Normative Reference for ISO 9001:2015 Awareness and Use of ISO 9000:2015 “Quality Management Systems — Fundamentals and Vocabulary” 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. Normative Reference for ISO 9001:2015 Compliments of US TAG to ISO TC 176 8/26/2015 1

Purpose and Scope The purpose of this presentation is to stress the importance of using ISO 9000:2015 for the auditing and implementation of ISO 9001:2015 The presentation is intended to be used for training by the public Stress the importance of using ISO 9000:2015 in understanding ISO 9001:2015 Compliments of US TAG to ISO TC 176 8/26/2015

“Normative References” As quoted directly from ISO 9001:2015 “The following referenced documents are indispensable for the application of this document:….” “ISO 9000:2015, Quality management systems — Fundamentals and vocabulary” Shown here is the wording used in all standards to define “Normative References” and 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. Compliments of US TAG to ISO TC 176 8/26/2015 3

“indispensable” Definition of indispensable from the “Merriam-Webster 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. Definition of indispensable from the “Oxford Dictionary” “Extremely Important & Necessary” – “Too Important to be Without” Pretty much says it all! Compliments of US TAG to ISO TC 176 8/26/2015 4

ISO 9000 Series ISO 9000 - • Quality management systems — Fundamentals and vocabulary ISO 9000 provides an essential background for the proper understanding and implementation of the ISO 9001 International Standard. ISO 9001 – Quality Management Systems - Requirement ISO 9001 specifies requirements aimed primarily at giving confidence in the products and services provided by an organization and thereby improving customer satisfaction. ISO 9004 - Managing for the sustained success of an organization - A quality management approach ISO 9004, Provides guidance for organizations that choose to progress beyond the requirements of the ISO 9001 International Standard to address a broader range of topics that can lead to continual improvement of the organization's overall performance. These three are the ISO 9000 Series Standards. Both ISO 9000 and ISO 9001’s new revisions are being released together. ISO 9004 is currently under revision. Compliments of US TAG to ISO TC 176 8/26/2015 5

ISO 9001 Provides Common Ground Standards which Normative reference ISO 9001 also require the use of ISO 9000, Some prime examples are shown here: SAE AS 9100C:2009 – Aerospace - Requirements ISO TS 16949:2009 - Automotive- Requirements ISO 13485:2003 Medical devices-Requirements QUEST TL9000 The Telecom Quality Management System – Requirements ISO 19600:2014 “Compliance management systems – Guidelines 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. 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. Compliments of US TAG to ISO TC 176 8/26/2015 6

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 Compliments of US TAG to ISO TC 176 8/26/2015

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. Compliments of US TAG to ISO TC 176 8/26/2015

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. Compliments of US TAG to ISO TC 176 8/26/2015 9

ISO 9000 Table of Contents Continued 3 Terms and definitions - Terms related to … 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. Required definitions of terms used in requirements standards such as ISO 9001 Compliments of US TAG to ISO TC 176 8/26/2015

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. Compliments of US TAG to ISO TC 176 8/26/2015

Method of Properly Using ISO 9000 Taking ISO 9001:2015 clause 10.2.1d; for example: “The Organization shall review the effectiveness of any corrective action taken” By substituting “effectiveness” and “corrective action” with their definitions from ISO 9000 this statement becomes: The Organization shall review the “extent to which planned activities are realized and planned results are achieved” for any “action taken 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. Compliments of US TAG to ISO TC 176 8/26/2015 12

Understanding the definitions and fundamental concepts in ISO 9001:2015 The Following are examples of some of the New, Revised or Removed Terms of ISO 9001 Interested party Risk Risk-based thinking Provider Documented information Effectiveness New Revised Competence Output Information Information system Verification Validation Corrective action Preventive action Revised Removed (This slide has two slide in sections which show which terms are New, Revised, and Removed.) On the first click state that “These examples are either New, Revised, and Removed.” (Give the group a slight pause to review the list then click in the two blocks showing them 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.” Compliments of US TAG to ISO TC 176 8/26/2015 13

New “Terms” in the first 6 Clauses 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 - f) address the “risks “ 5. “Leadership” 6. “Planning” 6.4 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. Compliments of US TAG to ISO TC 176 8/26/2015 14

Understanding “Context” 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. Context of the organization Combination of internal & external issues that can have an effect on an organization’s approach to developing and achieving its objectives. An organizations 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 which are truly important to your organization. Compliments of US TAG to ISO TC 176 8/26/2015 15

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 competitors opposing pressure group There are more!!! ISO 9000 helps you identify interested parties, your organization will define which ones it needs to react to. Compliments of US TAG to ISO TC 176 8/26/2015 16

Understanding “Risk” The term “Risk” has been added to ISO 9001:2015 and is noted in many places throughout the standard. “Risk” - effect of uncertainty positive or negative. consequence, or likelihood reference to potential events the consequences of an event This may apply, for example, to; a product, service, process, provider, customer, consumer, environment, employee, & the competition. 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. Compliments of US TAG to ISO TC 176 8/26/2015 17

Assisting Organizations The Price of ISO 9000 is 1/3 the cost of other ISO standards of similar size ISO 9000 terms are broken down by category to promote international understanding and increase confidence in the global market The electronic Adobe version of ISO 9000 includes click-on numerical links for defined terms. ASQ offers standard bundle packages to promote the use of Normative Reference Documents. ISO 9000 is 1/3 the cost of similar standards Compliments of US TAG to ISO TC 176 8/26/2015 18

Reference links for additional Information Paul Palmes article – “What’s Normative Anyway” http://www.insidestandards.com/iso-90002015-whats-normative-anyway/ ASQ.org Standards Connection http://asq.org/standardsconnection/ ASQ.org Standards Central http://asq.org/knowledge-center/standards-iso-9001-2015.html ASQ Standards Channel http://videos.asq.org/asq-standards-channel 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: http://www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf For additional information check out these links Compliments of US TAG to ISO TC 176 8/26/2015 19