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Understanding what’s required forISO 9001 Certificationby Core Business Solutions Co-Founder & PresidentScott Dawson

Written by: Scott Dawson, PresidentWelcome! This guide is designed to give you a highlevel overview of the ISO 9001 process and to brieflyexplain how Core Business Solutions can help youachieve ISO compliance.When my brother and I started this company, weknew the process to achieve ISO compliance wascomplicated and time-consuming, but also oftenrequired of small businesses by their customers. Withour experience in quality management and softwaredevelopment, we worked to simplify the ISO processand to make it easier than ever for companies likeyours to reach their goals.Scott Dawson02

?What is ISO?Why should I care?Why should I read further?ISO 9001 is an internationalstandard that specifiesrequirements for qualitymanufacturing and services.Companies all across the worlduse the standard to show theircustomer that they have theability to provide consistentproducts and services thatmeet, and often exceed, thecustomer’s requirements.This guide explains what is requiredto achieve certification and willalso explore how Core BusinessSolutions can partner with youto achieve certification – simply,quickly, and cost-effectively.03

What are the steps to get certified?Core Business Solutions’ step-by-step process can move at the pace you need to become certified.Because we work with hundreds of companies each year across the United States, we have aproven process and experienced consultants that specifically fit your organization.We boil the process down into four steps – a simple, achievable approach to ISO certification that isdesigned for your success.121 Learn the requirements of theISO 9001 StandardOnce you have chosen Core Business Solutions(CBS), your consultant will help you take thecomplicated, complex ISOjargon, and simplify it to fit your business on yourtime. You will learn all the ins and outs of therequirements before you start todig into the work.Example: ISO 9001 Standard Section 4: Contextof the Organization states “The organizationshall determine external and internal issuesthat are relevant to its purpose and its strategicdirection and that affect the ability to achievethe intended result(s) of its quality managementsystem (QMS).” Our consultants translate byasking you a question, “What are the internaland external conditions in which your businessoperates, things that surround your business:people, suppliers, competitors, workforce,regulations, etc.” We help you filter out thosethings that have the greatest impact on yourQMS and help you document and monitor thosethings.343 Implement QMSYour consultant will work with you to conductyour management review (the leadershipmeetings ensuring you meet the ISOrequirements). We also ensure you have theprocesses in place to make your quality systemmeasurable and repeatable for customersatisfaction.4 Conduct your Internal AuditYour consultant will assist you in conducting yourInternal Audit (it’s the practice audit to make sureyou are ready for the certification audit and haveall documentation and processes in order).After you’ve completed your preparation steps,you are ready for the Registrar certification audit.This is the real last step a Core-recommended,accredited third-party auditor will come to yourfacility and will perform an audit on the qualitymanagement system you have developed. WithCore’s help, certification will be no sweat!What do you do once you are certified?Staying Certified2 Create required documentationYour consultant will help you develop your QMSmanual and all required documentation toensure quality. We simplify wherever possible.Ok, we may have fibbed. The TRUE last step in theprocess is staying certified, and Core can helpyou ensure your new QMS system is sustainablefor years to come.04

How much time does it take?4 Months is the average time to achievecertification. We’ve gotten customers certifiedin as fast as 30 days to meet a contractdeadline, while other customers take a bitmore time (up to 6 months).How much does it cost?There are two costs involved in certification:1. The preparation cost or consulting fee2. The Registrar certification costCore Business Solutions has programs as lowas 5,000 for micro businesses to help youprepare for certification. The cost of theRegistrar audit varies depending on the scopeand size of your organization, but our averagecustomer can expect between 2,500 and 3,000 for the certification audit. A very smallbusiness can certify with as little as 7,500.05

So why ChooseCore Business Solutions?We are people people. We pride ourselveson connecting with our customers and onbuilding relationships that make the processof certification enjoyable. Our work isn’t justabout the certification – it’s about improvingyour business so that you can guarantee yourfuture success.customers with 150 employees or more.When you speak with a sales consultant, heor she can guide you to the program that isthe best fit for you.We provide training, too. We help youlearn the standard, we create yourdocumentation, and we help you conductAll of our consultants have worked inyour management reviews and yourindustry for several years (many of theminternal audit. Our CORE ISO Complianceare experienced quality managers) andPlatform is a great resource for yourhave a thorough knowledge of how totraining, documentation, process plans,implement ISO 9001. They have experiencemeasurement, and continuous improvement,with a variety of customer segmentsand our Community Forum connects you withincluding government services, machinehundreds of other businesses who are seekingshops, manufacturers, engineering firms,ways to improve and mature their QMS forelectronics, distributors, and many otheryears to come. We work WITH you every stepservice-orientated organizations. We pairof the way to get you ready for certification,up the perfect consultant for you based onand we provide continual learningwhere they are located in the United Statesopportunities for our customers so that theyand your business type to provide the perfect have the resources to constantly improvefit for efficient and effective ISO projecttheir QMS and maintain their certification.implementation.Choose us for our unique approach toOur consulting programs provide aISO certification. We pair technology withdedicated consultant, a project manager,personal consulting as you prepare forand a customer success team. We offer acertification. We provide you the peace ofnumber of options for small businesses atmind you need knowing you will be certified,costs you can afford. We even offer specialpainlessly and efficiently, in no time at all.micro business programs for businesses thatAnd we offer the tools and support to ensurehave 1-2 employees. Our average customer you can maintain and improve your QMSsize is 12 employees; however, we do haveyear after year.06

About the ISO 9001:2015 StandardThe ISO 9001:2015 Quality Management Systemstandard is the best known and most widelypursued ISO standard. More than 1.4 millioncompanies and organizations world-wide areformally certified to ISO 9001, proving that thequality of their products and services are thebest in their industry.Benefits of ISO Certification and an efficientQMS2. Improves quality and service Reduces your costs Highlights deficiencies Provides continuous assessment Showcases continuous improvement Ensures higher customer satisfaction Improves customer relationships Spurs business growth Encourages new business opportunities3.4.The ISO 9001 standard is based on the QMSprinciples found in ISO 9000:5. Customer Focus Leadership Engagement of People Process Approach Improvement Evidence-based Decision Making Relationship Managementdistributors, etc.), service-oriented, and othernon-manufacturing businesses.Put greater emphasis on the process approachand measurable results to demonstratecontinual improvement.Provide greater flexibility in howdocumentation, leadership and othermanagement system activities are addressedto adapt to specific needs of individualcompanies.Expand preventive action into risk-basedthinking to include planning, identification andaddressing risks faced by the company thatmay impact its products, services andcustomers.Align the ISO 9001 requirements with relatedstandards such as ISO 14001, ISO 45001 (oldOHSAS 18001), ISO 27001 and others to make iteasier to maintain more than one certification.The resulting changes make ISO 9001certificationmore effective in helping companies of any size,in any industry, manage risk, improve quality, andbetter serve their customers. At the same time,many aspects of the quality managementsystem will be able to be greatly simplified andspecifically tailored to your needs and your team.In 2015, the ISO standard was updated to makerequirements better suited for small businesses.The ISO 9001:2015 version is still widely used forglobal supply chains, government procurementofficers, and other market drivers as a suppliermanagement tool. Some of the top objectivesfor the ISO 9001:2015 version update are:Core Business Solutions aims to “interpret and fit”the standard requirements to your organization,simplifying the process, and adding valuewherever possible to create the most efficientand effective QMS for you.1. Make the requirements equally usefulto product-oriented, (e.g. manufacturers,07

Moe’ Youness, Quality Control Manager ISO 9001:2015 Certification American Label & Tag, Inc.What Core Business Solutions’ customers are saying:Jason S.Jean L.This group really knows their stuff!!!! The programthey offer is well documented, easy to implementand the project management is top notch! Theytruly deliver a white glove service! and guide,advise and lead you through the entire process.On behalf of my ISO Team and ExpandedTechnologies as a whole, I would like to thank TheCore Solution for guiding us to perhaps one of ourgreatest accomplishments. Certainly the greatestaccomplishment I have been at the helm of.Between your industry leading platform andPaula Taft (our consultant’s) ability to interpretthe Standard, we got to where we set out to be.We look forward to continuing our journey ofmanufacturing excellence with your companyand the resources it has to offer.Jodie D.Core Business Solutions provided top-tierguidance through the ISO 9001:2015 certificationprocess. Our consultant is a subject matter expertin the standard, highly organized, and readilyavailable for any questions outside of scheduledmeetings. VEQTOR received unconditionalrecommendation for certification by PRIRegistrar, based on our preparation throughCORE. VEQTOR received certification within 10days of Stage II Audit. The CORE documentationplatform is also easy to use, ISO compliant, andsimplifies document management.Lisa S.With Core Business Solutions’ help, we havebeen certified under both ISO 9001:2008 andISO 9001:2015 while other small businesses in ourarea remain uncertified despite having beguntheir ISO journey ahead of us and they’vespent significantly more money doing it. Core isa great value, great product and great service.Those are the same things we used to describeKegman too.Jeffrey J.We at Welbilt just want to once again say thankyou to the entire Core team for the excellentservice and support throughout our certificationprocess. A special thanks goes out to Marla, ourconsultant, she was AWESOME!Jack S.Accu-Mold Plastics just finished up our two anda half day Transition Audit. We made it throughwith zero non-conformances. The auditor hadonly good things to say about our QMS and thesupporting documents. Just wanted to say thankyou for all the support, recommendations andhelp with preparation. Core Business Solutions isawesome.08