2016 Newsletter Articles

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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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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