Standarde integrabile de ramura

• Sunt compatibile cu ISO 9001, permit

certificarea de terta parte, se adreseaza unor
ramuri industriale specifice:
• QS 9000, ISO/TS 16949:2002 industria auto;
• ISO 13485:2003, ISO 13488:1996 aparatura
medicala;
• AS 9100 industria aerospatiala;
• ISO 20000 servicii IT;
• TL 9000 industria electronica
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 QS 9000

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 ISO/TS 16949:2002

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 AS 9100
• AS9100 - Quality Management System
Requirements for Design and/or Manufacture of
Aerospace Products
• AS9110 - Quality Management System
Requirements for Maintenance Organizations
• AS9120 - Quality Management System
Requirements for Stocklist Distributors
• AS9003 Inspection & Testing
• AS9006 Aerospace Deliverable Software
Supplement to AS9100 standards.

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 ISO 13485:2003
• ISO 13485:2003 provides a good base model for compliance with
the EU CE marking Medical Devices Directives (Annex II, V, VI),
Japan Pal and Health Canada CMDCAS (class II, III & IV devices)
requirements.
• PD ISO/TR 14969:2004 - This standard provides guidance for the
application of the requirements for quality management systems
contained in ISO 13485:2003.
• ISO 14971:2007 - This standard specifies a procedure by which a
manufacturer can identify the hazards associated with medical
devices and their accessories. It also specifies a procedure to
estimate and evaluate the identified risks, control these risks and
monitor the effectiveness of the control.

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 ISO 13485
• ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a
comprehensive management system for the design and manufacture of medical devices. This
standard supersedes earlier documents such as ISO 46001 and ISO 46002 (both 1997), the ISO
13485 published in 1996 and ISO 13488 (also 1996).
• While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A
fundamental difference, however, is that ISO 9001 requires the organization to demonstrate
continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality
system is implemented and maintained. Other specific differences include:
• the promotion and awareness of regulatory requirements as a management responsibility, will
providing resources and during reviews. An example of the market specific regulatory
requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United
States.
• controls in the work environment to ensure product safety
• focus on risk management activities and design transfer activities during product development
• specific requirements for inspection and traceability for implantable devices
• specific requirements for documentation and validation of processes for sterile medical devices
• specific requirements for verification of the effectiveness of corrective and preventive actions
• Compliance with ISO 13485 is often seen as the first step in achieving compliance with European
regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical
Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed
before sale is permitted. The preferred method to prove conformity is the certification of the
Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by
a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for
the CE-identification and the permission to sell the high quality medical device in the European
Union.
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 ISO/TS 16949:2002

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 TL 9000

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