Nordika Pharmaceutical Engineering – First Company certificated in the New ISO: 9001:2015 standard
Nordika do Brasil a wholly Danish own company and one of the major pharmaceutical engineering companys in Latin America. Has as the first company – been ISO 9001:2015 certified by LRQA (Lloyds Register Quality Assurance).
The new ISO: 9001:2015 standard, was released Wednesday September 23t. Nordika do Brasil has received certificate of approval for ISO 9001:2015 valid by Friday, September 25. The certification is valid for Consulting Services and Projects for Pharmaceuticals, Biotech and Life Science Companies.
A big combined effort of LRQA and Nordika – has result in this ISO 9001:2015 approval. Earlier this year Nordika obtained the ISO 9001:2008 certification and the FDIS ISO 9001:2015, but it has been Nordika’s intention to adapt to the new improved standard as the first. In the spring of 2015 Nordika became an independent company as a spin-off of NNE Pharmaplan A/S, Denmark.
The changes in the new ISO 9001:2015 are fundamental, since they alter the principles of quality management and introduce risk-based thinking as a concept. The revised standard introduces changes that will help integrate Quality Management Systems in businesses’ strategic and operational processes, this includes changes in context of the organization, risks and opportunities assessment, leadership, communication, and documentation. The quality management is no longer additional to business, but an integral part of the way in which the organization operates.
Based on increased focus on quality by leadership and a sustainable business strategy, we at Nordika expect that the new standard will be widely required by the international pharmaceutical industry.
Ole Broch – CEO Nordika