Quality Management

 

In the European Union Medical Devices are subject to a series of uniform laws and the EC directive places rigid demands on surgical instruments. IMPLANT SURGICAL is proud to claim that we have always surpassed the legal requirements to ensure that each instrument reaching the surgeons hand is indeed a testament to surgical craftsmanship.

Our certifications are listed below:

 

ISO 9001:2008

IMPLANT SURGICAL Instruments has implemented a quality management system, which has been certified ISO 9001:2008. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to improvement of system and ongoing conformity to regulations. The system has been audited by Dynamex Certification accredited assessor and subject to surveillance audits to ensure ongoing compliance.

 

ISO 13485:2012

We are proud to not only achieve recognition as an ISO 13485 certified company, but we are also 100% compliant with the quality criteria required by this medical device manufacturing standard which ensures that we meet the regulatory requirements for the quality of medical instruments, medical devices and the medical technology.

The key aspects that the ISO 13485 requires but is not limited to are following:-

 

Promotion and awareness of regulatory requirements as a management responsibility.

Controls in the work environment to ensure product safety.

Focus on risk management activities and design control activities during product development.

Specific requirements for inspection and traceability for medical devices.

Specific requirements for documentation and validation of processes for medical devices.

Specific requirements for verification of the effectiveness of corrective and preventive actions.

 

cGMP (FDA)

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).

It provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

CGMP regulations assures the identity, strength, quality, and purity of medical products by requiring that manufacturers of Medical devices adequately control manufacturing operations.

IMPLANT SURGICAL conducts training for supervisors and workers to ensure that they have the necessary knowledge on regular basis once in a year.

 

EC Declaration of Conformity

This deceleration provides the assurance that products supplied by Implant Surgical Instruments are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship in accordance with the relevant national and international standards.