iten +39 0522 554200 Mon - Fri 08:00 - 12:30 / 13.30 - 17.00 Via Raffaello 33, Z.I. Mancasale - 42124 Reggio Emilia Italy

NEW ISO 9001: 2015 – Risk or Opportunity?

2018 will be a crucial year for the COMPANY QUALITY since it represents the deadline to compliance with the new ISO 9001:2015 standard.

The information disclosed during the past 3 years has been very discordant, causing several doubts about the effective implementation of the new standard in company’s everyday life.

OMIG started the upgrading process to these new quality standards between the end of 2016 and the beginning of the year 2017 with the significant help of DNV, that provided a truly effective service of Gap-Analysis. During these months, the company has almost completed all the activities to achieve the ISO 9001:2015.

Being at the end of this transition, we are now ready to express a concrete opinion on this very “foggy” subject.

We state here under a short list of what will change:

  • A feature of the new 2015 Standard is the great freedom left to the companies in the implementation and / or management of the Quality system, no longer extremely rigid and structured as per the previous 9001:2008.
  • There will no longer be the obligation to keep a written manual for the Quality Management;
  • There will no longer be the duty to have a system manager nor a management representative.
  • The Top Management itself will be responsible for the system and its implementation! Thus the Top Management take the field in a concrete way, assuming the RISK for the system implementation results.
  • All historical misalignments between Top Management decisions (investments and long term growth projects) and the NEEDS expressed by the KPI provided by the quality System, should finally disappear.

The watchwords of the new standard will be ORGANICITY and TRANSPARENCY at every company level:

from the definition of the goals to their achievement, from the delicate and fundamental management of the Resources to their growth and optimization in the short, medium and long term. It is important to point out that “RESOURCES” means everything that concerns the company: financial resources, machines, tools, but also all company stakeholders, both internal and external, from the employee to the environment, from the supplier to the COMPETITOR!

We can confidently say that this new regulation perfectly reflects the abolition of any physical limit, that we have been daily living for some years, and which brought even some new and unplanned RISK.


To date, we can frequently find the term RISK among the articles of the Regulations: it is recognized as the base element of the decision-making process, highlighting how this approach is still “unripe”.

However, only with an appropriate risk assessment, we can identify where we can have OPPORTUNITY of GROWTH and INNOVATION.

Who knows, maybe it will be really “OPPORTUNITY” to replace “RISK” in the near future standard…and we wish it!!!