ISO 9001:2015 The Sticky Clauses

About Your Presenter: Charlie Cianfrani Professional Experience o Business advisor with over 50 years of experience as an operations and quality executive o Over 25 years as a participant in TC 176 and the US TAG to ISO TC 176 the committee responsible for ISO 9001 o Direct contributor to writing ISO 9001:2008, ISO 9001:2000, ISO 9004:2009 and ISO 9004:2018 and the latest publication of the QMP s o ASQ Fellow, ASQ CQE, CRE, CQA and an Exemplar Globalcertified QMS auditor all rights reserved 2

Disclaimers o The information provided here today is meant to give an accurate picture of the meaning and intent of ISO 9001:2015. o The content presented is not an official view of ISO/TC176 but rather based on my 50+ years of experience in P & L and quality management assignments domestically and internationally. o Think carefully before making any changes to your system just to adhere to the perceived requirements of a Standard. o The real questions to ask are How does the process help the organization achieve its objectives and do the processes add value? all rights reserved 3

The evolution of ISO 9001 ISO has a requirement to review and reaffirm or update each Standard every 5 years ISO 9001 was first issued in 1987 Tweaked in 1994 (no major changes) Major updating in 2000 process approach introduced Tweaked again in 2008 Major updating in 2015 Annex SL format introduced (mandated by the ISO TMB) all rights reserved 5

ISO 9001:2015 journey to reality 2013 2014 2015 June 2013 CD Committee Draft June October 2014 DIS Draft International Standard FDIS was released for translation on 10 May 2015. FDIS ballot opened on 9 July and closed on 9 September 2015 September 2015 International Standard published all rights reserved 6

Our Goal For This Presentation We will address eight sticky clauses in ISO 9001:2015, their requirements, and possible approaches to address and comply with these requirements. 1. Understanding the Organization and its Context (Clause 4.1) 2. Needs and Expectations of Interested parties (Clause 4.2) 3. Leadership (Clause 5) 4. Actions to Address Risks and Opportunities (Clause 6.1 and others) 5. Knowledge, competence, and innovation (Clause 7.1.6, 7.2 and 10.1 note) 6. Understanding documented information requirements (clause 7.5) 7. Measuring customer satisfaction (Clause 9.1.2) 8. Alignment of objectives (Clauses 6.2, 7.3 and 7.4) all rights reserved 7

ISO 9001:2015 was developed to be consistent with the Quality Management Principles (QMPs) See ISO 9000:2015 Clause 2.3 The QMPs are Customer Focus Leadership Engagement of People Process Approach Improvement Evidence-based Decision Making Relationship Management all rights reserved 8

Think! 9

Sticky Clause #1: Understanding the Organization and its Context (Clause 4.1) Clause 4.1: The Requirement 1. Determine relevant external and internal issues that can impact the strategic and tactical directions of the organization and that directly affect the achievement of the intent of the QMS 2. Monitor and review information about the relevant external and internal issues Notes of factors to consider Both positive and negative issues External Issues can arise from legal, technological, competitive, market, cultural, social, and economic environments whether international, national, regional or local Internal ssues may be related to values, culture, knowledge and performance of the organization. all rights reserved 10

Why Do It? Understanding the Organization and its Context (Clause 4.1) o Ensure QMS is structured for both the needs of today and tomorrow o Integrate QMS processes into the organization strategic and tactical activities o Explore interactions between processes that may be related to external and internal issues o Discover, understand and plan to address threats, opportunities, and technology shifts all rights reserved 11

Examples Understanding the Organization and its Context (Clause 4.1) o Define (and in most cases document) a process or processes for considering internal and external issues Who should participate When and how often to consider issues How to document results o Method of follow-up to assess status who and with whom o Consider implementation of a self-assessment process (not a requirement) o Ensure integration into the strategic and tactical plans of the organization o Make this integral to a strategic planning process all rights reserved 12

Understanding the Essence Understanding the Organization and its Context (Clause 4.1 and 4.2) Strategic Risk Planning Input: Threats & Opportunities External Scan Self-Assessment Internal Scan Itemized Risks Focus Strategy Mission Vision Output: Action Plans & Objectives Execution Monitoring Learning all rights reserved 13

Understanding the Essence Understanding the Organization and its Context (Clause 4.1 and 4.2) Threats Strategic Planning Ideas External Scan Self Assessment Internal Scan Issues Risks Principles Innovations Mission Vision Strategies Develop And Implement New System Action Plans Objectives Alignment Objectives People System Development Process Management Optimization Identify Key Processes all rights reserved 14

Threats Strategic Planning Ideas External Scan Self Assessment Internal Scan Issues Risks Principles Innovations Mission Vision Strategies This is the essence of what is required by ISO 9001 Clauses 4.1 and 4.2 all rights reserved 15

Sticky Clause #2 Needs and Expectations of Interested Parties (Clause 4.2) Clause 4.2: The Requirement 1. Determine the interested parties that are relevant to the quality management system 2. Determine the relevant requirements of these interested parties 3. Monitor and review information about these interested parties and their relevant requirements 4. The results of the analysis of relevant interested parties should be used in planning the QMS (see also Clause 4.3) all rights reserved 16

Why Do It? Needs and Expectations of Interested Parties (Clause 4.2) o Risk avoidance o Interested parties is new language in ISO 9001:2015 o Needs of interests of parties beyond the direct customer may impact the content of the QMS of the organization o Ideas for new products or services that have marketplace relevance o Consideration of relevant needs/requirements/interests of interested parties can influence of product design, production or delivery processes all rights reserved 17

Examples Needs and Expectations of Interested Parties (Clause 4.2) o Define and deploy processes to determine if interested parties are impacted by the activities of the organization o Document processes for identification of interested parties o Establish criteria for assessing relevance o Keep records of identification and relevance decisions o Consider actions to lessen or eliminate the extent of any impact on relevant interested parties o Examples of organizations that could potentially be considered interested parties all rights reserved 18

Interested parties can impact process design Shareholders The QMS of the organization Regulators The organization Process Providers Customer Internal divisions Customer feedback Design consultants all rights reserved 19

Sticky Clause #3 Leadership (Clause 5) Clause 5: The Requirement 1. Clause 5 which has 4 sub-clauses; Clause 5.1 is titled Leadership and commitment 2. Prime leadership requirements are in 5.1.1 General top managers are required to demonstrate leadership and commitment to the QMS by carrying out specific duties specific activities that are required are articulated in Clause 5.1.1 all rights reserved 20

What are Top Managements Responsibilities? Leadership (Clause 5) o Taking accountability for the effectiveness of the quality management system o Ensuring that the quality policy and quality objectives are established for the organization and are compatible with the context and strategic direction of the organization o Ensuring the integration of the quality management system requirements into the organization s business processes o Promoting the use of the process approach and risk-based thinking o Ensuring that the resources needed for the quality management system are available all rights reserved 21

What are Top Managements Responsibilities (Continued)? Leadership (Clause 5) o Communicating the importance of effective quality management and of conforming to the quality management system requirements o Ensuring that the quality management system achieves its intended results o Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system o Promoting improvement o Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility all rights reserved 22

Management Commitment Leadership (Clause 5) ensure that the resources needed are available Establish Quality Policy Quality Objective Quality Objective Quality Objective Provide Resources Management Review all rights reserved 26

The Quality Hierarchy* Leadership (Clause 5) Organizational Sustainability EFQM, Baldrige World class performance ISO 9004 Beyond minimum requirements ISO 9001 Foundation * Concept developed by Joe Tsiakals and used with permission Prevent defects Meet minimum requirements Conform to customer requirements all rights reserved 27

Quality Policy Be the leading supplier of hi-tech bicycles as viewed by our customers Be proactive in listening to and communicating with customers Achieve 99% delivery to customer commitment date Ship replacement parts in 24 hours Maintain a competent staff Quality Objective - MD Hold quarterly meetings with key customers Visit 3 customers each quarter to solicit customer input (Quality and design) Quality Objective - Marketing VP Conduct market research to determine who is perceived as the leading supplier Quality Objective - Design Complete titanium disk brake project on time and w/in budget Quality Objective - Production Manager 99.5% on time delivery to customer all rights reserved commitment date 28

Engagement of Top Management? Why? How? Important to know what can and should not be delegated What gets measured gets done (follow the process approach!!) Engagement is a critical component of sustainability all rights reserved 29

Why do it? Leadership (Clause 5) o Facilitate top management strategic engagement with the QMS o Ensure responsibilities, accountabilities and authorities are clear and unambiguous o Enhance communication with and involvement of all staff throughout the organization o Enhance risk assessment and exploration of opportunities o Emphasize customer satisfaction throughout the organization o Integrate quality management into the tactical activities of the organization o Ensure alignment of processes and objectives with strategic and tactical plans all rights reserved 30

Examples Leadership (Clause 5) o Help determine what top managers should and should not delegate and how the delegation will work o Practice and learn to speak in the language of management ($$$$) o Design and deploy a Cost of Quality process o Provide management with actionable information all rights reserved 31

Sticky Clause #4 Risks and Opportunities (Clause 6.1) Clause 6.1: The Requirement 1. Consider issues relevant to the organization 2. Determine the risks and opportunities that need to be addressed in planning the QMS related to the issues that are considered 3. Consider risks and opportunities that impact the organization s ability to achieve intended results, prevent or reduce undesired effects, and achieve improvement 4. Address actions to be taken and how to integrate the actions into the QMS 5. Determine how to evaluate effectiveness of actions taken 6. Balance actions taken to address risks and opportunities to the potential impact of the risk on conformity of products and services all rights reserved 32

Risk and Opportunities (Clause 6.1) o Synopsis of the intent of the requirement is: Consider risks and opportunities that impact the organization s ability to achieve intended results, prevent or reduce undesired effects, and achieve improvement Address actions to be taken and how to integrate the actions into the QMS Determine how to evaluate effectiveness of actions taken Balance actions taken to address risks and opportunities to the potential impact of the risk on conformity of products and services all rights reserved 33

CC1 Why do it? o Mitigate liability exposure o Enhance sensitivity to safety o Mitigate financial exposure related to risks o Enhance customer satisfaction o Meet requirements of clause 6.1.1 o Expand breadth and depth of the QMS o Important to enhance sustainability o Improve product development cycle times o Prevent costly situations all rights reserved 34

Slide 34 CC1 Need words around next to last bullet Charlie Cianfrani, 10/14/2016

Internal Risks to Consider o Implement internal audit and self-assessment processes o Gather and analyze of quality cost data o Analysis of technology trend information o Competitive analysis o Analyze results of customer reviews and feedback o Assess actual vs intended internal values and culture o Analyze operational and financial data to assess performance o Implementing processes to consider best practices and comparisons with industry benchmarks o Analyze performance and interactions of processes all rights reserved 35

External Risks to Consider o Deploy processes to consider: The economic environment International trade conditions, processes and barriers. Competitive products and services Technology trends Regulatory changes Opportunities and conditions related to a wide variety of outsourcing strategies all rights reserved 36

Examples of how to do it - Tool Examples o SWOT (strengths, weaknesses, opportunities, threats) analysis o Process mapping and flow charting o FMEA (failure modes and effects analysis) all rights reserved 37

SWOT (strengths, weaknesses, opportunities, threats) analysis SWOT Strength Weaknesses Opportunities Threats Process Actions ISO requirement Determine external/internal issues relevant to org purpose Monitor info re issues Determine interested parties Requirements of interested parties Review info re interested parties Simple SWOT analysis format example for considering requirements of Clauses 4 and 6 all rights reserved 38

Risk Based Thinking o Teach Everyone Always consider risk Think about the positive aspect of risk (the risk of not taking action) Promote awareness and encourage personal involvement Reward risk input to reinforce the management desire for contribution from ALL employees all rights reserved 41

Sticky Clause #5: Understanding Knowledge, Competence and Innovation Requirements (Clause 7.1.6, 7.2 and 10.1 Note) Knowledge Requirements Clause 7.1.6 1. A new requirement ISO 9001 2. Somewhat vague and subject to a wide spectrum of understanding 3. Determine the knowledge necessary for the operation of processes 4. Maintain necessary knowledge and make it available 5. Determine how to acquire or access the necessary additional knowledge to address changing needs and trends all rights reserved 42

Why do it? Knowledge o To ensure the availability of the information needed to establish, implement, maintain and improve the quality management system o To ensure that currently required organizational knowledge is obtained o To plan to acquire any necessary additional knowledge and required updates for anticipated future needs o To ensure QMS is effectively implemented o To capture tacit knowledge all rights reserved 43

Examples of how to do it - Knowledge o Identify the processes of the QMS o Consider resource requirements for processes (personnel, time, buildings, equipment, utilities, materials, supplies, instruments, software, transport facilities, other infrastructure) o Deploy processes to codify, embed and communicate knowledge required to satisfy customer requirements o Ensure knowledge needed to meet requirements is available when and where it is needed o Consider short and long term resource needs; timing may be critical o Integrate longer-term needs into the organization s strategic and capital plans all rights reserved 44

Sticky Clause #5: Understanding Competence Requirements (Clause 7.2) 1. Determine the competence required for persons doing work that affects the performance and effectiveness of the QMS 2. Ensure that everyone has the capability to provide product that meets customer requirements based on appropriate education, training, or experience 3. Take actions to acquire necessary competence 4. Evaluate effectiveness of actions taken 5. Retain appropriate documented information as evidence of competence to effective implementation of the QMS all rights reserved 45

Why do it - Competence To Ensure That: o People have the capability to satisfy customer requirements o The capability exists to make the QMS effective o Continual improvement of the effectiveness of the QMS processes occurs o Competence is maintained when transferring workers o Competence is maintained when utilizing temporary staff o Competence is maintained under changing conditions o HR establishes job requirements when hiring all rights reserved 46

Examples of How to Do It - Competence o Use some form of written job requirements (i. e. job descriptions) o Competencies required should make sense for each job type; find the right combination of education, training, skill and experience o Some job requirements may be only a performance standard (for example, to produce a quantity of conforming product per day) o Establish processes to ensure newly hired or transferred personnel have the competence to perform assigned tasks to requirements o Train supervision to ensure staff competence, especially in a dynamic work environment o Engage HR in ensuring competence of staff for assignments all rights reserved 47

Sticky Clause #5: Understanding Innovation Requirements (note to Clause 10.1) 1. No requirements in ISO 9001:2015 2. There is note 1 in Clause 10.1 listing innovation as an example of improvement all rights reserved 48

Why do it - Innovation o Innovation is a vital component of sustainability o Innovation is a vital component of improvement o Competition is not static o Customer demands are always changing o Cost reduction is continually an issue o Technology is continually unveiling better ways to implement process activities all rights reserved 49

How to Do It - Innovation o Define a process o Requires periodic attention o Allocate resources o The QMS should not inhibit consideration of innovative product and process developments o In certain customer or regulatory situations, the changes related to innovation may not be permitted, but the process should capture future opportunities for later action all rights reserved 50

Sticky Clause #6: Understanding Documented Information Requirements (Clause 7.5). 1. Most significant change in 2015 is in the nomenclature 2. The previous terms of documents and records have been replaced with documented information 3. The essence of the requirements is that the QMS shall include: all documented information required by ISO 9001:2015 documented information that the organization determines to be necessary for effective operations as applicable, the availability of applicable documented information to establish control of production and service provision (See clause 8.5.1 4. All other requirements similar to the past editions of ISO 9001 all rights reserved 51

Why Address Documented Information Requirements o To Ensure: o Consistent performance of all activities affecting quality o Controls are in place to issue and approve documents o Changes in requirements are communicated to those who must implement them o To prevent the use of obsolete information o To make certain that people have up-to-date instructions and requirements all rights reserved 52

Examples of How to Address Documented Information Requirements o Define the types of documents in your system o Determine if any change in nomenclature is required or desired o Define the types of documentation that come from other organizations o Maintain a clear differentiation between documents and records o Where the term maintain documented information is used, the intent is the documented information be kept up to date o Where the term retain documented information is used, the intent is similar to the ISO 9001:2008 requirements for a record all rights reserved 53

Examples of How to Address Documented Information Requirements (Continued) o Define the control process appropriate for each type of document o The requirements for computer-based documentation may be different from those for paper drawings o Records are a special type of document and require different controls o See Annex A.6 Documented Information in ISO 9001:2015 o No requirement to do anything different without a good reason all rights reserved 54

This Table May Help to Understand Documented Information Requirements terminology Old Term New Term Purpose of Documented Information Changes & Corrections Documented procedure Maintain documented information Provide up to date information for process operations Keep up to date with changes Record Retain documented information Provide objective evidence of activities conducted No changes but corrections may be permitted all rights reserved 55

Sticky Clause #7: Measuring Customer Satisfaction (Clause 9.1.2) 1. Monitor information relating to customer perception as to whether the organization has met customer needs and expectations. 2. The methods to be used to get this information is not specified in the standard, but methods must be established. all rights reserved 56

Why Address Measuring Customer Satisfaction o To understand customers perceptions related to your products so that you can take action to improve the QMS of the organization to improve that perception o To understand actions needed to retain customers o To understand actions needed to expand business o To understand actions needed to grow markets o Typically customer satisfaction is a stated objective of many organizations, but not supported by processes to ensure it is achieved all rights reserved 57

Examples of How to Address Measuring Customer Satisfaction o Decide what information you will monitor o Determine how to get that information o Determine how to analyze information (see examples of sources of customer satisfaction information in next slide) o Consider that to demonstrate conformity in regulated markets, it may be sufficient to monitor customer reports of product deficiencies o Consider using focus groups and surveys of product users o Go beyond the requirements in Clause 9.1.2 to deploy aggressive processes to gather and USE customer satisfaction information to enhance sustainability o Consider ALL sources of customer satisfaction data all rights reserved 58

Examples of How to Address Measuring Customer Satisfaction o If you manufacture products for other companies, consider faceto-face interviews with the individuals who make key buying decisions in customer organizations o Consider that the products you produce may have associated services that are important to the customers o Keep the process dynamic and flexible; the results of monitoring may indicate a need to gather more information through measuring o Include methods to understand what is important to the customers, including price and delivery performance, when deciding what to monitor and measure o Consider using QFD and voice of the customer techniques all rights reserved 59

Sources of Customer Satisfaction Data Methods of Gathering Active Receptive Indirect Surveys Focus groups Site visits Interviews Complaints Warranty costs Allowances Letters Articles Trade Shows Repeat business all rights reserved 60

Sticky Clause #8: Alignment of Objectives (Clauses 6.2, 7.3 and 7.4) 1. Establish quality objectives at relevant functions, levels and processes needed for the quality management system 2. Quality objectives shall: be consistent with the quality policy; be measurable; take into account applicable requirements; be relevant to conformity of products and services and to enhancement of customer satisfaction; be monitored; be communicated; be updated as appropriate. 3. Plan achievement of objectives. Determine: what will be done; what resources will be required; who will be responsible; when it will be completed; how the results will be evaluated. all rights reserved 64

Why Align Objectives o To Ensure: Achievement of operational and financial objectives Commonality of understanding of vision and mission and how they will be realized Requirements are met Resources are allocated Staff works with commonality of purpose Communication of objectives and feedback of performance status all rights reserved 65

Managing to Achieve Results ensure that the resources needed are available Establish Quality Policy Quality Objective Quality Objective Quality Objective Provide Resources Management Review all rights reserved 66

Books by Cianfrani and West Jack and Charlie are Co-authors of several books published by the American Society for Quality (ASQ) Quality Press including: ISO 9001:2015 Explained (Fourth Edition) Cracking the case of ISO 9001:2015 for Manufacturing (Second Edition) Cracking the case of ISO 9001:2015 for Service(Second Edition) ISO 9001:2008 Explained & Expanded Unlocking the Power of your Quality Management System - Keys to Performance Excellence How to Audit the Process-Based QMS (Second Edition) Also see our many articles in Quality Progress on all aspects of ISO 9001 all rights reserved 69

C U S T O M E R Context of the Organization R E Q U I R E m E N T S Quality Management System Improvement Leadership, Planning, Support, & Resource Management Performance evaluation Operational planning and control (Product and/or service realization) S A T I S F A C T I O N C U S T O M E R all rights reserved 71

Get Real About What Leaders Need To Do Leadership (Clause 5) Establish Quality Policy Quality Objective Quality Objective Quality Objective Monitoring Measuring Customer satisfaction data Improving Analyzing Quality Management System Communicate! Improvement Management Review Processes all rights reserved 72