ISO 15378

ISO 15378, Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP), specifies requirements where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements.

ANAB plans a pre-launch of its accreditation program for ISO 15378 in the third quarter of 2018 and expects to announce the program launch in the third or fourth quarter of 2018.

For more information, contact Natalia Larrimer at nlarrimer@anab.org or 414-501-5445.

ISO 41001

Facilities management is a growing discipline worldwide about which there is a lack of knowledge and awareness. This should be corrected with the forthcoming publication of ISO 41011, Facilities management – Vocabulary, and ISO 41012, Facilities management – Guidance on strategic sourcing and the development of agreements. In addition, a new management system standard is under development.

ISO 41001, Facilities management – Management systems – Requirements with guidance for use, will support the development, implementation, and maintenance of effective facilities management regimens in all sectors of industry and commerce worldwide. ISO 41001 will allow the supply side of organizations to acquire certification as a market differentiator and help private- and public-sector organizations set benchmarks to which they expect supply partners to adhere. Facilities management has a significant influence on how well companies function in terms of finances, efficiency, compliance, and sustainability.

ANAB plans a pre-launch of its accreditation program for ISO 41001 in the third quarter of 2018 and expects to announce the program launch following publication of ISO/IEC 17021-11, Competence requirements for auditing and certification of Facility Management Systems. Publication of ISO/IEC 17021-11 is expected by year end 2018.

For more information, contact Natalia Larrimer at nlarrimer@anab.org or 414-501-5445.