Where is Risk Addressed in ISO 9001:2015?

March 15th, 2015

The number #1 topic of discussion in regards to the future ISO 9001:2015 Standard to be published late this year is the concept of risk‐based thinking.  Let’s look at the content of the ISO/TC176/SC2 document of how risk is explained in the introduction of ISO 9001:2015 standard.  


ISO 9001:2015 defines risk as the effect of uncertainty on an expected result.

  1. An effect is a deviation from the expected – positive or negative.
  2. Risk is about what could happen and what the effect of this happening might be
  3. Risk also considers how likely it is

The target of a management system is achieve conformity and customer satisfaction.  ISO 9001:2015 uses riskbased thinking to achieve this in the following way:

Clause 4 (Context) the organization is required to determine the risks which may affect this.

Clause 5 (Leadership) top management are required to commit to ensuring Clause 4 is followed.

Clause 6 (Planning) the organization is required to take action to identify risks and opportunities.

Clause 8 (Operation) the organization is required to implement processes to address risks and opportunities.

Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyse and evaluate the risks and opportunities.

Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

Why use riskbased thinking?

By considering risk throughout the organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service.  Risk‐based thinking therefore:

  • builds a strong knowledge base
  • establishes a proactive culture of improvement
  • assures consistency of quality of goods or services
  • improves customer confidence and satisfaction

Members of the ISO/TC176 agree that Risk has always been in the ISO 9001 Standard, such as preventive action. “The changes relating to risk, creates requirements for that which was always implicit in ISO 9001.”  Do you agree, or disagree with this conclusion?  Let us know.   


ISO 14001 EMS Revision to Final Stage

February 22nd, 2015

ISO 14001 Environmental Management Systems (EMS) has progressed to Final Draft International Standard – the next stage in the ISO standard revision process – following approval of the latest draft by an impressive 92 % at the end of 2014.

The current revision is an important step in the evolution of the standard and will see some improvements on the previous edition. Some of these changes are based on a user survey conducted by the committee, which received over 5000 responses from 110 countries. As a result, the new version will see greater focus on:

  • Strategic environmental management
  • Leadership
  • Protecting the environment
  • Environmental performance
  • Life-cycle thinking

This means that experts revising the standard will go through all the comments received during the previous public consultation (DIS) at their next meeting in Tokyo in February 2015. The outcome will be a final draft, which will be put forward for voting. Once approved, the standard will be published. The new version is expected by the end of 2015.

Key Manufacturing Trends for 2015

January 22nd, 2015

Welcome to 2015!!

Here we are in 2015, and many of you are looking at ambitious New Year’s resolutions and goals. Let’s take one final look at the key trends that kept U.S. manufacturing in the news in 2014, and will continue to be driving factors for business growth in 2015.


Technological advancements improved manufacturing in many ways in 2014. Additive manufacturing (otherwise known as 3D printing) and robotics in particular dominated the news. Although both have been around for quite some time, breakthroughs are allowing these technologies to become more affordable and accessible for small and midsized U.S. manufacturers. These advancements will help companies innovate, reduce production costs, and deliver more customization, higher quality, and better total value in the marketplace.

Industry growth

The year 2014 was a critical year for U.S. manufacturers. We experienced a lot of industry growth and now find ourselves increasingly optimistic for more of the same in 2015 and beyond.  Consider the following data from the latest Federal Reserve report:
U.S. manufacturing output rose 1.1 percent in November 2014, which was the largest increase in nine months.
• Utilities production, which addresses the demand for heat, water, etc., increased 5.1 percent.
• Factory output has now exceeded pre-recession levels. 


Ninety-five percent of the world’s customers live outside the United States, and manufacturers were catching on to this crucial opportunity in 2014. Exporting allows manufacturers to increase sales, introduce new product lines, diversify customer portfolios, test innovative approaches, and grow their customer bases.  U.S. International Trade Data reported that October 2014 exports of capital goods were the highest on record at $47.7 billion.

Employee training and retention

Improving worker skills and creating more diverse workplaces are ongoing challenges that reflect changing demands in the manufacturing workplace. In 2014, we focused more attention on these important issues to address requirements from enhanced technology and new processes. Although more work remains to be done, we are spreading the message about the importance of employee engagement initiatives to secure top talent, and introducing new programs to enlist the next generation of workers to U.S. manufacturing.


What manufacturing trends is your company following this year?   Let us Know!! 


Outsourcing Boom Drives New Standard

December 14th, 2014
As businesses worldwide look to be more nimble, reduce risks and tap into wider networks of expertise, it is no wonder that the trend towards outsourcing has exploded. Just as well that a new ISO standard for outsourcing has just been produced.

Outsourcing – transferring work to external companies – is nothing new. But Deloitte’s recent 2014 Global Outsourcing and Insourcing Survey showed that in recent years it has taken off, and they predict the trend to continue growing at rates of 12-26%. 

Providing access to the latest technologies, reducing headcounts and therefore reducing risks make outsourcing highly attractive. But it is not without its challenges, which is why ISO’s Technical Committee for Outsourcing, ISO/PC 259 developed a new international standard.

Developed by experts from both industry and standardization,  ISO 37500:2014 Outsourcing is for those who have already made the decision to outsource, focusing on the common processes and best practices for success, putting governance at the heart of the standard.   ISO 37500 addresses issues of flexibility in outsourcing arrangements, accommodating changing business requirements. The risks involved in outsourcing are confronted to enable mutually beneficial collaborative relationships. The standard is intended to relate to any outsourcing relationship, whether outsourcing for the first time or not, using a single-provider or multi-provider model, or draft agreements based on services or outcomes.

In addition it can be tailored and extended to industry-specific needs to accommodate international, national and local laws and regulations (including those related to the environment, labor, health and safety), the size of the outsourcing arrangement and the type of industry sector.

For more information on the 2014 Global Outsourcing Survey, visit the Deloitte Website.  For more information on the ISO 37500 Outsourcing Standard, visit the ISO Website.

Happy Holidays!

ISO 9001:2015 DIS Receives Approval Moves to FDIS

November 10th, 2014

The ISO 9001 Draft International Standard (DIS) was put to vote to ISO member nations and received nearly 90% approval, which is enough for it to progress to the next stage: Final Draft International Standard (FDIS) currently forecast for publication in March 2015.

The countries that voted against the DIS were the United States, along with Canada, Finland, Germany, Ireland, Israel, Japan, and South Africa. A majority rule is needed to push the draft onto its next stage. ISO body rules require that the negative comments be addressed prior to the FDIS (final draft international standard) publication, and the number of comments appears to have been many. Prior to the DIS approval, thousands of public comments were submitted regarding the DIS content, for example the Annex SL structure requirements and the “risk based thinking” including the lack of a structured risk based methodology such as ISO 3100 Risk Management Standard.

The ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward for voting. Once approved beyond the FDIS publication, the completed standard will then be published with a projected date of September 2015.

The main changes to the future ISO 9001 Standard include:

  • Emphasis on risk-based thinking and management involvement
  • Stronger emphasis on process monitoring, measurement effectiveness, and performance delivery
  • Increased systems value for the organization and customer
  • Increased flexibility on the use of documentation
  • More applicable to service organizations

We will keep all our readers posted on any further information received on this revision.  Contact us with any specific questions.