Comparación ISO 9001:2008 vs ISO 9001:2015
Nuestros consultores han trabajado en prepararles un análisis de las diferencias entre las 2 normas.
Para descargarla: entren a http://www.symaconsulting.com/iso-90012015/
While the world is fighting against the virus, company fighting about economical crisis, certificates are still expiring and notified bodies and auditing organizations have to look for new ways to work. Our partner GMED NA, has put in place exceptional provisions for certification audits impacted by this health crisis. Depending on the type of audit,…
Our recommendation in terms of effective corrective and preventive action plans is to be very systematic in every step…. 1) First of a all VERY good definition of the defect…. If not defined correctly the action plan will not be effective. 2) Define corrections and containment actions. Make sure everybody understands the difference between those…
When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from specified product requirements, it fails to conform. Nonconforming products must be identified and controlled to prevent unintended use or delivery. Nonconforming product is defined as product that does not…
Sterilization process is critical in the Medical Device industry…. I do not know what industry you are working in, but if you are selling sterilized products then the sterilization process is actually an outsourcing of your organization’s manufacturing. Now how often do you internally audit your own manufacturing process ? At least once per year……..
Reference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…
El curso de “Interpretación de la norma y Auditores Internos ISO/TS 16949” se llevará a cabo la semana del 16 de Noviembre en la Ciudad de México, D.F. Si deseas inscribirte puede hacerlo a través de este link http://goo.gl/forms/QAgQQzDOKf