Create a Common Language for Quality

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   August 2011

This Month
* Create a Common Language for Quality
* Fundamentals of Product Certification
* The Best Selling Standard
* In the News
* ISO Activity on Facilities Management
* Training Courses


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August 9, 2011
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Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes business and performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.


If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.




Create a Common Language for Quality

The current economic environment provides the best opportunity for your business to improve quality.  Whether you’re starting the quality journey now, or involved for many years it is critical that top leadership be committed and actively participating in quality improvement.

Top management needs to create a common language for quality. How do you define quality in your organization? There are various definitions, for example, “conformance to requirements” and “fitness for use.” Regardless of what you use, it is important that there be understanding and agreement on the quality requirements in order to achieve peak performance. This applies equally to internal transactions as well as external. Terms, definitions, and acronyms should have common definitions to promote communication and understanding.  These need to be widely communicated and incorporated into appropriate training, including new hire orientations and all-employee meetings.

Top management needs to talk about quality at every opportunity to grow a culture of quality. It cannot just be discussed at formal performance reviews, or delegated to the quality department.   People take note of what their leaders talk about, especially on a regular basis. World class organizations require all senior leaders to have strategic quality criteria and productivity plans in their areas, and regularly report status at leadership meetings. Quality should be a standing agenda item in the existing meeting architecture of your organization.

Developing specific criteria requires translating quality into the language of leadership – including cost – which is effective information for prioritizing and initiating improvement actions.  A well known and proven organizational quality improvement method is the Malcolm Baldrige National Award Criteria.  It places leadership, strategic planning, and customer focus categories together to emphasize the importance of a leadership focus on customers, stakeholders, and strategy.

Baldridge criteria for leadership include:

  • Creating and promoting a culture of quality and safety
  • Communicating with and engaging the entire workforce
  • Creating a focus on action to accomplish objectives
  • Improving performance and attaining its vision
  • Ensuring accountability for management’s actions

The next criteria category from the Baldrige triad is Strategic Planning. Long-term strategy is developed through (1) Identifying the key process steps, and (2) Ensuring that planning addresses:

  • Your organization’s strengths, weaknesses, opportunities, and threats
  • Risks or major shifts in technology, markets, services, customer preferences, competition or the regulatory environment
  • Long-term organizational sustainability, including needed core competencies for your ability to execute the Strategic Plan
  • Determining the processes needed and their application in the organization.

The third category for the Baldrige is Customer Focus.  How do your customers define quality? More importantly, how do they measure it? How do you obtain the “Voice of Your Customer” and use that information to:

  • Determine customer satisfaction, dissatisfaction, engagement
  • Use appropriate information to identify current and future customer and stakeholder groups and market segments
  • Use appropriate information to improve marketing to build a more customer- and stakeholder-focused culture
  • Identify opportunities for innovation.

Further questions your leadership team should be asking themselves include: (1) How do we identify and innovate product and service offerings to meet the requirements and exceed the expectations of your customers? (2) How do we determine key mechanisms to support use of your products or services and enable customers and stakeholders to seek information and otherwise utilize your products or services? (3) How do we create an organizational culture that ensures a consistently positive customer and stakeholder experience? (4) How do we build and manage relationships with customers and stakeholders?

The 2011 Baldrige Regional Conferences will showcase the best-in-class practices of the 2010 Baldrige Award Recipients as well as former recipients. Hear how the recipients improved their performance and results in Leadership; Strategic Planning; Customer Focus; Measurement, Analysis, and Knowledge Management; Workforce Focus; and Process Management.


For more information on the 2011 conferences, view the NIST web page.


For information on state and regional baldrige-based award programs, view this NIST web page.



Fundamentals of Product Certification


Traditionally, product certification has been applied to tangible products to provide independent and expert attestation that a product conforms to specified requirements. Today, product certification is being used in ever wider fields including services and agribusiness.

The purpose of product certification is to provide confidence to users and the general public that a product has the desired attributes, whether these relate to performance, interchangeability or the absence of harmful characteristics. The attributes need to be specified in a publicly available document, usually a standard – national, regional or international.

Product certification is carried out by bodies which can demonstrate their expertise and impartiality for example by conforming to ISO/IEC Guide 65 (soon to be replaced by ISO/IEC 17065). In addition, many product certification bodies also carry out evaluation activities such as testing, inspection or auditing, which provide the evidence of conformity. An important requirement is that the evidence is reviewed, and the attestation issued, by someone who has not been involved in the evaluation activities.


For a particular product, the rules and procedures used by the certification bodies and their clients (usually manufacturers and suppliers of the products) are specified in a product certification scheme, guidance on which will be given in ISO/IEC 17067, currently under development. A scheme could be developed and operated by a single certification body or could be set up by an organization with an interest in the conformity of the products with the specified requirements. For example, a regulatory authority could be concerned to protect the public interest or a group of interested parties, such as suppliers and users of the products could be seeking to improve the operation of the market.


The organization setting up the scheme would take on the role of scheme owner and would be responsible for ensuring that the scheme operated correctly and delivered the desired results. The operation of the scheme, though, would be undertaken by one or more product certification bodies (however named) working to the rules and procedures specified by the scheme owner. Many product certification bodies develop their own schemes, in which case they take on the role of scheme owner. ISO/IEC 17067 will provide guidelines for scheme owners and other parties and will make it clear that product certification bodies conforming to ISO/IEC 17065 would already meet many of its provisions.


The objective of ISO/IEC 17067 is to help in the development and operation of cost effective product certification schemes which meet the needs of suppliers, customers and society.


The Best Selling Standard


Did you know that the ISO 31000:2009 Risk Management series of standards is the second highest-selling series of standards in the world after ISO 9001:2008? The high worldwide interest in the approaches these standards provide reflects the needs of organizations to properly manage risk throughout their business processes.

Risk management is the identification, assessment, and treatment of “risks” that may negatively affect an organization, business or municipality, including those which can occur through accidents, disasters, natural causes, legal or financial liabilities. It also includes those things that can have positive effects, such as new technologies, business ventures, or continual improvement.

Worldwide, the ISO 31000 series of risk management standards is second only to the ISO 9000 series in popularity. These standards provide principles and guidelines on risk management that can be used by any public, private, or community enterprise, association, group or individual and therefore. The standards can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services, and assets.

The principles, framework, and process are applicable to all industries:

  • In manufacturing, a risk-based approach to manufacturing is more critical than ever for U.S. firms and has positively impacted the overall quality, safety and efficacy of the product, but also supply chain assurance, lean targets, product launch timing, and by removing unnecessary investments.
  • In service, risk management is specifically used to reduce risks associated with critical business information (client data, financial data, etc.) or risks that could undermine key business initiatives. ISO 31000 assisted organizations to place controls where they are needed across the entire information lifecycle (processes, management), helping to ensure information is always an asset and never a liability.
  • In healthcare, patient safety related risks decreased by applying process management methodology to healthcare processes. Hospitals implementing the ISO 31000 standard were seen as better equipped to manage the changing healthcare environment.

A bundle of three standards representing the U.S. Adoptions of ISO Guide 73:2009, IEC/ISO 31000:2009, and IEC/ISO 31010:2009 can be purchased at the ASQ Store.


In the News


Manufacturing Technology Orders up 108% in 2011

The May 2011 U.S. manufacturing technology orders totaled $388.27 million, according to the American Machine Tool Distributors’ Association (AMTDA) and The Association for Manufacturing Technology (AMT). This total, as reported by companies participating in the U.S. Manufacturing Technology Orders (USMTO) program, was down 2.6 percent from April but up 121.3 percent when compared with the total of $175.46 million reported for May 2010. With a year-to-date total of $1,984.87 million, 2011 is up 108.0 percent compared with 2010.

For more information and statistical data visit AMT online.

OEM’s Looking for Engineers

The recently released “Engineer Employment Study for Mobility Industries, 2011-2016,” from SAE International finds that U.S. Bureau of Labor Statistics (BLS) for the automotive, aerospace, and commercial vehicles industries is too negative and overlooks the reality that mobility industries are struggling to find good engineering talent. “Unemployment remains stubbornly high in many developed countries following the recent recession,” notes study author Winn Hardin. “What surprised us the most about this study’s findings were the aggressive employment plans from major original equipment manufacturers (OEMs), Tier 1, and Tier 2 companies compared to the latest BLS employment projections.”

For more information on the study visit SAE International.


Proposed ISO Activity on Facilities Management

The British Standards Institution (BSI) has submitted a proposal to the International Organization for Standardization (ISO) for a new field of technical activity on facilities management. As the U.S. member body to ISO, the American National Standards Institute (ANSI) invites all interested stakeholders to submit comments on the proposal by Fri., Aug. 12, 2011.

According to the proposal, facilities management is one of the world’s fastest-developing disciplines. A suite of international standards in this field would contribute to the maturation of the profession and provide the global facility-management industry with the tools to support best practices.

According to BSI, both public and private organizations use facility services to support their primary activities. Facility management influences an organization’s ability to act proactively, optimize performance, and meet its requirements. If approved, the technical committee in this area would focus on the preparation of international standards for facility management covering operational, tactical, and strategic levels to support primary processes.

All comments on the proposal should be sent to Steven P. Cornish, the ANSI senior director for international policy ( Feedback received by the Aug. 12 deadline will be reviewed and compiled for the recommended ANSI position and comments, which will then be presented to the ANSI ISO Council (AIC) for formal approval.


Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for these courses and customized training to fit your specific needs.  We offer group discounts.

View all our Courses


View Our Web Based E-Training Courses


ISO 9001 Quality Management


Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System


AS9100 Aviation, Space and Defense


Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System


ISO/TS 16949 Automotive


Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System


ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving


ISO 13485 Medical Devices


Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor


ISO 27001 Information Security


Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor


All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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