Update on ISO 9001:2015 Standard

The final draft of ISO 9001:2015 is close to being released. The focus is still on a process-based approach to produce desired outcomes, but several changes are to occur from the ISO 9001:2008 version: The process approach strongly emphasizes that the quality management system has to be woven into and fully aligned with an organization's strategic direction. The PDCA (plan-do-check-act) methodology is superimposed on the system of processes, which will apply both to individual processes as well as the quality management system as a whole. A strong focus on risk-based thinking is required now. It is aimed at "preventing undesirable outcomes," such as non-conforming products and services. The standard will be released in early 2015, with a 3-year transition period. Organizations and individuals should be proactive in upgrading their training and starting to implement changes of the requirements. CALISO will be releasing online courses for the new versions of ISO 9001, ISO 14001 and ISO 13485 shortly after the official released dates. The courses will be very competitively priced to ensure that our customers minimize the training cost of their transitions.


First draft of ISO's standard for sustainable communities

The First draft of ISO's standard for sustainable communities reaches CD stage; ISO 37101 sets requirements, guidance and supporting techniques and tools for sustainable development in communities, has now reached Committee Draft stage.

Energy audits with ISO 5002

Companies and organizations are integrating an energy management system to reduce consumption. Now, however, they can take this exercise a step further with the new ISO 50002:2014, the International Standard on energy audit, which will help them make informed decisions about how they use their energy.


US rejects the new ISO 9001 draft!

Do Not Rush Implementing Revisions

The ISO 9001 Committee Draft received has only received a 78% approval rate! There were 12 negative votes from representatives of major countries such as the US, Germany, Japan, and Canada and 3,000 comments that need to be addressed!

Only when the hurdles of these comments and negative votes are cleared, a Draft International Standard (DIS) can be released.

Same issues are facing Annex SL, which was developed as a skeleton on which all International Management System Standards will be built. Its purpose is to make life easier for organizations implementing multiple standards by standardizing their language, terminology and format.

The new draft international standard (DIS) of ISO 14001 is only expected in late 2014 and a final standard a year later with a 3-year transition period.

So it is better to wait and continue with the current versions of these standards, which may be around for another 4 years!!!

No Rush implementing revisions :)

Consult our eLearning catalog for standards and regulations


Strategic decisions before ISO 9001:2015

Strategic decisions before ISO 9001:2015

The new update to ISO 9001 is going to be major in nature, yet it can be painless for organizations that adopt a correct transition strategy.

For companies that are already certified:

  • Management marginally involved in the current ISO 9001 compliant management system, needs to increase its focus and start progressively build auditable records as objective evidence of its involvement.
  • Quality objectives need to be progressively fine-tuned to be more business oriented, and with greater emphasis on producing desired outputs and providing confidence in the organization’s products.
  • At upcoming management reviews, time needs to be spent at identifying risks and opportunities and planning actions to address these business and quality risks and opportunities identified. This activity will replace preventive actions when the new standard is finally released, so it would be smart to merge this risk analysis activity with Preventive Action reviews in the Management Review agenda form now on. Again, we are talking about identifying and addressing risks, which can affect conformity of goods and services and customer satisfaction.
  • NOTE: the major change to the ISO 9001 implies that ISO 13485, ISO/TS16949, ISO 22000 and ISO 14001 will also be seeing updates soon.

    For companies that dropped their certification or are not currently certified:
  • First advice, is that you should seriously consider achieving certification to ISO 9001:2008 registration by December 2014, which is an easier standard to be certified to. You will then have 3 years to transition to ISO 9001:2005.
  • For companies, which for economic or organizational reasons cannot get certified by December 2014, the Draft International Standard should be released before August 2014. It should be purchased so as to start progressively implementing some of the "heavy" requirements of ISO 9001:2015 such as risk analysis and the business focus of the management system. It will make a future registration effort less difficult.
  • Consult our eLearning catalog for standards and regulations

    Quality of our Online Courses:

    We are very proud of the quality of our online training program, it has taken years of development with the help of leading industry experts, auditors and consultants.  Our clients list includes HP, Baxter Healthcare, Philips, Bayer, the FDA, Dell, Philips Medical Systems, Boeing, Sun Microsystems, 3Com, Lucent, the US Military, and CISCO.  Our rate of repeat customers taking a second online training class or registering more members of their organizations is very high.  This is our ultimate validation of customer satisfaction with the online training classes.

    ISO Training growth

    You can view our new Free Document Control video: Tips for effective Document Control.


    Update on the upcoming changes to ISO 9001

    The revision of ISO 9001 due in 2015 has made yet one more advance: The draft is available for review.
    A close look shows that ISO 9001:2015 follows the new structure common to all management system standards: It has now 10 main clauses. The requirements are in clauses 4-10. Unfortunately many requirements you know are now located differently. I.e. requirements for both management review and internal audit are now under Clause 9 Performance Evaluation. 'Management Responsibilities' is now under Clause 5 Leadership.

    Other notable changes are:

  • Preventive action has been removed and replaced by Risk management.
  • A new clause 4 requires the organization to consider itself and its context, and to determine the scope of its quality management system. Which is a more comprehensive approach than that actual requirement of ISO 9001:2008 of just determining your scope.
  • Procedures and records were replaced by 'Documented information' with no mandatory procedures. That is going to open the door to a lot of interpretations and uncertainty both for organizations and auditors.
  • A terminology adjustment was made: the term 'product' was replaced with 'goods and services' to make the standard more generic a wide-reaching in nature.
  • The principle of 'A systems approach to management' was removed leaving only 7 Quality Management Principles, and 'Relationship Management' replaces "Mutually beneficial supplier relationships".
  • 01/11/2013

    Survey of ISO certifications worldwide

    ISO.CH has published it survey of ISO certifications worldwide. It reveals healthy growth across the board for all certifications including continual growth for ISO 9001: