Archive for October, 2016

ISO management system standards continue global growth trend

Saturday, October 22nd, 2016

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The 2015 results of the ISO Survey have just been released, showing the number of certifications to ISO management system standards continues to rise worldwide.   According to the results of the survey, a total of 1,519,952 valid certificates were reported worldwide in 2015 across nine management system standards, compared to 1, 476, 504 the previous year – an increase of 3 %.

ISO’s most widely used management system standards, ISO 9001 for quality management and ISO 14001 for environmental management, remain popular with  1, 033, 936 and 319,324 certificates respectively.  

The ISO Survey is an annual survey of valid certifications to our management system standards issued by accredited certification bodies worldwide. It is the most comprehensive overview of certifications to these standards currently available. ISO does not perform certification, therefore these results rely on the responses of some of the world’s largest certification bodies.

View the executive summary and full results on the ISO Survey page.

AS9100D Aviation, Space and Defense

Monday, October 3rd, 2016

This Month

 Events
 
2016 Southern Arizona Technology & Business Expo. October 13th. View more information
below. 
 
ISO 9001:2015 Training Courses

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 Newsletter?  Please let us know.

Aviation, Space and Defense

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The International Aerospace Quality Group (IAQG) has released, and SAE has published on September 20, 2016 , the “AS9100D Quality Management Systems Requirements for Aviation, Space, and Defense Organizations” standard.

AS9100D includes the requirements of ISO 9001:2015 with further enhanced requirements for industry specific needs. This revised standard does includes the new “Context of the Organization” requirements, including “Leadership and Actions to Address Risks and Opportunities”.

 

Some other changes include:
  • Operational Planning and Control adds requirements for FOD  and product obsolescence;
  • Clause 8.1.1 is changed to “Operation Risk Management” and clarifies that risk in this specific clause is only related to products and services;
  • New clause 8.1.4 on Prevention of Counterfeit Product. We have discussed this future requirement in past newsletters;
  • Maintained language about special processes;
  • Internal auditing now indicates that “performance indicators” can be used to assess QMS effectiveness;
  • A Management Representative is still required.

 

 Important dates for all transitioning organizations:

  • November 2016 : AS9101F – Quality Management Systems Audit Requirements and  AS9110C – Requirements for Aviation Maintenance Organizations
  • December 2016 : AS9120B – Requirements for Aviation, Space, and Defense Distributors
  • June 2017: Future audits must be to the AS9100D:2016, AS9110C:2016, or AS9120B:2016 standards using the AS9101F:2016 audit process.
  • September 2018: All transitions complete. AS9100C:2009, AS9110B:2012, and AS9120A:2009 certificates no longer will be valid.

 
Seeking onsite or offsite Transition Training to understand AS9100D:2016 Requirements?  
 
Contact Us! We will be announcing courses later this month on our website for delivery starting in November 2016. We are also here to support your company with any of your AS9100D transition consulting needs.   
 

 

ISO 9001 and ISO 14001 Anniversary

 

We are now one year into a three year transition period for ISO 9001:2015 and ISO 14001:2015. Although transitioning companies have 24 months to get registered to these new standards, related timelines are moving closer, notably scheduling a recertification or surveillance audit.

Some organizations have already passed their surveillance audits since the standards’ publication in 2015, but most audits have yet to take place.

We foresee many organizations will begin their recertification documentation development and audits to ISO 9001:2015 and ISO 14001:2015 around the middle of 2017. This doesn’t leave a lot of time for updating management systems to comply with new requirements, including ensuring the availability of a certification body auditor.

 

The ISO 9001:2015 standard includes a number of key changes for an organization to demonstrate. Requirements include:
  • 4.1 Context
  • 4.2 Interested party expectations
  • 4.4 Quality management system and its processes
  • 5.1.1 Leadership and commitment
  • 5.1.2 Customer focus
  • 6.1.1 Actions to address risks and opportunities
  • 6.3 Planning of changes
  • 7.1.6 Organizational knowledge
To efficiently implement the changes required by ISO 9001:2015 and ISO 14001:2015, organizations must begin planning and engaging in the process Now. As the surveillance audit and deadlines draw closer, organizations should avoid waiting until the last minute to begin this process. Otherwise, they will find themselves forced to focus only on conformance at a minimum to the standards, rather than building meaningful value into their operational management systems.

We are delivering ongoing training and documentation assistance with our clients now. Current month courses are defined below. Contact us for information for your transition next steps plan and assistance needs.

 

 

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.

 

IATF 16949 Automotive Standard
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The  new IATF 16949:2016 International Automotive Quality Management  System Standard was released on October 1st, 2016.

This standard, coupled with the applicable customer-specific requirements, defines the quality management system requirements for automotive production, service and/or accessory parts.

IATF 16949:2016 is an autonomous QMS standard that is fully aligned with the structure and requirements of ISO 9001:2015. However, it is not a stand-alone document, but is implemented as a supplement to, and in conjunction with, ISO 9001:2015, which must be purchased separately.

This revised standard cancels and replaces ISO/TS16949:2009.   AIAG will begin taking orders on Monday, October 3rd. For more information on IATF 16949:2016 visit the AIAG Website

 

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 are providing compete support services to assist transitioning organizations, including initial certification needs.    

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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.

 

Survey Results of Manufacturers Top Concerns    
       

The National Association of Manufacturers (NAM) released the results of its third quarter 2016 Manufacturers’ Outlook Survey, showing concerns over rising health care costs and regulatory compliance top the list of barriers to growth for manufacturers.

Key survey data points include:

  • Projected growth depends on firm size. Smaller firms anticipated sales growth of 1.3 percent while medium and larger firms averaged 2.1 percent growth expectations.
  • Manufacturers project 2016 interest rate increase. More than 58 percent of survey respondents felt the Federal Reserve would increase rates this year, but very few believed this increase would happen before December.
  • Manufacturers agree government regulations have a disproportionate impact on small businesses. Of those surveyed, 88.8 percent either somewhat or strongly disagreed with the notion that the federal government considers the point of view of small business owners when it imposes new regulations.

View the survey detailed results at the NAM Website.

 
Arizona Ranked #1 in Aerospace Manufacturing  
Arizona our home state, is home to more than 1,200 aerospace and defense companies, according to the Arizona Commerce Authority, and the industry’s growth in the state has put it in the top ranking for aerospace manufacturing.
PricewaterhouseCoopers released a ranking of the top places for aerospace manufacturing, and Arizona came in at No. 1, beating out Florida, Utah and Georgia, among others.

 According to the study, Arizona ranked high thanks to property and unemployment taxes, as well as operating costs and employment.

Arizona’s aerospace and defense total exports rose by almost 22 percent from 2011 to 2014, reaching a $3.47 billion total, primarily due to a near $400 million increase in aircraft, engines and parts exports, according to a 2015 study by the International Trade Administration.

 

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.
 
Quick Poll Results 
What is the largest challenge in implementing quality at your organization?
#1- 43% Understanding and meeting customer requirements
#2- 34% Driving continuous improvement
#3- 12% Adding value to processes
#4- 11% Measuring process performance
Source: Quality Progress Magazine

All QMS standards currently being executed require organizations to determine the “interested parties “that are relevant to the QMS; and the “requirements” of these interested parties that are relevant. This includes “monitor and review information” about these interested parties and their relevant requirements.

With the largest challenge above being “Understanding and meeting customer requirements” many companies will obviously see the value with the new standards in defining and documenting their customers, requirements, and relevant information.

Best Regards,

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