2019 Newsletter Articles

ISO 14001 Family of Standards

Jun 1, 2019 in Newsletter | Comments Off on ISO 14001 Family of Standards

The core standard for the ISO 14001 family of standards is ISO 14001:2015, Environmental management systems – Requirements with guidance for use. To support users of ISO 14001, TC207/SC1 has established four categories of related standards: Overall Understanding and Implementation ISO 14004:2016, EMS – General guidelines for implementation ISO 14005:2019, EMS – Guidelines for a flexible approach to phased implementation Evaluating Strategic and Financial Consequences ISO 14007 (due 2019), Environmental management:...

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ISO 14005:2019

Jun 1, 2019 in Newsletter | Comments Off on ISO 14005:2019

The second edition of ISO 14005, “Environmental management systems – Guidelines for a flexible approach to phased implementation” has been released. The document gives guidelines for a phased approach to establish, implement, maintain, and improve an environmental management system (EMS) that organizations, including small and medium-sized enterprises, can adopt to enhance their environmental performance. The phased approach provides flexibility for organizations to develop their EMS at their own pace, over a number of phases,...

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RCA/CAPA for the Medical Device Industry

Jun 1, 2019 in Newsletter | Comments Off on RCA/CAPA for the Medical Device Industry

We have a new course: Root Cause Analysis and Corrective Action/Preventive Action for the Medical Device Industry. It is available to be taught onsite by the course developer, Duke Okes. COURSE SUMMARY A 2-day course consisting of lectures, practices, and role plays that will provide attendees with an in-depth understanding of how to analyze a system in order to identify the root causes of problems. The following topics are covered: The requirements of ISO 13485 and 21-CFR-820 for corrective and preventive action The difference and links...

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Baldrige Award Winners

May 1, 2019 in Newsletter | Comments Off on Baldrige Award Winners

Noting that this year’s winners “are held in highest esteem in your communities and, now, in our nation,” U.S. Secretary of Commerce Wilbur Ross presented five U.S. organizations on April 7, 2019, with the Malcolm Baldrige National Quality Award, the nation’s only presidential award for performance excellence and innovation. The five honorees are: Alamo Colleges District, San Antonio, Texas (education) Donor Alliance, Denver, Colorado (nonprofit) Integrated Project Management Company, Inc., Burr Ridge, Illinois (small...

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New FMEA Handbook

May 1, 2019 in Newsletter | Comments Off on New FMEA Handbook

To improve the FMEA development process and make it easier for automotive manufacturing suppliers to meet the needs of their customer during the Failure Mode and Effects Analysis process, AIAG and VDA have harmonized their previous “regional” FMEA manuals into a single, co-copyrighted handbook. This handbook uses best practices from each manual and a process-oriented approach to meet the  requirements of both industry groups. The 7-Step Approach The most noticeable change in the AIAG and VDA FMEA Handbook is the new 7-step development...

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ISO 20671 – Brand Evaluation

May 1, 2019 in Newsletter | Comments Off on ISO 20671 – Brand Evaluation

ISO 20671:2019, “Brand evaluation – Principles and fundamentals”, is a new standard that includes an integrated framework for brand evaluation, as well as, the necessary brand input elements, output dimensions, and sample indicators. The standard is 12 pages and can be ordered at this ISO web page for about $58. According to ISO 20671, brands are one of the most valuable, yet least understood assets. A brand identifies an entity’s goods, services, or the entity itself, as distinct from what is offered by another entity. A brand can be...

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ISO 9001 on Human Error

May 1, 2019 in Newsletter | Comments Off on ISO 9001 on Human Error

The ISO 9001:2015 quality standard requires organizations to carry out production and service provision under controlled conditions, which may include taking actions to prevent human error. What is a human error? It has been defined as when a person does something wrong; a mistake. Some examples of human error are: failing to perform or omitting a task performing the task incorrectly including an extra or non-required task performing tasks out of sequence failing to do the task within the time limit not responding adequately to a...

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ISO 41001 – Facilities Management

Apr 1, 2019 in Newsletter | Comments Off on ISO 41001 – Facilities Management

ISO 41001:2018 specifies the requirements for a Facility Management (FM) system when an organization: a) needs to demonstrate effective and efficient delivery of FM that supports the objectives of the demand organization; b) aims to consistently meet the needs of interested parties and applicable requirements; c) aims to be sustainable in a globally-competitive environment. The requirements specified in ISO 41001 are non-sector specific and intended to be applicable to all organizations, whether public or private sector, and regardless of the...

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Quotes on Writing

Apr 1, 2019 in Newsletter | Comments Off on Quotes on Writing

If you’re responsible for developing or maintaining manuals, plans, specifications, procedures, instructions, or even forms, you may appreciate these quotes about writing.    The most valuable of all talents is that of never using two words when one will do.  Thomas Jefferson (1743 – 1826) 3rd U. S. President and Drafter of Declaration of Independence  Either write things worth reading, or do things worth the writing.  Benjamin Franklin (1706 – 1790) Statesman and Inventor  I have made this letter longer than usual, because I...

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ISO 9001 Classes in Orlando

Apr 1, 2019 in Newsletter | Comments Off on ISO 9001 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements June 24-25, 2019 August 12-13, 2019 December 9-10, 2019 ISO 9001:2015 Internal Auditor June 24-26, 2019 August 12-14, 2019 December 9-11, 2019 ISO 9001:2015 Lead Auditor June 24-27, 2019 August 12-15, 2019 December 9-12, 2019 Click on a course title to view the course description and enroll in a class. If you have questions about the training or registration process, please call...

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New FAQs for IATF 16949

Apr 1, 2019 in Newsletter | Comments Off on New FAQs for IATF 16949

The International Automotive Task Force (IATF) has approved the release of updated IATF 16949:2016 Frequently Asked Questions (FAQs) to clarify existing requirements. The new Frequently Asked Questions are included below. To view all the FAQs, as well as, the Sanctioned Interpretations, go to the IATF Global Oversight website: http://www.iatfglobaloversight.org. FAQ 23 – clause, Verification of job setups QUESTION: If first-off/last-off part validation is not performed or appropriate for a specific type of manufacturing process, are...

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Organizational Knowledge

Mar 1, 2019 in Newsletter | Comments Off on Organizational Knowledge

Our current business environment is characterized by accelerated change, globalization of markets, and the emergence of knowledge as a key resource. One of the quality management principles described in ISO 9000:2015 is the “engagement of people” to enhance an organization’s capability to create and deliver value, which can be facilitated by open discussion and the sharing of knowledge and experience. According to ISO 9001:2015, “organizational knowledge” is the knowledge specific to an organization, gained by experience, and...

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Integrated Audits

Mar 1, 2019 in Newsletter | Comments Off on Integrated Audits

Organizations implement management systems to support their quality, environmental, and health and safety activities. These systems are often implemented as separate systems instead of as an integrated system, resulting in reduced overall efficiency and effectiveness.  ISO 9001:2015 (quality), ISO 14001:2015 (environmental), and ISO 45001:2018 (health and safety) now have the same high-level clause structure, many common terms, and the same core requirements, making implementation of an integrated management system much easier....

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Integrated Management Systems

Mar 1, 2019 in Newsletter | Comments Off on Integrated Management Systems

The second edition of the ISO Handbook, “The Integrated Use of Multiple System Standards”, was published in November 2018. It is available for about $60 at this ISO web page. The Handbook uses the phrase “integrated management system” to refer to the outcome of the process of integrating requirements from multiple management system standards into a single management system within an organization. The Handbook contains three chapters: Chapter 1 describes the fundamentals of a management system and how it links an...

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Risk Management Principles

Feb 1, 2019 in Newsletter | Comments Off on Risk Management Principles

As mentioned in the earlier Risk Terminology article, the purpose of risk management is the creation and protection of value. It improves performance, encourages innovation and supports the achievement of objectives. ISO 31000:2018, “Risk Management – Guidance”, describes eight principles that provide guidance on the characteristics of effective and efficient risk management, communicating its value, and explaining its intention and purpose. These principles are the foundation for managing risk and should be...

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Risk Management Terminology

Feb 1, 2019 in Newsletter | Comments Off on Risk Management Terminology

According to ISO 31000:2018, risk management is the coordination of the activities that direct and control the risks faced by an organization. The purpose of risk management is to create and protect value. It improves performance, encourages innovation, and supports the achievement of objectives. Organizations of all types and sizes must deal with external and internal factors that make it uncertain whether they will achieve their objectives. Managing risk is an iterative process and helps organizations to set strategy, achieve...

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Risk Management Framework

Feb 1, 2019 in Newsletter | Comments Off on Risk Management Framework

The purpose of the risk management “framework” described in ISO 31000:2018 is to help the organization integrate risk management into its significant activities and functions. The effectiveness of risk management depends on its integration into the governance of the organization, including decision-making, which requires support from top management. Framework development includes 1) integrating, 2) designing, 3) implementing, 4) evaluating, and 5) improving risk management across the organization. 1....

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Risk Management Process

Feb 1, 2019 in Newsletter | Comments Off on Risk Management Process

According to ISO 31000:2018, the risk management “process” involves the systematic application of policies, procedures, and practices to the activities of communicating and consulting, establishing the context, and assessing, treating, monitoring, reviewing, recording, and reporting risk. The risk management process should be an integral part of management and decision-making and integrated into the structure, operations, and processes of the organization. It can be applied at strategic, operational, program, or project...

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ISO/TS 27008:2019 Published

Feb 1, 2019 in Newsletter | Comments Off on ISO/TS 27008:2019 Published

ISO/TS 27008:2019, Edition 1, “Information technology – Security techniques – Guidelines for the assessment of information security controls”, is available and replaces ISO/TR 27008:2011. The new technical specification supports the Information Security Risk Management process referenced in ISO 27001. Information security controls should be fit-for-purpose (appropriate and suitable mitigation of information risks), effective (properly specified, designed, implemented, used, managed and maintained), efficient (delivering net...

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Global Risks Report

Jan 21, 2019 in Newsletter | Comments Off on Global Risks Report

The Word Economic Forum, in partnership with Marsh & McLennan Companies and Zurich Insurance Group, has released The Global Risks Report – 2019, 14th Edition. The report is based on the annual Global Risks Perception Survey completed by 1000 members of the World Economic Forum’s global multi-stakeholder community. Respondents are drawn from business, academia, civil society, and the public. The survey asked respondents to consider 30 global risks categorized as societal, technological, economic, environmental, or geopolitical, over a...

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Documented Information

Jan 1, 2019 in Newsletter | Comments Off on Documented Information

Control of documented information is required by all management system standards. Their common document and record control requirements are based on Annex SL of ISO Directives, Part 1. This article identifies the requirements for documented information in Annex SL (black) and the added text for ISO 9001:2015 (blue), ISO 14001:2015 (green), and ISO 45001:2015 (red). 7.5 Documented information 7.5.1 General The organization’s (quality; environmental; occupational health and safety) management system shall include: a) documented...

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Auditor Certification

Jan 1, 2019 in Newsletter | Comments Off on Auditor Certification

Exemplar Global offers qualification-based QMS auditor certification. The program has been revised to add a Master Auditor grade and adjust the required audit experience for some of the existing grades. Auditor Grades Associate Auditor: Designed for those who attended an auditor course and have work experience, but no audit experience. Training: Completion of an EG-certified ISO 9001:2015 QMS “Auditor” course Work Experience: 4 years of full-time work experience Industry Experience: 2 years of QMS industry experience Audit...

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Threat Intelligence Report

Jan 1, 2019 in Newsletter | Comments Off on Threat Intelligence Report

The 2019 Nokia Threat Intelligence Report provides a view of malware activity in mobile and fixed networks around the world. Nokia examined network traffic for malware command-and-control communication, exploit attempts, hacking activity, scanning activity, and distributed denial of service attacks. The key findings of the report are described below. They are discussed in more detail in the report which can be downloaded from this Nokia web page. Note: The Internet of Things (IoT) is a network of physical objects (devices, vehicles,...

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Change in Measurements

Jan 1, 2019 in Newsletter | Comments Off on Change in Measurements

According to the National Institute of Standards and Technology (NIST), a convocation of delegates representing 60 countries voted recently to implement the most significant change to the International System of Units (SI) in more than 130 years. For the first time, all measurement units will be defined by natural phenomena rather than by physical artifacts. The event was the 26th General Conference of Weights and Measures and was hosted by the International Bureau of Weights and Measures. Although consumers and most industries will not notice...

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