WHAT IS ISO 13485?

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record-control, sterilization, and risk management.

WHAT IS AS 9100?

AS9100 (BS EN 9100) is the single common quality management standard for the aerospace industry. It is used and supported by the world's leading aerospace companies and throughout their supply chains. AS9100 can be used by organizations across the aerospace sector, including design, manufacturing, maintenance and distributing companies. If you certify to the standard you can be confident that you have an effective quality management system in place. AS9100 may also be essential to achieving your trade license, making it essential now and in the future.

We are one of the leading global providers of accredited management systems certification. We offer a broad portfolio of services within management system certification and related services.

Through our Next Generation Virtual Audit & Certification approach, we assess your system’s compliance with international standards and measure how well key systems support your business processes​ while building sustainable business performance over time.

Definition

CCI: Company Certification International

Applicant: Organisation applying for management system certification by Company Certification International.

Client: the Organisation has contracted Company Certification International for management system certification Systems.

Logo: This means the logo is approved by the CCI Services.

 At Company Certification International (CCI), we understand the importance of impartiality, handle conflict of interest and ensure the objectivity of our management system certification activities. We desire to achieve our goals & milestones as a major worldwide accredited certification body.

The reality that we understand in a good business sense involves effective management of our customers, personnel and certification process. It will be a basic and essential component of our business approach

Inquiry & Estimate:
Our procedure kicks off with your inquiry and the filing of your "Apply Online"Apply Online. Our auditing team will then conduct their primary estimates of the services you wish to avail of before further processing and discussions.

A remote audit, also known as a virtual audit, is the method of conducting an audit remotely, using electronic methods such as video conferencing, email, and telephone to obtain audit evidence, just like you would during an on-site audit.  

The overall aim is to evaluate this evidence objectively to determine the extent to which the audit criteria have been fulfilled. 

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