Effectiveness Versus Documented Information

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2016 World Conference on Quality and Improvement May 16-18 Milwaukee, WI

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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.

Effectiveness vs. Documented Information

Is ISO 9001:2015 Really Promoting Minimal Documentation?   
Remember the objectives/purposes of a QMS and its processes are to:
  • Consistently provide products and services that meet requirements;
  • Enhance customer satisfaction through the effective application of the system.

Effectiveness (according to ISO9000:2015 3.7.11) is the Extent to which planned activities are realized and planned results are achieved.

  • Planned Activities – (processes & monitoring and measurement methods to achieve products and services per 4.4.1c)
  • Planned Results – (evaluation to ensure that processes/methods achieve their intended results e.g., requirements, objectives per 9.1.3)

Per ISO9000 a Document – is information (meaningful data) and its supporting medium. Each organization determines the extent of documentation needed to demonstrate fulfillment of QMS requirements and the documentation medium it wants to use (hardcopy/electronic).


The extent of documented information is really dependent on multiple factors of an organization such as:
  • The type and size of the organization
  • The complexity and interaction of processes and/or of products and their control
  • Customer, applicable statutory and/or regulatory requirements
  • The demonstrated ability of personnel, and the extent required


Let’s take a further look into the ISO 9001:2015 “Documented Information” requirements.
ISO9001:2015 – 4.4.2 Quality Management System And Its Processes
To the extent necessary, the organization shall:
a) maintain documented information to support the operation of processes
b) retain documented information to have confidence that the processes are being carried out as planned

ISO9001:2015 – 7.5.1 Documented Information General

The organization’s quality management system shall include:
a) documented information required by the standard
b) documented information determined as being necessary for the effectiveness of the quality management system

Per ISO9001:2015 – 7.5.1a) The organization’s quality management system shall include: documented information required by the standard:

  • Quality Policy (5.2.2) and Quality Objectives (6.2.1)
  • Sequence and interaction of determined processes (4.4.1b)
  • Retained documented information (Records) to have confidence that the processes are being carried out as planned (4.4.2b)
  • Maintain documented information (procedures, instructions, etc.) to support the operation of processes (7.5.1b)
  • The availability of documented information that defines the characteristics of the products or services or activities to be performed and the results to be achieved (8.5.1)
BTW: The content of this article does not include all documented information requirements of ISO 9001:2015.  We will continue this topic in our next issue.

Points to Consider: (1) In the end is the ISO9001:2015 Standard truly driving minimal documentation given the fuller context of the requirements and the need to establish effectiveness?  We don’t think so, and neither should your organization.

(2) And in this transition to the new standard do you really think organizations are going to discard their existing QMS documentation?


Seeking ISO 9001:2015 transition training, an organizational gap assessment, internal auditing or documentation development services? We are here to support you. Contact us for all your ISO 9001:2015 transition needs.


AS9100:2016 Aviation, Space and Defense


In our last newsletter we discussed the AS9100 Standard pending revision. The IAQG 9100-series standards are planned for project completion in April 2016.  This also includes standards AS9110 Aviation Maintenance, and AS9120 Stockist Distributors.

We are continuing this month with presenting information on the new concepts under consideration (Draft Format) to be added to the new revision.


Areas of Focus Team Approach
Product Safety Added in carefully selected areas and consistent with 9110
Human Factors Added as a consideration in nonconformity/corrective action
Risk Merged current 9110 requirements with the new ISO requirements
Preventive Action Current clause requirements into risk, opportunities and nonconformance
Counterfeit Parts Enhanced in carefully selected areas and limited new requirements
Configuration Management Clarified and improved considerably to address stakeholder needs
Product Planning Clarified and enhanced planning throughout the standard


Post Delivery Support Merged current 9110 requirements with the new ISO requirements
Project Management Combined with operation planning clause to address user interpretation
Design Development & Supplier Management ISO text has been added back in a few places to meet the IAQG needs
Quality Manual Note added pointing to the requirements that make up a quality manual or the equivalent
Management Representative Requirement added back in for management representative for QMS oversight


For more information visit the IAQG 9100 webpage– Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.


Contact us with questions and for assistance with your future AS9100D:2016 transition needs.  


IATF Timeline ISO/TS 16949 Automotive


The International Automotive Task Force (IATF) has approved the first draft of the new ISO/TS 16949 automotive quality standard to include additional stakeholder feedback.

The revision work team is preparing for an April 2016 conference to obtain further stakeholder input. The IATF intends to release the transition strategy from ISO/TS 16949:2009 to the new automotive quality standard in April 2016.

Pilot gap assessments will be conducted May through June 2016 worldwide. Feedback from gap assessments will be used to further refine the new automotive quality standard and the associated rules for achieving and maintaining IATF recognition. The target date for completion of the new automotive quality standard is December 2016.


Some of the new enhancements to the automotive quality standard to address recent issues in the automotive industry include the following:
  • Requirements for safety-related parts and processes
  • Enhanced product traceability requirements to support latest regulatory changes
  • Requirements for products with embedded software
  • Warranty management process including addressing NTF (no trouble found) and use of automotive industry guidance
  • Clarification of sub-tier supplier management and development requirements
  • Addition of corporate responsibility requirements
 For more information, visit the IATF Website.

2016 A&D Conference Highlights


Sustaining Edge Solutions was a sponsor, presenter and exhibitor at the March 2016 Aerospace, Defense and Manufacturing Conference in Scottsdale, Arizona. Over 200 people attended the conference which included speaker and panel sessions on the state of the industry, future trends, and information on how to best meet industry supplier requirements.

During our presentation pictured above, we presented information on best practices from a recent major manufacturing study. One category, cost effectiveness represented the difference between top and bottom performers regarding total cost to manufacturer per dollars in revenue.

This included information on best practices used by top performers to maintain profits.

We also reviewed the timeline for all major management system standards transitioning and how Sustaining Edge Solutions can assist with all your transitioning and process improvement needs.

An area of great interest with attendees at our exhibitor booth was our current and ongoing training courses in the various standards, and how we can assist certified companies with all their transitioning needs, including companies wanting to pursue certification.  A great conference! Thanks very much to our clients who attended and the new connections that we made, even from Winslow, Arizona.



In the News
Congratulations to our Client, ChemResearch Corporation for a successful certification to AS9100C!

Founded in 1959, ChemResearch Corporation (CRC Surface Technologies) is an AS9100 & NADCAP certified, ITAR registered single-source metal finishing service provider for the aerospace, defense, medical, semiconductor, electronics, space and heavy equipment industries. Customers include OEMs such as Boeing, BAE Systems, Bombardier Aerospace and may others.  


Sustaining Edge Solutions worked with the management team defining additional system requirements and assisting with design and development of their aviation, space and defense management system. This included internal audit services and internal auditor training of company personnel.
We also want to congratulate ChemResearch for being selected one of the best finishing shops in the U.S., according to an industry benchmarking survey conducted by Products Finishing magazine, a trade publication.
For more information about ChemResearch services, visit the company website.
April 2016 – ISO 9001:2015 Internal Auditor Course  
Date: April 13-14, 2016
Location: Marriott Residence Inn 3021 E. Banner Gateway Drive Gilbert, AZ.

Click on link now for course description, registration and substantial pricing discounts!  Act now, we still have a few seats left! 

Students receive a comprehensive binder, and a certificate of training completion.  Lunch is provided.  If interested in onsite group internal auditor team training, let us know.


Training Courses
Don’t see a course or schedule that fits your needs?  Contact us.
Boost your creativity by breaking from the routine
Musician Miles Davis’s 1959 album Kind of Blue is considered to be one of the greatest jazz albums of all time. Why? He and his band broke from the usual bebop routine and explored new territory by “noticing and creating and discovering all simultaneously,” says Frank Barret in an interview with the Harvard Business Review.

Barret is author of the book Yes to the Mess: Surprising Leadership Lessons from Jazz and a professor of management at the Naval Postgraduate School in Monterey, California.

As a business leader, you too can benefit by embracing new ways of doing things. “By giving up control of how you always do things, you can create space for new ideas and a more receptive outlook,” writes Jane Porter in Help Scout.


So open your mind to new possibilities.

Best Regards,

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


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