Awareness and Use of ISO 9000:2015: Quality management systems — Fundamentals and vocabulary US TAG to ISO/TC 176 This presentation is intended to be used for training by the public and is provided compliments of US TAG to ISO/TC 176. Please cite the TAG as the creator and copyright holder and include the following credit line in any usage: © 2015, US TAG to ISO/TC 176 Questions regarding usage can be directed to the TAG through the ASQ Knowledge Center at knowledgecenter@asq.org.

Purpose and scope For use by the public in providing training on the importance of ISO 9000:2015 when it comes to: Understanding the significant differences between ISO 9001:2008 and ISO 9001:2015 Auditing and implementing ISO 9001:2015 The differences between ISO 9001:2008 and ISO 9001:2015 are so significant that using ISO 9000:2015 is the best way to implement the revised standard correctly. ISO 9000:2015 is a normative reference for ISO 9001:2015. US TAG to ISO/TC 176

Normative references = “indispensable” ISO 9001:2015 identifies only one document as “normatively referenced” and “indispensable for its application”: ISO 9000:2015 Quality management systems — Fundamentals and vocabulary Shown here is the wording used in all standards to define “normative references” and the statement that ISO 9000:2015 is the only normative reference to ISO 9001:2015. Be sure to point out the word “indispensable” when viewing this slide as it is defined in the next slide. US TAG to ISO/TC 176

“indispensable” Merriam-Webster Dictionary: Oxford Dictionary adjective in·dis·pens·able \ˌin-di-ˈspen(t)-sə-bəl\ extremely important and necessary 1: not subject to being set aside or neglected  <an indispensable obligation> 2: absolutely necessary: Essential <an indispensable member of the staff> /ˌɪndɪˈspɛnsəbl/ too important to be without synonym essential Cars have become an indispensable part of our lives. indispensable to somebody/something  She made herself indispensable to the department. indispensable for something/for doing something  A good dictionary is indispensable for learning a foreign language. Oxford Dictionary “Extremely important and necessary” – “Too important to be without” Pretty much says it all! US TAG to ISO/TC 176

ISO 9000 series Three standards in the series: ISO 9000 ISO 9001 Three standards make up the ISO 9000 Series: - New revisions of “ISO 9000: Quality management systems—Fundamentals and vocabulary” and “ISO 9001: Quality management systems—Requirements” have been released together in 2015 - “ISO 9004: Managing for the sustained success of an organization—A quality management approach” is, at the time of release of ISO 9000 and ISO 9001, currently under revision New Revisions released together in 2015 Currently under revision US TAG to ISO/TC 176

ISO 9000 series ISO 9000 Quality management systems—Fundamentals and vocabulary Essential background for the proper understanding and implementation of ISO 9001 ISO 9001 Quality management systems—Requirements Requirements aimed primarily at giving confidence in the products and services an organization provides, thereby improving customer satisfaction ISO 9004 Managing for the sustained success of an organization— A quality management approach Guidance for organizations that choose to progress beyond ISO 9001 requirements to address a broader range of topics that can lead to continual improvement of the organization's overall performance

ISO 9001 provides common ground Quality management systems (QMS) standards for which ISO 9001 is a normative reference also require use of ISO 9000. SAE AS9100C:2009 Aerospace ISO TS 16949:2009 Automotive ISO 13485:2003 Med. devices QUEST TL9000 Telecom ISO 9001 has been used to form the basis of quality management systems in many major industries and is therefore stated as their normative reference document. Emphasize that these are prime EXAMPLES. As ISO 9001 is the normative reference in many other standards, the need to understand the guidelines outlined in ISO 9000 to benefit an organization applying the requirements of standards is critical. ISO 9001 ISO 9000 US TAG to ISO/TC 176

ISO 9000 table of contents Foreword & Introduction 1 Scope 2 Fundamental concepts and quality management principles 2.1 General 2.2 Fundamental concepts 2.2.1 Quality 2.2.2 Quality management system 2.2.3 Context of an organization 2.2.4 Interested parties 2.2.5 Support ISO 9000 is far more useful than you may have been aware. The fundamental concepts are explained within ISO 9000 without burdening the reader with additional requirements. The better we all understand these fundamental concepts, the easier it is to create and maintain a truly beneficial quality management system. Descriptive language with no requirements US TAG to ISO/TC 176

ISO 9000 table of contents (continued) 2.3 Quality management principles 2.3.1 Customer focus 2.3.2 Leadership 2.3.3 Engagement of people 2.3.4 Process approach 2.3.5 Improvement 2.3.6 Evidence-based decision making 2.3.7 Relationship management No requirements Ideas useful in guiding organizations’ actions Used as a basis for developing ISO 9001 Quality management principles apply to every clause in a quality management standard. These are the guidelines that keep the entire system moving in the right direction. US TAG to ISO/TC 176

ISO 9000 table of contents (continued) 2.4 Developing the QMS using fundamental concepts and principles 2.4.1 QMS model 2.4.2 Development of a QMS 2.4.3 QMS standards, other management systems and excellence models ISO 9000 provides the framework needed to build a quality management system and have it work toward the success of the organization. US TAG to ISO/TC 176

ISO 9000 table of contents (continued) 3 Terms and definitions Terms related to … Required definitions of terms used in requirements standards such as ISO 9001 3.1 person or people 3.2 organization 3.3 activity 3.4 process 3.5 system 3.6 requirement 3.7 result 3.8 data, information and document 3.9 customer 3.10 characteristic 3.11 determination 3.12 action 3.13 audit There are 13 different groupings of terms in the ISO standard. An alphabetical index is also provided. US TAG to ISO/TC 176

ISO 9000 table of contents (continued) Annex A Concept relationships and their graphical representation Bibliography, Alphabetical index of terms Concept diagrams aid in understanding of interrelationships among terms and concepts US TAG to ISO/TC 176

Properly using ISO 9000—an example Clause 10.2.1d in ISO 9001:2015 states that the organization shall … Substituting “effectiveness” and “corrective action” with definitions from ISO 9000, this becomes: “review the effectiveness of any corrective action taken” “review the extent to which planned activities are realized and planned results are achieved of any action to eliminate the cause of a nonconformity and to prevent recurrence” This slide demonstrates the proper use of ISO 9000. All terms defined in ISO 9000 should be second nature to all organizations who are certifying. The importance of global understanding of the intent of these terms ensures the true value of being certified.

Definitions and fundamental concepts in ISO 9001:2015 Examples of new, revised or removed terms of ISO 9001 Interested party Risk Risk-based thinking Provider Documented information Effectiveness Competence New Revised Output Information Information system Verification Validation Corrective action Preventive action Revised Removed This slide has two sections to show which terms are new, revised, and removed. On the first click, state that “This list includes examples of terms that are new, revised, and removed.” Give the group a slight pause to review the list. Then click in the blocks showing which are which. Terms are grouped showing new first, then revised, and the only shown removed term is at the end. “All new and revised terms are defined in ISO 9000:2015.” US TAG to ISO/TC 176

New “terms” in clauses 1-6 of ISO 9001:2015 1. Scope of standard 2. Normative references 3. Terms and definitions 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…. b) the requirements of relevant “interested parties” 4.4 Quality management system and its processes…. 4.4.1 f) address the “risks” 5. “Leadership” 6. “Planning” 6.1 Actions to address “risks and opportunities” Not all of these new terms can possibly be covered in this presentation alone but we will go over a few of them. US TAG to ISO/TC 176

Understanding “context” From ISO 9000:2015: 2.2.3 Context of an organization “Understanding the context of the organization is a process. This process determines factors which influence the organization’s purpose, objectives and sustainability.” 3.2.2 context of the organization “combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives.” An organization’s purpose, objectives and sustainability are truly influenced by specific factors such as who the customer is or what the competition is doing. But not all factors apply to every organization. Defining your organization’s context gives you the focus needed to address only the factors that are truly important to your organization. US TAG to ISO/TC 176

Understanding “interested parties” When determining the scope of the organization, we shall consider the expectations of “relevant interested parties.” All of the following can be "interested parties”: Person having an interest in the success of an organization Person that can affect an activity Organization that perceives itself to be affected by a decision Stakeholder Person having an interest in the performance of an organization Providers’ regulators ISO 9000 helps you identify interested parties; your organization will define which ones it needs to react to. Competitors Opposing pressure group There are more!

Understanding “risk” The term “risk” has been added to ISO 9001:2015 and is noted in many places throughout the standard. This may apply, for example, to a product, service, process, provider, customer, consumer, environment, employee, and the competition. From ISO 9000:2015, clause 3.7.9: risk effect of uncertainty…positive or negative…. Often characterized by reference to potential events…. Often expressed in terms of the consequences of an event … and the associated likelihood of occurrence Risk-based thinking will be a new concept for many organizations. The degree at which Risk is addressed in each organization will depend on the context of the organization. US TAG to ISO/TC 176

Assisting organizations ISO 9000 terms are broken down by category to promote international understanding and increase confidence in the global market US TAG to ISO/TC 176

Assisting organizations The PDF version of ISO 9000 includes click-on numerical links for defined terms: US TAG to ISO/TC 176

About TAG (Technical Advisory Group) 176 Develops U.S. positions on ISO/TC (Technical Committee) 176, which covers quality management and assurance ISO/TC 176 vision: Through worldwide acceptance and use, the ISO 9000 family of standards will provide an effective means for improving the performance of individual organizations. This in turn will make people and organizations more confident that goods and services will meet their expectations, thereby enhancing trade, global prosperity, and individual well-being.

Join US TAG to ISO/TC 176 Learn how you can participate in the development of international standards related to quality terminology, systems, and technology. Visit asq.org/standards/standards-and-quality-management Contact standards@asq.org  

Reference links for additional Information “ISO 9000:2015—What’s Normative, Anyway?” by Paul Palmes www.insidestandards.com/iso-90002015-whats-normative-anyway/ Standards Connection newsletter asq.org/standardsconnection/ Learn About Standards asq.org/learn-about-quality/learn-about-standards/ ASQ Standards Channel videos.asq.org/asq-standards-channel ISO 9000 Series overview asq.org/learn-about-quality/iso-9000/overview/overview.html ISO/FDIS 9000:2015 “NOTE Guidance on some additional frequently used words in the QMS standards developed by ISO/TC 176, and which have an identified dictionary meaning, is provided in a glossary available at: www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf” For additional information check out these links © 2015, US TAG to ISO/TC 176