E-Stewards Certification – Characteristics Certification Standards For OHSAS 18001 Compliance.

In October 2010, iso 13485 consulting decided to pay $268 million to settle Usa lawsuits and claims related to its Sprint Fidelis group of defibrillation leads recalled 36 months ago as a result of faulty wires. During 2009, the corporation estimated that at least 13 people might have died due to problem. Situations like this emphasize why standards happen to be set up, standards including 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, in addition they 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

According to the United states Department of Commerce’s International Trade Association, the medical devices marketplace is expected to grow to greater than $285 billion in the end of 2012. Medical device manufacturers need quality management systems to make sure quality, standardize manufacturing and ensure their tools are safe for that end-user.

Many standards for example ISO 13485: 2003 have become the global standard for people 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 quality system consistent using this type of standard, and Canada requires device manufacturers marketing their goods in Canada to experience a quality system certified to ISO 13485 or 13488. Adoption of your standard is still under consideration by the FDA.

ISO 13485: 2003, “specifies requirements for ohsas 18001 where a corporation must demonstrate being able 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 enables you to minimize errors.

How do consistency be accomplished? The short fact 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 the international standard is “to facilitate harmonized medical device regulatory requirements for quality management systems.” The conventional is based on eight quality management principles: customer focus, leadership, involvement of individuals, process approach, system approach to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.

Revised in 2003, ISO 13485: 2003 shifts the value 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 targets how well the group assesses and manages risk, identification and traceability, and cleanliness of the work environment.

Tha harsh truth? ISO 13485: 2003 is actually a tool that reassures consumers that any hazards to them with all the medical devices they can come in contact with are now being managed through a systematic approach to making the items safer for usage.

The key to the standard is e-stewards certification that builds the real key themes of the standard into its processes from your very beginning. Because of this, medical device manufacturers can realize better product quality, cost-effectiveness and a chance to market.

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