Newsletter

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 8.5.1.3, 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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ISO 9001 Classes in Orlando

Dec 1, 2018 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 December 17-18, 2018 (confirmed) January 28-29, 2019 June 24-25, 2019 ISO 9001:2015 Internal Auditor December 17-19, 2018 (confirmed) January 28-30, 2019 June 24-26, 2019 ISO 9001:2015 Lead Auditor December 17-20, 2018 (confirmed) January 28-31, 2019 June 24-27, 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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Education Management System

Dec 1, 2018 in Newsletter | Comments Off on Education Management System

The new ISO 21001:2018, Educational organizations – Management systems for educational organizations – Requirements with guidance for use, is available. Requirements ISO 21001 specifies requirements for a management system for educational organizations when such an organization: 1. needs to demonstrate its ability to support the acquisition and development of competence through teaching, learning, or research; 2. aims to enhance satisfaction of learners, other beneficiaries, and staff through the effective application of its...

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Management of Change – ISO 9001

Dec 1, 2018 in Newsletter | Comments Off on Management of Change – ISO 9001

Management of change is a systematic way to handle changes within an organization to effectively deal with the change and to capitalize on possible opportunities. It involves adapting to the change, controlling the change, and effecting new change. ISO 9001:2015 Management of change is addressed in multiple requirements of ISO 9001, including: maintaining the quality management system (see 4.4.1), organizational roles, responsibilities and authorities (see 5.3.e), planning of changes (see 6.3), operational control (see...

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Management of Change – ISO 14001

Dec 1, 2018 in Newsletter | Comments Off on Management of Change – ISO 14001

Management of change is a systematic way to handle changes within an organization to effectively deal with the change and to capitalize on possible opportunities. It involves adapting to the change, controlling the change, and effecting new change. ISO 14001:2015 Management of change is an important part of maintaining the environmental management system to ensure it achieves the intended outcomes on an ongoing basis. Management of change is addressed in multiple requirements of ISO 14001, including: maintaining the...

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Management of Change – ISO 45001

Dec 1, 2018 in Newsletter | Comments Off on Management of Change – ISO 45001

Management of change is a systematic way to handle changes within an organization to effectively deal with the change and to capitalize on possible opportunities. It involves adapting to the change, controlling the change, and effecting new change. ISO 45001:2018 Management of change is addressed in multiple requirements of ISO 45001, including: maintaining the OH&S management system (see 4.4), actions to address risks and opportunities (see 6.1.1, 6.1.2.1, 6.1.2.3, 6.1.4), internal communication (see 7.4.2.a), management...

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ISO 9001:2015 Classes in Orlando, Florida

Nov 1, 2018 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando, Florida

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements   December 17-18, 2018 January 28-29, 2019 June 24-25, 2019 ISO 9001:2015 Internal Auditor December 17-19, 2018 January 28-30, 2019 June 24-26, 2019 ISO 9001:2015 Lead Auditor December 17-20, 2018 January 28-31, 2019 June 24-27 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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Energy Management Systems

Nov 1, 2018 in Newsletter | Comments Off on Energy Management Systems

Using energy efficiently helps organizations save money, conserve resources, and tackle climate change. ISO 50001 supports organizations to use energy more efficiently through the development of an Energy Management System (EnMS). The new ISO 50001:2018 edition, Energy management systems – Requirements with guidance for use, provides a framework of requirements to: develop a policy for more efficient use of energy; fix targets and objectives to meet the policy; use data to better understand and make decisions about energy...

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FDA and ISO 13485

Nov 1, 2018 in Newsletter | Comments Off on FDA and ISO 13485

According to the U. S. Food and Drug Administration (FDA), it intends to harmonize and modernize the Quality System regulation for medical devices. The FDA announcement states that the revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. ISO 13485 ISO 13485:2016, “Medical devices...

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ISO Guide 41 on Consumer Packaging

Nov 1, 2018 in Newsletter | Comments Off on ISO Guide 41 on Consumer Packaging

A recent ISO article described packaging as having come a very long way since its humble beginnings of gourds and clay pots. These days, the world of packaging is much more complex, needing to be safe and sustainable, while remaining appealing and functional. The article related that the humble glass bottle, which is making a comeback thanks to its facility for recycling, was first commercialized by the ancient Egyptians some 3,500 years ago. About 1,300 years later, the Chinese gave us paper, but it wasn’t until the 19th century that...

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Integrated Management Review

Nov 1, 2018 in Newsletter | Comments Off on Integrated Management Review

Top management reviews of a management system are critical to evaluate performance and determine trends for decisions and actions. The quality standard (ISO 9001:2015), environmental standard (ISO 14001:2015), and health and safety standard (ISO 45001:2018) all include requirements for management review. This article describes a management review process for an integrated quality, environmental, and health and safety management system. Requirements for Review Top management must review the organization’s management system, at planned...

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Guidelines for Recruitment

Oct 1, 2018 in Newsletter | Comments Off on Guidelines for Recruitment

ISO 30405:2016, “Human resource management – Guidelines for recruitment” Recruitment is a major part of human resource management, including the necessary activities an organization undertakes to attract, source, assess, and employ people. The impact of recruitment on organizational performance was noted in a survey conducted of 4,288 executives from 102 countries by the World Federation of People Management Association. It found that organizations ranked in the top 20% in terms of ability to deliver on recruiting,...

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Internal Auditor Code of Conduct

Oct 1, 2018 in Newsletter | Comments Off on Internal Auditor Code of Conduct

Purpose To communicate the integrity, objectivity, confidentiality, and competence expected of internal auditors, as well as, to provide a means for them to pledge their commitment to these principles. Integrity  The integrity of internal auditors establishes trust and provides the basis for relying on their judgment. As an internal auditor, I pledge to: 1. Perform my audit assignments with honesty, accuracy, fairness, and discretion. 2. Not engage in activities that might discredit the audit program or our organization. 3. Report audit...

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Risk-Based Auditing

Oct 1, 2018 in Newsletter | Comments Off on Risk-Based Auditing

ISO 19011:2018, Guidelines for Auditing Management Systems, includes a new audit principle, the “Risk-based approach: an audit approach that considers risks and opportunities.” The risk-based approach should substantively influence the planning, conducting, and reporting of audits to ensure that audits are focused on matters that are significant for the audit client, and for achieving the audit program objectives. This article highlights the references to risk throughout the ISO 19011:2018 standard. Risk Definition Risk is...

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Audit Program Risks

Oct 1, 2018 in Newsletter | Comments Off on Audit Program Risks

According to ISO 19011:2018, Guidelines for auditing management systems, a main difference compared to ISO 19011:2011, is the expansion of the guidance on managing an audit program, including audit program risk. An “audit program” is defined in clause 3.4 as the arrangements for a set of one or more audits planned for a specific timeframe and directed towards a specific purpose. According to clause 5.1, the extent of an audit program should be based on the size and nature of the auditee, as well as, on the nature,...

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ISO 20000-1:2018

Oct 1, 2018 in Newsletter | Comments Off on ISO 20000-1:2018

The third edition of ISO 20000-1, Information technology – Service management – Part 1: Service management system requirements, has been published. ISO 20000-1:2018 specifies requirements for an organization to establish, implement, maintain, and continually improve a service management system (SMS). The specified requirements include the planning, design, transition, delivery, and improvement of services to meet the service requirements and deliver value. ISO 20000-1:2018 can be used by: a) a customer seeking services and...

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ISO Certificate Survey

Sep 4, 2018 in Newsletter | Comments Off on ISO Certificate Survey

ISO has released the results of its annual survey of certificates. My summary below shows the number of worldwide certificates as of year-end 2017 for eight management system standards, the top ten countries for each standard, as well as, the USA totals. ISO/TS 16949 has been replaced by IATF 16949, so ISO no longer provides survey results for the automotive standard. ISO has changed from counting certificates and sites, to counting only certificates due to inconsistent site data. They attribute the decrease in certificates in part to this...

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Codes of Conduct

Sep 1, 2018 in Newsletter | Comments Off on Codes of Conduct

ISO 10001:2018, Quality management – Customer satisfaction – Guidelines for codes of conduct for organizations, is available. This second edition of ISO 10001 states that maintaining a high-level of customer satisfaction is a significant challenge for many organizations. One way of meeting this challenge is to put in place and use a customer satisfaction code of conduct. A customer satisfaction code of conduct consists of promises and related provisions that address issues such as product and service delivery, product returns,...

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Complaints Handling

Sep 1, 2018 in Newsletter | Comments Off on Complaints Handling

ISO 10002:2018, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations, is available. This standard gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.ISO 10002 is intended for use by any organization regardless of its type...

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Dispute Resolution

Sep 1, 2018 in Newsletter | Comments Off on Dispute Resolution

ISO 10003:2018, Quality management – Customer satisfaction – Guidelines for dispute resolution external to organizations, is available. This standard gives guidelines for an organization to plan, design, develop, operate, maintain, and improve an effective and efficient dispute-resolution process for complaints that have not been resolved by the organization. ISO 10003 is applicable to: a) complaints relating to the organization’s products and services, the complaints-handling process, or dispute-resolution process; b)...

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Customer Satisfaction

Sep 1, 2018 in Newsletter | Comments Off on Customer Satisfaction

ISO 10004:2018, Quality management – Customer satisfaction – Guidelines for monitoring and measuring, is available. ISO 10004 gives guidelines for defining and implementing processes to monitor and measure customer satisfaction. It is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of the standard is on customers external to the organization. Customer Satisfaction According to ISO 10004, one of the key elements of organizational success is the...

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Quality Plan Guidance

Aug 1, 2018 in Newsletter | Comments Off on Quality Plan Guidance

The third edition of ISO 10005, Quality management – Guidelines for quality plans, has been published. This document gives guidelines for establishing, reviewing, accepting, applying, and revising quality plans. It is applicable to quality plans for any intended output, whether a process, product, service, project, or contract, and any type or size of organization. ISO 10005:2018 is applicable whether the organization has a management system in conformity with ISO 9001:2015 or not. It provides guidance and does not specify...

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IATF 16949 SIs and FAQs

Aug 1, 2018 in Newsletter | Comments Off on IATF 16949 SIs and FAQs

The International Automotive Task Force (IATF) has approved the release of updated IATF 16949:2016 Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs). Sanctioned Interpretations alter the existing published requirements of the IATF 16949:2016 standard.  Frequently Asked Questions clarify an existing requirement. Sanctioned Interpretations The approved Sanctioned Interpretations include “revised” SI 8, clause 8.4.2.3, Supplier quality management system development and SI 10, clause 7.1.5.3.2, External...

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ISO 22000:2018

Aug 1, 2018 in Newsletter | Comments Off on ISO 22000:2018

ISO 22000:2018, “Food safety management systems — Requirements for any organization in the food chain”, has been published to replace ISO 22000:2005. ISO 22000 specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain to: a) plan, implement, operate, maintain, and update a FSMS providing products and services that are safe, in accordance with their intended use; b) demonstrate compliance with applicable statutory and regulatory food...

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ISO 27005:2018

Aug 1, 2018 in Newsletter | Comments Off on ISO 27005:2018

ISO 27005:2018, Information technology – Security techniques – Information security risk management, is available with guidelines for information security risk management. ISO 27005 supports the general concepts specified in ISO 27001 and is designed to assist the implementation of information security based on a risk management approach. Knowledge of the concepts, models, processes, and terminologies described in ISO 27001 and ISO 27002 is important for a complete understanding of ISO 27005. ISO 27005 is applicable to all types...

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ISO 19011:2018

Aug 1, 2018 in Newsletter | Comments Off on ISO 19011:2018

ISO 19011:2018, the third edition of the “Guidelines for Auditing Management Systems” standard, has been released and replaces the second edition (ISO 19011:2011). According to the standard itself, the main differences compared to the second edition are: 1. addition of the risk-based approach to the principles of auditing; 2. expansion of guidance on managing an audit program, including audit program risk; 3. expansion of guidance on conducting an audit, particularly the section on audit planning; 4. expansion of the generic...

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Risks and Opportunities

Jul 1, 2018 in Newsletter | Comments Off on Risks and Opportunities

ISO 9001:2015, clause 6, describes these planning requirements: 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes This article is about: ISO 9001:2015, 6.1, Actions to address risks and opportunities 6.1.1 When planning for the quality management system (QMS), the organization must consider the issues referred to in 4.1 (relevant to its purpose and strategic direction), and the requirements referred to in 4.2 (regarding interested parties), and determine the risks and...

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IATF 16949 Risk Additions

Jul 1, 2018 in Newsletter | Comments Off on IATF 16949 Risk Additions

The automotive quality standard, IATF 16949:2016, expands on the ISO 9001:2015 risk requirements in 6.1.2 with these sub-clauses: 6.1.2.1 Risk Analysis Include in the risk analysis, at a minimum, lessons learned from: product recalls and product audits; field returns and repairs; complaints, scrap, and rework. Retain documented information as evidence of the results of risk analysis. 6.1.2.2 Preventive Action Determine and implement actions to eliminate causes of potential nonconformities to prevent their occurrence. Preventive actions...

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Establishing Objectives

Jul 1, 2018 in Newsletter | Comments Off on Establishing Objectives

A “quality objective” is defined by ISO 9000:2015 as a quality result to be achieved. It can be a strategic, tactical, or operational target. Quality objectives are set to be consistent with the quality policy and specified for the relevant functions, levels, and processes within an organization (to ensure the effective deployment of the strategic direction and quality policy). This article addresses the requirements to “establish” quality objectives. A later article in this newsletter covers the requirements for...

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Achieving Objectives

Jul 1, 2018 in Newsletter | Comments Off on Achieving Objectives

An earlier article in this newsletter addressed the requirements to “establish” quality objectives. This article covers the requirements for planning how to “achieve” quality objectives. ISO 9001:2015, 6.2.2, states that when planning how to achieve quality objectives, the organization must determine: a) what will be done; According to ISO/TS 9002:2016, this simply means to determine the actions that need to be implemented to achieve the quality objectives. b) what resources will be required; Ensure that sufficient...

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Sample Objectives

Jul 1, 2018 in Newsletter | Comments Off on Sample Objectives

As auditors, we are called upon to assess conformity and effectiveness. To assess process effectiveness, we need to evaluate to what extent the planned activities are being realized and the planned results are being achieved. We may need to venture outside the defined scope of a specific process audit to fully judge its effectiveness (results). To assess how well the process is meeting the needs of its internal customers, interview those internal customers. They may have a different view of the process outputs than the process supplying...

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Cybersecurity Framework

Jun 1, 2018 in Newsletter | Comments Off on Cybersecurity Framework

The U.S. Commerce Department’s National Institute of Standards and Technology (NIST) has released version 1.1 of its “Framework for Improving Critical Infrastructure Cybersecurity”, more widely known as the Cybersecurity Framework. You can download the 44-page “Framework for Improving Critical Infrastructure Cybersecurity” at this NIST web page. The framework was developed with a focus on industries vital to national and economic security, including energy, banking, communications, and the defense industrial base....

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ISO 14000 Standards

Jun 1, 2018 in Newsletter | Comments Off on ISO 14000 Standards

The ISO 14000 family of standards provides practical tools for companies and organizations of all kinds looking to manage their environmental responsibilities. The standards listed below that are under development use the following terms to indicate their status: NP = New Project AWI = Approved Work Item WD = Working Document CD = Committee Draft DIS = Draft International Standard FDIS = Final Draft International Standard You can read about these standards and order the published versions at  www.iso.org. We offer public courses: ISO...

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Leadership Principle

Jun 1, 2018 in Newsletter | Comments Off on Leadership Principle

Leadership is one of the quality management principles defined in ISO 9000:2015, the Fundamentals and Vocabulary standard. The seven quality management principles are: 1. customer focus; 2. leadership; 3. engagement of people; 4. process approach; 5. improvement; 6. evidence-based decision making; 7. relationship management. Leadership Leaders establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives. Rationale Creation of unity of purpose, and the...

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Leadership Requirements

Jun 1, 2018 in Newsletter | Comments Off on Leadership Requirements

ISO 9001:2015, clause 5.1, states that top management must demonstrate leadership and commitment with respect to the quality management system. Top management is defined in ISO 9000:2015 as the person (or group of people) who directs and controls an organization at the highest level. Top management has the power to delegate authority and provide resources within the organization. We should remember that a Manager administers, controls, and directs; a Leader influences, motivates, and inspires trust. The sub-clauses of clause 5.1.1 state that...

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Customer Focus

Jun 1, 2018 in Newsletter | Comments Off on Customer Focus

ISO 9001:2015, clause 5.1, Leadership and Commitment, includes requirements in sub-clause 5.1.2 for Customer Focus. It states that top management must demonstrate leadership and commitment with respect to customer focus by ensuring that: a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;   b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;   c. the focus on enhancing...

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Safety Walk-Arounds

May 1, 2018 in Newsletter | Comments Off on Safety Walk-Arounds

OSHA has a two-page Fact Sheet for “Safety Walk-Arounds” that provides guidance on conducting workplace safety inspections. Workplace inspections are important for identifying hazards and resolving them. You should set up a schedule to inspect the workplace on a regular basis. Pre-Inspection Familiarize yourself with the workplace and operation, and the hazards previously identified. Review prior inspection reports, injury and workers compensation records, incident investigation reports, and recent near-miss incidents. Check to see...

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Auditor Competence

May 1, 2018 in Newsletter | Comments Off on Auditor Competence

The ISO 17021 conformity assessment standards state the requirements for bodies providing audit and certification of management systems. ISO 17021-3:2017 provides the competence requirements for auditing and certification of “quality” management systems. If you are a certification body auditor, do you have this knowledge? If you are an internal auditor, shouldn’t you possess the same level of knowledge? Fundamental concepts and quality management principles Each Quality Management System (QMS) auditor must have knowledge...

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ISO 9004:2018 Available

May 1, 2018 in Newsletter | Comments Off on ISO 9004:2018 Available

ISO 9004:2018, “Quality management – Quality of an organization – Guidance to achieve sustained success”, has been published.  It replaces ISO 9004:2009, “Managing for the sustained success of an organization – A quality management approach”. The 4th edition of ISO 9004 provides guidance for organizations to achieve sustained success in a complex, demanding, and ever-changing environment, with reference to the seven quality management principles described in ISO 9001:2015. Where they are applied...

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ISO 45001:2018

Apr 4, 2018 in Newsletter | Comments Off on ISO 45001:2018

ISO 45001:2018, “Occupational health and safety management systems — Requirements with guidance for use”, is now available. ISO 45001 is a replacement for OHSAS 18001:2007. ISO 45001 adopts Annex SL, thus sharing the same clause structure, core text, and terms and definitions as ISO 9001:2015 (quality management) and ISO 14001:2015 (environmental management). ISO 45001 specifies requirements for an occupational health and safety (OH&S) management system and gives guidance for its use. It enables organizations to...

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IATF 16949 Nonconformities

Apr 4, 2018 in Newsletter | Comments Off on IATF 16949 Nonconformities

A recent article in the OMNEX Navigator provided an analysis of 181 transition audits to the IATF 16949:2016 automotive standard. Top 5 Nonconformities The top five IATF 16949 clauses with nonconformities are listed below by percentage of total nonconformities: 1. Total Productive Maintenance (8.5.1.5) = 4.9% 2. Control Plan (8.5.1.1) = 3.9% 3. Contingency Plans (6.1.2.3) = 3.8% 4. Control of Production and Service Provision (8.5.1) = 2.7% 5. Internal Auditor Competency (7.2.3) = 2.4% Top 5 Majors The top five IATF 16949 clauses with majors...

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Safety Report

Apr 4, 2018 in Newsletter | Comments Off on Safety Report

The 2018 Annual Safety Progress Report from SafeStart and EHS Daily Advisor was developed based on the survey responses from 531 environmental, health, and safety professionals. Concerns The participants listed their top seven most pressing safety concerns as: 1. Employee engagement (48%) 2. Employees taking shortcuts or ignoring the rules (44%) 3. Supervisor participation in safety programs (38%) 4. Common recurring injuries, e.g., slips, trips, and falls (32%) 5. Lackluster safety culture (30%) 6. Organizational and/or leadership buy-in...

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Tackling Counterfeit

Apr 4, 2018 in Newsletter | Comments Off on Tackling Counterfeit

A new brochure on “Tackling Counterfeit with IEC and ISO Standards” is available for a free download from this web page. The first page of the brochure sets the stage: “In Roman times it was wine, in mediaeval times it was textiles and weapons, today it is everything from personal computers to potency pills. Counterfeit goods are nothing new, but with globalization, the Internet and increased movement of goods, the fakes business is booming.” The brochure answers the questions “What exactly are counterfeit...

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QMS and Processes

Apr 4, 2018 in Newsletter | Comments Off on QMS and Processes

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its: external and internal issues (4.1) relevant interested parties (4.2) quality management system scope (4.3) processes and their interaction (4.4) This article is on clause 4.4 and establishing a quality management system and the interaction of its processes. See the External Issues and Internal Issues articles in our February 2018 newsletter. See the Interested Parties and Scope Statement articles in our March 2018...

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ISO 9001:2015 Classes in Orlando

Mar 1, 2018 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements  April 9-10, 2018 June 4-5, 2018 ISO 9001:2015 Internal Auditor April 9-11, 2018 June 4-6, 2018 ISO 9001:2015 Lead Auditor April 9-12, 2018 June 4-7, 2018 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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Interested Parties

Mar 1, 2018 in Newsletter | Comments Off on Interested Parties

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its: external and internal issues (4.1) relevant interested parties (4.2) quality management system scope (4.3) processes and their interaction (4.4) This article is focused on clause 4.2 and determining interested parties. 4.2 Understanding the needs and expectations of interested parties   Requirements Due to their effect or potential effect on the organization’s ability to consistently provide products and services that...

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Scope Statement

Mar 1, 2018 in Newsletter | Comments Off on Scope Statement

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its: external and internal issues (4.1) relevant interested parties (4.2) quality management system scope (4.3) processes and their interaction (4.4) This article is on clause 4.3 and determining the Scope of a quality management system. See the Interested Parties article in this March 2018 newsletter. See the External Issues and Internal Issues articles in our February 2018 newsletter. 4.3 Determining the scope of the quality...

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Risk – ISO 31000:2018

Mar 1, 2018 in Newsletter | Comments Off on Risk – ISO 31000:2018

ISO 31000:2018, Risk Management – Guidelines, has been published. This second edition standard states that the purpose of risk management is the creation and protection of value. It improves performance, encourages innovation, and supports the achievement of objectives. According to ISO 31000:2018, its main changes from ISO 31000:2009 are: Review of the principles of risk management, which are the key criteria for its success; Highlighting of the leadership by top management and the integration of risk management, starting with the...

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Quality Manual Templates

Mar 1, 2018 in Newsletter | Comments Off on Quality Manual Templates

We have quality manual templates for IATF 16949:2016, AS9100D, AS9110C, AS9120B, and ISO 9001:2015-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100D:2016 Quality Manual Template, 42 pages ($135) AS9110C:2016 Quality Manual Template, 43 pages ($135) AS9120B:2016 Quality Manual Template, 40 pages ($135) ISO 9001:2015 Quality Manual Template, 29 pages ($95) We have a policy manual template for an ISO 14001:2015-based environmental management system, and a policy manual template for...

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Gap Analysis Checklists

Mar 1, 2018 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

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ISO 9001:2015 Classes in Orlando

Feb 1, 2018 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements February 5-6, 2018 (confirmed class) April 9-10, 2018 June 4-5, 2018 ISO 9001:2015 Internal Auditor February 5-7, 2018 (confirmed class) April 9-11, 2018 June 4-6, 2018 ISO 9001:2015 Lead Auditor February 5-8, 2018 (confirmed class) April 9-12, 2018 June 4-7, 2018 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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Ransomware Report

Feb 1, 2018 in Newsletter | Comments Off on Ransomware Report

Cybersecurity Insiders, in partnership with the 370,000+ member Information Security Community on LinkedIn, commissioned Crowd Research Partners to conduct an in-depth study to gather insights, reveal the latest ransomware trends, and provide valuable guidance on effectively addressing the ransomware threat. The key findings of the 2017 Ransomware Report were: 1. Ransomware is the fastest growing security threat, perceived as a moderate or extreme threat by 80% of cybersecurity professionals. 75% of organizations affected by ransomware...

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External Issues

Feb 1, 2018 in Newsletter | Comments Off on External Issues

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its: external and internal issues (4.1) relevant interested parties (4.2) quality management system scope (4.3) processes and their interaction (4.4) This article is focused on clause 4.1 and determining external issues. A different article in this newsletter addresses internal issues. Both articles include the same Requirements, Notes, and References sections. The Guidance sections are unique to internal issues or external...

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Internal Issues

Feb 1, 2018 in Newsletter | Comments Off on Internal Issues

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its: external and internal issues (4.1) relevant interested parties (4.2) quality management system scope (4.3) processes and their interaction (4.4) This article is focused on clause 4.1 and determining internal issues. A different article in this newsletter addresses external issues. Both articles include the same Requirements, Notes, and References sections. The Guidance sections are unique to internal issues or external...

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Quality and Policy Manual Templates

Feb 1, 2018 in Newsletter | Comments Off on Quality and Policy Manual Templates

We have quality manual templates for IATF 16949:2016, AS9100D, AS9110C, AS9120B, and ISO 9001:2015-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100D:2016 Quality Manual Template, 42 pages ($135) AS9110C:2016 Quality Manual Template, 43 pages ($135) AS9120B:2016 Quality Manual Template, 40 pages ($135) ISO 9001:2015 Quality Manual Template, 29 pages ($95) We have a policy manual template for an ISO 14001:2015-based environmental management system, and a policy manual template for...

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Gap Checklists

Feb 1, 2018 in Newsletter | Comments Off on Gap Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist  The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

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1. ISO 9001 Classes in Orlando

Jan 2, 2018 in Newsletter | Comments Off on 1. ISO 9001 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements February 5-6, 2018 ISO 9001:2015 Internal Auditor February 5-7, 2018 ISO 9001:2015 Lead Auditor February 5-8, 2018 Click on a course title to view the course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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2. Tips for Using a Consultant

Jan 2, 2018 in Newsletter | Comments Off on 2. Tips for Using a Consultant

If you are considering the use of a consultant to help you implement or improve your management system, I offer these ten tips. Choosing a qualified consultant is no easy task. The importance of taking the time to make a thoughtful selection cannot be underestimated. Your choice could end up affecting the efficiency and effectiveness of your business operations. 1. Understand the reasons for using a consultant Why do organizations use consultants? An organization may realize it lacks the expertise, time, experience, or objectivity to perform...

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3. Papers, Glossary, and Links

Jan 2, 2018 in Newsletter | Comments Off on 3. Papers, Glossary, and Links

Look at the updated “Resources” tab at the top of our website home page. Papers The Papers section provides 22 handouts that can be downloaded for: AS9100:2016 AS9110:2016 AS9120:2016 ISO 9001:2015 ISO 14001:2015 IATF 16949:2016 ISO 27001:2013 ISO 13485:2016 Glossary The Glossary section includes 123 quality and audit-related definitions based upon ISO 9000:2015 and ISO 19011:2011. Links The Links section includes 146 web links to quality and industry-related associations, councils, centers, forums, societies, institutes,...

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4. AS9116A:2017

Jan 2, 2018 in Newsletter | Comments Off on 4. AS9116A:2017

AS9115A:2017, Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations – Deliverable Software, is a supplement for AS9100D:2016 to clarify the requirements for deliverable software. AS9115 contains quality management system requirements for organizations that design, develop, and/or produce deliverable software and services for the aviation, space, and defense industry. This includes, as required, support software that is used in the development and maintenance of deliverable software and services....

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5. Quality Manual Templates

Jan 2, 2018 in Newsletter | Comments Off on 5. Quality Manual Templates

We have quality manual templates for IATF 16949:2016, AS9100D, AS9110C, AS9120B, and ISO 9001:2015-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100D:2016 Quality Manual Template, 42 pages ($135) AS9110C:2016 Quality Manual Template, 43 pages ($135) AS9120B:2016 Quality Manual Template, 40 pages ($135) ISO 9001:2015 Quality Manual Template, 29 pages ($95) We have a policy manual template for an ISO 14001:2015-based environmental management system, and a policy manual template for an integrated...

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6. ISO 10006:2017

Jan 2, 2018 in Newsletter | Comments Off on 6. ISO 10006:2017

ISO 10006:2017, “Quality management – Guidelines for quality management in projects” is available for the application of quality management in projects. This third edition of the standard replaces ISO 10006:2003. ISO 10006 is applicable to organizations working on projects of varying complexity, small or large, of short or long duration. It can be an individual project or part of a program or portfolio of projects, in different environments, and irrespective of the kind of product/service or process involved. The intent is...

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7. ISO 17025:2017

Jan 2, 2018 in Newsletter | Comments Off on 7. ISO 17025:2017

ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories”, third edition, is available to replace ISO 17025:2005. ISO 17025 specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO 17025 to...

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8. Gap Checklists

Jan 2, 2018 in Newsletter | Comments Off on 8. Gap Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist  The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

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IAF on ISO 9001 and ISO 14001

Dec 1, 2017 in Newsletter | Comments Off on IAF on ISO 9001 and ISO 14001

The International Accreditation Forum (IAF) has posted this notice at their website: IAF has published a communiqué entitled ‘Important information for Certification Bodies regarding transition to ISO 9001 and ISO 14001′ following the passing of IAF Resolution 2017-13, which states that as of 15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and re-certification audits to the new versions – ISO 9001:2015 and ISO 14001:2015.   This resolution continues the efforts of...

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ISO 9001:2015 Classes in Orlando

Dec 1, 2017 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: IISO 9001:2015 Requirements December 18-19, 2017 (confirmed) February 5-6, 2018 ISO 9001:2015 Internal Auditor December 18-20, 2017 (confirmed) February 5-7, 2018 ISO 9001:2015 Lead Auditor December 18-21, 2017 (confirmed) February 5-8, 2018 Click on a course title to view the course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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Internal Audit Requirements

Dec 1, 2017 in Newsletter | Comments Off on Internal Audit Requirements

ISO management system standards are required to adopt the high-level structure, identical core text, and common terms and definitions of Annex SL of the ISO Directives, Part 1. The Annex SL base text for clause 9.2, Internal Audit, is shown below, and followed by the actual internal audit requirements for these management system standards: ISO 9001:2015 ISO 14001:2015 AS9100:2016; AS9110:2016; AS9120:2016 IATF 16949:2016 ISO 27001:2013. Annex SL 9.2 Internal audit 9.2.1 The organization shall conduct internal audits at planned intervals to...

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ISO 27007 Audit Guidance

Dec 1, 2017 in Newsletter | Comments Off on ISO 27007 Audit Guidance

The second edition of ISO 27007, “Information technology – Security techniques – Guidelines for information security management systems auditing,” has been published. ISO 27007:2017 provides guidance on managing an information security management system (ISMS) audit program, on conducting audits, and on the competence of ISMS auditors. It gives guidance for auditing all the requirements stated in ISO 27001. ISO 27007 is intended to be used in conjunction with the audit guidance contained in ISO 19011:2011, and...

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Millennials and Cybersecurity

Dec 1, 2017 in Newsletter | Comments Off on Millennials and Cybersecurity

Although millennials grew up as a tech-savvy generation, a ConsumerAffairs.com article says they appear to have a more relaxed attitude toward cybersecurity than their parents. A recent FirstData study shows that baby boomers are generally more concerned about security than their younger peers. The researchers found that, overall, boomers did a better job of protecting personal information than millennials. The study highlights two areas where millennials could do a better job — passwords and the use of social media. Reusing...

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Quality Manual Templates

Dec 1, 2017 in Newsletter | Comments Off on Quality Manual Templates

We have quality manual templates for IATF 16949:2016, AS9100D, AS9110C, AS9120B, and ISO 9001:2015-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100D:2016 Quality Manual Template, 42 pages ($135) AS9110C:2016 Quality Manual Template, 43 pages ($135) AS9120B:2016 Quality Manual Template, 40 pages ($135) ISO 9001:2015 Quality Manual Template, 29 pages ($95) We have a policy manual template for an ISO 14001:2015-based environmental management system, and a policy manual template for...

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Gap Analysis Checklists

Dec 1, 2017 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist  The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy...

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ISO 9001:2015 Classes in Orlando, Florida

Nov 1, 2017 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando, Florida

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements December 18-19, 2017 ISO 9001:2015 Internal Auditor December 18-20, 2017 ISO 9001:2015 Lead AuditorDecember 18-21, 2017 Click on a course title to view the course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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ISO 14001:2005 Changes – Clause 9

Nov 1, 2017 in Newsletter | Comments Off on ISO 14001:2005 Changes – Clause 9

9. Performance Evaluation 9.1 Monitoring, Measurement, Analysis, and Evaluation 9.1.1 Changes – General Replaces old 4.5.1 on Monitoring and Measurement Adds to communicate environmental performance and effectiveness of EMS Adds to determine criteria for evaluating environmental performance (and indicators) Adds “what” and “when” for monitoring and measurement Adds “when” for analysis and evaluation 9.1.2 Changes – Evaluation of Compliance Replaces old 4.5.2 on Evaluation of...

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ISO 14001:2015 Changes – Clause 10

Nov 1, 2017 in Newsletter | Comments Off on ISO 14001:2015 Changes – Clause 10

10. Improvement 10.1 Changes – General New clause. Improvements determined by: monitoring, measuring, analysis, evaluation (9.1) internal audit (9.2) management review (9.3) Take actions to achieve “intended outcomes” referenced in 4.1, 4.4, 5.1.f, and 6.1.1. 10.2 Changes – Nonconformity and Corrective Action Replaces old 4.5.3 on Nonconformity, Corrective Action, and Preventive Action Drops need for separate preventive action Preventive concept covered by 4.1 and 6.1 Adds to deal with consequences of...

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ISO 13485:2016 Handbook

Nov 1, 2017 in Newsletter | Comments Off on ISO 13485:2016 Handbook

This article is an edited version of an ISO news release. The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose. Medical devices range from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants, and software for disease screening. These medical devices play a key role in the welfare of the public, whose safety depends on the...

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IATF 16949 Interpretations and FAQs

Nov 1, 2017 in Newsletter | Comments Off on IATF 16949 Interpretations and FAQs

The International Automotive Task Force (IATF) has issued the first set of IATF 16949:2016 “Sanctioned Interpretations” and “Frequently Asked Questions”. The sanctioned interpretations are for these clauses: S1. Definition of customer requirements (3.1) S2. Product safety (4.4.1.2) S3. Contingency plans (6.1.2.3) S4. Internal auditor competency (7.2.3) S5. Quality management system documentation (7.5.1.1) S6. Special characteristics (8.3.3.3) S7. Type and extent of control – supplemental (8.4.2.1) S8. Supplier...

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Quality Manual Templates

Nov 1, 2017 in Newsletter | Comments Off on Quality Manual Templates

We have quality manual templates for IATF 16949:2016, AS9100D, AS9110C, AS9120B, and ISO 9001:2015-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100D:2016 Quality Manual Template, 42 pages ($135) AS9110C:2016 Quality Manual Template, 43 pages ($135) AS9120B:2016 Quality Manual Template, 40 pages ($135) ISO 9001:2015 Quality Manual Template, 29 pages ($95) We have a policy manual template for an ISO 14001:2015-based environmental management system, and a policy manual template for...

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Gap Analysis Checklists

Nov 1, 2017 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

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ISO 9001:2015 Classes in Orlando

Oct 2, 2017 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements  December 18-19, 2017 ISO 9001:2015 Internal Auditor  December 18-20, 2017 ISO 9001:2015 Lead Auditor  December 18-21, 2017 Click on a course title to view the course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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