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Gregory Peckfordmanagement; realizing that the organization and its externalpartners must have an interdependent relationship thatpromotes value. Both have a stake in the game and mustwork together to achieve consistent and yet flexible results tocreate value for both parties.So these are the 7 principles for quality management thatstructure the ISO 9001:2015 standard, and although these are notauditable requirements, it is wise that an organization build off ofthese principles when developing a quality management system.Process ApproachThe process approach has always been a very important part of theISO 9001 standard and this has not changed in the 2015 revision.ISO strongly encourages organizations to adopt a process approachwhen developing and implementing a quality management system,and asks that top management exercise leadership by promoting anawareness of this approach. But what exactly does this mean? Aprocess is an activity or set of activities that uses resources and ismanaged in order to enable the transformation of inputs intooutputs. The process approach is a management strategy; whenmanagement chooses to implement a process approach, it means thatthey manage and control the processes that make up theirorganizations, the interactions between these processes, and theinputs and outputs that tie these processes together as a coherentsystem. It is essential that processes be monitored and measured foreffectiveness throughout all stages.So what does applying the process approach in a qualitymanagement system enable? It aids organizations in the betterunderstanding of requirements whether they are customer,contractual or regulatory, and the importance of maintaining18

Mastering ISO 9001:2015consistency in meeting those requirements. It helps organizationsview its processes in terms of requirements, and a means to meetthose specific requirements. A process approach helps to ensureprocess performance is achieved effectively and continues to meet itsdesired goal efficiently and consistently, and helps organizationsimprove on process performance based on the evaluation of data andinformation gathered through continuous monitoring activities. (SeeFigure 1)19

Gregory PeckfordFigure 1: Elements of a process20

Mastering ISO 9001:2015Plan-Do-Check-Act Cycle (P.D.C.A.)In addition, ISO recommends applying the PDCA or Plan-DoCheck-Act methodology in the development of a quality managementsystem and its processes. This methodology provides a repeatingcycle of action and monitoring that promotes continuousimprovement and effective process management. The four-step cycleconsists of the following: Plan - Planning your objectives, activities and resourcesnecessary to develop effective processes that will meetrequirements. Do - Do what you planned in the previous step andimplement the processes. Check - Check or monitor the process for effectivenessagainst established requirements and record the results. Act - Act on the data collected while monitoring the processand make the required adjustments to continually improvethe process.Continue to repeat this cycle to maintain process effectiveness, asbusiness needs change.21

Gregory Peckford22

Mastering ISO 9001:2015CHAPTER 2“Happiness does not come from doing easy work but from theafterglow of satisfaction that comes after the achievement of adifficult task that demanded our best.”-Theodore Isaac RubinIn this chapter we will discuss the concept of risk-based thinking, andthe importance ISO 9001:2015 places on building this into the wholemanagement system in order to better manage risk and takeadvantage of possible opportunities. Also, in Chapter 2 we willdiscuss the transition process from the 2008 to 2015 revision, andwhat that transition means for an organization.Risk-based thinkingOne of the key changes in the 2015 revision of the ISO 9001standard is the addition of risk-based thinking. Making risk inherent inall aspects of a quality management system as opposed to treatingpreventive action as a separate component to be considered inisolation. Of course, risk has always been a factor in ISO 9001, butnow it has been given more of an integral role in the latest revision,and organizations are now required to plan and implement processesto address risk, and it is something that should be considered in all23

Gregory Peckfordaspects of an organization's quality management system. Somethingto note is that with the addition of risk-based thinking, the section onpreventive action (Section 8.5.3 of ISO 9001:2008) has becomeredundant and removed in the 2015 edition. Organizations areencouraged to consider risk in terms of negative and positiveoutcomes. It is common sense that you would want to identifynegative scenarios and plan to mitigate against them, however it isequally important to identify possible opportunities that may ariseand take advantage of those opportunities for positive growth.Let’s look at this from a more practical perspective. Let’s say forexample, you are planning a family vacation, by implementing riskbased thinking, you would consider the risks involved prior tobooking your trip: You might decide against purchasing flight insurance in orderto reduce the cost of your plane ticket. Is the risk ofcancellation and losing the cost of the ticket acceptable? What is the weather generally like in your city of departureand arrival at the time you plan to travel? Is there a chance of severe weather that could affect yourtravel plans? What about illness? Is there a risk of disease or sickness thatis common to the area you plan to visit? Are therevaccinations available to help prevent contracting such anillness prior to taking your trip?Alternatively, there are possible opportunities to consider such as: If you are flexible with your travel dates, you could takeadvantage of flight, or hotel sale prices that are only availableat certain times. What activities, or special events are taking place, which youcould attend if you are aware of them in advance?24

Mastering ISO 9001:2015These are things we would normally consider in our daily lives, sowhy would we not take the same approach in business?So now that we understand the concept of risk-based thinking,how do we incorporate this into a quality management system?I. The first step is to identify risks and opportunities dependant on thecontext of the organization, and scope of the QMS. Until risk andopportunity have been adequately identified, it is impossibleto factor this into process development.II. Once identified, organizations can begin to assess and understandthese risks and opportunities, and make determinations on what isacceptable and what is unacceptable, as well as theopportunities to be taken advantage of – planning actions toaddress these risks and take advantage of possibleopportunities.III. Determining the options available in order to adequately mitigaterisk factors and the necessary steps required.IV. Then take action, and implement the strategies developed during theplanning stage, and incorporate these actions into businessprocesses.V. Lastly, organizations must assess the effectiveness of these actions, andlearn from the collected data in order to refine processes forcontinuous improvement.25

Gregory PeckfordRevision changes and making the transitionOK, so let's take a look at some of the key changes with ISO9001:2015. On September 23, 2015, ISO released the latest revisionto the ISO 9001 standard. So I thought it would be a good idea togive you a brief explanation of the changes, and what effect thosechanges will have on organizations, and the people who have theresponsibility of implementing, managing and auditing the newstandard. While many of the concepts from the 2008 version of thestandard remain, there are some significant changes, and additions, tothe 2015 edition, which we will take a closer look at right now. One of the more obvious changes to the 2015 revision is inthe look and structure of the standard itself. In an effort tomaintain consistency across multiple ISO managementsystems, the latest revision takes on the new Annex SL formatthat is shared by other standards such as ISO 14001Environmental Management Systems. Both the IS0 14001,and new ISO 9001:2015, share the same clause structure, toallow organizations the ability to implement, and integratemultiple management systems more easily and effectively. As discussed earlier, the ISO 9001:2015 revision promote theincorporation of risk-based thinking within the managementstructure of the organization. This is not to be confused witha stand-alone risk management procedure, but theincorporation of risk awareness and identification throughoutthe system as a whole. Top management are now required to develop processes thatallow foresight and planning for possible risk factors that mayhave a negative impact on process and performance, as well26

Mastering ISO 9001:2015as identify and take advantage of possible opportunities. Asmentioned earlier, with the addition of risk-based thinking,the section addressing preventive action, sub-clause 8.5.3 inISO 9001:2008, has been deemed redundant, and thereforeremoved from the 2015 revision. Another change in ISO 9001:2015 is greater emphasis onLeadership, and Management Commitment. The newstandard is intended to promote integration and alignmentwith business processes and strategies. With this integration,top management now have more responsibility in taking on aproactive role in the health and promotion of the qualitymanagement system. The requirement for a single point ofcontact or management representative regarding the QMS hasbeen removed, and a new section on leadership has beenadded to better emphasize a greater involvement from theleadership team. Another notable change is the replacement of the term“product” with “product and services”, which is intended to betteraddress service-based organizations. Along with the change in the term “product”, the 2015 revisionalso replaces the common terms “documents” and “records” with“documented information”. Organizations are required to retaindocumented information as evidence of the implementationof the audit program and audit results. ISO 9001:2015 has no specific requirement fordocumentation of procedures, leaving it up to theorganization to define their own needs for documentation,while taking into consideration client and regulatoryrequirements.27

Gregory Peckford In ISO 9001:2008 there were 6 required documentedprocedures that every organization must have as part of itsQMS. This is no longer a requirement in the 2015 edition.This is not an exhaustive list of amendments to the new versionof the standard, but a high-level look at the new content andstructure of the newly released standard.The new ISO 9001:2015 standard has been formally released forpublic consumption and implementation; however, organizations arenot expected to be compliant to the new changes immediately.Organizations have been granted a 3-year transition period beforecompliance to the new standard is required, for those that maintaincertification to ISO 9001:2008. So don't throw out your copy of theexisting 2008 standard just yet! Organizations and qualityprofessionals are urged to become familiar with the newrequirements, and perform gap analysis of their current system todetermine the steps required for eventual implementation of the new2015 revision by September 2018. Once the gaps have beenidentified, it is important to develop a plan for closing the gaps, anddetermining the steps and resources required to meet therequirements of the new standard. It is also imperative to providetraining and awareness of the new requirements, and actionsnecessary to meet those requirements, so that all personnel are on thesame page and moving in the same direction towards theorganization's goals – and of course, implementation of the plan, andupdating of the existing QMS to meet the requirements of ISO9001:2015.28

Mastering ISO 9001:2015CHAPTER 3“Markets change, tastes change, so the companies and theindividuals who choose to compete in those markets mustchange.”-An WangIn this chapter, I will introduce you to the standard content itself, andtalk about the first 3 clauses of the ISO 9001:2015 standard. Thesefirst sections are very short with minimal content, and essentiallyprovide a reference to other documents included in the ISO 9000family that have been referenced, and form as support for thestandard itself. It also provides the scope of the standard, and laysout the general purpose, and where and when the standard applies toan organization.So let's get started!Clause 1: ScopeThe first clause which defines the scope of the standard itself asspecifying the requirements for a quality management system thatenables an organization to demonstrate its ability to consistentlyprovide a product or service that meets customer, regulatory andstatutory requirements, and aims to enhance customer satisfactionthrough the effective application of the system, processes for29

Gregory Peckfordcontinuous improvement of the system, and assurance of conformityto requirements. This should not be confused with the scope of aquality management system itself, which should be based on thenature of the organization's products and services as well as theirrealization processes, the result of risk assessment, commercialconsiderations, and contractual, statutory and regulatoryrequirements.Section 1 also highlights the broad range and flexibility of theISO 9001 standard, stating that all requirements of the standard aregeneric, and applicable to all organizations regardless of type, size orproduct & service offered. This diversity in application has beenmade even more apparent in this latest 2015 revision of the standardby becoming less prescriptive, and highlighting the applicability toservice-based organizations, as opposed to product alone. So ISO9

Mastering ISO 9001:2015 15 CHAPTER 1 ISO 9000 SERIES OF STANDARDS “If you don't drive your business, you will be driven out of business.”-B. C. Forbes So we touched on what the ISO 9000