2014 Newsletter Articles

Whittington Speaks on ISO 9001:2015

Dec 1, 2014 in Newsletter | Comments Off on Whittington Speaks on ISO 9001:2015

ISO 9001:2015 – Plan for the Changes Presented by Larry Whittington ASQ Atlanta Dinner Meeting Thursday, January 22, 2015 The new edition of ISO 9001 is coming and will be a major revision of the current standard. Are you aware of the significant changes? Will your organization be ready to successfully make the transition? Larry Whittington will be the presenter. He has trained, consulted, and audited on all four of the ISO 9001 editions (1987, 1994, 2000, and 2008) and will guide us on how to prepare for the 2015 edition. Presentation...

Read More

ISO 9001 to FDIS

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001 to FDIS

The ISO 9001 Draft International Standard (DIS) was recently put to a vote according to ISO procedures and received nearly 90% approval, which allows it to progress to the Final Draft International Standard (FDIS) stage. Experts in the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward for voting. Once approved, the standard can then be published. The new fifth edition of ISO 9001 is expected by the end of 2015 and will...

Read More

ISO 9001:2015, 4.1

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.1

The first requirements clause of ISO/DIS 9001:2015, clause 4, Context of the Organization, has four sub-clauses: 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 This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.1 and highlights the changes from ISO 9001:2008. The other articles in this newsletter describe clauses 4.2,...

Read More

ISO 9001:2015, 4.2

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.2

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.2 and highlights the changes from ISO 9001:2008. 4.2 Understanding the Needs and Expectations of Interested Parties Due to their impact, or potential impact, on your ability to consistently provide products and services that meet customer and applicable legal requirements, determine: Interested parties that are relevant to system Relevant requirements of these interested parties Monitor and review information about these interested parties and their relevant...

Read More

ISO 9001:2015, 4.3

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.3

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.3 and highlights the changes from ISO 9001:2008. 4.3 Determining the Scope of the Quality Management System Determine the boundaries and applicability of the system to establish its scope. When determining the scope, consider: External and internal issues (see 4.1) Requirements of interested parties (see 4.2) Products and services of organization Apply the requirements of ISO 9001 when they can be applied within the scope. If an organization can’t apply a...

Read More

ISO 9001:2015, 4.4

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.4

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.4 and highlights the changes from ISO 9001:2008. 4.4 Quality Management System and its Processes Establish, implement, maintain, and continually improve the quality management system, including the processes needed and their interactions, per ISO 9001 requirements. Determine the processes needed for the system and their application throughout the organization. Determine for these processes the: Inputs required and outputs expected; Sequence and interaction; Criteria and...

Read More

Energy Management

Dec 1, 2014 in Newsletter | Comments Off on Energy Management

An effective energy management system is an essential business ingredient. Are you aware of the ISO standards for energy management systems? ISO 50001:2011, Energy management systems — Requirements with guidance for use ISO 50001 specifies the requirements for establishing, implementing, maintaining, and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy use and consumption. The...

Read More

ISO 9001:2015, 0.6

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 0.6

Clause 0.6 in the Introduction section of the draft ISO 9001:2015 standard is titled, “Compatibility with other Management System Standards.”  It notes that ISO 9001:2015 has adopted the new high-level structure developed by ISO to improve the alignment of its management system standards. The high-level structure is defined in Annex SL of the ISO Directives and provides common: Clause sequence Text Terminology The ISO 9001:2015 requirements are defined in an order that is consistent with organizational planning and process...

Read More

ISO 9001:2015, 1

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 1

Clause 1.1, General, in the Scope section of ISO 9001:2008 has been slightly reworded in clause 1, Scope, of the draft ISO 9001:2015 standard. The term “product” has been expanded to include “service”. Otherwise, the Scope section continues to state that the ISO 9001 standard specifies requirements for a quality management system where an organization: Needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements Aims to enhance...

Read More

ISO 9001:2015, 10.1

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.1

ISO/DIS 9001:2015, clause 10, Improvement, has three sub-clauses: 10.1 General 10.2 Nonconformity and Corrective Action 10.3 Continual Improvement This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.1, General, and also identifies changes from ISO 9001:2008. Other articles in this newsletter describe the requirements in clauses 10.2 and 10.3. 10.1 General The organization must determine and select opportunities for improvement and implement the necessary actions to meet customer requirements and enhance customer...

Read More

ISO 9001:2015, 10.2

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.2

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.2, Nonconformity and Corrective Action, and also identifies the changes from ISO 9001:2008. 10.2 Nonconformity and Corrective Action 10.2.1 When a nonconformity occurs, including those arising from complaints, the organization must react to the nonconformity, and as applicable, take action to control and correct it, as well as, deal with the consequences. In addition, the organization must evaluate the need for action to eliminate the causes of the nonconformity...

Read More

ISO 9001:2015, 10.3

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.3

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.3, Continual Improvement, and also identifies the changes from ISO 9001:2008. 10.3 Continual Improvement The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system. Consider the outputs of analysis and evaluation and the outputs of management review to confirm if there are areas of underperformance or opportunities that must be addressed as part of continual improvement. Where applicable, select and...

Read More

ISO Certificate Survey

Nov 1, 2014 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 seven of the management system standards, along with the USA totals. ISO 9001 (Quality) Certificates in 2013 = 1,129,446 (USA = 34,869) Certificates in 2012 = 1,096,987 (USA = 26,177) Increase = +32,459 (USA = +8,692) Percentage = +3% (USA = +33%) ISO 14001 (Environment) Certificates in 2013 = 301,647 (USA = 6,071) Certificates in 2012 = 284,654 (USA = 5,699) Increase = +16,993 (USA = +372) Percentage =...

Read More

ISO/DIS 14001:2015

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015

The current ISO 14001:2004 environmental management standard is being revised after more than a decade of use. The draft ISO 14001:2015 standard has adopted Annex SL of the ISO Directives and will have the same clause structure as the draft ISO 9001:2015 standard. In addition to providing the clause framework for all management system standards, Annex SL also provides common definitions and, where applicable, common text for the requirements. The ISO/DIS 14001:2015 additions to the common Annex SL text are described in the following articles...

Read More

ISO/DIS 14001:2015, Clause 4

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 4

4. Context of the Organization 4.1 Understanding the Organization and its Context ISO/DIS 14001:2015 adds to the common Annex SL text that the issues to be determined include environmental conditions that are capable of affecting or being affected by the organization. According to Annex A of ISO/DIS 14001:2015, these conditions may include climate, air quality, water quality, land use, existing contamination, natural resource availability, and biodiversity. 4.2 Understanding the Needs and Expectations of Interested Parties The draft 14001:2015...

Read More

ISO/DIS 14001:2015, Clause 5

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 5

5. Leadership 5.1 Leadership and Commitment The draft ISO 14001:2015 standard adds another way that top management must demonstrate its leadership and commitment – by taking accountability for the effectiveness of the environmental management system. 5.2 Environmental Policy The policy commitment to meet requirements has been clarified as conforming to compliance obligations. The commitment for continual improvement has been clarified as improving the environmental management system to enhance environmental performance. A third policy...

Read More

ISO/DIS 14001:2015, Clause 6

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 6

6 Planning 6.1 Actions to Address Risk Associated with Threats and Opportunities ISO/DIS 14001:2015 split this clause into five sub-clauses: 6.1.1 General The draft ISO 14001:2015 standard adds that the organization is to plan and implement a process to meet the requirements in clause 6.1. Documented information is to be maintained to the extent necessary to have confidence that the process has been carried out as planned. 6.1.2 Significant Environmental Aspects The draft standard adds that the organization must identify the environmental...

Read More

ISO/DIS 14001:2015, Clause 7

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 7

7 Support 7.1 Resources No additions to the Annex SL text for resources. 7.2 Competence No additions to the Annex SL text for competence. 7.3 Awareness The only ISO/DIS 14001:2015 addition to this clause is that persons doing work under the organization’s control must be aware of the significant environmental aspects and related actual or potential impacts associated with their work. These persons must also be aware of the implications of not conforming with the environmental management system requirements, including compliance...

Read More

ISO/DIS 14001:2015, Clause 8

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 8

8 Operation 8.1 Operational Planning and Control The draft ISO 14001:2015 standard clarifies that operational controls are implemented to prevent deviation from the environmental policy and objectives, as well as, compliance obligations. It also states that the type and degree of control or influence of any outsourced processes must be defined within the environmental management system. The concept of “life cycle perspective” is added that requires the organization to: a) determine environmental requirements for the procurement of...

Read More

ISO/DIS 14001:2015, Clause 9

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 9

9 Performance Evaluation 9.1 Monitoring, Measurement, Analysis, and Evaluation 9.1.1 General The draft ISO 14001:2015 standard adds to the Annex SL text that what needs to be monitored and measured must be related to operations (that can have a significant environmental impact), compliance obligations, operational controls, and progress towards meeting environmental objectives (using indicators). The current ISO 14001:2004 standard does not explicitly require the use of indicators, although their use is widespread. Now it is a clear...

Read More

ISO/DIS 14001:2015, Clause 10

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 10

10. Improvement 10.1 Nonconformity and Corrective Action The common Annex SL text for this clause has been expanded by ISO/DIS 14001:2015 to react to a nonconformity with “immediate” action to control and correct it, as well as, to mitigate adverse environmental impacts. It also adds that corrective actions must be appropriate to the “significance” of the effects of the nonconformity, including the environmental impact. 10.2 Continual Improvement ISO/DIS 14001:2015 clarifies that the reason for continually improving...

Read More

Internet Vulnerability

Oct 1, 2014 in Newsletter | Comments Off on Internet Vulnerability

What is Heartbleed? The Heartbleed vulnerability is a bug in OpenSSL, a popular open-source protocol used extensively on the Internet, which allows anyone who knows how to exploit the vulnerability to access and read the memory of systems thought to be protected. Vulnerable versions of OpenSSL allow compromise of secret keys, user names, passwords, and even actual content. Many security experts believe that this vulnerability has actually existed for at least two years and might have been exploited for just as long. Although many companies...

Read More

ISO/DIS 9001:2015, Clause 0.1

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.1

The General section (clause 0.1) of the Introduction to the ISO 9001:2015 draft standard can be summarized as: Adoption of a quality management system is a strategic decision A robust quality management system can improve performance Its design and implementation is influenced by the context of the organization Specific objectives and associated risks Needs and expectations of customers Products and services Process complexity and interactions Competence of employees Size and organizational structure Culture and socio-economic...

Read More

ISO/DIS 9001:2015, Clause 0.2

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.2

A new sub-clause, “The ISO Standards for Quality Management” has been added to the Introduction to the ISO 9001:2015 draft standard. It provides an overview of the three core quality management system standards: ISO 9000 – Fundamentals and Vocabulary Essential background for understanding ISO 9001 Key terms and their definitions Quality Management Principles (QMPs) The quality management principles form the foundation of ISO 9001. An outline of the QMPs is provided in ISO 9001 Annex B. ISO 9001 –...

Read More

ISO/DIS 9001:2015, Clause 0.3

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.3

ISO 9001:2008 states that it promotes the adoption of a process approach, but it seems to be more an encouragement than a requirement. Clause 0.3 of the draft ISO 9001:2015 standard now refers to specific requirements that are essential for a process approach. Process Approach Consistent and predictable results are achieved more effectively and efficiently when: Activities are understood Managed as interrelated processes Function as a coherent system ISO 9001 promotes use of the process approach to develop, implement, and improve the...

Read More

ISO/DIS 9001:2015, Clause 0.4

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.4

ISO 9001:2008 only mentions the PDCA cycle in a Note within clause 0.2 on the Process Approach.  The draft ISO 9001:2015 standard gives PDCA its very own section. Clause 0.4 states that the PDCA methodology can be applied to all processes and to the quality management system as a whole. It also states that the ISO 9001 clauses broadly follow the PDCA cycle as summarized below: Plan: establish objectives and resources Do: implement what was planned Check: monitor, measure, and report results Act: take actions to improve process performance A...

Read More

ISO/DIS 9001:2015, Clause 0.5

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.5

Clause 0.5 of the Introduction section of the draft ISO 9001:2015 standard states that risk is the “effect of uncertainty on an expected result”, and that the concept of risk-based thinking has always been implicit in ISO 9001. As background information, an “effect” is a deviation from the expected, and can be positive or negative. The term “uncertainty” is the state, even partial, of a deficiency of information related to the understanding or knowledge of an event, its consequence, or likelihood. Risk is...

Read More

Free ISO/DIS 14001

Sep 1, 2014 in Newsletter | Comments Off on Free ISO/DIS 14001

The American Society for Quality (ASQ) is providing a free copy of the Draft International Standard (DIS) version of ISO 14001:2015 for review and comment. Send an email to standards@asq.org to request a review copy. Your comments must be submitted by October 19, 2014. Note that ISO/DIS 14001 is being provided for the purpose of review and comment related to the preparation of the U.S. position. All other rights are reserved. Please note that the ISO/DIS 14001 is not final and should not be used for making changes to existing environmental...

Read More

ISO 9001:2015

Sep 1, 2014 in Newsletter | Comments Off on ISO 9001:2015

Certification bodies have information to share on the ISO 9001:2015 revision. I have identified links provided at the web sites of two of our business partners: National Quality Assurance (NQA) See these web pages at the NQA web site for information on the ISO 9001:2015 revision: ISO 9001:2015 Revision Information ISO 9001:2015 Slide Presentation (36 slides) British Standards Institution (BSI) See these web pages at the BSI web site for information on the ISO 9001:2015 revision: ISO 9001:2015 Revision Information Two Videos on ISO 9001:2015...

Read More

Service PPAP

Sep 1, 2014 in Newsletter | Comments Off on Service PPAP

Developed to address the specific requirements of service part production, the new AIAG Service Production Part Approval Process (Service PPAP) is a supplement to the Production Part Approval Process (PPAP) 4th edition. Service PPAP identifies requirements and provides clarification for the PPAP process for service unique parts, including remanufactured parts, service unique chemicals, third party packagers, and service software requirements. Service PPAP is intended to provide evidence that all customer engineering design record and...

Read More

Most Dangerous Jobs

Sep 1, 2014 in Newsletter | Comments Off on Most Dangerous Jobs

According to the Census of Fatal Occupational Injuries published by the Bureau of Labor Statistics, 3 employees out of every 100,000 are killed annually in a work-related incident in the United States. These 10 jobs have a significantly higher fatality rate than the national average: 1. Loggers Loggers experienced 62 fatalities in 2012 for a fatality rate of 127.8 out of 100,000 workers, making it the most dangerous profession. Risks: Falls, struck-by, dangerous tools such as chainsaws and axes. 2. Fishermen Fishermen and women experienced 117...

Read More

ASQ Fall Conference

Sep 1, 2014 in Newsletter | Comments Off on ASQ Fall Conference

Register for the ASQ Technical Communities Fall Conference in Orlando: October 27 – 29, 2014 – Preconference Tutorials October 29, 2014 – Opening Reception October 30 – 31, 2014 – Conference The Technical Communities Fall Conference has a full slate of exciting keynotes, tutorials, workshops, and speakers.  Larry Whittington will speak Friday morning on Auditing: Prepare Well to Perform Well. Registration is available at the conference website. The conference will be held at the Wyndham Orlando Resort, 8001...

Read More

ISO/DIS 9000, Terms

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, Terms

The terms defined in ISO 9000:2005 were grouped into 10 categories: quality, management, organization, process and product, characteristics, conformity, documentation, examination, audit and measurement processes. The draft ISO 9000:2015, Quality management systems – Fundamentals and vocabulary, has expanded the defined terms by nearly 75% and has revised the term categories as shown below: 3.1 Terms related to person or people 3.2 Terms related to organization 3.3 Terms related to activity 3.4 Terms related to system 3.5 Terms related...

Read More

ISO/DIS 9000, Index

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, Index

The following terms are defined in ISO/DIS 9000:2015, Quality management systems – Fundamentals and vocabulary. All the terms defined in ISO 9000:2005 have been retained in the draft standard except for “qualification process”. The 61 added terms are shown in bold. activity association audit audit client audit conclusion audit criteria audit findings audit plan audit program audit scope audit team auditee auditor capability change control characteristic combined audit competence competence...

Read More

ISO/DIS 9000, QMPs

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, QMPs

The draft version of ISO 9000:2015, Quality management systems – Fundamentals and Vocabulary, has expanded coverage of the quality management principles. The 8 quality management principles of ISO 9000:2005 are each described by a single sentence in the Introduction section of that standard. The 7 quality management principles in ISO/DIS 9000:2015 have been placed in a more prominent location in section 2, Quality management principles and fundamental concepts. Quality management principles 1. Customer focus 2. Leadership 3. Engagement...

Read More

Use of AS9101E

Aug 1, 2014 in Newsletter | Comments Off on Use of AS9101E

The International Aerospace Quality Group (IAQG) has posted Resolution 117 to its IAQG OPMT ICOP Resolutions Log. The resolution states that Certification Bodies (CBs) must implement the AS9101E / 9101:2014 audit requirements standard no later than July 01, 2015. This timeline may be accelerated and implementation can occur upon completion of the following: CB procedures and processes must be updated to address conformance to the requirements of the revised standard, including access to approved 9101 Forms on the IAQG Forms Management System...

Read More

ISO 9001:2015, 6.1

Aug 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 6.1

Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. According to the draft ISO 9001:2015 standard, management of these processes and the system as a whole can be achieved using a “Plan-Do-Check-Act” (PDCA) methodology, with an overall focus on “risk-based thinking” aimed at preventing undesirable outcomes. Risk-based Thinking Section 0.5 in ISO/DIS 9001:2015 states that risk is the...

Read More

Complaints Handling

Aug 1, 2014 in Newsletter | Comments Off on Complaints Handling

The ISO 10002 standard on complaints handling has been revised. ISO 10002:2014, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations, is available at this ANSI e-Standards Store web page. ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The described complaints handling process is suitable for use as one of the processes of an overall quality management...

Read More

Free ISO/DIS 9001

Jul 1, 2014 in Newsletter | Comments Off on Free ISO/DIS 9001

The American Society for Quality (ASQ) is providing the Draft International Standard (DIS) version of ISO 9001:2015 free to anyone, with the condition that you review it and provide comments to prepare the U.S. position. Send an email to standards@asq.org to request a copy for review. Your comments must be submitted before July 15, 2014. According to ASQ, the timeline for ISO 9001:2015 is: Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of the International Standard as ISO 9001:2015 Please...

Read More

ISO 13485 Revision

Jul 1, 2014 in Newsletter | Comments Off on ISO 13485 Revision

ISO/DIS 13485:201X, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was published in February 2014.  The five month voting period for comments to be submitted by the National Standards Bodies to the ISO Central Secretariat will close in July 2014. The DIS comments will be reviewed at a September 2014 meeting of the ISO/TC 210 Working Group 1. The Final Draft International Standard (FDIS) version should be issued for a two month vote late in 4Q/2014. Assuming the FDIS is approved,...

Read More

ISO 9001:2015, 9.1.1

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.1

This article provides a summary of the General requirements section of Monitoring, Measurement, Analysis, and Evaluation as stated in the Draft International Standard (DIS) version of ISO 9001:2015. The changes from the related ISO 9001:2008 requirements are also identified. ISO/DIS 9001:2015 Summary 9.1.1 General Determine: what needs to be monitored and measured the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results when the monitoring and measuring will be performed when the results from...

Read More

ISO 9001:2015, 9.1.2

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.2

This article provides a summary of the Customer Satisfaction requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS customer satisfaction differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.2 Customer Satisfaction Monitor customer perceptions of degree to which requirements have been met Obtain information on customer views and opinions of the organization and its products and services Determine methods for obtaining and using this...

Read More

ISO 9001:2015, 9.1.3

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.3

This article provides a summary of the Analysis and Evaluation requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The draft analysis and evaluation differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.3 Analysis and Evaluation Analyze and evaluate appropriate data and information arising from monitoring, measurement, and other sources. Use the output of this analysis and evaluation to: demonstrate conformity of products and services to...

Read More

EHSQ Manager Job

Jul 1, 2014 in Newsletter | Comments Off on EHSQ Manager Job

A client is looking for a Manager of EHSQ Management Systems, located in Atlanta, GA.  Please see the job description below, and if you are qualified and interested, contact David DiBoyan, Director of Americas EHSQ, at David.DiBoyan@Kemira.com. Position Summary: This position is responsible for managing the integrated safety, quality, and environmental management systems registered in Kemira’s Americas region.  This is a regional position interfacing with all functional departments, including sales, manufacturing, and logistics, with...

Read More

ISO 9001:2015, Clause 9.3

Jun 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, Clause 9.3

This article provides a summary of the Management Review requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS Management Review differences from ISO 9001:2008 are also described. ISO/DIS 9001:2015 Summary 9.3 Management Review 9.3.1 Review the quality management system at planned intervals to ensure a suitable, adequate, and effective system. Plan and carry out management review considering: Status of actions from previous management reviews Changes in external and internal...

Read More

ISO 9001:2015, Clause 9.2

Jun 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, Clause 9.2

This article provides a summary of the Internal Audit requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS internal audit differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary 9.2 Internal Audit 9.2.1 Conduct internal audits at planned intervals to provide information on whether the quality management system: Conforms to the organization’s own requirements Conforms to the requirements of ISO 9001 Is effectively implemented and maintained 9.2.2 The...

Read More

Standard for Cities

Jun 1, 2014 in Newsletter | Comments Off on Standard for Cities

  A landmark ISO standard outlining key measurements for evaluating a city’s service delivery and quality of life has been published as ISO 37120:2014, “Sustainable development of communities – Indicators for city services and quality of life”. Its use will help city managers, politicians, researchers, business leaders, planners, designers, and other professionals to focus on key issues, and put in place policies for more livable, tolerant, sustainable, resilient, economically attractive, and prosperous cities. Why...

Read More

Publicize Certification

Jun 1, 2014 in Newsletter | Comments Off on Publicize Certification

You are proud of achieving your management system certification and want to communicate your success to the marketplace. And, publicizing your certification may attract additional business. However, be careful how you promote your certification to avoid the pitfalls of false, misleading, or confusing statements. You may end up harming the credibility of your organization. The International Organization for Standardization (ISO) has issued guidelines on how to correctly publicize your certification. You should follow these guidelines with the...

Read More

Guiding Principles

May 1, 2014 in Newsletter | Comments Off on Guiding Principles

The world’s largest automakers have reached an agreement on their corporate responsibility expectations for suppliers regarding human rights, environment, working conductions, and business ethics. Participating members of AIAG and CSR Europe that reached this agreement include BMW, Chrysler, Daimler, Fiat, Ford, GM, Honda, Jaguar/Land Rover, Peugeot, Scania, Toyota, VW, and Volvo. The agreement is shown below. Guiding Principles We endeavor to achieve excellence, innovation and performance in a sustainable manner. People and the...

Read More

Data Breaches

May 1, 2014 in Newsletter | Comments Off on Data Breaches

Last year a lot of attention was focused on cyber-espionage, threats to privacy, and the acts of malicious insiders. Events at the end of 2013 provided a painful reminder that cybercrime remains prevalent and that damaging threats from cybercriminals continue to loom over businesses and consumers. Eight breaches in 2013 each exposed more than 10 million identities. Targeted attacks increased and end-user attitudes towards social media and mobile devices resulted in wild scams. Symantec’s 2014 Internet Security Threat Report covers a wide...

Read More

Auditor Certification

May 1, 2014 in Newsletter | Comments Off on Auditor Certification

Some students that complete Internal Auditor or Lead Auditor training mistakenly consider themselves to be certified auditors. They may be qualified based on that training to conduct audits for their company, but there are additional steps to become an Exemplar Global (was RABQSA) certified auditor. Perhaps the confusion is that they receive a course certificate after the class. While that is evidence of their auditor training for organizational reasons, the certificate is just proof they have met the training prerequisite for Exemplar Global...

Read More

ISO/TR 18128:2014

May 1, 2014 in Newsletter | Comments Off on ISO/TR 18128:2014

Companies spend a tremendous amount of time and money managing business records to control their activities, improve their operations, and demonstrate compliance with the law. But what happens when these records are misfiled, damaged, or deleted? ISO/TR 18128:2014, Information and documentation — Risk assessment for records processes and systems, will help organizations assess risks to their records processes and systems so they can ensure records continue to meet their business needs for as long as required. The consequence of risk...

Read More

ISO 45001 for OH&S

Apr 1, 2014 in Newsletter | Comments Off on ISO 45001 for OH&S

We announced in an October 2013 newsletter article that ISO is developing a standard for Occupational Health and Safety (OH&S) to replace the BSI standard OHSAS 18001:2007. The new ISO standard will be known as ISO 45001 and is expected to be published in 2016. The proposed schedule for the development and publication of ISO 45001 is: ISO/CD 45001 (Committee Draft) – May 2014 ISO/DIS 45001 (Draft International Standard) – February 2015 ISO/FDIS 45001 (Final Draft International Standard) – March 2016 ISO 45001 to be...

Read More

Quality in the Public Sector

Apr 1, 2014 in Newsletter | Comments Off on Quality in the Public Sector

How can government increase efficiency, prevent errors, and improve customer service? Two new public sector standards using ISO 9001:2008 could be the answer. ISO 18091 provides guidance for local government and ISO/TS 17582 is available for electoral bodies. ISO 18091:2014, Quality management systems – Guidelines for the application of ISO 9001:2008 in local government The objective of ISO 18091 is to provide local governments with guidelines for achieving reliable results through the application of ISO 9001:2008 on an integral basis....

Read More

Auditee Tactics

Apr 1, 2014 in Newsletter | Comments Off on Auditee Tactics

The reactions of interviewed people may range from full cooperation to rare cases of outright hostility. Negative responses may be due to negative management attitudes and the way the audit was announced. Attitudes are contagious. It could also be due to a lack of audit experience and the fear of the unknown. The word “audit” does have a negative connotation. If people believe audits make people look bad, trigger punitive actions, and cause extra work – guess what – they may try to delay your appointed audit rounds to...

Read More

Auditee Responsibility

Apr 1, 2014 in Newsletter | Comments Off on Auditee Responsibility

Auditors are trained on their audit responsibilities, but do the managers of the areas to be audited understand their audit responsibilities? Audit Objectives The objectives of an audit are to determine conformity to the audit criteria, evaluate the capability to meet customer needs, ensure compliance with legal requirements, and determine the effectiveness of the management system. In addition, the audit may identify opportunities for improvement, reduce the risk of product and service failures, and increase the awareness of the...

Read More

Cybersecurity

Mar 1, 2014 in Newsletter | Comments Off on Cybersecurity

The National Institute of Standards and Technology (NIST) recently issued a 40 page document titled, “Framework for Improving Critical Infrastructure Cybersecurity”. It states that the national and economic security of the United States depends on the reliable functioning of critical infrastructure. Cybersecurity threats exploit the increased complexity and connectivity of critical infrastructure systems, placing the nation’s security, economy, and public safety and health at risk. Similar to financial and reputational risk,...

Read More

ISO 14001:2015

Mar 1, 2014 in Newsletter | Comments Off on ISO 14001:2015

ISO 14001:2004, the environmental management system standard, is being revised. The updated third edition is expected in early 2015. The Committee Draft (CD) of ISO 14001:2015 was issued in October 2013. The plan is to review the CD comments, revise the text, and issue a Draft International Standard (DIS) in mid-2014. An article in issue 44 of IRCA’s INform e-magazine identified these emerging ISO 14001 changes: Leadership – to ensure the success of the system, a new clause has been added that assigns specific responsibilities to...

Read More

ISO/TS 16949 Rules

Mar 1, 2014 in Newsletter | Comments Off on ISO/TS 16949 Rules

The latest revision of the rules for achieving and maintaining International Automotive Task Force (IATF) recognition were released by the IATF on October 1, 2013 and will come into effect April 2014 with a full transition to be completed by April 2015. 2013 IATF Global Certification Body (CB) conference CB’s were given the opportunity to hear directly from IATF members the rational of the new rules, explanations of change, and ongoing requirements of the scheme including the changes expected as a result of the 9001:2015 revision. The...

Read More

Electronic Manifests

Mar 1, 2014 in Newsletter | Comments Off on Electronic Manifests

      The Environmental Protection Agency (EPA) has issued a final rule that authorizes the use of electronic manifests to track hazardous waste. The e-Manifest system will track off-site shipments of hazardous waste from a generator’s site to the site of the receipt and disposition of the hazardous waste. The final rule implements provisions of the Hazardous Waste Electronic Manifest Establishment Act, which directs the EPA to establish a national e-Manifest system, and to impose reasonable user service fees as a means...

Read More

Auditor Behavior

Feb 2, 2014 in Newsletter | Comments Off on Auditor Behavior

Confidence in the audit process and its ability to achieve the audit objectives depends on the competence of the individuals who are involved in planning and conducting audits, including auditors and audit team leaders. All auditors should possess generic knowledge and skills, and should also be expected to possess some discipline and sector-specific knowledge and skills. Audit team leaders should have the additional knowledge and skills necessary to lead the audit team. According to clause 7.2.2 of ISO 19011:2011, auditors should also possess...

Read More

Audit Principles

Feb 2, 2014 in Newsletter | Comments Off on Audit Principles

Auditing relies upon a set of principles to help make an audit an effective and reliable tool in support of management policies and controls. Audits provide information for organizations to act on to improve their business performance. According to ISO 19011:2011, audits should be based on these six principles: 1. Integrity: foundation of professionalism. 2. Fair presentation: obligation to report truthfully and accurately. 3. Due professional care: application of diligence and judgment in auditing. 4. Confidentiality: security of...

Read More

Audit Findings

Feb 2, 2014 in Newsletter | Comments Off on Audit Findings

Auditors evaluate audit evidence against audit criteria to determine audit findings. These audit findings can indicate conformity or nonconformity with the audit criteria. Nonconformities and their supporting audit evidence should be recorded. Nonconformities may be graded in terms of severity, e.g. minor or major, for prioritizing corrective actions. Review nonconformities with the audited area to obtain acknowledgement that the audit evidence is accurate and the nonconformities are understood. Attempt to resolve any diverging opinions...

Read More

Cyber Warfare

Feb 2, 2014 in Newsletter | Comments Off on Cyber Warfare

Cyber threats continue to plague governments and businesses around the world. These threats are on the rise as cyber criminals increase their focus and know-how. The problem demands an international solution. ISO 27001 provides a management framework for assessing and treating risks (whether cyber-oriented or otherwise) that can damage business, governments, and even a national infrastructure. Information security incidents are on the rise as cyber criminals increase their focus on both large and small businesses. The 2013 Information Security...

Read More

ASQ Quality Research

Jan 1, 2014 in Newsletter | Comments Off on ASQ Quality Research

For the past year, the American Society for Quality (ASQ) has developed, gathered, and analyzed survey results, data, information, and personal interviews from organizations in more than 22 countries. This effort has culminated in the seven reports described below. According to ASQ, each report is packed with valuable information for any organization. All the reports are free to ASQ members. Non-members can receive two of the reports for free. They must pay $29 to $49 for each of the remaining five reports. ASQ Global State of Quality...

Read More

Measurements Course

Jan 1, 2014 in Newsletter | Comments Off on Measurements Course

We have published articles on performance measurements. You can see a partial list at the end of this article. We are now pleased to offer a new 2-day course, “Measuring Process and Organizational Performance”. Course Description: A key aspect of organizational performance management is selecting, defining, collecting data on, monitoring, and responding to performance metrics. However, it is important that the right ones be selected, tracked, and responded to. This workshop will present a process for selecting what to measure, how...

Read More

Papers on Auditing

Jan 1, 2014 in Newsletter | Comments Off on Papers on Auditing

The ISO 9001 Auditing Practices Group is an informal group of quality management system experts, auditors, and practitioners drawn from the ISO Technical Committee 176 and the International Accreditation Forum. It has developed a number of brief guidance papers that contain explanations about the auditing of quality management systems. These papers reflect the process-based approach that is essential for auditing the requirements of ISO 9001. The International Register of Certificated Auditors (IRCA) has selected some of these audit guidance...

Read More

ISO Certificate Survey

Jan 1, 2014 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 seven of the management system standards, along with the USA totals. ISO 9001 (Quality) Certificates in 2012 = 1,101,272 (USA = 26,177) Certificates in 2011 = 1,079,647 (USA = 25,811) Increase = +21,625 (USA = +366) Percentage = +2% (USA = +1%) ISO 14001 (Environment) Certificates in 2012 = 285,844 (USA = 5,699) Certificates in 2011 = 261,957 (USA = 4,957) Increase = +23,887 (USA = +742) Percentage =...

Read More

ISO 9001:2015 Survey

Jan 1, 2014 in Newsletter | Comments Off on ISO 9001:2015 Survey

The Chartered Quality Institute (CQI) conducted a survey of its members on the Committee Draft of ISO 9001:2015. This major revision of ISO 9001 is planned for publication in late 2015, and is expected to significantly impact certification bodies, training firms, and certified businesses, and of course, auditors. The CQI survey was conducted to determine which elements their members liked, viewed as a cause for concern, and those with which they disagreed. The INform magazine summarized the more than 1,400 responses into the following...

Read More