Support for ISO 13485 Implementation and FDA Regulated Industries

ACACD's comprehensive ISO 13485 training and consulting program and support program for FDA regulated industries enables your organization to implement an effective ISO 13485 quality management system, and meet FDA requirements for medical device and pharmaceuticals manufacturers.

Our ISO 13485 training courses include ISO 13485 Awareness Training for Management, ISO 13485 Awareness Training for Staff, ISO 13485 internal auditors Training, and ISO 13485 Design, Development and Implementation Workshop for FDA regulated industries.

The deadline for ISO 13485:2003 implementation is July 15, 2006 , possibly earlier in some markets. ACACD's ISO 13485 training and consulting program can help you protect your international medical device sales.

ISO (the International Organisation for Standardisation) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees.

International Standard ISO 9001:2000 was prepared by Technical Committee ISO/TC 176, Quality Management and quality assurance, subcommittee SC2, Quality Systems.

ISO 9001:2000 is the third edition of ISO 9001. This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organisations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding certain requirements in accordance with 1.2 of the ISO 9001:200 requirements.

ISO 9001:2000 international standard specifies requirements for a quality management system when an organisation

• needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
  
  
• aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.