The Organization and its Context


This Month

2016 Southern Arizona Technology and
Business Expo. October 13, 2016.  View further information below

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for a future 2016 Newsletter?  Please let us know.


The Organization and its Context

One of the major changes as a new requirement of the ISO 9001:2015 standard, is to Understand the Organization and its Content. The requirement states that the organization will determine external and internal issues that are relevant to its purpose and its strategic direction, and that affect its ability to achieve the intended result(s) of its quality management system.

This includes the organization will monitor and review information about these external and internal issues.

For the purpose of effective planning all organizations need to   understand its current status, what it wants to achieve and when, and its strategy on how to achieve it. If you don’t have a clear starting point, it will be difficult for your organization to achieve the desired destination for growth and sustainability.

There are a number of effective methods and supporting techniques for organizations to analyze their context. It will be very useful to retain documented information to help understand the rationale and level of understanding that challenges all companies.


The information which may be helpful in this process can include:
  • Business plans
  • Review of strategic initiatives
  • Competitor analysis
  • Reports from business sectors
  • SWOT analysis
  • Minutes of Meetings
  • Action lists
  • Spreadsheets
  • External consultant’s reports


This process is the responsibility of the organization’s top management. It should be evident whether top management has adequately considered their organization’s context. The evidence of this may be adequately demonstrated by showing how the review outputs became the inputs into the QMS planning process.  The output from this activity should also be evident in the determined risks and opportunities regarding 6.1 Actions to address risks and opportunities.


The Needs and Expectations of Interested Parties


Along with organizational context, management also has to  understand and determine how the organization decides on the requirements of interested parties which are relevant for the quality management system. Areas of consideration can be


  • the range of interested parties considered
  • criteria to select relevant interested parties
  • aspects to select relevant requirements


Examples of relevant interested parties are given in ISO 9000:2015, definition 3.2.3, and clarification related to these requirements is provided in ISO 9001:2015, Annex A, clause


The relevant requirements of those relevant interested parties should be evident as inputs into the planning process, as potential risks and opportunities. For example this could be defined from:
  • meeting minutes
  • spreadsheets and databases
  • external documentation


Specific methods that management personnel use to monitor and review information on the interested parties and their relevant requirements must be demonstrated.


Establishing a solid foundation for shared understanding of an organizations purpose, strategic direction, interested parties, risks and opportunities will require a continuous active role within the leadership team and the quality group.
Moving quality out of the quality department is now expanding more than ever before within quality management systems compliance and effectiveness.


Seeking onsite or offsite training to understand ISO 9001:2015? View our training courses here. Don’t see a date that fits your company needs, let us know.  


Regulatory and Statutory Requirements


All quality system standards and beyond require an organization to identify and control the regulatory and statutory requirements applicable to its products and services. It is up to the organization to determine what are these requirements.

The organization should demonstrate that the statutory and regulatory requirements applicable to its products and services have been properly identified, are available understood and easily retrievable. These statutory and regulatory requirements requirements can be derived from internal and external sources, including relevant information, and of course your interested parties.

These requirements need to be identified and integrated within the resource management and identification processes, your product realization, product and service processes, including what is relevant to the activities of the organization.
Requirements can include:
  • ensure that the organization has a methodology in place for identifying, maintaining and updating all applicable statutory and regulatory requirements; this includes proper record keeping;
  • ensure that these statutory and regulatory requirements are utilized as ‘process inputs’ while monitoring ‘process outputs’ for compliance with requirements.


Meeting regulatory and statutory requirements is serious business. If for example, an auditor become aware of any deliberate legal noncompliance that could affect the image and potential credibility of the business and/or QMS before, during, or after the audit (including, for example, breach of antitrust law, labor law, health and safety or environmental regulations) then this should be taken into consideration and investigated further.


Arizona Techology and Business Expo

The Arizona Technology Council and the Arizona Commerce Authority present the 4th Annual Southern Arizona Technology and Business Expo on Thursday, October 13, 2016 at the Tucson Convention Center.


Sustaining Edge Solutions is a Company Expo Sponsor for this important event. Walter Tighe, SES President will be speaking as a Company Technology Innovator Presenter. We are an exhibitor at the Expo.

Drop by our booth to learn how we can assist your organization with all your management system transition needs, and business improvement strategy goals. See you there!

Top Three Reasons to Attend the 2016 Expo:

 1. Connect and Network. Generate credible leads for sales growth and connect with new customers.
2. Powerhouse Keynote Speaker. Learn from a local CEO, Ryan George, about building a successful and thriving global company.
3. Company Technology Innovator Presentations. Promote the success of your company innovation and connect with 350+ attendees.

For more information and registration visit the Arizona Technology Council Website.


Automotive Quality Management


In October 2016, IATF 16949:2016 will be published by the International Automotive Task Force (IATF) and will supersede and replace ISO/TS 16949:2009 defining the requirements of a quality management system for organizations in the automotive industry.

After 1 October 2017 no audits (initial, surveillance, recertification or transfer) shall be conducted to ISO/TS 16949:2009. Organizations certified to ISO/TS 16949:2009 shall transition to the new IATF 16949, through a transition audit in line with the current audit cycle for ISO/TS 16949:2009 (i.e. at a regularly scheduled recertification audit or surveillance audit), according to the allowable timing requirements defined in the IATF Rules, section 5.1.1.


Examples of key changes to IATF 16949:
  • Addition of Product Safety
  • Flow down of requirements to suppliers -special characteristics , regulatory and statutory
  • Total Productive Maintenance (use of word TPM invokes the methodology)
  • Enhanced Product Traceability requirement for all Automotive Parts
  • Manufacturing Process and Product Audits -formal approaches
  • Warranty Management, e.g., AIAG CQI 14 -Automotive Warranty Failure Guidelines


Initial Certification to IATF 16949 – All organizations seeking initial certification can be certified to ISO/TS 16949:2009 until 1 October 2017, however the ISO/TS 16949:2009 certificate will only be valid until 14 September 2018. After 1 October 2017, the organization can only be audited and certified to IATF 16949 standard.
We will be providing compete support services to assist transitioning organizations, including initial certification needs.    



In the News
Training to the New ISO 9001:2015 Standard

Date: Monday, October 24, 2016

Location: Hyatt Place 3535 W. Chandler Boulevard Chandler, AZ

Date: Wednesday-Thursday, October 26-27, 2016

Location: Hyatt Place 3535 W. Chandler Boulevard Chandler, AZ 

Click on enclosed link for course description, registration and payment method. Students receive a comprehensive workbook, and a certificate of training completion.  Lunch is provided and seats are limited.  Contact us with any questions.


AS9100D:2016 Aviation, Space and Defense    

The AS9100D:2016 Aviation, Space and Defense Standard was initially projected since the publication of ISO 9001:2015 last September to be released in April 2016. Then a delay was announced by the IAQG for an October 2016 release date.

We have been informed that the publication dates were announced at a recent TC176 committee meeting. Publication for the AS9100D:2016 has been scheduled for September 22, 2016.
The International Aerospace Quality Group (IAQG) has agreed to align transition to the forthcoming revised 9100:2016 series standards with the International Accreditation Forum’s (IAF) Resolution 2013-15, which requires transition to the ISO9001:2015 quality management system (QMS) standard no later than September 15, 2018.


Sustainable Procurement Guidance

Procurement makes up a substantial budget of any organization, so wouldn’t the world be a better place if it was done in a sustainable way? A new standard in development aims to help organizations do just that, and it has now reached one of the final stages in its development.

A new standard in initial development, ISO 20400, Sustainable Procurement – Guidance, will provide guidelines for organizations wanting to integrate sustainability into their procurement processes. It has just reached a second Draft International Standard (DIS) stage, meaning interested parties can once more submit feedback on the draft before final publication in 2017.


For more information visit the ISO Website.


Training Courses
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
Don’t see a course or schedule that fits your needs?  Contact us.
Survey Says-Quick Poll Results 
What is the most important element of risk management?
#1 – 45 % Fully understanding a risk’s potential consequences
#2 – 32.2% Knowing which risks to accept, transfer or mitigate
#3 – 22.5% Ensuring correct data are used in risk analysis
#4 – Accurately gauging the frequency of a risk’s recurrence

Source: Quality Progress Magazine

Management system standard revisions are now requiring all of us to take a “risk-based approach” which requires a greater strategic view of risk within your business. Top managers must implement and promote a culture of risk-based thinking throughout the organization to determine and address the risks and opportunities associated with providing assurance that your management system can achieve its intended results.


Best Regards,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642




Leave a Reply