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16Jun/170

E Stewards Certification – Just What Are The Accreditation Specifications For E Stewards Certification.

In October 2010, iso 13485 consulting agreed to pay $268 million to settle United states lawsuits and claims related to its Sprint Fidelis group of defibrillation leads recalled 36 months ago on account of faulty wires. During 2009, the company estimated that no less than 13 people could possibly have died because of the problem. Situations similar to this emphasize why standards have been put in place, standards for example ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk.

Medical devices such as pacemakers and diabetic pumps can 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 accordance with the Usa Department of Commerce’s International Trade Association, the medical devices industry is expected to grow to over $285 billion at the end of 2012. Medical device manufacturers need quality management systems to guarantee quality, standardize manufacturing and make sure that the tools are safe for your end-user.

Many standards for example ISO 13485: 2003 have become the international standard for many 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 utilize a top quality system consistent using this standard, and Canada requires device manufacturers marketing their goods in Canada to possess a quality system certified to ISO 13485 or 13488. Adoption in the standard is still under consideration with the FDA.

ISO 13485: 2003, “specifies requirements for ohsas 18001 where a business must 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 true secret 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 principal objective with this international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The typical is dependant on eight quality management principles: customer focus, leadership, involvement of men and women, 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 following production to responsibility for quality control throughout every aspect 28dexmpky production and builds quality assurance procedures in the process itself. The revised standard targets how well the group assesses and manages risk, identification and traceability, and cleanliness of the workplace.

The bottom line? ISO 13485: 2003 is really a tool that reassures consumers that any hazards in their mind with all the medical devices they could come in touch with are being managed through a systematic strategy to making the merchandise safer to use.

The true secret for this standard is e stewards certification that builds the key themes of the standard into its processes through the very beginning. For that reason, medical device manufacturers can realize better product quality, cost-effectiveness and a chance to market.

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