Medical Imaging Systems
About us » Quality Management
Quality management
Mediso has established and applies a quality system for medical devices for the following scope: Design, Manufacturing, Marketing and Servicing of Gamma Camera Systems.
The quality management system at MEDISO Medical Imaging Systems is certified according to EN ISO 13485:2003.
The certification represents international recognition of the manufacturing department's quality production processes. The entire company is dedicated to earning certifications for meeting international standards.
The company meets all the relevant requirements specified by the Medical Device Directive (Directive 93/42/EEC Annex II, Article 3 – Full Quality Assurance System Medical Devices).
- Certificates.
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History
Mediso started to implement own quality management system in 2000.
Mediso received ISO 9001:94, ISO 46001:93 certification and Directive 93/42/EEC Annex II, Article 3 approval from the TÃœV Reinland for meeting international standards on January 15, 2001. TÃœV Reinland is a member of the TÃœV CERT located in Germany, which operates under the auspices of the International Organization for Standardization (ISO). Mediso have been accredited to use release products with CE-mark CE0197.
In September, 2003 Mediso achieved ISO 13485:2003 Certification in addition to its previous certifications. The new certificate and the MDD approval are valid until January 14, 2006.
ISO 13485:2003
With regards to medical devices there is no standard that better represents the requirements for a comprehensive management system than ISO 13485:2003.
On the 24th July 2003 BS EN ISO 13485:2003 was published. This superseded the previous incarnations of this standard, such as EN 46001:1997, EN 46002:1997, ISO 13485:2001 and ISO 13488:2001. As before, the new 2003 standard is aligned to ISO 9001:2000, but interestingly, it has also been written in such a manner that it can be utilized as a stand-alone document.
Increasingly, accredited certification to ISO 13485:2003 is becoming the preferred method for medical device manufacturers to demonstrate compliance with all applicable regulatory and statutory requirements.