Newsletter

Transition Timelines

Jul 1, 2016 in Newsletter | Comments Off on Transition Timelines

This article covers the current Transition Timeline for key ISO management system standards, as well as, the End-of-Life Timeline for ISO 9001:2008 and ISO 14001:2004. Transition Timeline The list below identifies the release date (or projected release date) for the standards, along with their transition end date and the duration of their transition period. Since the ISO 9001:2008 quality management system standard will be withdrawn in September 2018, organizations must transition to the replacement ISO 9001:2015 edition by that date. The...

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ISO 9001:2015, 8.5

Jun 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.5

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.5 Production and Service Provision. 8.5.1 Control of Production and Service Requirements: Implement production and service provision under controlled conditions. Include,...

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ISO 13485:2016 Documents

Jun 1, 2016 in Newsletter | Comments Off on ISO 13485:2016 Documents

The recently revised medical device standard, ISO 13485:2016, requires a quality management system that includes these documents and procedures. Required Documents and Procedures (Clause) 01. Roles undertaken by organization under applicable regulatory requirements (4.1.1) 02. Procedures for validation of the application of software used in QMS (4.1.6) 03. Statement of quality policy (4.2.1.a) See 5.3. 04. Statement of quality objectives (4.2.1.a) See 5.4.1. 05. Quality manual (4.2.1.b) See 4.2.2. 06. Procedures required by the standard...

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ISO 13485:2016 Records

Jun 1, 2016 in Newsletter | Comments Off on ISO 13485:2016 Records

The recently revised medical device standard, ISO 13485:2016, requires a quality management system that includes these records. Required Records (Clause) 01. Records to demonstrate conformance to standard and compliance to regulations (4.1.3.e) 02. Records of validations and revalidations of application of software used in QMS (4.1.6) 03. Records required by the standard (4.2.1.c) 04. Records necessary to ensure effective process planning, operation, and control (4.2.1.d) 05. A least one copy of obsolete documents retained for defined period...

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2015 Edition Classes

Jun 1, 2016 in Newsletter | Comments Off on 2015 Edition Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. August 3-4, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention...

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Risk Management

Jun 1, 2016 in Newsletter | Comments Off on Risk Management

Risk Management According to ISO 31000, “Risk management – Principles and guidelines”, organizations of all types and sizes face internal and external factors and influences that make it uncertain whether and when they will achieve their objectives. The effect this uncertainty has on an organization’s objectives is “risk”. All activities of an organization involve risk. Organizations manage risk by identifying it, analyzing it, and then evaluating whether the risk should be modified by risk treatment in...

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Gap Checklists

Jun 1, 2016 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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ISO 9001:2015, 8.4

May 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.4

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.4 Control of Externally Provided Processes, Products, and Services. 8.4.1 General Requirements: Ensure that externally provided processes, products, and services conform to...

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Environmental Claims

May 1, 2016 in Newsletter | Comments Off on Environmental Claims

The ISO 9001:2015 quality management system standard has added a new “claims” requirement. Clause 8.2.2.b of the standard states that an organization must ensure it can meet the claims for its products and services. If your company makes environmental claims in ads or on your products, you’ll want to know about the Federal Trade Commission (FTC) Green Guides. The summary below of the Guides introduces how truth-in-advertising principles apply to green marketing and highlights terms often used in environmental ads. General...

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Records Management

May 1, 2016 in Newsletter | Comments Off on Records Management

ISO 15489-1, “Information and documentation — Records management — Part 1: Concepts and principles”, has been updated with a 2016 edition. ISO 15489-1:2016 defines the concepts and principles from which approaches to the creation, capture, and management of records are developed. This part of ISO 15489 describes concepts and principles relating to: a) records, metadata for records, and records systems; b) policies, assigned responsibilities, monitoring, and training supporting the effective management of records; c)...

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ISO 9001:2015 Classes

May 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. May 17-18, 2016 in Atlanta, GA (Class Confirmed) SpringHill Suites – Atlanta Airport...

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Gap Analysis Checklists

May 1, 2016 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, 8.3

Apr 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.3

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.3 Design and Development of Products and Services. 8.3.1 General Requirements: Establish, implement, and maintain a design and development process that is appropriate to...

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ISO 14004:2016

Apr 1, 2016 in Newsletter | Comments Off on ISO 14004:2016

The third edition of ISO 14004 has been published with a new title, “Environmental management systems – General guidelines on implementation”. It replaces ISO 14004:2004 that had the title, “Environmental management systems – General guidelines on principles, systems and support techniques”. ISO 14004:2016 provides guidance for an organization on the establishment, implementation, maintenance, and improvement of a robust, credible, and reliable environmental management system (EMS). The guidance provided is...

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Data Breach Report

Apr 1, 2016 in Newsletter | Comments Off on Data Breach Report

The Verizon 2015 Data Breach Investigations Report (DBIR) provides a detailed analysis of almost 80,000 incidents, including 2,100+ confirmed data breaches. Protecting your organization from a data breach could save your business tens of millions of dollars, and help maintain customer loyalty and shareholder confidence. Data security isn’t something that should be left to the IT department. It’s so important that it should matter to leaders, and indeed employees, from all functions. The motives for attacks are varied: attackers may...

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ISO 9001:2015 Classes

Apr 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. May 17-18, 2016 in Atlanta, GA (Confirmed Class) SpringHill Suites – Atlanta Airport...

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Top Ten Hacks

Apr 1, 2016 in Newsletter | Comments Off on Top Ten Hacks

According to a recent Black Hat Survey by Balabit, the ten most popular hacking methods in the USA are: 1. Social Engineering (e.g., phishing) – 81% 2. Compromised Accounts (e.g. weak passwords) – 62% 3. Web-Based Attacks (e.g., SQL/command injection) – 51% 4. Client Side Attacks (e.g., against doc readers, web browsers) – 33% 5. Exploit Against Popular Server Updates (e.g., OpenSSL, Heartbleed) – 23% 6. Unmanaged Personal Devices (e.g., lack of BYOD policy) – 21% 7. Physical Intrusion – 15% 8. Shadow...

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Gap Analysis Checklists

Apr 1, 2016 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 13485:2016

Mar 1, 2016 in Newsletter | Comments Off on ISO 13485:2016

The third edition of ISO 13485 has been published as the replacement for ISO 13485:2003. ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, sets out the requirements for a quality management system specific to the medical devices industry. The new edition was issued to respond to the latest developments in quality management, technology, and regulatory requirements. With the standard applicable to so many types of products, the revision was no easy task. A medical device is any...

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ISO/TS 16949:2016

Mar 1, 2016 in Newsletter | Comments Off on ISO/TS 16949:2016

The International Automotive Task Force (IATF) has approved the first draft of the new ISO/TS 16949:2016 automotive quality standard to include additional stakeholder feedback. The revision work team is preparing for an April 2016 conference to obtain further stakeholder input. The IATF intends to release the transition strategy from ISO/TS 16949:2009 to ISO/TS 16949:2016 in April 2016. Pilot gap assessments will be conducted May through June 2016 worldwide. Feedback from these gap assessments will be used to further refine ISO/TS 16949:2016...

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ISO 45001 Review

Mar 1, 2016 in Newsletter | Comments Off on ISO 45001 Review

ISO 45001, the safety management system replacement for OHSAS 18001, has advanced to the Draft International Standard (DIS) stage, and is available for review at this web page. Your comments must be submitted by April 1, 2016. Every 15 seconds, a worker dies from a work-related accident or disease, and 153 people experience a work-related injury. These represent an enormous burden for organizations and society as a whole, costing over 2.3 million deaths a year, not to mention the more than 300 million non-fatal accidents. Now, with the draft...

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ISO 9001:2015 Classes

Mar 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. May 17-18, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention...

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New ISO 27000:2016

Mar 1, 2016 in Newsletter | Comments Off on New ISO 27000:2016

The recently revised ISO 27000:2016, Information technology – Security techniques – Information security management systems – Overview and vocabulary, gives a comprehensive view of information security management systems (ISMS) and defines related terms and definitions. All information held and processed by an organization is subject to the risks of attack, error, and natural disaster, and other vulnerabilities inherent to its use. Information security is therefore at the heart of an organization’s activities and...

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Gap Analysis Checklists

Mar 1, 2016 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001 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 checklist...

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Workshop on Risk-Based Thinking

Mar 1, 2016 in Newsletter | Comments Off on Workshop on Risk-Based Thinking

ISO 9001:2015 replaces the requirement for preventive action with that of risk-based thinking (RBT). While the intent is to alleviate confusion, it may have actually created more due to the introduction of terminology not widely used elsewhere. Although it may mean greater variability in interpretation, it also allows more flexibility to adapt to the context of each organization. We now offer a 1.0-day on-site workshop to cover the specific risk-based thinking requirements, and to compare and contrast them with a formal risk management (RM)...

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ISO 9001:2015, Clause 8.2

Feb 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, Clause 8.2

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.2 Requirements for Products and Services. 8.2.1 Customer Communication Requirements: Communicate with customers to: a) provide information relating to products and...

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ISO 9000:2015 Terms

Feb 1, 2016 in Newsletter | Comments Off on ISO 9000:2015 Terms

The ISO 9001:2015 requirements standard refers to ISO 9000:2015 for the definitions of its terms. The ISO 9000:2015 Fundamentals and Vocabulary document contains 146 definitions. ISO 9000:2015 dropped 3 terms from ISO 9000:2005, kept 81 terms from ISO 9000:2005, and added 65 new terms beyond those in ISO 9000:2005. Clause 3 of ISO 9000:2015 is titled, Terms and Definitions. You can view for free the entire clause at this ISO web page. It consists of 13 sections that group terms into the following categories: 3.1 Person or People For example,...

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Safety Guidelines

Feb 1, 2016 in Newsletter | Comments Off on Safety Guidelines

The Occupational Safety and Health Administration (OSHA) has published a draft revised Safety and Health Program Management Guidelines document for public comment. The voluntary guidelines document updates and replaces the guidelines document that was first published in 1989. These guidelines provide employers, workers, and worker representatives with a sound, flexible framework for addressing safety and health issues in diverse workplaces. They are intended for use in any workplace, but will be particularly helpful in small and medium-sized...

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2015 Edition Classes

Feb 1, 2016 in Newsletter | Comments Off on 2015 Edition Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as well as, our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. February 22-23, 2015 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine...

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Anti-Bribery Standard

Feb 1, 2016 in Newsletter | Comments Off on Anti-Bribery Standard

According to the World Bank, 1 in 7 global transactions involve a bribe. With over a $trillion dollars paid in bribes each year, the consequences are catastrophic, reducing quality of life, increasing poverty, and eroding public trust. Yet despite efforts on national and international levels to tackle bribery, it remains a significant issue. Recognizing this, ISO is currently developing a new standard to help organizations fight bribery and promote an ethical business culture. ISO 37001, Anti-bribery management systems, will specify a series...

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Gap Analysis Checklists

Feb 1, 2016 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001 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 checklist...

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Risk-Based Thinking

Feb 1, 2016 in Newsletter | Comments Off on Risk-Based Thinking

ISO 9001:2015 replaces the requirement for preventive action with that of risk-based thinking (RBT). While the intent is to alleviate confusion, it may have actually created more due to the introduction of terminology not widely used elsewhere. Although it may mean greater variability in interpretation, it also allows more flexibility to adapt to the context of each organization. We now offer a 1.0-day on-site workshop to cover the specific risk-based thinking requirements, and to compare and contrast them with a formal risk management (RM)...

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ISO 9001:2015, 8.1

Jan 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.1

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.1, Operational Planning and Control. Requirements: Plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and...

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Value of IoT

Jan 1, 2016 in Newsletter | Comments Off on Value of IoT

Any business that fails to invest heavily in the internet of things in the next 10 years is unlikely to be able to remain competitive. The value of the internet of things (IoT) may exceed the hype, according to research by the McKinsey Global Institute. They estimate that the total potential value of IoT will be between $3.9 trillion and $11.1 trillion a year by 2025. The McKinsey research says that most of this value will come from operations and equipment optimization in factories, chore automation and security in the home, automation in the...

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Transition to ISO 9001:2015

Jan 1, 2016 in Newsletter | Comments Off on Transition to ISO 9001:2015

Larry Whittington presented “ISO 9001:2015 – Plan for the Changes” at the ASQ Audit Conference in Reno, Nevada. This article shares information from the transition guidance part of that presentation. ISO 9001:2015 was issued on September 15, 2015. Organizations certified to ISO 9001:2008 have a three year transition period to make their move to the new standard before ISO 9001:2008 is withdrawn. As you plan for the transition, remember to obtain funding for your transition activities. You will need to arrange for training on...

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2015 Edition Classes

Jan 1, 2016 in Newsletter | Comments Off on 2015 Edition Classes

We are offering public ISO 9001:2015 and ISO 14001:2015 courses on “Requirements and Transition Guidance” in Atlanta, GA and Orlando, FL. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. February 22-23, 2015 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533 Group Rate Reservation Link Free breakfast and Internet Free airport...

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OHSA Top Ten

Jan 1, 2016 in Newsletter | Comments Off on OHSA Top Ten

The Occupational Safety and Health Administration (OSHA)’s top ten most cited violations for fiscal year 2015 are: 1. Fall Protection – General Requirements Standard 1926.501 Total Violations= 7,402 This standard outlines where fall protection is required, which systems are appropriate for given situations, the proper constructions and installation of safety systems, and the proper supervision of employees to prevent falls. It is designed to protect employees on walking and working surfaces (horizontal or vertical) with an...

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ISO 9004 Revision

Jan 1, 2016 in Newsletter | Comments Off on ISO 9004 Revision

ISO 9001:2015 was published in September 2015. However, its companion standard, ISO 9004:2009, was not revised and released. ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach, provides guidance for organizations to support the achievement of sustained success through a quality management approach. A project to revise ISO 9004 has been approved and a working draft is being developed. It is expected to follow a three year development program, which would put its release in 2018. The work...

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New ISO/TS 9002 Standard

Jan 1, 2016 in Newsletter | Comments Off on New ISO/TS 9002 Standard

A new standard, ISO/TS 9002, Guidelines for the application of ISO 9001:2015, is being developed to assist users in implementing an ISO 9001-based quality management system. The Technical Specification (TS) is intended to be informative and provide guidance on the requirements in ISO 9001, with a clause by clause correlation to clauses 4-10 in ISO 9001. ISO/TS 9002 will not add new requirements to ISO 9001. However, it will give examples of what an organization can do. These examples will not be definitive and only represent possibilities, not...

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Gap Analysis Checklists

Jan 1, 2016 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, 9.3

Dec 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 9.3

This article provides a summary of the Management Review requirements of ISO 9001:2015. After the summary, the Management Review differences from ISO 9001:2008 are described. ISO 9001:2015 Summary 9.3 Management Review 9.3.1 General Review the quality management system (QMS) at planned intervals to ensure a suitable, adequate, and effective QMS and alignment with the strategic direction of the organization. 9.3.2 Management Review Inputs Plan and carry out the management review considering: Status of actions from previous management...

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Technology Trends

Dec 1, 2015 in Newsletter | Comments Off on Technology Trends

The Gartner report, Top 10 Strategic Technology Trends for 2016, identifies technology trends with the potential for significant impact on an organization. Factors that denote significant impact include a high potential for disruption to the business, end users or IT, the need for a major investment, or the risk of being late to adopt. These technologies impact the organization’s long-term plans, programs and initiatives. The first three trends address merging the physical and virtual worlds and the emergence of the digital mesh. While...

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Cybersecurity Insights

Dec 1, 2015 in Newsletter | Comments Off on Cybersecurity Insights

According to an AT&T Cybersecurity Insights Report, businesses suffered nearly 43 million known security incidents in 2014. This increased 48% compared with 2013 and equals some 117,000 attacks daily. And still, many boards and executives don’t have the information and resources they need to make effective business decisions on cybersecurity. The report says every company either has been breached or will be breached. Keeping a business protected should be a company-wide priority. Every employee, contractor, and administrator is...

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ISO 9001:2015 Class

Dec 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Class

Enrollment for our two day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: January 26-27, 2016 in Atlanta, GA (already a confirmed class) SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Group Rate Reservation Link Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students February 22-23, 2015 in Orlando,...

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ISO 14001:2015 Class

Dec 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment for our 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course is $725 and includes lunch on the first day. February 24-25 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533407-816-5533 Group Rate Reservation Link Free breakfast and Internet Free airport shuttle No parking fee May 19-20, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Group...

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ISO 9001:2015 Checklist

Dec 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Checklist

Larry Whittington has developed an extensive, 27 page, ISO 9001:2015 Gap Analysis Checklist. It 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 checklist for $95. When you click the Buy Now button at the checklist description, you will be taken to PayPal. You do not need a PayPal account to make a credit card purchase. After payment, you will...

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ISO 14001:2015 Checklist

Dec 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Checklist

Larry Whittington has developed an extensive, 17 page, ISO 14001:2015 Gap Analysis Checklist. It contains 213 questions for organizations new to ISO 14001, and 96 delta questions for ISO 14001:2004 certified organizations. To read a description of the ISO 14001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the checklist for $95. When you click the Buy Now button at the checklist description, you will be taken to PayPal. You do not need a PayPal account to make a credit card purchase. After payment, you...

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ISO 9001:2015, 9.2

Nov 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 9.2

This article provides a summary of the Internal Audit requirements as stated in the new ISO 9001:2015 standard. The internal audit differences from ISO 9001:2008 are identified. 9.2 Internal Audit 9.2.1 Conduct internal audits at planned intervals to provide information on whether the quality management system (QMS): Conforms to the organization’s own requirements for its QMS Conforms to the requirements of this international standard (ISO 9001) Is effectively implemented and maintained 9.2.2 The organization must: Plan, establish,...

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ISO Certificates

Nov 1, 2015 in Newsletter | Comments Off on ISO Certificates

ISO has released the results of its annual survey of certifications. The summary below shows the number of worldwide certificates issued for seven of the management system standards, along with the USA totals and the top ten countries. ISO 9001 (Quality) Certificates in 2014 = 1,138,155 (USA = 33,008) Certificates in 2013 = 1,126,460 (USA = 34,869) Increase = +11,695 (USA = -1861) Percentage = +1% (USA = -5%) Note: According to ISO, the USA decrease in 2014 is explained by a major contributor reporting significantly less certificates than in...

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Counterfeit Parts

Nov 1, 2015 in Newsletter | Comments Off on Counterfeit Parts

(The following is an extract from an article that appeared in the NTS newsletter) Electronics are an indispensable part of our lives today. Whether you’re flying an airplane or driving a car, talking on your phone or using your computer, a majority of our life is enabled by electronic components. Unfortunately, electronic components in consumer electronics, cars, military and commercial planes are increasingly being counterfeited. Fake components lead to product failures and can even cause personal injury and death. The Serious Problem...

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ISO 9001:2015 Class

Nov 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Class

Enrollment is open for our two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: November 12-13, 2015 in Atlanta, GA Enrollment Closed January 26-27, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880 Group Rate Reservation Link Free breakfast and Internet Free ATL SkyTrain Parking fee waived for...

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Strategic Directions

Nov 1, 2015 in Newsletter | Comments Off on Strategic Directions

According to a recent Gartner report, “Top Strategic Predictions for 2016 and Beyond: The Future Is a Digital Thing”, the dramatic rise of smart machines and autonomous devices is driving radical shifts in business practices and individual behaviors. Enterprises and individuals face the urgent need to define and develop harmonious relationships between people and machines. Gartner’s top predictions for 2016 and beyond continue to offer a look into the digital future, a world driven by algorithms and smart machines, where...

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ISO 14001:2015 Class

Nov 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment is open for our 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the classes listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students February 24-25 in Orlando, FL SpringHill...

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ISO 9001:2015, Clause 9.1

Oct 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, Clause 9.1

This article summarizes the ISO 9001:2015 requirements in clause 9.1, Monitoring, Measurement, Analysis, and Evaluation, plus its changes from ISO 9001:2008. ISO 9001:2015, 9.1.1, General Determine: what needs to be monitored and measured the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results when the monitoring and measuring must be performed when the results from monitoring and measurement must be analyzed and evaluated Evaluate the performance and effectiveness of the quality management...

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Changes from FDIS to IS

Oct 1, 2015 in Newsletter | Comments Off on Changes from FDIS to IS

The new ISO 9001:2015 standard has been published. You can order it from the ISO, ANSI, and ASQ websites. At the present time, the lowest list price is at ISO (138 Swiss Francs, or $141). The ANSI member price is $138 and their list price is $173. The ASQ member and list prices are both $173. The minor changes from ISO/FDIS 9001:2015 to the newly published ISO 9001:2015 are shown below: 0.3.2 Plan-Do-Check-Act The Plan description has added “and identify and address risks and opportunities”. Plan: establish the objectives of the...

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Audit Conference

Oct 1, 2015 in Newsletter | Comments Off on Audit Conference

Larry Whittington will be a speaker at the 24th Annual ASQ Audit Conference on October 29-30, 2015. The conference will be held at the Peppermill Resort and Casino in Reno, Nevada. Click here to view the program. Click here to register for the conference. Click here to book a room at the hotel. Larry Whittington will speak at two sessions during the audit conference: Session A2: 10:45 AM on Thursday, October 29, 2015 ISO 9001:2015 – How Will It Change Your Audits? Session E3: 1:45 PM on Friday, October 30, 2015 ISO 9001:2015 – Plan...

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ISO 9001:2015 Classes

Oct 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Classes

Enrollment is open for our two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: November 12-13, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Group Rate Reservation Link Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students January 26-27, 2016 in Atlanta,...

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Ordering New Standards

Oct 1, 2015 in Newsletter | Comments Off on Ordering New Standards

The new ISO 9001:2015, ISO 9000:2015, and ISO 14001:2015 standards have been published. You can order them from the ISO, ANSI, and ASQ websites. If you are not a member of ANSI or ASQ, it is cheaper to order the standards from the ISO website. ISO 9001:2015 ISO = $141 (at present exchange rate for 138 CHF) ANSI = $138 Member and $173 List ASQ = $173 Member and $173 List (Member discounted price coming mid-October) ISO 9000:2015 ISO = $182 (at present exchange rate for 178 CHF) ANSI = $192 Member and $240 List ASQ = $189 Member and $239...

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ISO 14001:2015 Classes

Oct 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Classes

Enrollment is open for our 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the classes listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students February 24-25 in Orlando,...

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TL 9000 Release 6.0

Oct 1, 2015 in Newsletter | Comments Off on TL 9000 Release 6.0

With the release of ISO 9001:2015, many sector specific schemes are in the process of updating their standards. QuEST Forum, the global industry organization aimed at improving the quality of products and services delivered for the information communication technologies (ICT) industry, and the developer of the TL 9000 standard, was one of the first industry organizations to announce that its standard will continue to align with ISO 9001. The current TL 9000 Release 5.5 Requirements Handbook is being revised for ISO 9001:2015. The new Release...

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Exemplar Global Auditor Transition

Sep 1, 2015 in Newsletter | Comments Off on Exemplar Global Auditor Transition

All Exemplar Global (EG) certified auditors for the ISO 9001:2008 and ISO 14001:2004 standards must update their certifications through an online transition exam for the new 2015 editions of the standards. All grades of auditors for Quality Management Systems (QMS) and Environmental Management Systems (EMS) under both the Qualification scheme and the Competency scheme must update their certifications. Transition Assessment Certified auditors must demonstrate their transition adequacy by completing a transition assessment. This transition...

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ISO 9001:2015, 10, Improvement

Sep 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 10, Improvement

ISO/FDIS 9001:2015, clause 10, Improvement, has three sub-clauses: 10.1 General 10.2 Nonconformity and Corrective Action 10.3 Continual Improvement This article provides a summary of the Improvement requirements and identifies the changes from ISO 9001:2008. 10.1 General The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These actions must include: a) improving products and services to meet requirements, as well as,...

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Webinar on Audit Interviews

Sep 1, 2015 in Newsletter | Comments Off on Webinar on Audit Interviews

How to Improve the Effectiveness of Audit Interviews Thursday, September 17, 2015 11:30 AM PDT | 2:30PM EDT This 1.5 hour webinar by Larry Whittington will explain how to improve your audit interviewing skills. Webinar Description Audit interviews are one of four ways to gather information during an audit, the others being to review documents, observe operations, and examine records. Efficient and effective interviews lead to a successful audit. During interviews, we gather information about processes that may not be described in a documented...

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Audit Conference in Reno

Sep 1, 2015 in Newsletter | Comments Off on Audit Conference in Reno

Larry Whittington will be a speaker at the 24th Annual ASQ Audit Conference on October 29-30, 2015. The conference will be held at the Peppermill Resort and Casino in Reno, Nevada. Click here to view the program. Click here to register for the conference. Click here to book a room at the hotel. Larry Whittington will speak at two sessions during the audit conference: Session A2: 10:45 AM on Thursday, October 29, 2015 ISO 9001:2015 – How Will It Change Your Audits? Session E3: 1:45 PM on Friday, October 30, 2015 ISO 9001:2015 – Plan...

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ISO 14001:2015 Transition Class

Sep 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Transition Class

Enrollment is open for our new 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the class listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students To see the course description,...

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ISO 9001:2015 Transition Class

Sep 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Transition Class

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: September 15-16, 2015 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533407-816-5533 Reservation link for $109 rate Free breakfast and Internet Free airport shuttle No parking fee November 12-13, 2015 in Atlanta, GA SpringHill Suites –...

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ISO 14001:2015 Class

Aug 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment is open for our new 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington and Don Dickerson will be the instructors for the class listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students To see the...

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ISO 9001:2015 Webinar

Aug 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Webinar

Tuesday, August 25, 2015 10:00 AM PDT | 01:00 PM EDT The new 2015 edition of the ISO 9001 quality management system standard is due in September and is considered a major revision of the current 2008 edition. Are you aware of the significant changes? Will your organization be ready to make a timely and successful transition? This one hour webinar by Larry Whittington will explain the key ISO 9001:2015 requirement changes and how they may affect your quality management system. Larry, who has trained, consulted, and audited on all four of the...

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Audit Conference

Aug 1, 2015 in Newsletter | Comments Off on Audit Conference

Larry Whittington will be a speaker at the 24th Annual ASQ Audit Conference on October 29-30, 2015. The conference will be held at the Peppermill Resort and Casino in Reno, Nevada. Click here to view the program. Click here to register for the conference. Click here to book a room at the hotel. Larry Whittington will speak at two sessions during the audit conference: Session A2: 10:45 AM on Thursday, October 29, 2015 ISO 9001:2015 – How Will It Change Your Audits? Session E3: 1:45 PM on Friday, October 30, 2015 ISO 9001:2015 – Plan...

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ISO 9001:2015 Classes

Aug 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Classes

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: September 15-16, 2015 in Orlando, FL (class is confirmed) SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533407-816-5533 Reservation link for $109 rate Free breakfast and Internet Free airport shuttle No parking fee November 12-13, 2015 in Atlanta, GA (class...

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Worker Engagement

Aug 1, 2015 in Newsletter | Comments Off on Worker Engagement

You may have heard that ISO 9001:2015 will include a new requirement for top management to “engage” everyone that contributes to the effectiveness of the quality management system. To understand that requirement, we need to first understand what is meant by engagement. Principle The Quality Management Principle on Leadership states that leaders at all levels establish unity of purpose and direction, and create conditions in which people are engaged in achieving the quality objectives of the organization. The rationale for this...

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ISO 14001:2015 Class

Jul 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment is open for our new 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the class listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students To see the course description,...

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Audit Conference

Jul 1, 2015 in Newsletter | Comments Off on Audit Conference

Larry Whittington will be a speaker at the 24th Annual ASQ Audit Conference on October 29-30, 2015. The conference will be held at the Peppermill Resort and Casino in Reno, Nevada. Click here to view the program. Click here to register for the conference. Click here to book a room at the hotel. Larry Whittington will speak at two sessions during the audit conference: Session A2: 10:45 AM on Thursday, October 29, 2015 ISO 9001:2015 – How Will It Change Your Audits? Session E3: 1:45 PM on Friday, October 30, 2015 ISO 9001:2015 –...

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2020 Quality Report

Jul 1, 2015 in Newsletter | Comments Off on 2020 Quality Report

The Automotive Industry Action Group (AIAG), in collaboration with Delotte Consulting, has published “2020 Quality”, a report on the “Automotive Industry’s View on the Current State of Quality and a Strategic Path Forward.” The survey results reveal that OEMs and suppliers both rank Problem Solving and Customer-Specific Requirements as the most critical issues impacting quality. Quality Management System, Product Development, and Loss of Experience round out the top five issues as ranked by all respondents. The...

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ISO 9001:2015 Class

Jul 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Class

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: August 18-19, 2015 in Atlanta, GA (No seats remaining) September 15-16, 2015 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533407-816-5533 Reservation link for $109 rate Free breakfast and Internet Free airport shuttle No parking fee November...

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ISO 17021-1:2015

Jul 1, 2015 in Newsletter | Comments Off on ISO 17021-1:2015

The newly published ISO 17021-1:2015, Conformity assessment – Requirements for bodies providing audit and certification of management systems, Part 1: Requirements, deals with the competence of certification bodies and their auditors. The new standard applies to the auditing and certification of all types of management systems in order to increase their value to organizations worldwide. This first edition of ISO 17021-1:2015 replaces the second edition of ISO 17021:2011. Certification Process Audits and certifications to management...

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ISO 45001 for Safety

Jul 1, 2015 in Newsletter | Comments Off on ISO 45001 for Safety

A new international standard for occupational health and safety got a big vote of confidence last month, taking it another step closer to publication. Work-related accidents and illness are an enormous burden for organizations, and society as a whole, costing over 2.3 million deaths a year, not to mention the more than 300 million non-fatal accidents (according to the International Labor Organization). With robust and effective processes in place, many incidents can be prevented. ISO 45001, Occupational health and safety, will help...

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ISO 14001:2015 Class

Jun 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment is open for our new 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the class listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students To see the course description, go this web...

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ISO 9001:2015 Webinar

Jun 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Webinar

ISO/DIS 9001:2015 – Planning for the Changes 1:00 PM ET – Thursday, June 11, 2015 The new 2015 edition of the ISO 9001 quality management system standard is coming soon and is considered a major revision of the current 2008 edition. Are you aware of the significant changes? Will your organization be ready to make a timely and successful transition? This one hour webinar by Larry Whittington will explain the key ISO 9001:2015 requirement changes and how they may affect your quality management system. Larry, who has trained,...

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ISO 9001:2015 Class

Jun 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Class

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: September 15-16, 2015 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National Drive Orlando, FL 32822 407-816-5533407-816-5533 Reservation link for $109 rate Free breakfast and Internet Free airport shuttle No parking fee November 12-13, 2015 in Atlanta, GA SpringHill Suites –...

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ISO 9001:2015, 8.5

Jun 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.5

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 9001:2015, 8.6

Jun 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.6

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 9001:2015, 8.7

Jun 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.7

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 14001:2015 Class

May 1, 2015 in Newsletter | Comments Off on ISO 14001:2015 Class

Enrollment is open for our new 1.5 day “ISO 14001:2015 Requirements and Transition Guidance” course. The student fee is $725 and includes lunch on the first day. Larry Whittington will be the instructor for the class listed below: November 10-11, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students To see the course description,...

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ISO 9001:2015 Webinar

May 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Webinar

ISO 9001:2015 – Planning for the Changes 1:00 PM ET – Thursday, June 11, 2015 The new 2015 edition of the ISO 9001 quality management system standard is coming soon and is considered a major revision of the current 2008 edition. Are you aware of the significant changes? Will your organization be ready to make a timely and successful transition? This one hour webinar by Larry Whittington will explain the key ISO 9001:2015 requirement changes and how they may affect your quality management system. Larry, who has trained, consulted,...

Read More

ISO 9001:2015 Classes

May 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Classes

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: August 18-19, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation link for $149 rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students September 15-16, 2015 in Orlando,...

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ISO 9001:2015, 8.3

May 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.3

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 9001:2015, 8.4

May 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.4

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 9001:2015 Class

Apr 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Class

Enrollment is open for our new two day “ISO 9001:2015 Requirements and Transition Guidance” course. The student fee is $795 and includes lunch both days. Larry Whittington will be the instructor for the classes listed below: August 18-19, 2015 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention Center Concourse College Park, GA 30337 770-907-8880770-907-8880 Reservation Link for $149 Room Rate Free breakfast and Internet Free ATL SkyTrain Parking fee waived for students September 15-16, 2015 in Orlando,...

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Types of Changes

Apr 1, 2015 in Newsletter | Comments Off on Types of Changes

ISO/DIS 9001:2015 introduces the terms “planned” change, “unplanned” change, and “unintended” change. What are the differences? Planned Change An example of this usage in ISO 9001:2015 is clause 6.3, Planning of Changes: “Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.” A “planned” change is based on a deliberate decision to make a needed change. A planned change is...

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Risk Assessment

Apr 1, 2015 in Newsletter | Comments Off on Risk Assessment

All of us manage risk in our everyday lives. It comes so naturally, that most of us don’t have to stop and think about the actions we take to reduce risk. You wear a helmet when biking. You walk across at the light. You use your seatbelt in the car. You wash your hands before eating. But at work, we are often unprepared for the risks that may keep us from achieving our business objectives. To understand how we can better control business risks, let’s start by defining “risk”. What is Risk? Risk is the “effect of...

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ISO 9001:2015 Webinar

Apr 1, 2015 in Newsletter | Comments Off on ISO 9001:2015 Webinar

ISO 9001:2015 – Planning for the Changes 1:00 PM ET – Thursday, June 11, 2015 The new 2015 edition of the ISO 9001 quality management system standard is coming soon and will be a major revision of the current 2008 edition. Are you aware of the significant changes? Will your organization be ready to make a timely and successful transition? This one hour webinar by Larry Whittington will explain the key ISO 9001:2015 requirement changes and how they may affect your quality management system. Larry, who has trained, consulted, and...

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ISO 9001:2015, 8.1

Apr 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.1

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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ISO 9001:2015, 8.2

Apr 1, 2015 in Newsletter | Comments Off on ISO 9001:2015, 8.2

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support). Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Determination of Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Products and Services 8.5 Production and Service Provision 8.6 Release of...

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Our New Course on ISO 9001:2015

Mar 12, 2015 in Newsletter | Comments Off on Our New Course on ISO 9001:2015

The new edition of ISO 9001 is coming and will be a major revision of the current standard. Are you aware of the significant changes? Will your organization be ready to make the transition in a timely and successful manner? Larry Whittington has completed his 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course using the DIS (Draft International Standard) version of ISO 9001:2015. The course will be available for on-site and public classes after it is updated with the upcoming FDIS (Final Draft International...

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ISO 9001:2015, 7.1

Mar 12, 2015 in Newsletter | Comments Off on ISO 9001:2015, 7.1

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System). Clause 7, Support, has five sub-clauses (shown below). This article is on the six sub-clauses of 7.1 Resources. 7. Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 7.1.5 Monitoring and Measuring Resources 7.1.6 Organizational Knowledge 7.2 Competence 7.3...

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ISO 9001:2015, 7.2

Mar 12, 2015 in Newsletter | Comments Off on ISO 9001:2015, 7.2

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System). Clause 7, Support, has five sub-clauses (shown below). This article is on 7.2 Competence. 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.2 Competence Requirements: The organization must: a) determine the necessary competence of person(s) doing work under its control...

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ISO 9001:2015, 7.3

Mar 12, 2015 in Newsletter | Comments Off on ISO 9001:2015, 7.3

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System). Clause 7, Support, has five sub-clauses (shown below). This article is on 7.3 Awareness. 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.3 Awareness Requirements: Persons doing work under the organization’s control must be aware of: a) the quality policy; b)...

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ISO 9001:2015, 7.4

Mar 12, 2015 in Newsletter | Comments Off on ISO 9001:2015, 7.4

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System). Clause 7, Support, has five sub-clauses (shown below). This article is on 7.4 Communication. 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.4 Communication Requirements: Determine the internal and external communications relevant to the system, including: a) on what it...

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