How To Implement ISO 9001 - NQA
How to ImplementISO 9001
Table of ContentsIf you know where you’re going, go ahead and click on a chapter.Introduction1Chapter 1: What is ISO 9001?4Chapter 2: The Benefits of ISO 90018Chapter 3: Transitioning From ISO 9001:200810Chapter 4: Preparing For ISO 9001 Implementation14Chapter 5: Steps to Implementing ISO 900118Chapter 6: Achieving and Maintaining Certification23Conclusion: Working With A Professional Certification Body25ii
IntroductionA Standard That Creates TrustBefore a customer decides to work1.A focus on the customerwith you, they’ll want to know they can2.Leadershiptrust you to consistently deliver quality3.The involvement of peopleproducts and services. There’s no better4.Using a process approachway to show customers that you prioritize5.A systematic managementmeeting their needs than becomingapproach6.independently certified and complying withthe internationally recognized standard forA fact-based, decision-makingprocess7.Quality Management Systems (QMS).Mutually advantageous supplierrelationships8.That standard, ISO 9001 has over 1.1 millioncertified participating organizations inContinual performanceimprovement178 countries, making it the world’s mostprominent QMS. The standard follows eightunderlying principles:1
As a business leader,you understand how following theseemployees, suppliers and all otherprinciples could benefit your companystakeholders. You’ll see customerand its stakeholders. Not only willsatisfaction go up. You’ll also attract newimplementing ISO 9001 into yourcustomers, and you’ll reduce operatingbusiness can increase your company’scosts. Complying with ISO 9001 alsoprofits and productivity, and improveensures you’re following all relevantthe experiences of your customers,statutory and regulatory requirements.Before you can reap these benefits, youThe Resources You Need ToSucceedmust, of course, know how to implementISO 9001, and it’s an attainable goal forbusinesses of any size. Some businessesfeel that implementing a QMS, as wellas maintaining compliance, will be tooexpensive and time-consuming and requirecreating a position dedicated solely to ISO9001 implementation. Some fear they willhave to change their processes entirely. This,however, is not typically the case, as yourQMS should be based on the systems youcurrently use.The QMS implementation process can,in reality, require relatively little fundingand time. Besides, the benefits ofcompliance significantly outweigh the costsif the process is executed accurately andefficiently — especially since compliancetypically results in increased profits.2You need to thoroughly prepare forimplementation, understand the steps toimplementing ISO 9001 and determine howbest to proceed with your business’ needsand current situation in mind. This will helpyou to get the most out of your new QMS.This guide can serve as a valuable resourceand will help you understand the process ofimplementing ISO 9001 as it applies to yourcompany. It will cover the basics of ISO 9001and how it can benefit your company andits stakeholders. It will also take into accountyour current compliance status and guideyou through the steps from preparing forthe process to implementing the standardand what to do afterward.
Another way to get the most out of thethe technical requirements and steps ofprocess of attaining and maintainingthe certification process, so that you cancompliance involves working with aimplement changes correctly and efficiently.professional certification body such as NQA.We seek to provide as much value asWe can perform the audits you need topossible through our audits, all for a fairmeet the requirements of the standard andprice.improve your organization’s performance.In addition to this guide, our websiteNot only will we inform you of the gapscontains other valuable resources. If youyou need to fill to meet the standards, butneed more information or are interested inwe’ll identify ways for you to improve yourour services, please contact us. Thank youorganization. We help you to understandfor using this guide as you seek to improveyour organization.3
Chapter 1: What is ISO 9001?The International Organization for Standardization (ISO) established the standard known asISO 9001 to create benchmarks for quality management systems. These systems, often calledQMS, are sets of procedures designed to ensure a company consistently meets the needs ofcustomers and other stakeholders. The process, for instance, helps the business to reliablyprovide customers with products of a high quality.The Purpose Of ISO 9001 Although following the standard will createAllows for better leadership:changes that reverberate through all areasThis principle focuses on thoseof a company, one can categorize the eightleading an organization andunderlying principles mentioned earlierencourages them to set clearas creating two primary enhancements:objectives and expectations. improved efficiency and increased customerKeeps employees informed:satisfaction. Implementing ISO 9001 also hasThis is the principle of keepingmany other effects. Another central tenet ofemployees informed about andthe standard is continual improvement of ainvolved in what the company isbusiness’ operations in the following areas:doing. It encourages accountabilityamong staff and creates enhanced1. Improved Efficiencyemployee motivation andperformance. Adequate processes and systems relatedImproves process approach:to these principles increase a company’sUsing a process approach meansefficiency and effectiveness. Thoughthinking about your work as a setimproving in these areas may indirectlyof activities that together help youincrease customer satisfaction, they directlyreach a goal, rather than a stringimprove the company’s operations:of separate tasks. This keeps you4
more organized and focused on first principle that ISO 9001 lists,Establishes a systematicsignaling its importance. It saysapproach to management: Thisthat businesses should focus theirprinciple involves grouping yourattention on what customers needinterrelated process together intoand how to meet or surpass thoseexpectations.systems to achieve more efficientmanagement. It requires you to Customer focus: This is theyour objective. Mutually beneficial suppliermanage operations proactively,relationships: Businesses andrather than reactively.their suppliers depend on eachFacilitates fact-based decision-other to reach their goals. Thismaking: ISO encouragesprinciple encourages strongbusinesses to use data andrelationships with suppliers thatanalysis to make decisions,benefit both the business and therather than relying on opinions,supplier.immediate reactions, traditions orother means.The eighth principle, continual improvement,deals with all aspects of a business. It asserts2. Increased Stakeholder Satisfactionthat always improving products, servicesand internal operations should be a primaryMeeting customers’ needs is the primarybusiness goal. You can utilize the Plan, Do,goal of any business. These principlesCheck, Act — or PDCA — Cycle to achievedirectly help business to meet theirthis improvement. The PDCA Cycle says youexpectations, as well as those of othershould create a plan, implement that plan,stakeholders:evaluate how successful it was and thenimprove it.5
Who Is ISO 9001 For?ISO designed ISO 9001 to be used bytheir business’ systems won’t fit into thevirtually any business. Organizations of allstandard. When you explore ISO 9001,types, sizes and sectors can benefit fromyou’ll find that this is not an issue. ISOimplementing the standard. One of the9001 guides participants and asks themprimary changes made in the most recentto define their own objectives. It doesn’tupdate of the standard seeks to make itrequire that all certified organizations usemore easily applicable to a wider variety ofthe same structure in their systems orentities.their documentation clauses, and it doesn’trequire them to use ISO’s terminologyA common misconception is that ISO 9001within their organization.is too complex or resource-exhaustive forsmall businesses to employ. For example,Some businesses seek complianceorganizations may think they need tocertification because a supplier, tradehire a dedicated compliance employee,group or large client requires it before theywhich could be cost-prohibitive to a smallwill work with them. In these situations,operation. While larger businesses mightcertification is extremely beneficial and,create such a position because it could besometimes, necessary for a company’sbeneficial, doing so is not a requirement —success. It can also, however, providenor is it necessary.advantages to organizations that do nothave such requirements, as you’ll discover inOther organizations might worry that6the next chapter.
Versions Of ISO 9001You can trace the history of ISO 9001 allThe standard saw a more minor revisionthe way back to Britain during World Warin 2008. The changes primarily sought toII when the British Ministry of Defenseoffer clarification and increase the abilitycreated a standard to reduce mistakes in theto integrate ISO 9001 with ISO’s othermanufacturing of ammunition. In 1979, afterstandards. Although ISO 9001:2008 is notthe government recommended a standardthe most recent version of the standards, itthat applied to industries besides defense,is still in use to day, and certifications for itthe British Standards Institution created BSremain valid until September 2018.5750, the first quality standard of its kind.The most recent update came about in 2015As this idea spread to the United States,and included more extensive changes thanISO created an international version of thethe 2008 revision did. ISO 9001:2015 soughtstandard, ISO 1900: 1987. ISO revised theirto make the standard applicable to morestandard in 1994 to clarify aspects of thetypes of organizations, increased the focusfirst version. This version focused more onon risk management and introduced Annexquality assurance than the original did.SL, a new structure to be used across all ofISO’s standards.In 2000, it underwent its first significantrevision, which made process managementthe standard’s main idea. ISO 9001:2000also reduced the amount of documentationrequired and introduced the eightunderlying principles.7
Chapter 2: The Benefits ofISO 9001ISO 9001 is so widely used across industriesEven those that don’t require theseand countries because of the benefits itcredentials will likely still choose a certifiedbrings. It makes people more likely to workcompany over a non-verified one. It showswith or purchase from you, and those whothem that you’ve taken the time to ensuredo will typically be more satisfied. It achievesquality and gives them a window into howthis by providing guidelines you can useyour company operates.to improve the internal processes of yourThe ISO 9001 principle of customer focuscompany.directly impacts customer satisfaction byExternal Benefitsencouraging companies to make meetingcustomer needs a priority and to establishBecoming certified as an ISO 9001-compliantprocesses for doing that. The principles thatbusiness can increase how likely peopleimprove a company’s internal processes willare to trust that you’ll provide them qualityalso benefit customers because they help toproduct and meet their needs. They’ll knowproduce a quality product more efficiently,you underwent independent audits thateffectively and consistently.verified the processes you use against awidely accepted international standard.The customer is not theonly stakeholder thatimplementing ISO 9001can benefit, either.Some clients, suppliers and otherentities you may work with even requireorganizations they do business with to havethis certification. This assures them that theirpartners will consistently provide them withIt impacts virtually all stakeholders includingquality results and won’t jeopardize theirsuppliers, employees and partneringprogress or hamper their efforts to meetbusinesses. The principle of mutuallytheir needs.beneficial supplier relationships directlybenefits suppliers. Working with an ISO8
9001-certified business may also benefit them more indirectly, such as a reduction in thenumber of last-minute orders and more predictability in the needs of the business.Internal BenefitsAlong with meeting customer needs,another primary goal of any business is ahealthy bottom line. Implementing ISO 9001can help achieve this by reducing costs andmaking employees more productive, ISO9001 certification can also lead to higherpay. According to the University of Californiaat Berkeley and Harvard Business Schoolincreasing profits.study, wages at ISO compliant companiesWell-defined and more effective internalat non-certified firms. Total payroll, whichprocesses mean that a business canoperate more efficiently. This means it canproduce more quality products in less time,increasing productivity and profitability.These consistent, high-quality results canalso enable business to sell more of theirproducts. The adoption of ISO 9001 led to awere approximately 7.5 percent higher thanincludes salary increases and new hires,grew approximately 17.7 percent more atISO-approved companies.These improved processes also help toreduce the occurrence of mistakes. Moreefficient processes mean fewer mistakes10 percent increase in sales in one study.will be made, and when they are made,A QMS helps to define the roles ofplace for addressing the issue. Reducingindividuals and departments, reducingoverlap and making each employee moresuccessful by enabling them to focus onwhat they need to know. In addition to9employees will have an effective system inmistakes also leads to less expense andfewer wasted funds.
Chapter 3: Transitioning FromISO 9001:2008When To Transition To ISO9001:2015If your company is already certified ascompliant with ISO 9001:2008, the processof implementing ISO 9001:2015 into yourbusiness will be different than if you wereIf you need to upgrade to ISO 9001:2015,starting from scratch. Rather than build youryou have several options for your transitionQMS form the ground up, you just have totimeline. You can transition during a regulartransition to the 2015 version and take notere-certification audit or surveillance audit.of the changes.You may also schedule a special visit.If you have a 2008 certification, you havePerhaps the easiest route to take is tountil September 14, 2018 to transition totransition during your regularly scheduledthe new version of ISO 9001:2015. That datere-certification audit visit. This is amarks three years after ISO published itsconvenient option because it doesn’t require2015 revisions. Keep in mind that you mustany extra time or money outside of yourremain compliant with ISO 9001:2008 untilregular audits. If you pass the audit to ISOyou have fully transitioned. If you achieve9001:2015 standards, you will receive theISO 9001:2015 certification, it will be valid for2015 certification instead of a renewal ofthree years — at which point you’ll need toyour 2008 certificate.renew it.10
NQA will automatically upgrade you toto meeting quality standards. Because thisthe 2015 version upon passing your re-is an additional visit to a company’s regularlycertification audit if you are ready to doscheduled ones, it will require extra time andso. The process may take additional timecosts.compared to a regular re-certification visitdepending on the results of the audit. IfChanges To Focus Onyou do not wish to transition at your recertification visit, we ask that you contact usIf you plan to move from 2008 certificationin advance to let us know.to 2015, you need to focus on what’schanged between the two versions so thatIf your three-year renewal cycle does notyou meet compliance requirements andwork with your transition needs, you canattain certification.upgrade during a routine surveillance auditvisit. If you select this option, please let usNQA created several tools and documents toknow ahead of time as well. We will addhelp its clients identify changes between theadditional time to the surveillance visit totwo versions of the standard and compareallow for a full evaluation based on thetheir QMS to ISO 9001:2015. The documentsrevised standards.include Transition Guidance, the TransitionChecklist and an ISO 9001:2008- ISOThe visit will last at least as long as a9001:2015 comparison. These documentsre-certification audit, but it may requirehighlight what changed in the revisions.additional time depending on the resultsof the audit. If you are successful, you willNQA also created a Gap Analysis Tool, whichreceive a 2015 certification, and your three-enables you to compare your QMS to ISOyear cycle will reset to the date you become9001:2015 standards. It contains two tables.certified.The first covers the new concepts that ISOintroduced in its 2015 revision and explainsYou can also schedule a special visit to attainthe related clauses, processes and activities.your 2015 certification. You might choose toThe second section deals with requirementsdo this because of the timing of your typicalthat ISO introduced or amended. Youannual sequence. Some companies choosecan use the results of your latest audit tothis option because they want to beat theircomplete the tables. We ask that you do socompetitors to compliance with the 2015before your transition assessment.version to show customers their dedication11
The most significant change in the 2015Another notable difference is that ISOstandard is the introduction of Annex SL.9001:2015 requires fewer documents thanISO now uses this document across all ofthe previous version did. When preparingits standards. This common structure, textyour documentation procedures forand shared terms and definitions allow forcompliance, you may change wording togreater interoperability and are designed tomeet the new standards. You should not,make the implementation process easier forhowever, delete procedures required byof all of ISO’s standards. Annex SL organizesthe 2008 version but not the 2015 untilthe standard into 10 sections:your transition is complete. This is becauseyou must maintain complaint with ISO1.Scope2.Normative references3.Terms and definitions4.Context of the tion9.Performance evaluation10. Improvement129001:2008 until you have fully transitioned.
The Transition ProcessThe transition process includes four majorYou may opt to have an auditor evaluatesteps:your transition before your audit. You willthen have an idea ahead of time of how well1.Developing a transition planyour revised QMS meets 2015 standards2.Pre-assessmentand have an opportunity to adjust your plan.3.The audit4.CertificationBusinesses can use the documents andtools mentioned above to identify the newrequirements in the 2015 standard anddetermine what they need to do to reachcompliance. Using these tools, you shouldcreate an implementation plan that you willuse to transition to the new standard. Theplan will focus on the changes from the 2008version.13When you are ready for youraudit, you can contact NQA toschedule it or prepare for itto occur during a regular visit.If you pass the audit, you willbecome certified to the latestversion of the standard, ISO9001:2015.
Chapter 4: Preparing ForISO 9001 ImplementationImplementing ISO 9001 can be an intimidating task, especially if you haven’t soughtcertification before. Following an organized process and working with a professionalorganization like NQA can make it doable. It’s a rather long process, so breaking it down intomore manageable steps can help as well. That’s what we’ll do in the next few chapters, startingwith preparing for ISO 9001 implementation.Gap AnalysisThe first step you should undertake whento the standard. The checklist methodseeking ISO 9001 certification is completingis often not adequate for developing ana gap analysis. This differs from the gapeffective QMS and may overlook cer
to integrate ISO 9001 with ISO’s other standards. Although ISO 9001:2008 is not the most recent version of the standards, it is still in use to day, and certifications for it remain valid until September 2018. The most recent update came about in 2015 and included more extensive changes than the 2008 revision did. ISO 9001:2015 sought
ISO 9001:2015 QMS and ISO 14001:2015 EMS and ISO 45001:2018 Internal audit 6. Principals of Quality Management System-ISO 9001:2015 7. ISO 9001 and 14001 and ISO 45001:2018 EQHSMS audit records 8. Table of Documented information Summary against ISO 9001:2015 and ISO 14001:2015 require
ISO 9001.2015 & ISO 14001.2015 Gap Analysis Checklists* ISO 9001.2015 & ISO 14001.2015 Internal Audit Checklists* ISO 9001 & ISO 14001 Employee Newsletters *Sample Included. ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM ***** QMS - EMS MANUAL Your Company Name
ISO 9001:2015 vs ISO 9001:2008 Description: This document is provided by American System Registrar. It shows relevant clauses, side-by-side, of ISO 9001:2008 standard and the ISO 9001:2015 standard. Purpose / Usage: The purpose of the document is to highlight the changes between the new and old standard. Use this document to better understand
ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO 9001:2015 where the requirement is essentially the same 3. "Documented Information" has been adopted. Consequently, the The reverse mapping Table 1 will help if you are considering a transition project from ISO 9001:2008 to the .
Final Draft International Standard (FDIS) of ISO 9001 and vice versa. This guide provides the following: 1. An overview of the changes, deletions, new or enhanced ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO FDIS 9001:2015 where the requirement is essentially the same 3.
The differences in ISO 9001:2008 vs. ISO 9001:2000 are described below. Deleted ISO 9001:2000 text is indicated by strikethroughs. New ISO 9001:2008 text is highlighted and underlined. The underlining will allow readers to distinguish the new text, even if this paper is printed without color.
ISO 9001 requirements 2. A mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO 9001:2015 where the requirement is essentially the same 3. "Documented Information" has been adopted. Consequently, the The reverse mapping Table 1 will help if you are considering a transition project from ISO 9001:2008 to the .
ISO 9001 is all about, how to produce an ISO 9001 Quality Manual, and how to write ISO 9001 Quality Procedures. The Bizmanualz ISO 9001 Manual comes with practical documentation in proper ISO format and reflects 2015 changes to the standard. You also get a detailed explanation of ISO 9000 and helpful information and guidance. US 595.00 How to .
