Newsletter

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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ISO 14001:2005 Changes – Clause 7

Oct 2, 2017 in Newsletter | Comments Off on ISO 14001:2005 Changes – Clause 7

7. Support 7.1 Changes – Resources Accepts Annex SL text without change Replaces old clause 4.4.1 on Resources, Roles, Responsibility, and Authority Management Representative not required Resources can include: human resources (specialized skills and knowledge); natural resources; technology; financial resources; infrastructure (buildings, equipment, underground tanks, and drainage system). 7.2 Changes – Competence Replaces “Competence” part of old 4.4.2 on Competence, Training, and Awareness Changes from persons...

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ISO 14001:2015 Changes – Clause 8 

Oct 2, 2017 in Newsletter | Comments Off on ISO 14001:2015 Changes – Clause 8 

8. Operation 8.1 Changes – Operational Planning and Control Replaces old clause 4.4.6 on Operational Control Introduces the term “life cycle perspective” Adds to determine environmental requirements for procurement of products and services Adds to consider providing information on potential significant environmental impacts during: transportation or delivery; use and end-of-life treatment; final disposal of products and services. Introduces the term “outsourced” process and need to define extent of control or...

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IATF 16949:2016 Changes

Oct 2, 2017 in Newsletter | Comments Off on IATF 16949:2016 Changes

ISO/TS 16949:2009 was based on ISO 9001:2008 and included both sets of requirements. IATF 16949:2016 includes references to ISO 9001:2015 clauses, but you need the ISO 9001:2015 standard to view its requirements. The key changes from ISO 9001:2008 to ISO 9001:2015 are listed below with bullet points. The main changes from ISO/TS 16949:2009 to IATF 16949:2016 are indicated below with + signs. ISO 9001:2015 Changes *   Annex SL clause structure and common text *   Expanded applicability to service organizations *   Organizational...

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ISO 14001:2015 Interpretations

Oct 2, 2017 in Newsletter | Comments Off on ISO 14001:2015 Interpretations

The ISO/TC 207/SC 1 sub-committee has a process for managing interpretations of ISO 14001:2015. If you’d like to view the interpretations for the questions below, go to this ISO/TC 207/SC 1 web page. 1. ISO 14001:2015 has a very different structure than the two previous versions. Our documentation is aligned to the clauses that existed in the previous version. Do we have to restructure our documentation to follow the new clause structure? 2. Are the references to other standards in the Notes to Entry in Clause 3 (Terms and...

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ISO Certificate Survey

Oct 2, 2017 in Newsletter | Comments Off on ISO Certificate Survey

ISO has released the results of its annual survey of certifications. My summary below shows the number of worldwide certificates as of year-end 2016 for eight of management system standards, along with the USA totals and the top ten countries for each standard. ISO 9001 (Quality): 2008 and 2015 Editions Certificates in 2016 = 1,106,356 (USA = 30,474) Certificates in 2015 = 1,034,180 (USA = 33,103) Increase = + 72,176 (USA = – 2,629) Percentage = + 7 % (USA = – 8 %) 1. China = 350,631 2. Italy = 150,143 3. Germany = 66,233 4....

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Gap Analysis Checklists

Oct 2, 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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Quality Manual Templates

Oct 2, 2017 in Newsletter | Comments Off on Quality Manual Templates

We’re pleased to announce that we now have quality manual templates available for IATF 16949:2016, AS9100D, AS9110C, and AS9120B-based quality management systems: IATF 16949:2016 Quality Manual Template, 67 pages ($150) AS9100:2016 Quality Manual Template, 42 pages ($135) AS9110:2016 Quality Manual Template, 43 pages ($135) AS9120:2016 Quality Manual Template, 40 pages ($135) In addition, we have an ISO 9001:2015 quality manual template, ISO 14001:2015 policy manual template, and an integrated QMS-EMS policy manual template: ISO...

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ISO 9001:2015 Gap Analysis Checklist

Sep 1, 2017 in Newsletter | Comments Off on 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 for $95. ISO 14001:2015 Gap Analysis Checklist The 17 page ISO 14001:2015 Gap Analysis Checklist contains 213 questions for organizations new to ISO 14001, and 96 delta questions for ISO 14001:2004 certified organizations. To read a...

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ISO 45001 Draft Approved

Sep 1, 2017 in Newsletter | Comments Off on ISO 45001 Draft Approved

The second draft of the new ISO 45001 standard has been approved. Its title will be “Occupational health and safety management systems – Requirements with guidance for use”.  It is expected to be published in late 2017 or early 2018. Over 6300 people die each day from work-related accidents or diseases – that’s nearly 2.3 million every year, according to the International Labor Organization (ILO). The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting...

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New Edition of ISO 9004

Sep 1, 2017 in Newsletter | Comments Off on New Edition of ISO 9004

The 3rd edition of ISO 9004 was released in 2009 and titled “Managing for the sustained success of an organization – A quality management approach”. The 4th edition of ISO 9004 is titled “Quality management – Quality of an organization – Guidance to achieve sustained success”. The revised ISO 9004 version is due to be published in 2018. ISO 9004 provides a framework, based on a quality management approach, for organizations to achieve ongoing success by identifying their strengths and weaknesses, and...

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Auditing Outsourced Audits

Sep 1, 2017 in Newsletter | Comments Off on Auditing Outsourced Audits

Many organizations have chosen to outsource the internal audits of their management system. They do this for a variety of reasons: use of more competent and experienced auditors no more training auditors and then replacing them volunteer auditors can be kept at their regular jobs more impartial, objective auditors and audit reports emphasis on evaluating effectiveness of processes focus on identifying opportunities for improvement However, you still need to ensure that an outsourced audit meets requirements. The external auditor may ask...

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ISO 14001:2015 Changes – Clause 6

Sep 1, 2017 in Newsletter | Comments Off on ISO 14001:2015 Changes – Clause 6

6. Planning 6.1 Actions to Address Risks and Opportunities 6.1.1 Changes – General 6.1.1 is a new clause on risks and opportunities Adds to consider internal and external issues from 4.1 Adds to consider requirements of interested parties from 4.2 Adds to document risks and opportunities Must document processes for 6.1 to extent needed for confidence carried out as planned Auditors don’t determine risks or opportunities; they assess application of risk methodology ISO 14001:2004 in 4.1 – 4.6 does not mention...

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ISO 14001:2005 Changes – Clause 5

Sep 1, 2017 in Newsletter | Comments Off on ISO 14001:2005 Changes – Clause 5

5. Leadership 5.1 Changes – Leadership and Commitment New clause on leadership and commitment Identifies actions for top management’s personal involvement, direction, and support Adds to ensure policy and objectives are compatible with “strategic direction” Adds to ensure EMS requirements are integrated into business processes Top management is critical to EMS success May delegate some responsibilities, but still accountable to ensure they are performed Adds to Annex SL that top management must take accountability for...

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ISO 9001:2015 Classes in Orlando, Florida

Sep 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 September 18-19, 2017 (Confirmed – Crowne Plaza Universal) December 18-19, 2017 ISO 9001:2015 Internal Auditor September 18-20, 2017 (Confirmed – Crowne Plaza Universal) December 18-20, 2017 ISO 9001:2015 Lead Auditor September 18-21, 2017 (Confirmed – Crowne Plaza Universal) December 18-21, 2017 Click on a course title to view the course description and enroll in a class. If you have questions...

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ISO 9001:2015 Quality Manual Template

Sep 1, 2017 in Newsletter | Comments Off on ISO 9001:2015 Quality Manual Template

Larry Whittington has developed a comprehensive, 24-page quality manual template for use by organizations new to ISO 9001:2015 and those moving to ISO 9001:2015 from ISO 9001:2008. ISO 9001:2015 does not require a quality manual, but most organizations are choosing to have one and update their policies for the new and changed requirements of ISO 9001:2015. Why are organizations making that decision? ISO 9001:2015 still requires specific documents be maintained, e.g., quality management system scope; justifications for any not applicable...

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ISO 9001:2015 Classes in Orlando

Aug 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: ISO 9001:2015 Requirements September 18-19, 2017 December 18-19, 2017 ISO 9001:2015 Internal Auditor September 18-20, 2017 December 18-20, 2017 ISO 9001:2015 Lead Auditor September 18-21, 2017 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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Guide for Implementing ISO 14001:2015

Aug 1, 2017 in Newsletter | Comments Off on Guide for Implementing ISO 14001:2015

“ISO 14001:2015 – Environmental management systems – A practical guide for SMEs” has been released. This handbook aims to help small businesses understand the requirements of an environmental management system and to help them successfully implement ISO 14001:2015. Implementing an environmental management system at a small business can be a challenge since technical resources, financial resources, and staff time are limited. The handbook shares expert advice, tools, templates, and lessons learned on the implementation...

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ISO/IEEE 15289:2017

Aug 1, 2017 in Newsletter | Comments Off on ISO/IEEE 15289:2017

ISO/IEEE 15289:2017 specifies the purpose and content of all identified systems and software life-cycle information items, as well as, information items for information technology service management. The information item contents are defined according to generic document types and the specific purpose of the document. Information items are combined or subdivided as needed for project or organizational purposes. This standard is based on the life-cycle processes specified in: ISO/IEEE 12207:2008, Systems and software engineering –...

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ISO 14001:2015 Changes – Clause 4

Aug 1, 2017 in Newsletter | Comments Off on ISO 14001:2015 Changes – Clause 4

This article summarizes the new and changed ISO 14001:2015 requirements in Clause 4 compared to ISO 14001:2004. 4. Context of the Organization 4.1 Changes – Understanding the Organization and its Context New requirement on context of organization. High-level, conceptual understanding of the important issues that affect the way the organization manages its environmental responsibilities. These issues are: important topics, problems for debate and discussion, or changing circumstances that affect ability to achieve intended...

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Gap Analysis Checklists

Aug 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, Florida

Jul 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 September 18-19, 2017 December 18-19, 2017 ISO 9001:2015 Internal Auditor September 18-20, 2017 December 18-20, 2017 ISO 9001:2015 Lead Auditor September 18-21, 2017 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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Configuration Management

Jul 1, 2017 in Newsletter | Comments Off on Configuration Management

ISO 10007:2017, “Quality management – Guidelines for configuration management”, provides guidance on the use of configuration management within an organization. It is applicable to the support of products and services from concept to disposal. The purpose of this third edition of ISO 10007 is to enhance understanding of the subject, promote the use of configuration management, and assist organizations applying configuration management to improve their performance. ISO 10007 outlines the responsibilities and authorities before...

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Vulnerability Scoring System

Jul 1, 2017 in Newsletter | Comments Off on Vulnerability Scoring System

The Common Vulnerability Scoring System (CVSS) is an open framework for communicating the characteristics and severity of software vulnerabilities. CVSS consists of three metric groups: Base, Temporal, and Environmental. 1. Base group represents the intrinsic qualities of a vulnerability. 2. Temporal group reflects the characteristics of a vulnerability that change over time. 3. Environmental group represents the characteristics of a vulnerability that are unique to a user’s environment. CVSS is owned and managed by FIRST.org, a US-based...

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AS9100D, AS9110C, and AS9120B Courses

Jul 1, 2017 in Newsletter | Comments Off on AS9100D, AS9110C, and AS9120B Courses

We have AS9100D, AS9110C, and AS9120B Requirements and Transition Guidance courses. You can view the course descriptions by clicking on the course titles below. If you are interested in scheduling a 2.5 day onsite class, please call us at 770-862-1766 or send an email to Larry@WhittingtonAssociates.com. AS9100D Requirements AS9100:2016 (Revision D) replaces AS9100:2009 (Revision C). Organizations must transition to AS9100D by September 15, 2018, the date that AS9100C will be withdrawn. Our 2.5 day AS9100D Requirements and Transition...

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Gap Analysis Checklists

Jul 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, Florida

Jun 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  June 5-6, 2017 – Confirmed September 18-19, 2017 ISO 9001:2015 Internal Auditor June 5-7, 2017 – Confirmed September 18-20, 2017 ISO 9001:2015 Lead Auditor June 5-8, 2017 – Confirmed September 18-21, 2017 Click on one of the course titles above to view its course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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Technologies Impacting Supply Chain

Jun 1, 2017 in Newsletter | Comments Off on Technologies Impacting Supply Chain

A recent article posted at the Material Handling & Logistics website said that if your company wants to ensure its long-term survival, it had better take a close look at these technologies: drones, driverless vehicles, 3-D printing, wearable technology, and robotics. Of these technologies, the Global Supply Chain Institute thinks that Robotics will be the greatest potential disrupter over the next five years. The Institute stated that robots have been around for more than 50 years, but they have become dramatically more dynamic in the last...

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Sustainable Procurement

Jun 1, 2017 in Newsletter | Comments Off on Sustainable Procurement

ISO 20400:2017, Sustainable procurement – Guidance, provides guidance to organizations, independent of their activity or size, on integrating sustainability within procurement, as described in ISO 26000:2010, Guidance on social responsibility. It is intended for stakeholders involved in, or impacted by, procurement decisions and processes . Procurement is a powerful instrument for organizations wishing to behave in a responsible way and contribute to sustainable development. By integrating sustainability in procurement policies and...

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New MDR and IVDR Regulations

Jun 1, 2017 in Newsletter | Comments Off on New MDR and IVDR Regulations

The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union. The transition period for manufacturers selling medical devices into Europe began on May 25, 2017. Medical Devices Regulation (MDR) – 2017/745 The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have until May 2020 to update their technical...

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Gap Analysis Checklists

Jun 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 requirements 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

May 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: ISO 9001:2015 Requirements June 5-6, 2017 September 18-19, 2017 ISO 9001:2015 Internal Auditor June 5-7, 2017 September 18-20, 2017 ISO 9001:2015 Lead Auditor  June 5-8, 2017  September 18-21, 2017 Click on one of the course titles above to view its course description and enroll in a class. If you have questions about the training, or the registration process, please call...

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Nokia Threat Intelligence Report

May 1, 2017 in Newsletter | Comments Off on Nokia Threat Intelligence Report

The Nokia Threat Intelligence Report examines the trends for malware infections in devices connected through mobile and fixed networks. The key findings are summarized below. Mobile Networks The overall monthly smart phone infection rate averaged 0.90 percent in the second half of 2016. This is up 83 percent from the first half of 2016. Smart phone infections accounted for 85 percent of infections detected in mobile networks. The infection rate in mobile networks rose steadily throughout 2016, reaching a new high of 1.35 percent of devices in...

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Management Review Template

May 1, 2017 in Newsletter | Comments Off on Management Review Template

If you want a copy of a management review template for recording your meeting results, please send a request to larry@whittingtonassociates.com. The template is a Word file. It includes clickable date fields for Review Date and Next Review, as well as, entries for the Chairperson and Recorder. The main sections of the template are Attendees, Topics, and Minutes. The names of the regular Attendees are listed and you click on the box next to their name to indicate their attendance. All the required Topics are listed with clickable boxes to...

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ISMS Guidance in ISO 27003:2017

May 1, 2017 in Newsletter | Comments Off on ISMS Guidance in ISO 27003:2017

ISO 27003:2017, Information technology – Security techniques – Information security management systems – Guidance, has been published. It replaces ISO 27003:2010. The main changes in the second edition of ISO 27003 are: 1. The scope and title have been changed to cover the explanation of, and guidance on, the requirements of ISO 27001:2013 instead of those in ISO 27001:2005; 2. The structure is now aligned to the structure of ISO 27001:2013 to make it easier for ISO 27003:2017 to be used together with ISO 27001:2013; 3....

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Gap Analysis Checklists

May 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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Five Data Breach Threats

Apr 1, 2017 in Newsletter | Comments Off on Five Data Breach Threats

According to a recent Business News Daily article, securing sensitive information has never been more difficult with new malware threats that seem to pop up every single year. Being ready for a data breach is essential to survival if, or more likely, when one occurs. Based on Experian’s 2017 Data Breach Industry Forecast report, here are some of the cyber threats businesses can expect: 1. Aftershock password breaches will become more common Experian predicts that “aftershock” breaches, repeated unauthorized logins after...

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ISO 9001:2015 Classes in Orlando

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

Larry Whittington will teach these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements April 10-11, 2017: Confirmed Class – Crowne Plaza – Orlando Universal June 5-6, 2017 September 18-19, 2017 ISO 9001:2015 Internal Auditor April 10-12, 2017: Confirmed Class – Crowne Plaza – Orlando Universal June 5-7, 2017 September 18-20, 2017 ISO 9001:2015 Lead Auditor April 10-13, 2017: Confirmed Class – Crowne Plaza – Orlando Universal June 5-8, 2017 September 18-21, 2017 Click on a course...

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IATF 16949 Auditor Competency

Apr 1, 2017 in Newsletter | Comments Off on IATF 16949 Auditor Competency

IATF 16949:2016, the replacement standard for ISO/TS 16949:2009, includes new competency requirements for internal auditors and second-party auditors. 7.2.3 Internal Auditor Competency Organizations must maintain a documented process to verify that internal auditors are competent, considering any customer-specific requirements. A list of qualified internal auditors must be maintained. Quality management system auditors, manufacturing process auditors, and product auditors must be able to demonstrate the following minimum competencies...

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Internal Audit: ISO 9001 and ISO 14001

Apr 1, 2017 in Newsletter | Comments Off on Internal Audit: ISO 9001 and ISO 14001

The clause 9.2 internal audit requirements for ISO 9001:2015 and ISO 14001:2015 are very similar, because they both incorporate the common Annex SL internal audit requirements. Internal Audit Requirements In the requirements summary below, Annex SL appears in blue italics, ISO 9001:2015 is shown in black font, and ISO 14001 text is distinguished by green font. 9.2.1 General Conduct internal audits at planned intervals to provide information on whether the quality (environmental) management system   a) conforms to: 1. organization’s own...

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Gap Analysis Checklists

Apr 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, Clause 4

Mar 4, 2017 in Newsletter | Comments Off on ISO 9001:2015, Clause 4

This article summarizes the ISO 9001:2015 requirements in Clause 4, Context of the Organization, and identifies the changes from ISO 9001:2008. 4. Context of the Organization 4.1 Understanding the Organization and its Context 4.2 Understanding the Needs and Expectations of Interested Parties 4.3 Determining the Scope of the Quality Management System 4.4 Quality Management System and its Processes 4.1 Understanding the Organization and its Context Determine the external and internal issues that: are relevant to the organization’s purpose...

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Role of a Process Owner

Mar 4, 2017 in Newsletter | Comments Off on Role of a Process Owner

Processes need to be established, implemented, maintained, and improved for an organization to consistently deliver products and services that satisfy its customers. To ensure this happens, each process should have a named owner. What is a process? It is a set of interrelated or interacting activities that use inputs to deliver an intended result, for example, an output, product, or service. The inputs to a process are the outputs from other processes, and the outputs of a process are inputs to other processes. Processes are planned and...

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Interested Parties

Mar 4, 2017 in Newsletter | Comments Off on Interested Parties

An “interested party”, according to ISO 9000:2015, 3.2.3, is a person or organization that can affect, be affected by, or perceive itself to be affected by, a decision or activity. ISO 9001:2015, 4.2, states that an organization must determine the interested parties that are relevant to its quality management system, along with the relevant requirements of those interested parties. The reason for doing this is that an interested party may affect an organization’s ability to consistently provide products and services that meet...

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External and Internal Issues

Mar 4, 2017 in Newsletter | Comments Off on External and Internal Issues

ISO 9001:2015, 4.1, Understanding the organization and its context, states that an organization must determine the internal and external issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended quality results. It also requires the organization to monitor and review information about these external and internal issues. Note 1 in the standard says that issues can include positive and negative factors or conditions for consideration.   Note 2 states that understanding the external...

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Examples of External Issues

Mar 4, 2017 in Newsletter | Comments Off on Examples of External Issues

According to ISO 9001:2015, 4.1, Note 2, external issues arise from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international). Examples of external issues are: Supply chain disruption Loss of a key supplier Technology shifts Competitive pressures Money exchange rates Oil price changes Increased regulations Patent expirations Trade union regulations Ventures into new markets Changes in financial markets Tightening of lending from banks Funding for non-profits Scarcity...

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Examples of Internal Issues

Mar 4, 2017 in Newsletter | Comments Off on Examples of Internal Issues

According to ISO 9001:2015, 4.1, Note 3, internal issues are related to values, culture, knowledge, and performance. Examples are: Structure of organization Implementation or transition to ISO 9001:2015 Expected retirement of key personnel Availability of reliable, qualified workforce Capacity for product production; service delivery Addition of a second shift for increased sales Aging machinery or obsolete equipment Aging workforce and new hires Formation of a labor union Relocation of the company Business performance Poor customer...

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Gap Checklists

Mar 4, 2017 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, Clause 5, Leadership

Feb 1, 2017 in Newsletter | Comments Off on ISO 9001:2015, Clause 5, Leadership

Top Management is defined in ISO 9000:2015, 3.1.1, as the person or group of people who directs and controls an organization at the highest level (within the scope of the quality management system). Top Management has the power to delegate authority and provide resources within the organization. Clause 5 of ISO 9001:2015 has three sub-clauses: 5. Leadership 5.1 Leadership and Commitment 5.2 Policy 5.3 Organizational Roles, Responsibilities, and Authorities This article summarizes the ISO 9001:2015 requirements in Clause 5 and highlights the...

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RASCI Diagram

Feb 1, 2017 in Newsletter | Comments Off on RASCI Diagram

The RASCI Diagram can be used to clarify the roles and responsibilities for cross functional processes. It helps determine who is Responsible, Accountable, Supporting, Consulted, and Informed. The RASCI Diagram splits activities into five types of roles that make up the acronym RASCI: R = Responsible: the person(s) who performs the activity A = Accountable: the person held accountable for completion of the activity S = Supporting: the person(s) that provides support for the work C = Consulted: the person(s) consulted before performing the...

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ISO 27004:2016 on Security Measurements

Feb 1, 2017 in Newsletter | Comments Off on ISO 27004:2016 on Security Measurements

ISO 27004:2016, Information technology – Security techniques – Information security management – Monitoring, measurement, analysis and evaluation, is available. ISO 27004:2016 provides guidelines to assist organizations in evaluating the information security performance and the effectiveness of an information security management system to meet the requirements of ISO 27001:2013, clause 9.1. It establishes: a) the monitoring and measurement of information security performance; b) the monitoring and measurement of the...

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ISO 27011:2016 for Telecommunications Organizations

Feb 1, 2017 in Newsletter | Comments Off on ISO 27011:2016 for Telecommunications Organizations

ISO 27011:2016, Information technology – Security techniques – Code of practice for Information security controls based on ISO 27002 for telecommunications organizations, is available. The revised standard defines guidelines for supporting the implementation of information security controls in telecommunications organizations. It will allow telecommunications organizations to meet baseline information security management requirements of confidentiality, integrity, availability, and any other relevant security properties. The 31...

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Top Three IT Concerns

Feb 1, 2017 in Newsletter | Comments Off on Top Three IT Concerns

A Forbes blog says the trends analysis report by the Society for Information Management (SIM) has identified the CIOs’ top three concerns for 2017 as being business alignment, security, and skills shortages. The SIM 2017 report reflects the continuing evolution of business trends being information technology trends. Moreover, IT has increasingly become a priority for most businesses. SIM notes that IT budgets increased in 2016 by an average of 4.15%, short of last year’s increase of 4.6%, but positive nevertheless. The report also...

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AS9120B Requirements and Transition Guidance

Feb 1, 2017 in Newsletter | Comments Off on AS9120B Requirements and Transition Guidance

The new AS9120B:2016 standard replaces the AS9120A:2009 standard. Organizations certified to AS9120A:2009 must transition to AS9120B:2016 by September 2018, the date that AS9120A:2009 will be withdrawn. Our new 2.5 day “AS9120B Requirements and Transition Guidance” course explains the underlying requirements based on ISO 9001:2015 and the additional requirements unique to AS9120B. To help with the transition, the course highlights all the requirement changes from those in the ISO 9001:2008 and AS9120A:2009 standards. The course...

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Gap Analysis Checklists

Feb 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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AS9100D:2016 Requirements and Transition Guidance

Jan 2, 2017 in Newsletter | Comments Off on AS9100D:2016 Requirements and Transition Guidance

The new AS9100:2016 (Revision D) standard replaces the AS9100:2009 (Revision C) standard. Organizations must transition to AS9100D by September 2018, the date that AS9100C will be withdrawn. Our new 2.5 day “AS9100D Requirements and Transition Guidance” course explains the requirements based on ISO 9001:2015 and the additional requirements in AS9100D. To help with the transition, the course highlights all the requirement changes from those in the ISO 9001:2008 and AS9100C standards. The course also includes specific transition...

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IATF 16949:2016 Requirements and Transition Guidance

Jan 2, 2017 in Newsletter | Comments Off on IATF 16949:2016 Requirements and Transition Guidance

The new IATF 16949:2016 standard replaces the ISO/TS 16949:2009 standard. Organizations certified to ISO/TS 16949:2009 must transition to IATF 16949:2016 by September 2018, the date that ISO 9001:2015 will be withdrawn. Our new 2.5 day “IATF 16949:2016 Requirements and Transition Guidance” course explains the requirements in ISO 9001:2015 and the supplemental requirements in IATF 16949:2016. To help with the transition, the course highlights all the requirement changes from those in the ISO 9001:2008 and ISO/TS 16949:2009...

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Gap Analysis Checklists

Jan 2, 2017 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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ISO 9001:2015, Clause 6, Planning

Jan 1, 2017 in Newsletter | Comments Off on ISO 9001:2015, Clause 6, Planning

 Clause 6 on Planning has three sub-clauses: 6.1 Actions to Address Risks and Opportunities 6.2 Quality Objectives and Planning to Achieve Them 6.3 Planning of Changes This article summarizes the ISO 9001:2015 requirements in sub-clauses 6.1, 6.2, and 6.3 and highlights the changes from ISO 9001:2008. 6.1 Actions to Address Risks and Opportunities 6.1.1 (untitled) When planning for the quality management system (QMS), consider the issues in clause 4.1, and the requirements in 4.2. Determine the risks and opportunities that need to be...

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ISO/TS 9002:2016 Guidelines for ISO 9001:2015

Jan 1, 2017 in Newsletter | Comments Off on ISO/TS 9002:2016 Guidelines for ISO 9001:2015

The new standard, ISO/TS 9002:2016, Guidelines for the Application of ISO 9001:2015, provides guidance on the intent of requirement clauses 4 through 10 of ISO 9001:2015.  Since ISO 9001 is designed to be applicable to all types and sizes of organizations, its requirements are necessarily broad. ISO/TS 9002 provides guidance supported by in-depth explanations, examples, and options to help organizations fully benefit from the implementation of their quality management system.  While the guidelines in this document are consistent with the...

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IATF 16949 Gap Analysis Tool

Jan 1, 2017 in Newsletter | Comments Off on IATF 16949 Gap Analysis Tool

The Automotive Industry Action Group (AIAG) is providing a free Gap Analysis Tool to help organizations transition from ISO/TS 16949:2009 to the new IATF 16949:2016 standard.  The tool assists you in performing a gap analysis against IATF 16949:2016 to identify differences that need to be addressed to ensure your organization’s quality management system meets all the new requirements.  The tool also allows you to create a framework for completing an initial evaluation to determine the level of complexity of transitioning your QMS to...

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Information Security for Small Businesses

Jan 1, 2017 in Newsletter | Comments Off on Information Security for Small Businesses

Hackers are targeting smaller, less secure businesses. These small companies need to understand the security risks and be prepared to protect their systems and information. The National Institute of Standards and Technology (NIST) recently published Small Business Information Security: The Fundamentals. It provides a framework to minimize security risks. The NIST guide contains the following sections: 1. Background: What is Information Security and Cybersecurity? 2. Understanding and Managing Your Risks 2.1 Elements of Risk 2.2 Managing Your...

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ISO 9001:2015, 7.5

Dec 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 7.5

Previous newsletter articles have described the ISO 9001:2015 requirements and changes for Clause 8 – Operation, Clause 9 – Performance Evaluation, and Clause 10 – Improvement. Our last three newsletters included articles on the requirements in Clause 7 – Support for Resources (7.1), Competence (7.2), Awareness (7.3), and Communications (7.4). This article is on: 7.5 Documented Information 7.5.1 General 7.5.2 Creating and Updating 7.5.3 Control of Documented Information Before reviewing the requirements, lets discuss...

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Data Breaches

Dec 1, 2016 in Newsletter | Comments Off on Data Breaches

If your business experiences a data breach, what should you do? The Federal Trade Commission’s new Data Breach Response: A Guide for Business and accompanying video can help you figure out what steps to take and who to contact. Among the key steps are: securing physical areas, cleaning up your website, and providing breach notification. The guide also includes a model data breach notification letter. For related advice on implementing a plan to protect customer information and prevent breaches, check out the FTC’s Protecting...

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Vision, Mission, Values, Goals, and Objectives

Dec 1, 2016 in Newsletter | Comments Off on Vision, Mission, Values, Goals, and Objectives

Does your organization understand the differences between statements of Vision, Mission, Values, Goals, and Objectives? You SEE a Vision (a verbal image of what we ultimately want to achieve) You HAVE a Mission (your business purpose and market sector) You BELIEVE in Values (your moral compass and expected behavior) You PURSUE Goals (the results we choose to accomplish) You ACHIEVE Objectives (measurable targets along the path to our goals) Shared Views Organizational purpose comes from a shared view of our vision, mission, and values....

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SMARTER Objectives

Dec 1, 2016 in Newsletter | Comments Off on SMARTER Objectives

SMART has become a useful acronym for setting objectives. Each letter in SMART refers to a different criterion for judging objectives. One usage is Specific, Measurable, Achievable, Relevant, and Timely. Specific: Identify the expected result. Be precise on the desired outcome. Ensure the concerned persons know what is required. Measurable: Quantify the result and ensure you have a reliable system for measuring it. You should know when you have achieved the objective. Achievable: Establish a realistic and attainable objective given the target...

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ISO 9001:2015, 7.3

Nov 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 7.3

Previous newsletter articles have described the ISO 9001:2015 requirements and changes for Clause 8 – Operation, Clause 9 – Performance Evaluation, and Clause 10 – Improvement. Our last two newsletters included articles on the requirements in Clause 7 Support for Resources (7.1) and Competence (7.2). This article is on 7.3 Awareness. Another article in this newsletter is about 7.4 Communication. REQUIREMENTS: Ensure persons doing work under the organization’s control are aware of: a) the quality policy; b) relevant...

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ISO 9001:2015, 7.4

Nov 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 7.4

Previous newsletter articles have described the ISO 9001:2015 requirements and changes for Clause 8 – Operation, Clause 9 – Performance Evaluation, and Clause 10 – Improvement. Our last two newsletters included articles on the requirements in Clause 7 Support for Resources (7.1) and Competence (7.2). This article is on 7.4 Communication. Another article in this newsletter is about 7.3 Awareness. REQUIREMENTS: Determine the internal and external communications relevant to the quality management system, including: a) on what it...

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ISO Certificate Survey

Nov 1, 2016 in Newsletter | Comments Off on ISO Certificate Survey

ISO has released the results of its annual survey of certifications. The summary below shows the number of worldwide certificates issued for eight of the management system standards, along with the USA totals and the top ten countries. ISO 9001 (Quality) Certificates in 2015 = 1,033,936 (USA = 33,103) Certificates in 2014 = 1,036,321 (USA = 28,125) Increase = – 2,385 (USA = + 4,978) Percentage = – 0.2% (USA = + 17.7%) 1. China = 292, 559 2. Italy = 132,870 3. Germany = 52,995 4. Japan = 47,101 5. India = 36,305 6. UK = 40,161 7....

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IATF 16949:2016

Nov 1, 2016 in Newsletter | Comments Off on IATF 16949:2016

The International Automotive Task Force (IATF) has issued a new IATF 16949:2016 standard to cancel and replace the current ISO/TS 16949:2009 standard. IATF 16949:2016 is fully aligned with the ISO 9001:2015 structure and requirements. IATF 16949:2016 is not a standalone quality management standard. It has been implemented as a supplement to ISO 9001:2015, which must be purchased separately. ISO/TS 16949 was first issued in 1999 by the IATF in conjunction with ISO’s technical committee for quality management, ISO/TC 176. IATF will ensure...

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Anti-Bribery Standard

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

The International Organization for Standardization has published a new business tool designed to fight bribery. The ISO 37001 standard is the first international anti-bribery management system standard designed to help organizations combat bribery risk in their own operations and throughout their global value chains. It has the potential to reduce corporate risk and costs related to bribery by providing a manageable business framework for preventing, detecting, and addressing bribery. Bribery is a significant business risk in many countries...

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Gap Checklists

Nov 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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Transition Dates

Nov 1, 2016 in Newsletter | Comments Off on Transition Dates

ISO 9001:2008, and industry sector standards that embed ISO 9001:2008, will be withdrawn in September 2018. Some industry groups have established dates after which the old standards can no longer be used for audits by certification bodies. After June 1, 2017, the aerospace AS9100C:2009 standard can no longer be used as the audit criteria (only AS9100D:2016 after that date). After October 1, 2017, only the new automotive IATF 16949:2016 can be used for audits (not ISO/TS 16949:2009). One registrar has established similar dates for other...

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ISO 9001:2015, 7.2

Oct 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 7.2

Previous newsletter articles have described the ISO 9001:2015 requirements and changes for Clause 8 – Operation, Clause 9 – Performance Evaluation, and Clause 10 – Improvement. Our last newsletter included an article on 7.1 Resources. This article is on 7.2 Competence. REQUIREMENTS: a) Determine necessary competence of persons doing work under organizational control that affects QMS performance and effectiveness; b) Ensure these persons are competent on basis of appropriate education, training, or experience; c) Where...

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ANAB Complaints

Oct 1, 2016 in Newsletter | Comments Off on ANAB Complaints

The ANSI-ASQ National Accreditation Board (ANAB) accredits certification bodies for ISO 9001, ISO 14001, and many other management system standards. The ANAB Complaint Center addresses complaints about certification bodies, certified organizations, and ANAB itself. A summary of the complaint types over the past ten years is shown below: Complaints About Certification Bodies Auditor = 12 Conflict of Interest = 23 Marketing = 28 Service = 108 Use of Mark = 8 Other = 62 Total = 241 Complaints About Certified Organizations Mark =...

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IAF MD Series

Oct 1, 2016 in Newsletter | Comments Off on IAF MD Series

The International Accreditation Forum (IAF) publishes Mandatory Documents which must be used by accreditation bodies when accrediting certification bodies to assure that they operate their programs in a consistent and equivalent manner. Although for use by accreditation bodies and certification bodies, your organization may find some of these documents to be of interest. For example, how would your organization qualify for a multi-site certificate? How is the audit sample calculated? See IAF MD1:2007 – Certification of Multiple Sites...

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ISO 9001:2015 FAQs

Oct 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 FAQs

If you have questions about the new ISO 9001:2015 revision, they may have been answered in the list of Frequently Asked Questions at the ISO Technical Committee 176 web site: 1. Why has it been decided to issue a new version of ISO 9001? Business needs and expectations have changed significantly since the last major revision of ISO 9001 in the year 2000. Examples of these changes are ever more demanding customers, the emergence of new technologies, increasingly more complex supply chains, and a much greater awareness of the need for...

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AS9100D Published

Oct 1, 2016 in Newsletter | Comments Off on AS9100D Published

The International Aerospace Quality Group (IAQG) has released, and SAE has published, the “AS9100D Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations” standard. AS9100D can be purchased from SAE for $74 at this web page. Supporting material for AS9100D can be found at the IAQG website: AS9100D Key Changes Presentation AS9100D Clause-by-Clause Presentation AS9100D to AS9100C Clause Maps Important Dates: September 2016 AS9100D – Requirements for Aviation, Space, and Defense...

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Gap Checklists

Oct 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, 7.1

Sep 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 7.1

ISO 9001:2015, clause 7, Support, has five sub-clauses (shown below). This article is on 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 Awareness 7.4 Communication 7.5 Documented Information 7.1.1 General Requirements: Determine and provide resources needed to establish, implement, maintain, and continually improve the quality management system. And, consider: a)...

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Integrated 9K and 14K

Sep 1, 2016 in Newsletter | Comments Off on Integrated 9K and 14K

The 2015 editions of ISO 9001 and ISO 14001 are considered major revisions. Many organizations use both these standards and need training on the new and changed requirements. This new 2.5 day course provides that training in an integrated format. Our “Integrated ISO 9001:2015 and ISO 14001:2015 Requirements and Transition Guidance” course explains all the quality and environmental requirements, and identifies the specific changes from the prior editions. Guidance is also provided on transition activities and how to adjust your...

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TL 9000 R6 Handbook

Sep 1, 2016 in Newsletter | Comments Off on TL 9000 R6 Handbook

QuEST Forum has announced the publication of the sixth revision of its TL 9000 Requirements Handbook. The 70 page TL 9000:2016 includes the new ISO 9001:2015 format and language, along with clarifications, modifications, deletions, and additions to the Information and Communications Technology industry-specific added requirements and notes. You can order a hardcopy of the handbook for the member price of $85.00 or the non-member price of $150.00. You can order an electronic copy of the handbook for the same prices. Go to this web page at the...

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ISO 9001:2015 Class

Sep 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 Class

We are offering a public “ISO 9001:2015 Requirements and Transition Guidance” class in 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. September 14-15, 2016 in Orlando, FL SpringHill Suites – Orlando Airport 5828 Hazeltine National...

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IATF 16949:2016

Sep 1, 2016 in Newsletter | Comments Off on IATF 16949:2016

The replacement for the ISO/TS 16949:2009 automotive standard will be IATF 16949:2016, a new standard developed by the International Automotive Task Force (IATF). The expected publication date is October 2016. IATF has published “Transition Strategy ISO/TS 16949 > IAFT 16949” to provide guidance on the transition from ISO/TS 16949:2009 to the IATF 16949:2016 standard. Certificates to ISO/TS 16949:2009 will no longer be valid after September 14, 2018. TRANSITION TIMING REQUIREMENTS After 1 October 2017, no audits (initial,...

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Gap Checklists

Sep 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, 8.7

Aug 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.7

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 8.7 Control of Nonconforming Outputs. Requirements: 8.7.1 (untitled) Ensure process outputs that do not conform to their requirements are identified and controlled to prevent...

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Energy Management

Aug 1, 2016 in Newsletter | Comments Off on Energy Management

Improving energy performance and reducing energy costs is one of the most important tasks facing organizations throughout the world. ISO 50001, “Energy management systems – Requirements with guidance for use”, can help organizations with this activity. ISO 50001 has gained in importance since its publication five years ago. In fact, nearly 7,000 organizations were certified to the standard by the end of 2014 (the latest survey results). ISO 50001 specifies requirements for establishing, implementing, maintaining, and...

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ISO 27009:2016

Aug 1, 2016 in Newsletter | Comments Off on ISO 27009:2016

The new ISO 27009:2016 standard defines the requirements for the use of ISO 27001:2013 in any specific sector (field, application area, or market sector). ISO 27009 explains how to include requirements additional to those in ISO 27001, how to refine any of the ISO 27001 requirements, and how to include controls or control sets in addition to ISO 27001, Annex A. ISO 27009 ensures that additional or refined requirements are not in conflict with the requirements in ISO 27001. It is applicable to those involved in producing sector-specific...

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ISO 9001:2015 Classes

Aug 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. August 3-4, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention...

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Auditing to ISO 9001:2015

Aug 1, 2016 in Newsletter | Comments Off on Auditing to ISO 9001:2015

ISO Technical Committee 176 is responsible for the development of ISO 9001. You can view their website at this web page. A related ISO 9001 Auditing Practices Group is an informal group of quality management system experts, auditors, and practitioners from ISO/TC 176 and the International Accreditation Forum (IAF). The APG website has been established as an on-line source of papers and presentations on auditing a quality management system (QMS). The provided ideas, examples, and explanations reflect the process-based approach that is essential...

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Gap Checklist

Aug 1, 2016 in Newsletter | Comments Off on Gap Checklist

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, 8.6

Jul 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.6

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 8.6 Release of Products and Services. 8.6 Release of Products and Services Requirements: Implement planned arrangements, at appropriate stages, to verify that the product and...

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Free Safety Check

Jul 1, 2016 in Newsletter | Comments Off on Free Safety Check

Are you wondering if you are in compliance with Occupational Safety and Health Administration (OSHA) requirements? Through its Onsite Consultation Program, OSHA provides free and confidential safety and occupational health advice to small and medium-sized businesses. Note that the Onsite Consultation services are separate from enforcement actions and do NOT result in penalties or citations. Process Using a free consultation service largely funded by the OSHA, employers can find out about potential hazards at their worksites, improve their...

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New OSHA Reporting

Jul 1, 2016 in Newsletter | Comments Off on New OSHA Reporting

OSHA has issued a final rule to improve tracking of workplace injuries and illnesses. The provisions call or employers to electronically submit injury and illness data that they already record. Why is OSHA issuing this rule? OSHA says this simple change in their rulemaking requirements will improve safety for workers across the country. One important reason they believe stems from an understanding of human behavior and motivation. Behavioral economics indicates that making injury information publicly available will “nudge”...

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2015 Edition Classes

Jul 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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EU Data Protection

Jul 1, 2016 in Newsletter | Comments Off on EU Data Protection

In January 2012, the European Commission proposed a comprehensive reform of data protection rules in the European Union (EU). In May 2016, the official texts of the Regulation and the Directive were published in the Official Journal of the European Union. The General Data Protection Regulation (GDPR) introduces tough penalties for non-compliance, with breached organizations facing fines of up to 4% of annual global turnover or about $22 million dollars – whichever is greater. The Regulation went into force on 24 May 2016 and shall apply...

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Gap Checklists

Jul 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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