BS ISO 15378:2006

Cross References: ISO 9000:2000*ISO 9001:2000*ISO 14644-1:1999 *ISO 14644-2:2000*ISO 14644-3*ISO 14644-4:2001 *ISO 14644-5*ISO 9004:2000*ISO 10012:2003*ISO 11135*ISO 11137-1*ISO 11137-2*ISO 13485:2003*ISO 14001:2004*ISO 14644-7:2004*ISO 14644-8*ISO 14698-1:2003*ISO 14698-2:2003*ISO 14937:2000*ISO 14971:2000*ISO 19011:2002*ISO/IEC 90003:2004*ISO/IEC Guide 2:1996*ISO/IEC Guide 51:1999*VIM:1993*IEC 60601-1-4:2000*IEC 60812:1985*IEC 61025:1990*IEC 61882:2001*



Keywords: Drugs; Packaging materials; Pharmaceutical technology; Packaging; Packages; Quality management; Quality assurance; Quality; Consumer-supplier relations

Product Code(s): 30114809,30114809

This product references:ISO 9001:2000 - Quality management systems -- Requirements
ISO 10012:2003 - Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14644-7:2004 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14698-2:2003 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
ISO/IEC Guide 51:1999 - Safety aspects -- Guidelines for their inclusion in standards
ISO 19011:2002 - Guidelines for quality and/or environmental management systems auditing
ISO 14644-2:2000 - Cleanrooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO/IEC 90003:2004 - Software engineering - Guidelines for the application of ISO 9001:2000 to computer software
ISO 14937:2000 - Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14698-1:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 1: General principles and methods
ISO 14001:2004 - Environmental management systems - Requirements with guidance for use
This product referenced by:BS DD 264:2007 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to good manufacturing practice (GMP)