Archive for December, 2011

Houston Police Get ISO 9001-Certified

Tuesday, December 27th, 2011

Our friends at the Phoenix Police Department’s Records and Identification Bureau were the first U.S. police department registered to the ISO 9001 standard back in 2003.

We just read that another police department, The Emergency Communications and Property Room Divisions of the Houston Police Department (HPD) was recently certified to ISO 9001:2008. HPD is the largest police department in Texas and the fifth largest in the United States.  They pursued ISO 9001 certification, in part, because it establishes clear guidelines and goals against which they can measure achievements. Primarily, HPD determined that the ISO quality management system provides the ideal business model to further the Department’s commitment to continually improve its effectiveness in serving the needs of the community.

The Emergency Communications Division (ECD) is typically the first point of contact that the HPD has with the citizens of Houston. More than 1.2 million calls for service are dispatched by the ECD every year, which further include calls to utilize alternate response strategies. The process is designed so that 9-1-1 calls are initially received by a cadre of independent call takers who then distribute calls-for-service requests to the HPD or the fire department, accordingly.

A cultural shift

Countless improvements were realized in both divisions during the course of the QMS implementation. As stakeholders became more engaged and empowered, several time-saving ideas became evident and cost-savings were revealed. Creating process maps allowed everyone to actually see the sequence and flow of tasks and to identify nonvalue-added activity. This visual approach also made it possible to ensure process interconnectivity, or lack thereof.

There is a burgeoning interest in continuous improvement. With quantified performance improvement in virtually every work process, the incentive to sustain mutually beneficial supplier-customer relationships is now established.

Congratulations to another major police department achieving ISO 9001 success!  Another example that certification success is obtainable for any organization; even ones that carry weapons.  🙂



ISO 19011:2011 Auditing Management Systems

Sunday, December 4th, 2011

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              December 2011

This Month
* ISO 19011:2011 Released
* Medical Device Regulations
* Issues Impact Global Conformance
* In the News
* Training Courses



January 25-26, 2012 Phoenix Convention Center Phoenix, AZ


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ISO 19011:2011 Just Released

ISO 19011:2011 2nd Edition dated 11/15/2011 has just been released.  ISO 19011 provides guidance on auditing management systems, including the principles of auditing, managing an audit program and conducting management system audits.  It also provides guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit program, auditors and audit teams.

It is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit program.  This includes small and medium-sized organizations, for both first party auditing (auditing your own company) and second party auditing (where customers audit their suppliers).  It can be used for the purposes of self declaration, and can also be used for auditor training or personnel certification.


For third party auditing, users should also consider the use of ISO/IEC 17021:2011, “Conformity assessment – Requirements for bodies providing audit and certification of management systems.”

This edition reflects the need for a more generic guide for a wider range of auditing requirements, beyond covering just quality and environmental management systems standards. In this edition, remote auditing methods and the concept of risk management to systems auditing are introduced.  The relationship between the document and ISO/IEC 17021 has been clarified.  Confidentiality has been added as a new principle of auditing.  A new Annex A gives illustrative examples of discipline-specific knowledge and skills.  And additional information has been included in Annex B, resulting in the removal of help boxes.

The main body of ISO 19011:2011 establishes good practice for Managing an Audit Program and Performing an Audit. The update reflects current thinking and in parts is expanded significantly. These sections provide detailed guidance; intended to be used flexibly according to the size, level of maturity of an organization’s management system, and the nature and complexity of the organization to be audited. The concept of risk in auditing is introduced.


Some guidance will be provided on combined audits, where two or more management systems of different disciplines are audited together (for example QMS and EMS, EMS and OHSAS, QMS and OHSAS).  Also, the use of technology in remote auditing is acknowledged.


Annex A (informative) of the standard provides examples of discipline specific knowledge and skills of auditors, including:

  • Transportation safety management
  • Environmental management
  • Quality management
  • Records management
  • Resilience, security, preparedness and continuity management
  • Information security
  • Occupational health and safety

The new ISO 19011:2011 replaces the previous edition ISO 19011:2002, as well as ISO 10011-1, ISO 10011-2, and ISO 10011-3.  It was prepared by ISO Technical Committee 176, Subcommittee 3.


ISO 19011:2011 can be purchased here at the ANSI website.



2011 Guide to Medical Devices Regulations Released


If you’re a medical device provider and registered to the ISO 13485 Medical Device Quality Management System, it’s your job to know the FDA’s medical device regulations that apply to your organization and product inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights.

In its first revision in three years, the 2011 Guide to Medical Device Regulations is the most comprehensive, authoritative, up-to-the-minute guide to device regulations available anywhere. It includes full texts of every device-related regulation currently in force, plus executive summaries and analyses outlining their impact on companies like yours.


You’ll discover back-to-basics explanations of premarket submissions; user fees and how they work; guidance on inspection procedures and practices; reporting and tracking requirements; guidance on labeling; and FDA priorities for future regulatory initiatives.

The guide also features:

  • A comprehensive overview of the FDA’s regulatory framework for medical devices, from requirements to registering as a device maker to postmarket obligations.
  • A summary for each of the 65 device-related guidance documents included in the guide.
  • A rundown on the Center for Devices and Radiological Health’s  future plans for its medical-device regulation system.


Already the Center for Devices and Radiological Health has revealed plans to strengthen premarket review, enhance data collection, improve tracking of devices and adverse events, harmonize standards with other nations, and share inspections data with foreign regulators.

Failure to heed FDA regulations is a sure path to refusals, 483s, and warning letters, not to mention liability lawsuits that could bankrupt a company.

The 2011 Guide to Medical Device Regulations is available in print or PDF formats.  The guide can be purchased on the FDA website.


ANSI: Key Issues Impacting Global Standardization and Conformance


The American National Standards Institute (ANSI) International Policy Committee (IPC) has published a white paper examining standards and conformance issues affecting the ability of U.S. industry to conduct global trade. The IPC is responsible for the development of ANSI strategic directions and policies related to international and regional standardization, as well as the general coordination and oversight of ANSI’s implementation of the relevant initiatives of the United States Standards Strategy (USSS).

According to the paper Key Issues Impacting Global Standardization and Conformance: Today and Tomorrow,” the expansion of global trade is increasingly important to the growth of the U.S. economy and the continued revitalization of the U.S. workforce. As the technical underpinning of many products and services, standards play a critical role in removing barriers to trade, enforcing free trade agreements, and expanding foreign markets for U.S. products, services, and personnel.


The paper contends that U.S. companies that do business abroad are exposed to-and typically adopt-internationally accepted standards and conformity assessment practices, which in turn enable them to compete more effectively in the global marketplace. The paper identifies that one in every five American factory workers owes his or her job to exports. Agreed-upon standards and conformance activities form the basis of dynamic, global strategic partnerships that can spur economic growth, development, and job creation.


Particularly in emerging technology areas-including smart grid, health-care informatics, energy efficiency, nanotechnology, and cyber-security-developing and developed economies are playing an increasingly significant role in standardization activities. According to the white paper, these priority areas require significant cross-sectoral collaboration, and new models of standards development must evolve to support such collaboration. The challenge for today and into the future is to bring diverse parties from various sectors and organizations together to collaborate and develop the needed deliverables.

In the News

Four Organizations Awarded 2011 Baldrige NQA Award

U.S. Commerce Secretary John Bryson announced four organizations-three health care operations and one nonprofit business-as the recipients of the 2011 Malcolm Baldrige National Quality Award, the nation’s highest honor for performance excellence through innovation, improvement, and visionary leadership. This marks the first year that three health care organizations have been selected at one time.


The Baldrige Performance Excellence Program (BPEP) not only manages the Malcolm Baldrige National Quality Award, it also raises awareness about the importance of performance excellence in driving the U.S. and global economy; provides organizational assessment tools and criteria; educates leaders in businesses, schools, health care organizations, and government and nonprofit organizations about the practices of national role models; and recognizes them by honoring them with the only presidential award for performance excellence.


For more information, visit the NIST website.


ISO Management Systems Standards for Records

In the wake of recent failures in corporate governance, two new standards from the International Organization for Standardization (ISO) will help organizations to disclose corporate information quickly and effectively. Increased pressure by industry regulators obliges companies to provide such information because irregularities in financial management, ethical dealings, disclosure, and transparency of decisions have become common.


ISO 30300:2011-“Information and documentation-Management systems for records-Fundamentals and vocabulary,” and ISO 30301:2011-“Information and documentation-Management systems for records-Requirements,” distill the expertise of experts drawn from 27 countries on five continents.


“The ISO 30300 series offers the methodology for a systematic approach to the creation and management of records, aligned with organizational objectives and strategies,” say Judith Ellis and Carlota Bustelo, leaders of the working groups that developed the standards. “Managing records using an MSS supports cost-effective operational processes, such as storage, information retrieval, information reuse, litigation, and due diligence.”


The ISO 30300 series can be purchased through the ISO Store.


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.

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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


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