimated that a minimum of 13 people might have died because of the problem. Situations like this emphasize why standards have been put in place, standards such as 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 are certainly 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 United states Department of Commerce’s International Trade Association, the medical devices market is expected to grow to a lot more than $285 billion in the end of 2012. Medical device manufacturers need quality management systems to make sure quality, standardize manufacturing and ensure that the tools are safe for that end-user.
Many standards like ISO 13485: 2003 are becoming the global standard for individuals 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 hire a quality system consistent with this standard, and Canada requires device manufacturers marketing their products and services in Canada to have a quality system certified to ISO 13485 or 13488. Adoption of the standard remains to be under consideration through 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 helps you to minimize errors.
How do consistency be achieved? The short fact is through documentation of processes, incorporating quality control into all the production process and utilizing a computerized quality management system.
The main objective of this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The standard is founded on eight quality management principles: customer focus, leadership, involvement of people, 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 benefit through 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 into the process itself. The revised standard is focused on how good the organization assesses and manages risk, identification and traceability, and cleanliness of your workplace.
The conclusion? ISO 13485: 2003 is really a tool that reassures consumers that any hazards to them with all the medical devices they might come in touch with are now being managed using a systematic strategy to making the products safer for use.
The real key for this standard is e stewards certification that builds the important thing themes in the standard into its processes from your beginning. Because of this, medical device manufacturers can realize better product quality, cost-effectiveness and time for you to market.