SkillFront Program Book: ISO 9001 Quality Management Systems Certification

(1)

(2)

Skill Platform For

Professionals

SKILLFRONT

WWW.SKILLFRONT.COM

(3)

PROGRAM BOOK

For ISO 9001

Quality Management Systems Certification Programs

ISO 9001 Quality Management Systems Framework

(4)

Dedication

To all of the SkillFront Professionals, thank you for inspiring us, keeping us focused, and making sure we do our best to guide you to execute ideas, grow businesses, and dominate your markets online and offline.

We are proud of seeing you while you serve your clients at your highest levels possible and positively influence their lives that wouldn't happen otherwise.

Without you, your engagement, and your loyal support, SkillFront could not come where it is today.

(5)

Table Of Contents _________________________________________________________ 5 Welcome To The SkillFront ________________________________________________ 13 Become A Bit Better Than You, Everyday ______________________________________ 18 Why Does ISO 9001 Matter? _______________________________________________ 24

The Problems That ISO 9001 Certification Solves ____________________________________ 24 How ISO 9001 Certification Benefits Your Career and Company _________________________ 25

1. Improved Processes _______________________________________________________________ 25 2. Better Decision-Making ____________________________________________________________ 26 3. More Revenue and Profit ___________________________________________________________ 26 4. Support for Other Industry-Specific Standards __________________________________________ 28 5. Better Credibility and Improved Perception ____________________________________________ 28

CLICKABLE

5

(6)

6. Meets Requirements for Government Contracts ___ 29 7. Reduced Costs _ 29 8. Smoother Ordering and Customer Interaction 30 9. Greater Customer Satisfaction _ 30 10. No Need to Reinvent the Wheel __________________________ 31

ISO 9001 Step-By-Step Implementation Guide _________________________________ 32

Step 1. Get Management Support _________________________________________________ 32 Step 2. Identify Key Requirements ________________________________________________ 32 Step 3. Define The QMS Scope ___________________________________________________ 33 Step 4. Define Processes and Procedures ___________________________________________ 33 Step 5. Implement Processes and Procedures _______________________________________ 33 Step 6. Create or Use Training and Awareness Programs _______________________________ 34 Step 7. Choose A Reasonable Certification Body _____________________________________ 34 Step 8. Operate the QMS / Measure your Systems ____________________________________ 34 Step 9. Conduct Internal Audits __________________________________________________ 35

6

(7)

Step 10. Conduct Management Review ____________________________________________ 35 Step 11. Implement Corrective Actions ____________________________________________ 35 Step 12. Stage 1 Certification Audit ________________________________________________ 36 Step 13. Stage 2 Certification Audit _______________________________________________ 36

Benefits of ISO 9001:2015 Quality Management Systems Certified Business™ 37 ISO 9001 Quality Management Systems Framework _ 39 1. Scope ___________________ 40 2. Normative References _ 41 3. Terms and Definitions 42 4. Context of the Organization ____________________ 44

4.1. Understanding the Organization and its Context _________________________________ 44

4.2. Understanding the Needs and Expectations of Interested Parties _____________________ 44

4.3. Determining the Scope of the Quality Management System _________________________ 45

4.4. Quality Management System and its Processes ___________________________________ 46

(8)

5. Leadership ___________________________________________________________ 47

5.1. Leadership and Commitment ________________________________________________ 47

5.1.1. General ______________________________________________________________________ 47

5.1.2. Customer Focus _________________________________________________________ 48 5.2. Policy __________________________________________________________________ 48

5.2.1. Developing the Quality Policy _____ 48 5.2.2. Communicating the Quality Policy _ 48

5.3. Organizational Roles, Responsibilities, and Authorities ____________________________ 49

6. Planning _____________________________________________________________ 50

6.1. Actions to Address Risks and Opportunities _____________________________________ 50 6.2. Quality Objectives and Planning to Achieve Them ________________________________ 50 6.3. Planning of Changes _______________________________________________________ 51

7. Support ______________________________________________________________ 52

7.1. Resources ________________________________________________________________ 52

7.1.1. General ______________________________________________________________________ 52

8

(9)

7.1.2. People _______________________________________________________________________ 52 7.1.3. Infrastructure _________________________________________________________________ 52 7.1.4. Environment for the Operation of Processes _________________________________________ 53 7.1.5. Monitoring and Measuring Resources _______________________________________________ 53 7.1.6. Organizational Knowledge _______________________________________________________ 54

7.2. Competence ______________________________ 55 7.3. Awareness _ 55 7.4. Communication _ 55 7.5. Documented Information _______________________ 56

7.5.1. General ______________________________________________________________________ 56 7.5.2. Creating and Updating __________________________________________________________ 56 7.5.3. Control of Documented Information _______________________________________________ 56

8.1 Operation ___________________________________________________________ 58

8.1. Operational Planning and Control ____________________________________________ 58 8.2. Requirements for Products and Services _______________________________________ 59

8.2.1. Customer Communication _______________________________________________________ 59

9

(10)

8.2.2. Determining the Requirements Related to Products and Services _________________________ 59 8.2.3. Review of Requirements Related to Products and Services ______________________________ 60 8.2.4. Changes to Requirements for Products and Services ___________________________________ 61

8.3. Design and Development of Products and Services ________________________________ 61

8.3.1. General ______________________________________________ 61 8.3.2. Design and Development Planning _ 61 8.3.3. Design and Development Inputs ___ 62 8.3.4. Design and Development Controls _ 62 8.3.5. Design and Development Outputs _ 63 8.3.6. Design and Development Changes _________________________ 64

8.4. Control of Externally Provided Processes, Products, and Services ____________________ 64

8.4.1. General ______________________________________________________________________ 64 8.4.2. Type of Extent Control __________________________________________________________ 65 8.4.3. Information for External Providers ________________________________________________ 66

8.5. Production and Service Provision ____________________________________________ 66

8.5.1. Control of Production and Service Provision _________________________________________ 66

10

(11)

8.5.2. Identification and Traceability ____________________________________________________ 67 8.5.3. Property Belonging to Customers or External Providers ________________________________ 68 8.5.4. Preservation __________________________________________________________________ 68 8.5.5. Post-delivery Activities __________________________________________________________ 68 8.5.6. Control of Changes _____________________________________________________________ 69

8.6. Release of Products and Service ____ 69 8.7. Control of Nonconforming Outputs _ 70

9. Performance Evaluation _________________________________________________ 71

9.1. Monitoring, Measurement, Analysis and Evaluation _______________________________ 71

9.1.1. General ______________________________________________________________________ 71 9.1.2. Customer Satisfaction ___________________________________________________________ 71 9.1.3. Analysis and Evaluation _________________________________________________________ 71

9.2. Internal Audit ____________________________________________________________ 72 9.3. Management Review _______________________________________________________ 73

9.3.1. General ______________________________________________________________________ 73 9.3.2. Management Review Inputs ______________________________________________________ 73

11

(12)

9.3.3. Management Review Outputs _____________________________________________________ 74

10. Improvement ________________________________________________________ 75

10.1 General _________________________________________________________________ 75 10.2. Nonconformity and Corrective Action _________________________________________ 75 10.3. Continual Improvement ___________________________________________________ 76

ISO 9001 - Roles And Responsibility In Organizations ____________________________ 78

Why Understanding Roles is Critical to the Quality Management Program? _______________ 78 Five Typical Roles and Responsibilities ____________________________________________ 79

1. ISO 9001 Quality Management Systems Associate ________________________________________ 79 2. ISO 9001 Quality Management Systems Internal Auditor __________________________________ 80 3. ISO 9001 Quality Management Systems Lead Auditor _____________________________________ 81 4. ISO 9001 Quality Management Systems Lead Implementor ________________________________ 82 5. ISO 9001 Quality Management Systems Quality Manager __________________________________ 83

Next Steps For The Pursuit Of Growth ________________________________________ 85

Thanks For Learning With The SkillFront _____________________________________ 88

(13)

13

Welcome To The SkillFront

New Year's Eve 2010.

As the rest of the world went about celebrating the dawn of a new year heading into 2011, I lay in my bed, next to my baby, who was born less than four short months ago.

My husband sat next to me, and I can still remember the sound of fireworks set off in the neighborhood.

I could see the colors of fireworks, reflecting off my husband's face. He turned and looked at me, while tears were pouring down my cheeks, and he said, "You didn't sign up for this. We're going to fix it!"

I lay down and put my hands back behind my head;

closing my eyes, I felt every aspect of my being filled with rage.

“

As to methods, there may be million and then some, but skills are few. The one who grasps skills can successfully select his or her own methods. The one who tries methods, ignoring skills, is sure to have trouble.”

— Ralph Waldo Emerson, Essayist and Poet

(14)

14

My mind raced back to the winter, nearly twelve months before, to me getting promoted to a leadership position at one of Switzerland's largest local banks. As the manager of the busiest branch in the middle of the city of Zurich, I was leading thirty to forty employees, contractors, and agency staff. To this day, I can't help but marvel at the thousands of working hours, the millions of Swiss francs, and the enormously complex processes necessary to make a simple financial investment product shown in our portfolio of products.

And yet, there I was lying, heading into 2011, with the termination letter in my hand. It turned out that my employer didn't want to occupy their demanding positions with mothers of newborn babies. They couldn't wait any longer and quickly sent me my notification at the end of my twelve-weeks of officially deserved maternity leave.

At this moment, you may be wondering why I didn't go

back to my corporate career, although I could have reasonably quickly find another job, given my qualifications and job experiences, even if I had this big

"obstacle" of having a few months old baby.

Let me tell you this. The shock of getting fired helped me admit three very important things that I haven't been entirely honest to myself before:

1. Large companies move slowly. Good ideas often died on the vine simply because they had to be approved by too many people.

2. Climbing the corporate ladder is an obstacle to doing great work. I wanted to focus on getting things done and making things better, not constantly positioning myself for promotion. Politics and turf wars are an inescapable part of the daily experience of working for a large company.

(15)

15

3. Frustration leads to burnout. I wanted to enjoy my daily work experience, but instead, I felt like I was running a gauntlet each day. It began to affect my health during my pregnancy, happiness, and relationships with my husband, friends, and family.

The longer I thought of these facts, the more I realized I wanted out. I desperately wanted to work on my own terms, as an entrepreneur.

The next ten years took me on a journey, trying to bring up my baby, become a good wife, and transform myself into the practical scientist to unlocking measurable results in every area of my life every day. A scientist I call the SkillFront Entrepreneur.

My name is Yeliz Obergfell.

I am a married woman.

I am a mother.

I am a businesswoman.

And most important:

I am a SkillFront Entrepreneur.

I train entrepreneurs at all levels —from want-to-be entrepreneurs to owners of large enterprises— to execute ideas, grow businesses, and dominate their markets online and offline.

I wasn't trying to become an expert.

In fact, I wasn't even sure what being an expert meant. I was, and I am still trying to be a student of my own passion; helping and serving other entrepreneurs succeed in business.

I wanted to set myself free after getting laid off. I had no clue that what would start with a decision to change my life would transform into a global movement thanks to the principles, frameworks, and support of SkillFront, the Skill Platform for Entrepreneurs.

(16)

16

I started the idea of SkillFront in 2011 with zero knowledge of marketing, sales, persuasion, closing, e- commerce, or automated digital marketing systems.

On top of that, I had never delivered a service that was 100 percent created by me, and I had spent most of my career selling other services.

From 2011 to 2014, I struggled to get the message I felt in my heart and soul out to the world. Although we were having some mild success, I was paralyzed trying to figure out not only the psychology of being a female leader with my message, but also the science and technology to sustain and scale my business.

I have always been an avid learner, but before I decided to learn everything I could about how I can succeed as an entrepreneur, most of what I read was fiction. If there is one thing I am good at it, it is taking in a huge amount of information and distilling it into essentials. I am a

synthesist by nature, and my travels through the business literature quickly became an exercise in separating the diamonds from the rough.

The more I learned, the more helpless I felt. For every great resource I found, I had to process ten other resources to figure out how to apply that resource in practice to excel on my own entrepreneurship journey.

I started to wonder: how much of what's out there —and there is a lot out there— I really needed to know. How could I separate practical business and entrepreneurship skills from the dry theory and technobabble? I only had so much time and energy, so I started searching for a filter: something that would direct me to the useful skills and keep me away from the chaff. The more I searched, the more I realized it didn't exist — so I decided to create the SkillFront.

(17)

17

As of this moment, 143,487 SkillFront Entrepreneurs are actively using the SkillFront Platform to quickly get their ideas, products, and services out to the world!

I don't share that with you to impress you. To some of you hearing this, that is a big thing, and to others, it's nothing. I share it to demonstrate what is possible when you learn, live, and leverage the practical science and art of being an entrepreneur while combining those skills with lessons you are going to earn in real practice.

So take a deep breath. It's time for you to unlock the blueprint of success as an entrepreneur and get to work.

Welcome to the SkillFront.

Yeliz Obergfell, SkillFront

Cofounder, Vice President – Entrepreneur Experience

(18)

18

Become A Bit Better Than You, Everyday

The Key To Success: Model The Best

During one of the seminars I attended more than a decade ago in Nashville, Tennessee, I had one of the most significant aha moments in my personal and entrepreneurial growth journey, which impacted my business more than everything else I learned until today.

That was the discovery of thoughtful modeling to build my own skills and career. Children use modeling all the time to learn how to speak, use tools, or tie their shoes.

If you look at it carefully, modeling is not only essential to build new skills, but also it's necessary for the continuity of skills, lessons, know-how, and the world's intellectual and cultural legacy from one generation to another.

“

Before you can be great, you must be good. Before you can be good, you must be bad. Before you can be bad, you must try.”

— Jim Edwards, Copywriter and Digital marketer

(19)

19

One caveat here: I have seen and met many people who mix modeling with copying someone else's materials, patents, works, ideas as they’re, and use them for their own goals. Don't do this. That is illegal and unethical.

What I mean with thoughtful modeling is:

1. Look for a business that is already successful in your chosen field or a leader who has created the kind of life you want to live.

2. As Tony Robbins rightly put out there: Success leaves clues. Find them. There's no need to reinvent the wheel. Those who have succeeded before you have done so, followed a plan, and you can do the same thing. Look into their history and their rise to the top. How did they get to where they are today? What kind of obstacles and setbacks did they face, and how did they overcome them? What are their philosophies about their work and their life?

3. Use this information to build the path of your success that mirrors theirs. Your strategy may be similar to the business or leader you're modeling, or you adjust it for your present circumstances.

So, I started looking at other businesses, studying how they came to where they're today. After all, their techniques worked for them, they could work for me.

But for some reason, my efforts made very little (if any) success and income. I was frustrated because I could see others making money successfully. What was I doing wrong?

It took me almost four years of studying, researching, and interviewing successful business people before I realized that what I was seeing on the surface wasn't their full arsenal of skills and strategies. The entrepreneurs who were making decent money were doing it through steps and processes invisible to the naked eye.

(20)

20

I was modeling what I could see happening on the surface of successful businesses, but they made

the real money in ways I couldn't see.

While I had learned and modeled the part of their businesses that I could see, multiple things were happening behind the scenes that made the magic work.

I found that the difference between a $10,000 and

$1,000,000 business was all the things happening after a buyer initially contacted those businesses.

It took me years to discover and master these hidden skills below the surface of the iceberg, but when I did it, the results spoke for themselves. I wanted to launch SkillFront because I know there are entrepreneurs like me who have been trying to be successful, yet are not having much success.

This and other SkillFront programs are the culmination of a decade spent analyzing thousands of companies and their success models. I have built a number of successful companies of my own, and I have worked with

(21)

21

tens of thousands of students and clients to guide them to build businesses in every industry you can dream of - both online and offline.

This and other programs in the SkillFront platform will unlock the practical skills and frameworks that are mastered and continuously used by champion businesses and leaders in their industries.

I hope that while you're learning those skills, you will realize your dreams of success are a lot closer than you think. You will soon see that by providing a ton of value, communicating effectively with your audience, and building out your sales processes and flows in a very strategic way, you can get your product, service, and message out to the world. And you can get paid what you're worth while doing it.

All Skills You're Going To Learn Are Evergreen

If you've tried to learn how to build and grow your company in the past, you've probably purchased courses and courses that teach systems that worked when they were created but became outdated. Often, before they even reached a wider audience and found their way to you.

SkillFront programs, on the other hand, are playcourses for creating and scaling successful businesses that will exponentially increase your sales and income. SkillFront teaches evergreen skills, frameworks, and strategies that will be just as useful 20 years from now as they are today. It's the mission of the SkillFront to focus on principles and methods that are timelines, even if technologies and tools change.

(22)

22

We don't just teach this stuff;

We actually do it.

There are many people teaching business and entrepreneurship from one or another angle, and the vast majority of them are making money by teaching other people’s business strategies. Russell Brunson calls those people "shovel sellers" because during the gold rush, the people who made the most money were the ones selling the shovels. Today's modern shovel sellers are selling you those strategies without actually using any of the techniques themselves.

The difference between SkillFront and most others is that we actually do this for real. That's right. The skills we're going to reveal to you have been learned and then verified by our own real-world practices, or we have earned them after thousands of tests, sleepless nights, mistakes, trials, errors, successes, as well as failures.

One of our amazing partners MicroTrain from Chicago, the United States of America, and their valuable trainees for their successful course and

certification programs.

(23)

23

We have tried these skills in countless different industries, from law practices to multinational e- commerce giants, from coaching services to software- as-a-service providers, from physical product retailers online and offline to real estate brokers, from healthcare, fitness, wellness and leisure providers to sports clubs and educational institutions, and everything else you ever imagine in between.

We also directly work with hundreds of other businesses, advising them and increasing their profitability in almost every niche and industry you can dream of.

I am excited for you to dive in and have some fun with this. So, let's get started!

(24)

24

Why Does ISO 9001 Matter?

The benefits of ISO certification are numerous, yet, you may still be wondering if an ISO 9001 certification is right for your company. No matter how big or small the business, the ISO 9001 quality management standard can make a huge difference for your company.

The Problems That ISO 9001 Certification Solves

Imagine a world without quality management systems.

Companies would sell bad products without ever improving. Companies would make countless mistakes

without ever learning from them. There would be constant repairs and reworking - or the customer would receive bad products or services. Costs would increase.

Customers would be increasingly dissatisfied. Products could not be used as advertised, some would be dangerous to use. Think of hospital services without quality management.

Quality management leads to products and services that are as required by the customer, consistent, safe, and reliable. Quality management also leads to efficient and profitable companies. ISO 9001, an international standard brought to us by the International Organization for Standardization (ISO) provides us with a reliable framework through which companies can set up their quality management system.

ISO has developed 21,985 standards to help improve quality of life for people around the world. These international standards include guidelines on everything

(25)

25

from air and water quality to road safety and hygienic medical packaging.

The ISO 9001 Quality Management Standard is the most well-known and most widely implemented standard for a quality management system worldwide.

How ISO 9001 Certification Benefits Your Career and

Company

A total of more than 1,5 million organizations had ISO 9001 certificates worldwide, with an annual growth rate of 6.9%. Interest in ISO 9001 certification has increased for good reason - the ISO 9001 quality management standard can make a significant difference for your business. Below are just a few of the benefits:

1. Improved Processes

ISO 9001 is a comprehensive framework that addresses all key processes throughout the company - not just quality control. By taking such a broad view, ISO 9001 leads not only to quality products and services, but also to improved production and service provision with less rework and lower cost. From process integration to improvement, the ISO 9001 standard is all about quality processes. In fact, the current year 2015 revision of ISO 9001 focuses on the "process approach " as a central pillar of ISO 9001. The idea is that a process-based QMS (Quality Management System) connects interrelated processes to form a cohesive whole to ensure that processes are not only managed individually but with a view towards how they affect other processes within the company.

ISO 9001 won't give you details on all of your interconnected processes and how they individually

(26)

26

work. However, ISO 9001 gives you the guidelines to think holistically and systemically about your processes and how they relate to one another, resulting in more effective and better integrated processes.

2. Better Decision-Making

Good decision-making is key to business success. ISO 9001's structured framework for quality management provides management with both information and processes for fact-based decisions that rely on evidence, not merely on gut feelings.

An ISO 9001-based Quality Management System, especially one that has been audited and certified, will have a built-in process for gathering and analyzing data.

Management will gain insights into which processes are working and which ones need tweaking or improvement.

All of this will help you improve your decision-making

process. Never again will you be throwing darts in the dark but charting a direction based on real, actionable information.

3. More Revenue and Profit

Customers want quality and they will reward companies that provide it. For this reason, ISO 9001-certified organizations are not only perceived as being more competent, they are paid 7% more on average than non- ISO 9001 companies.

ISO 9001 companies also post better sales growth and improved financial performance (based on return on assets). Moreover, 85% of companies with ISO 9001 certifications experienced more demand for their products or services, as well as an increase in market share.

(27)

27

(28)

28

4. Support for Other Industry- Specif ic Standards

ISO 9001 has the additional benefit in that it sets the foundation for other industry-specific standards, such as ISO 14001 (environmental management), ISO 20000 (IT service management), ISO 13485 (medical devices), and ISO/TS 16949 (automotive industry). Implementing ISO 9001 first makes the addition of other management standards rather quick and easy. This is particularly true since the 2015 revision of ISO 9001 (and other ISO standards), as all new ISO standards now use the same structure and numbering system.

In other words, what you invest in achieving an ISO 9001 certification will not only provide you with the benefits of a worldwide recognized quality management system but also with a significant reduction in required cost and time should you decide to add certification to your

industry's specific standards.

5. Better Credibility and Improved Perception

ISO 9001 certification is a clear indicator that a professional and a company is committed to quality. As ISO 9001 is the world's most well-known quality standard, your potential customers will automatically have a better perception of your company if you can advertise your ISO 9001 certification. An ISO 9001 certification mark adds credibility to advertising and marketing.

(29)

29

6. Meets Requirements for Government Contracts

For certain types of companies, government contracts can be a lucrative business. Unfortunately, obtaining government contracts can require a lot of hoops to jump through, starting with an involved RFP or tender process. ISO 9001 helps set your organization up for success with public sector work. And, in fact, for some municipalities and government agencies, ISO 9001 certification will be a requirement.

Not only governments but also companies tend to make ISO 9001 a prerequisite. Particularly companies that have themselves achieved ISO 9001 accreditation require the same from their suppliers. Amazon, for example, advertises their ISO 9001 compliance for their AWS business cloud services noting that "using an ISO 9001 certified provider like AWS can make your

certification process easier”.

7. Reduced Costs

How much money does your company waste every year on rework? Repairs? Rejected products? Recalls?

Outdated inventory? Warranty claims? What about the cost of lost opportunity or angry customers? By improving your quality management system with ISO 9001, you will see less and less need for rework as there will be less and less problems with your products or services. With improved operational processes, production and service provision will become efficient and error-free, resulting in reduced cost and an improved bottom line.

It's a win/win for the business as well as its customers.

This is why ISO 9001 doesn't only benefit the company that pursues certification. It also offers tremendous

(30)

30

benefits to customers as well.

8. Smoother Ordering and Customer Interaction

ISO 9001 certified companies have an improved order process in place. The communication of customer orders will become smoother, misunderstandings will be avoided, and there won't be a need to ask the customer the same questions again. These improvements not only increase operational efficiency, they also reduce friction with customers.

9. Greater Customer Satisfaction

If your operational processes are running more smoothly and more efficiently, and your product or service quality

has improved as a result, your customers will be happier.

In fact, companies who have gone through the ISO 9001 certification process have reported that their customers are more satisfied. Increased customer satisfaction not only leads to increased customer loyalty, but satisfied customers are also willing to pay more: on average 7%

more, as we've noted earlier.

The fact is, ISO 9001 certified companies are generally better at delivering quality products or services on time than companies that aren't using this quality management system model. Certainly, some companies have developed their own in-house quality management systems without using ISO 9001. However, data shows that ISO 9001 companies overall perform better than their non-ISO 9001 counterparts.

Increased customer satisfaction and more efficient operations will both reflect positively on the bottom line, increasing value for your shareholders.

(31)

31

10. No Need to Reinvent the Wheel

There are many frameworks for quality management systems, ranging from the general experience and gut feelings of the CEO to detailed requirements. The ISO 9001 standard is a set of detailed requirements that are proven to work. By using ISO 9001 as the framework for your quality management system, you don't need to start from scratch and you can avoid mistakes.

Not only does ISO 9001 provide a proven framework for your company's quality management system, it is recognized as the gold standard. ISO 9001 is the most well-known and most widely-implemented standard for quality management systems worldwide. Using ISO 9001 as the foundation for your quality management system leverages tried and true processes created, tested, and implemented by international experts and top companies worldwide.

(32)

32

ISO 9001 Step-By- Step

Implementation Guide

If your company is looking at implementing a quality management system (QMS) based on the ISO 9001 standard and becoming certified, you might be overwhelmed with figuring out where to start. To help with this, here is an overview of the 13 steps that are needed to help you make sure that nothing is missed during your implementation and preparations for certification:

Step 1. Get Management Support

This is critical. Without the support of management your implementation of ISO 9001 will almost certainly fail.

Plan your sales pitch well to convince your management that ISO 9001 is a good idea. Use the previous chapter of this material to prepare good arguments.

Step 2. Identify Key Requirements

Another crucial step to make sure your implementation succeeds is to make sure you have identified all the requirements that exist for your QMS. These will include customer requirements, as well as other requirements such as regulations and the needs of your company

(33)

33

culture.

Step 3. Define The QMS Scope

Defining the scope of your QMS will help to ensure you know the limits of what needs to be done, so that you do not include areas of your business that might not have an effect on your system. The key tool to define the scope is the quality policy which will be the first document you will need to create for the QMS.

Step 4. Define Processes and Procedures

These will include the mandatory procedures defined by

the ISO 9001 standard, but also any additional processes and procedures required by your company to ensure consistent and adequate results with respect to quality.

The key is to define all the processes in your company and look at how they interact within your organization. It is in these interactions that problems can occur.

Step 5. Implement Processes and Procedures

Often, these processes will already be in place at your company and will just need to be adequately documented to ensure consistent results. Not all processes need to be documented procedures, but it is important to decide which ones need to be in order to ensure compliant products and services.

(34)

34

Step 6. Create or Use Training and Awareness Programs

It is important that everyone in your organization know what you are doing with your QMS and how they fit into the equation. Employees should have training on what ISO 9001 is, so that they are aware of why you are doing this, as well as the important training of any changes to the processes they are involved in.

Step 7. Choose A Reasonable Certification Body

This can be a very important step in how effective your implementation is. The certification body is the company that will ultimately come in to audit your QMS and decide if it is compliant with ISO 9001 requirements, as

well as whether it is effective and improving. It is best to interview several certification bodies to decide which is right for your company.

Step 8. Operate the QMS / Measure your Systems

This is when you will collect the records that will be required in audits to show that your processes meet the requirements set out for them, that they are effective, and that improvements are being made in your QMS as needed. Certification bodies need this to happen over a certain length of time, which they will identify, in order to ensure that the system is mature enough to show compliance.

(35)

35

Step 9. Conduct Internal Audits

Before the certification body comes in to audit your system, they will first want you to audit each process internally. This will give you a chance to make sure that the processes are doing what you had planned. You will also have a chance to implement the necessary corrective actions to fix any problems that you find.

Step 10. Conduct

Management Review

Just as it is important that management support the implementation of ISO 9001, it is also important that they are involved in the continued maintenance of the QMS. Management needs to review specified data from

the activities of the QMS in order to ensure that the processes have adequate resources to be effective and improve.

Step 11. Implement Corrective Actions

This is the step where you find the root cause of any problems found during your measurements, internal audits and management review and take action to correct the root cause. This is the key step toward improvement, which is a main focus of having an ISO 9001 QMS.

(36)

36

Step 12. Stage 1 Certification Audit

This is a review of your documentation by the certification body auditors to verify that, on paper, you have addressed all the necessary requirements of the ISO 9001 standard. The auditors will issue a report outlining where you comply and where there are problems, and you will have a chance to implement any corrective actions to address the problems. This may take place during the timeframe defined for the initial operation of the QMS.

Step 13. Stage 2 Certification Audit

This is the main audit when the certification body

auditors will review the records you have accumulated by operating your QMS processes, including your records of internal audits, management review and corrective actions. From this review, which will take several days, they will issue a report detailing their findings and whether they have found your QMS to be effective and in compliance with the ISO 9001 requirements. The auditors will also make a recommendation for certification if you meet all requirements. If you have any major non-conformances, then you will need to take corrective action for these problems before certification can be recommended.

A good plan will help a lot when you implement ISO 9001 and work toward certification, so do take the time to plan and know what resources you need – this will save you time and resources later on.

(37)

37

Benefits of ISO

9001:2015 Quality Management

Systems Certified Business™

ISO 9001 are the standards that set out the requirements for quality management systems. It helps businesses and organizations to be more efficient and improve customer satisfaction. Implementing ISD 9001 quality management systems will help you:

• Assess the overall context of your organization to

define who is affected by your work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.

• Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to repeat customers, new clients and increased business for your organization.

• Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.

• Meet the necessary statutory and regulatory requirements.

• Expand into new markets, as some sectors and clients require ISO 9001 before doing business.

• Identify and address the risks associated with your organization.

• Accredited by the standards of ISO/IEC 17024:2012 Conformity: General requirements for bodies

(38)

38

operating certification of persons, ISO/IEC 17021:2015 Conformity: Requirements for bodies providing audit and certification of management systems; Authorized and regulated by the Swiss Federal Government.

More info about ISO 9001:2015 Quality Management Systems Certified Business™ Program:

https://www.skillfront.com/ISO-9001-Company- Certification

(39)

39

ISO 9001 Quality Management

Systems

Framework

At An ISO 9001 Company we know that an inferior product or service can cost you money, time and credibility. In business, the only tolerance is zero defects. We understand the importance of prompt client response, quality and on time delivery. An ISO 9001 Company has achieved customer loyalty by practicing a policy of strong communication and working closely with customers to deliver to their exact expectations.

This Quality Management System (QMS) specifies

requirements that An ISO 9001 Company uses to address customer satisfaction, to meet customer and applicable regulatory and statutory requirements and to meet ISO 9001:2015 requirements, and is supported by additional procedures where necessary. The quality management principles stated in ISO 9000, and ISO 9004, have been taken into consideration too during the development of this Quality Policy Manual.

A Quality Manual specifies the general requirements for An ISO 9001 Company competence towards a management system for quality, administrative and technical operations.

(40)

40

1. Scope

This Quality Management System (QMS) specifies requirements for a quality management system where An ISO 9001 Company:

a) Needs to demonstrate its ability to consistently provide product and services that meet customer a n d a p p l i c a b l e s t a t u t o r y a n d r e g u l a t o r y requirements, and

b) Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of this ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and

services it provides.

(41)

41

2. Normative References

A Quality Management System, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9001:2015, Quality management systems — Fundamentals and vocabulary.

(42)

42

3. Terms and Definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

(43)

43

(44)

44

4. Context of the Organization

4.1. Understanding the

Organization and its Context

An ISO 9001 Company has determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

An ISO 9001 Company monitors and reviews information about these external and internal issues.

4.2. Understanding the Needs and Expectations of

Interested Parties

Due to their effect or potential effect on An ISO 9001 Company’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, An ISO 9001 Company determined:

a) The interested parties that relevant to the quality management system;

b) The requirements of these interested parties that are relevant to the quality management system.

An ISO 9001 Company monitors and reviews the information about these interested parties and their relevant requirements.

(45)

45

4.3. Determining the Scope of the Quality Management

System

An ISO 9001 Company has determined the boundaries and applicability of the quality management system to establish its scope. When determining this scope, An ISO 9001 Company considered:

a) The external and internal issues referred to in 4.1;

b) The requirements of relevant interested parties referred to in 4.2;

c) The products and services of An ISO 9001 Company.

An ISO 9001 Company applies all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of An ISO 9001 Company’s quality management system is available and maintained as documented information. The scope states the types of products and services covered, and provides justification for any requirements that An ISO 9001 Company has determined is not applicable to the scope of its quality management system. Conformity to ISO 9001 are only claimed if the requirements determined as not being applicable do not affect An ISO 9001 Company’s ability to ensure the conformity of its product and services and the enhancement of customer satisfaction.

Scope of Registration

The Scope associated with An ISO 9001 Company activities and registration.

(46)

46

4.4. Quality Management System and its Processes

4.4.1. An ISO 9001 Company has established, implemented, maintains, and continually improves a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

An ISO 9001 Company has determined the processes needed for the quality management system and their application throughout An ISO 9001 Company, and

a) Determined the inputs required and the outputs expected from these processes;

b) Determined the sequence and interaction of these processes;

c) Determined and applied the criteria and methods (including monitoring, measurements and related

performance indicators) needed to ensure the effective operation and control of these processes;

d) Determined the resources needed for these processes and ensure their availability;

e) Assigns the responsibilities and authorities for these processes;

f) Addresses the risks and opportunities as determined in accordance with the requirements of 6.1;

g) Evaluates these processes and implement any changes needed to ensure that these processes achieve their intended results.

h) Improves the processes and the quality management system.

4.4.2. To the extent necessary, An ISO 9001 Company:

a) Maintains documented information to support the operation of its processes;

b) Retain documented information to have confidence that the processes are being carried out as planned.

(47)

47

5. Leadership

5.1. Leadership and Commitment

5.1.1. General

Top management demonstrates leadership and commitment with respect to the quality management system by:

a) Taking accountability for the effectiveness of the quality management system;

b) Ensuring that the quality policy and quality objectiveness are established for the quality management system and are compatible with the context and strategic direction of An ISO 9001

Company;

c) Ensuring the integration of the quality management system requirements into An ISO 9001 Company’s business process;

d) Promoting the use of the process approach and risk- based thinking;

e) Ensuring that the resources needed for the quality management system are available;

f) Communicating the importance of effective quality management and of conforming to the quality management system requirements;

g) Ensuring that the quality management system achieves its intended results;

h) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) Promoting improvement; and

j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

(48)

48

5.1.2. Customer Focus

Top management demonstrates leadership and commitment with respect to customer focus by ensuring that:

a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b) The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; and

c) The focus on enhancing customer satisfaction is maintained.

5.2. Policy

5.2.1. Developing the Quality Policy

Top management has established, implemented and maintains a quality policy that:

a) Is appropriate to the purpose and context of An ISO 9001 Company and supports its strategic direction;

b) Provides a framework for setting quality objectives;

c) Includes a commitment to satisfy applicable requirements; and

d) Includes a commitment to continual improvement of the quality management system.

5.2.2. Communicating the Quality Policy

The Quality Policy:

(49)

49

a) is available and maintained as documented information;

b) is communicated, understood and applied within the organization; and

c) is available to relevant interested parties, as appropriate.

Our quality policy ensures that quality is present from inception to completion in all that we do.

5.3. Organizational Roles, Responsibilities, and

Authorities

Top management ensures that the responsibilities and a u t h o r i t i e s fo r re l eva nt ro l e s a re a s s i g n e d , communicated and understood within An ISO 9001

Company.

Top management assigns the responsibility and authority for:

a) Ensuring that the quality management system conforms to the requirements of this International Standard;

b) Ensuring that the processes are delivering their intended outputs;

c) Reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;

d) Ensuring the promotion of customer focus throughout An ISO 9001 Company; and

e) Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

(50)

50

6. Planning

6.1. Actions to Address Risks and Opportunities

6.1.1. When planning for the quality management system, An ISO 9001 Company considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to:

a) Give assurance that the quality management system can achieve its intended results;

b) Enhance desirable effects;

c) Prevent, or reduce, undesired effects; and d) Achieve improvement.

6.1.2. An ISO 9001 Company plans:

a) Actions to address these risks and opportunities;

b) How to:

1. Integrate and implement the actions into its quality management system processes (See 4.4) 2. Evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities are proportionate to the potential impact on the conformity of products and services.

6.2. Quality Objectives and Planning to Achieve Them

6.2.1. An ISO 9001 Company has established quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives are:

a) Consistent with the quality policy;

(51)

51

b) Measurable;

c) Taken into account applicable requirements;

d) Relevant to conformity of products and services and to enhancement of customer satisfaction;

e) Monitored;

f) Communicated; and g) Updated as appropriate.

An ISO 9001 Company maintains documented information on the quality objectives.

6.2.2. When planning how to achieve its quality objectives, An ISO 9001 Company has determined:

a) What will be done;

b) What resources will be required;

c) Who will be responsible;

d) When it will be completed; and e) How the results will be evaluated.

6.3. Planning of Changes

When An ISO 9001 Company determines the need for changes to the quality management system, the changes are carried out in a planned manner (see 4.4).

An ISO 9001 Company considers:

a) The purpose of the changes and their potential consequences;

b) The integrity of the quality management system;

c) The availability of resources; and

d) The allocation or reallocation of responsibilities and authorities.

(52)

52

7. Support

7.1. Resources

7.1.1. General

An ISO 9001 Company determines and provides the r e s o u r c e s n e e d e d f o r t h e e s t a b l i s h m e n t , i m p l e m e n t a t i o n , m a i n te n a n c e a n d c o n t i n u a l improvement of the quality management system.

An ISO 9001 Company considers:

a) The capabilities of, and constraints on, existing internal resources; and

b) What needs to be obtained from the external providers.

7.1.2. People

An ISO 9001 Company determines and provides the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

7.1.3. Infrastructure

An ISO 9001 Company determines, provides, and maintains the environment necessary for the operation of its processes and to achieve conformity of products and services.

a) Buildings and associated utilities;

b) Equipment, including hardware and software;

c) Transportation resources; and

d) Information and communication technology.

(53)

53

7.1.4. Environment for the Operation of Processes

An ISO 9001 Company determines, provides and maintains the environment necessary for the operation of its processes and to achieve conformity of products and services.

a) Social (e.g. non-discriminatory, calm, non- confrontational);

b) Psychological (e.g. stress reducing, burnout prevention, emotionally protective);

c) Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

7.1.5. Monitoring and Measuring Resources

7.1.5.1. General

An ISO 9001 Company determines and provides the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

An ISO 9001 Company ensures that the resources provided:

a) Are suitable for the specific type of monitoring and measurement activities being undertaken; and

b) Are maintained to ensure their continuing fitness for their purpose.

An ISO 9001 Company retains appropriate documented information as evidence of fitness for purpose of the

(54)

54

monitoring and measurement resources.

7.1.5.2. Measurement Traceability

When measurement traceability is a requirement, or is considered by An ISO 9001 Company to be an essential part of providing confidence in the validity of measurement results, measuring equipment are:

a) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standard exist, the basis used for calibration or verification is retained as documented information;

b) Identified in order to determine their status; and

c) Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

An ISO 9001 Company determines if the validity of

previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and takes appropriate action as necessary.

7.1.6. Organizational Knowledge

An ISO 9001 Company determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

This knowledge is maintained and made available to the extent necessary.

When addressing changing needs and trends, An ISO 9001 Company considers its current knowledge and determines how to acquire or access any necessary additional knowledge and required updates.

(55)

55

7.2. Competence

An ISO 9001 Company:

a) Determines the competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

b) Ensures that these persons are competent on the basis of appropriate education, training, or experience;

c) Where applicable, take actions to acquire the n e c e s s a r y co m p ete n c e, a n d eva l u ate t h e effectiveness of the actions taken; and

d) Retain appropriate documented information as evidence of competence.

7.3. Awareness

An ISO 9001 Company ensures that persons doing work

under the An ISO 9001 Company’s control are aware of:

a) The quality policy;

b) Relevant quality objectives;

c) Their contribution to the effectiveness of the quality management system, including the benefits of improved performance; and

d) The implication of not conforming with the quality management system requirements.

7.4. Communication

An ISO 9001 Company determined the internal and external communications relevant to the quality management system, including:

a) On what it will communicate;

b) When to communicate;

c) With whom to communicate;

(56)

56

d) How to communicate; and e) Who communicates.

7.5. Documented Information

7.5.1. General

An ISO 9001 Company’s quality management system includes:

a) Documented information required by ISO 9001:2015;

and

b) Documented information determined by An ISO 9001 Company as being necessary for the effectiveness of the quality management system.

7.5.2. Creating and Updating

When creating an updating documented information, An

ISO 9001 Company ensures appropriate:

a) Identification and description (e.g. title, date, author, or reference number);

b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic); and

c) Review and approval for suitability and adequacy.

7.5.3. Control of Documented Information

7.5.3.1. Documented information required by the quality management system and by ISO 9001:2015 are controlled to ensure:

a) Availability and suitable for use, where and when it is needed; and

b) It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

(57)

57

7.5.3.2. For the control of documented information, An ISO 9001 Company has addressed the following activities, as applicable.

a) Distribution, access, retrieval and use;

b) Storage and preservation, including preservation of legibility;

c) Control of changes (e.g. version control); and d) Retention and disposition.

Documented information of external origin determined by An ISO 9001 Company to be necessary for the planning and operation of the quality management system is identified as appropriate and controlled.

Documented information retained as evidence of conformity are protected from unintended alterations.

(58)

58

8.1 Operation

8.1. Operational Planning and Control

An ISO 9001 Company planned, implemented and controls the processes (see 4.4) needed to meet the requirements for the provision of products and services, and implemented the actions determined in Clause 6, by:

a) Determining the requirements for the products and services;

b) Establishing criteria for:

1. The processes;

2. The acceptance of products and services;

c) Determining the resources needed to achieve conformity to the product and service requirements;

d) Implementing control of the processes in accordance with the criteria; and

e) Determining and keeping documented information to the extent necessary:

1. To have confidence that the processes have been carried out as planned;

2. To demonstrate the conformity of products and services to their requirements.

The output of this planning is in a form suitable to An ISO 9001 Company’s method of operations. An ISO 9001 Company ensures that outsourced processes are controlled (See 8.4).

(59)

59

8.2. Requirements for Products and Services

8.2.1. Customer Communication

Communication with Customers includes:

a) Providing information relating to products and services;

b) Handling inquiries, contracts or orders, including changes;

c) Obtaining customer feedback relating to products and services, including customer complaints;

d) Handling or controlling customer property; and

e) Establishing specific requirements for contingency actions, when relevant.

8.2.2. Determining the

Requirements Related to Products and Services

When determining the requirements for the product and services to be offered to customers, An ISO 9001 Company ensures that:

a) The requirements for the product and services are defined, including:

1. Any applicable statutory and regulatory requirements;

2. Those considered necessary by An ISO 9001 Company;

b) An ISO 9001 Company can meet the claims for the product and services it offers.

(60)

60

8.2.3. Review of Requirements Related to Products and Services

8.2.3.1. An ISO 9001 Company ensures that it has the ability to meet the requirements for products and services offered to customers. An ISO 9001 Company conducts a review before committing to supply products and services to a customer, to include:

a) Requirements specified by customer, including the requirements for delivery and post- delivery activities;

b) Requirements not stated by the customer, but necessary for the specified intended use, when known;

c) Requirements specified by An ISO 9001 Company;

d) Statutory and regulatory requirements applicable to the products and services; and

e) Contract or order requirements differing from those

previously expressed.

An ISO 9001 Company ensures that the contract or order requirements differing from those previously defined are resolved.

The customer’s requirements are confirmed by An ISO 9001 Company before acceptance, when the customer does not provide a documented statement of their requirements.

8.2.3.2. An ISO 9001 Company retains documented information, as applicable:

a) On the results of the review; and

b) On any new requirements for the products and services;

(61)

Referensi

Unduh sekarang ( PDF - 89 Halaman - 4.68 MB )

Garis besar

Requirements Related to Products and Services Five Typical Roles and Responsibilities

Dokumen terkait

Pengaruh Implementasi Quality Management System ISO 9001:2000 terhadap Kinerja Rumah Sakit Duren Sawit

Berdasarkan teori tentang mutu produksi rumah sakit, Quality Management System ISO 9001:2000, kinerja organisasi serta pengukuran kinerja organisasi dengan kerangka strategis

MANAJEMEN SEKOLAH BERMUTU PERSPEKTIF TQM DAN MANAJEMEN ISO 9001 THE QUALITY SCHOOL MANAGEMENT TQM AND ISO 9001 MANAGEMENT PERSPECTIVE

Adapun Manajemen sekolah dengan ISO 9001 merupakan sistem dan model penjaminan dalam desain/pengembangan, produksi, instalasi, dan pelayanan dalam lembaga pendidikan,

Pengaruh Penerapan ISO 9001:2008 terhadap Total Quality Management

Masih dalam Iwan (2010), studi empiris dari Terziovski et al (1997) dalam The Effect of the ISO 9000 Certification Process on Business Performance Over Time melakukan

REQUIREMENTS ENGINEERING FOR CUSTOMER SATISFACTION MANAGEMENT SYSTEM OF HIGHER EDUCATION IMPLEMENTING E-CRM AND ISO 9001:2008

This paper presented requirements engineering processes for customer satisfaction management systems that adopt quality management system with international standards ISO 9001:

Faktor Kritikal Efektivitas Penerapan Quality Management System Iso 9001-2008 Pada Industri Komponen Automotif

Berdasarkan hasil pengujian hubungan faktor sistem dengan indikatornya (ketersediaan sumber daya, jumlah dokumentasi yang dipersyaratkan dalam ISO 9001:2008, dan