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ISO 14001 How to determine significant environmental aspects ?

December 14, 2016

In any ISO 14001-certified EMS (Environmental Management System), identifying and dealing with environmental aspects is key to performance, and to the success of the system. With regulatory requirements, and considerations regarding your customers, shareholders, stakeholders and local community, there will be many things to consider when populating your environmental aspect register and identifying what aspects may […]

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ISO 9001:2015 section 7.3 awareness and 7.4 communication

October 29, 2016

Let’s review the changes from ISO 9001:2008 to ISO 9001:2015 from section 7 of the standard. 7.3 Awareness. REQUIREMENTS: The organization shall ensure that persons doing work under the organization’s control are aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management system, including the […]

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Latest Edition of ISO 13485

September 16, 2016

The latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry was published in March 2016. Its primary objective is to facilitate harmonized medical device regulatory requirements. This new revision will bring the standard up to date with the evolving European requirements and other international regulatory changes that have occurred since the previous revision in 2003. The previous edition of ISO 13485:2003 was based on the old ISO 9001:2000 standard, the new one is based on ISO 9001:2008 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.

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