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Risk Assessing for AEO

The most common question I get from clients when applying for AEO status is what security measures must be in place before applying, and the simple answer is the security measures that are required to mitigate the current risks to which the organisation is exposed.

Overview of IS EN IEC 60812:2018 Failure modes and effects analysis (FMEA and FMECA)

The standard describes how to perform a systematic failure modes and effects analysis (FMEA). An analysis of this kind establishes how a product or process might fail to perform its function and suggests how an identified failure might be treated or remedied.

IUMSS Handbook: Guidance on integrated management system standards just updated

The IUMSS handbook has been updated to reflect the many changes in management system standards. This handbook provides a practical guide for organisations to effectively align their management systems with their strategies, plans and operations.

ISO FDIS 22000 Update May 2018

Food safety is related to the presence of food-borne hazards in food at the point of consumption. As the introduction of food safety hazards can occur at any stage of the food chain, adequate control throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of all the parties participating in the food chain.

ISO 9004 Overview April 2018

In April 2018, ISO published ISO 9004: 2018 Quality management – Quality of an organisation – Guidance to achieve sustained success. This document was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, which also developed ISO 9001:2015. ISO 9004:2018 replaces ISO 9004:2009. The main changes compared to the previous edition are as […]

Implementing ISO 45001:2018

Antaris Consulting is the first organisation to be certified to ISO 45001:2018 in Ireland. It was also one of the first technical consultancies in Ireland to achieve certification to ISO 9001:2015 and ISO 14001:2015. These distinctions support Antaris’ ambition to be the leading management systems consultancy in Ireland and it also demonstrates our ongoing commitment […]

EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the […]