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What Is ISO 9001? The Complete Overview

Having a full-fledged QMS guide your organization is useful to improve the quality of your products and services. With ISO 9001 you can get your quality management system officially certified and reap the benefits of implementing one of the most successful ISO standards in the world.

Nicky Liedtke

by Nicky Liedtke | June 03, 2022 | Reading time: 8 minutes

What Is ISO 9001?


ISO 9001 is part of the ISO 9000 family, issued by the acclaimed International Organization for Standardization (ISO) and is a standard for quality management systems (QMS).


As a QMS, ISO 9001 is used in order to demonstrate that an organization or company has the consistent ability to provide products or services that


  1. meet industry regulatory requirements.
  2. meet customer requirements.

Note: ISO 9001 is one of the most popular ISO 9000 standards and is also the only one that necessarily requires official certification.


ISO 9001's popularity stems from its incredible flexibility – no matter the size of your organization, ISO can be applied to any kind of company in any industry or sector.


But what kind of quality does ISO 9001 certify? Indeed, the standard is not applicable to products and therefore says nothing about the quality of a product that is being produced. Instead, ISO 9001 is used to control and oversee the quality of processes which should ultimately translate to high product quality. For if the processes are in smooth working order, well defined and structured it is ultimately the product, the service and the consumer that benefit as well.


Note: With a QMS you don’t manage the product, but the quality of the management structures in their own right.


ISO published the standard in 1987 and states that, as of now, more than one million companies all across the globe have been certified to ISO 9001. A staggering number that highlights the importance of the standard.


Becoming ISO certified simply means that your company has met all necessary requirements detailed in the ISO 9001 standard by the International Organization for Standardization (ISO) and can therefore present a functioning and effective QMS.


If you too wish for your organization to become ISO 9001 certified, we have compiled the ultimate guide for you to learn everything you need to know in order to take your current quality management system to the next level and benefit from the perks of certification. Read on and discover why you should aim for a certification, which requirements you need to fulfill and how to actually achieve certification.



In this guide we will discuss:


1. Why quality management systems are important


1.1 The reasons for implementing a QMS system in your organization


1.2 The 7 quality management principles


1.3 Why you should get ISO 9001 certified


2. The requirements of ISO 9001


3. What it means to be ISO 9001 certified


3.1 How long an ISO 9001 certification is valid


3.2 How much it costs to get ISO 9001 certified


3.3 Whether an ISO 9001 certification is mandatory



The seven principles of QMS graphic

The Importance of Quality Management Systems


Why Quality Management Systems Are Necessary


Before we jump into all the benefits that ISO 9001 offers, you may wonder why a QMS is even important. Of course, in general it is always better to be organized and have systems in place that help you stay organized and hold you and your team accountable. In the past, this may have worked without a strict system in place, however nowadays in our rapidly changing world that is becoming more globalized than ever, you want to offer the highest level of quality on every plane of your business – from product to management.


With a solid QMS in place you can organize everything you do, meet requirements effortlessly and document your entire processes. This way you improve every aspect of your business and can therefore prevent errors, save money and unnecessary man-power and improve your productivity and image continuously.


National standards are becoming more and more outdated and it is becoming more and more important to be able to function and compete on an international playing field. And this is where the International Organization of Standardization comes into play. Coordinating and developing standards with global validity, creating unity and trust across borders.


What Are The Seven Quality Management Principles?


The quality management principles or QMPs are the foundation upon which any quality management system should be built upon. While they are all relevant and necessary, some organizations may, for example, choose to focus more on leadership and improvement, while another company prioritizes customer focus and relationship management. You can set your own focal points, depending on your needs and as your company grows and changes over time, you can shift your focus and prioritize new different principles over others.


Note: ISO 9001 teaches us that we need to be flexible in all our approaches, especially regarding our quality management. From re-evaluating your perspectives, re-assessing your values and constantly observing data in order to continually improve, change is inevitable and should be embraced.


Before we go on to outline the 7 principles and give you illustrative explanations for a successful implementation, you can find an overview for quick reference here:


QMP 1: Customer focus


QMP 2: Leadership


QMP 3: Engagement of people


QMP 4: Process approach


QMP 5: Improvement


QMP 6: Evidence-based decision making


QMP 7: Relationship management



1. CUSTOMER FOCUS


It should be part of any good QMS to develop a good understanding of their customers and their specific needs in order to satisfy them. Gather client and customer feedback data in order to make out any gaps and non-conformities so that you can improve continuously. By paying attention to your customers you strengthen your bond and ensure loyalty.


By prioritizing customer focus, you can expect to


  • increase overall customer satisfaction.
  • deepen customer loyalty.
  • enhance your business reputation.
  • expand your customer range.

2. LEADERSHIP


A strong leader and management team is vital for the health and success of any organization that aims to be lucrative. By developing strong organization heads that succeed in translating their vision and making it approachable, your company will flourish. Such guidance creates purpose and increases motivation and, as a result, productivity.


Communicate the organization’s mission and vision throughout the company and establish a healthy company culture so that you can


  • improve coordination.
  • improve communication between different departments.
  • increase efficiency.

3. ENGAGEMENT OF PEOPLE


A strong leadership team will know how vital their employees are to any operation and will succeed in making this admiration felt. Employee care is actively included in the ISO 9001 and therefore not only strongly encouraged, but a mandatory component of QMS as one of the 7 quality management principles.


Benefits of a high focus on employees include:


  • more employee involvement.
  • more employee trust.
  • better internal communication.
  • more motivation.

The engagement of people in this one of the QMPs can be achieved through open communication and issue discussion. Make sure that every team member feels like a valued member of the team and receives praise for contributions and successes.


4. PROCESS APPROACH


Define activities as processes and make them more approachable and easier to grasp. By introducing a project culture, you establish a holistic business approach that functions interrelatedly, thus allowing for optimized performance and predictable outcomes.


Employing methods and tools like the PDCA cycle facilitates the process approach by defining the system’s objectives.


5. IMPROVEMENT


A mere bettering of your processes is not enough, as with ISO 9001 you strive for continuous and continual improvement. Implement measures that help you and your team identify risks, spot inconsistencies and opportunities to improve. By thusly weeding out the root cause of an issue, you can be sure that your efforts will be rewarded with improved performance, more efficient prevention efforts and eventually much higher customer satisfaction.


6. EVIDENCE-BASED DECISION MAKING


It is important to prioritize and value good decision making – even though it can be a complex process, decisions based on data analysis and clear information are infinitely more likely to produce results. Lean into facts, assess evidence and consider multiple sides in order to improve your decision making processes and your team’s ability to do what is best for the organization.


7. RELATIONSHIP MANAGEMENT


In order to run a successful business, it is important to keep all parties involved satisfied. This includes workers, but also extends over to clients and suppliers. By focussing and working on said relationships and putting an effort into keeping them healthy, you can enhance performance by actively optimizing your supply chain.


Aim to see suppliers, customers, investors or your employees as your partners that can offer you just as much as you can offer them. Share information, evaluate your relationships, work on collaborations and encourage and recognize wherever appropriate.


Why Is ISO 9001 Important?


As a standardization for quality management systems, ISO 9001 gives you the opportunity to grow internationally and garner trust and an excellent reputation. You can achieve more reach and increase your overall operational efficiency. As previously discussed, ISO 9001 is one of the most popular, sought-after and renowned standards worldwide and is generally used by every organization in order to validate their QMS.


As ISO has published these set guidelines and requirements for ISO 9001:2015, improving your quality management structures becomes easy, as you have a set and approved framework to follow. This way there is no second guessing and you can fully focus on improvements.


BENEFITS OF ISO 9001 FOR YOUR BUSINESS


Implementing an ISO 9001 quality management system into your organization and following the 7 QMPs comes with many benefits for your organization, including:


  1. More efficiency in your processes
    Streamline your procedures according to the ISO 9001 regulatory requirements and watch your efficiency increase.
  2. Higher chances of securing new partnerships
    Since ISO 9001 is internationally recognized, a certification can help you in securing contracts. An ISO 9001 certification proves that your business is efficient, well-run and trustworthy, signaling potential partners that you are a party that can be relied upon.
  3. Better relationships with suppliers
    In the same vein that a certification can attract new partnerships, it can also aid you in bettering your relationships with already existing partners by adding a new layer of credibility to your operations.
  4. International Recognition
    On an even larger scale, a certification signals to businesses worldwide that your operations are meeting the requirements of ISO 9001 and that your quality management system is in impeccable shape.
  5. Higher customer satisfaction
    Benefitting both you and your customers, adhering to QMP 1 and making sure you have feedback loops in place helps you identify what your customers desire and how you can better cater to their needs.
  6. More Profit
    By potentially expanding onto an international market or, at the very least, attracting more suppliers and improving your client relationships, you can expect to save costs while at the same time attracting more business and increasing your revenue.
  7. Increased employee motivation
    Not only can partners benefit from your organization being certified, even internally you will be able to foster employee morale and have your staff enjoy their work more.
  8. Better documentation
    Since ISO 9001 requires you to keep records and document your processes meticulously, you can keep track of everything that is going on.
  9. Continuous improvement
    The pathway to better quality management is never ending as there are always processes to be streamlined, relationships to be improved, customers to be satisfied. Meeting the requirements of ISO 9001 is not a one-off thing, you need to uphold the new standards, thus allowing for constant progress.

BENEFITS OF ISO 9001 FOR YOUR CLIENTS


However, it is not only your business that benefits from you meeting the requirements that ISO 9001 stipulates, but your customers profit from a successful implementation as well. An ISO 9001 certification offers your clients


  1. higher service quality, which means they can trust your business operations.
  2. a more satisfactory customer experience due to a focus on client-business relationships (QMP 1, QMP 7).
  3. fewer issues. Items need to be returned less frequently as problems are resolved much quicker and often already internally before they turn into real issues.
  4. an internationally recognized proof of quality of service.


The 7 Principles of QMS illustrated

What Are The ISO 9001 Requirements?


As an international standard, ISO 9001 requirements are meticulous – and they need to be in order to prove that your organization can be trusted. ISO lists over 350 individual requirements in ten clauses.


While many of the stipulations are mandatory, there are also non-mandatory requirements that can benefit your processes and documentation but that are not necessary to receive an ISO 9001 certification.


The 10 ISO 9001 clauses define the standard and its terms and definitions (clause 1-3) before going into the actual requirements of the standard (clause 4-10). There exists also a 0 clause that goes into detail about the benefits of a QMS and further presents the PDCA (Plan-Do-Check-Act) cycle and process approach. The 0 clause is useful and should not be overlooked.


  1. Scope
    The first clause defines when and why an organization should adopt ISO 9001.
  2. Normative references
    The normative references support organizations in better understanding the standard by going into detail about the terminology used and covering the fundamentals.
  3. Terms and definitions
    In order to understand the entire document and to be able to implement ISO 9001 successfully, clause 3 defines terms, vocabulary and definitions used.
  4. Context of the organization
    Clause 4 is the first clause of the mandatory requirements that asks you to align your objectives with the quality management system. Take a look at your business, determine any existing issues (be they internal or external), figure out expectations of all stakeholders and parties involved and the scope of your QMS. Clause 4 helps you deal with any influences and provides you with a bigger picture viewpoint.
  5. Leadership
    ISO 9001 puts many requirements and responsibilities regarding leadership forward that need to be fulfilled. Top management therefore needs to be able to
    • demonstrate leadership and full commitment,
    • promote a customer focused culture,
    • establish (if not already existing) a quality policy, and
    • precisely determine responsibilities and assign authorities.

  6. Planning
    Clause 6 focuses on organization and requires precise planning for the QMS by addressing questions of risk management and considering opportunities. Ask yourself: how do you plan to reach set quality objectives?
  7. Support & resource management
    Enlisting all the resources needed for the QMS, clause 7 asks management to provide some of the following resources:
    • Informed, well trained, competent human resources
    • Adequate infrastructure (e.g. hardware, software, equipment, facilities)
    • Suitable work environment
    • Knowledge
    • Communication
    • Documented information

  8. Operational planning
    Covering planning for your product or service, clause 8 asks you to
    • determine the product/service requirements.
    • review the product/service requirements.
    • question your design and development(if applicable).
    • review external providers.
    • determine the product manufacturing/service provision.

  9. Performance evaluation
    This section describes all requirements that need to be fulfilled in order to assess customer satisfaction through monitoring, measuring, analyzing and evaluating your QMS.
  10. Improvement
    The final clause deals with continual improvement and asks of you to select areas and consider opportunities that lend themselves to improvement, much like during a Gemba walk. Here you take action against any nonconformities that may occur, consider corrective actions and therefore make sure you are actively striving for continuous improvement at all times.


What Is An ISO 9001 certification?


An ISO 9001 certification procedure follows the general ISO audit guidelines and consists of the following steps:


  1. Offer & contract
  2. Audit preparation: the auditor assesses all documents handed in by the organization.
  3. Stage 1 Audit: includes an assessment of the customer and his understanding of the requirements, a thorough examination of the site(s) and a collection of necessary information amongst others.
  4. Stage 2 Audit or Certification audit: during this stage the auditor compares the practical application of the requirements to the QMS by questioning employees, examining documentation and visiting relevant areas.
  5. Certification issuing: as soon as the audit has been reviewed and released and any nonconformities have been corrected the certificate will be issued.
  6. Surveillance audit: performed at most 12 months after the initial audit, the surveillance audit includes the verification of measures and requirements, as well as the correction of any nonconformities.
  7. Recertification audit: before the certification expires, a re-certification audit has to be performed, where all requirements are re-audited once more to ensure compliance.

How Long Does An ISO 9001 Certification Last?


An ISO certification is generally valid for 3 years. However, during that time period it is essential that you consistently prove that you are maintaining all the ISO requirements and are staying compliant with ISO stipulations.


Maintenance is a deciding factor for any ISO certification that firstly guarantees continuous improvement and secondly sets you up for recertification. During the 3-year period, someone from a registered certification body needs to conduct check-ins to ensure that the QMS is being maintained.


How Much Does It Cost To Get An ISO 9001 Certification?


There is no set price for an ISO certification, as the cost depends on the certification body that performs the certification audit. Further, the size of your organization also plays a big role in determining how much money you need to spend to get certified, as well as the complexity of your QMS.


Ideally, you want to aim to get a free quote by an accredited body and go from there, all the while considering:


  • whether you want to get a software to build a QMS that is compliant with ISO 9001 requirements. Such a software can support your internal quality management teams, however you need to factor in the cost as well.
  • whether you want to handle most of the work with an internal team or whether you require external assistance that will also need to be paid for.
  • whether you wish to apply for a grant to support your ISO certification.

Is An ISO 9001 Certification Mandatory?


No, unless requested by business partners that you wish to enter into contract with, an ISO 9001 certification is not mandatory.


It is, however, worthwhile to consider a certification as the standard is important in many industries and not having it may reflect negatively on your organization and cost you potential deals and clients in the future.


Further, the mere adherence to the requirements listed in ISO helps structure your business, helps in increasing your productivity and assists you in maintaining legal requirements based on a strict and recognized standard. This way you can be sure that your organization is always on the right track.


Internal Auditing Team Preparing For ISO 9001 Certification
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Nicky Liedtke

Nicky Liedtke

Mit einem Masterabschluss in Literatur- und Kulturwissenschaften in Deutsch, Englisch und Französisch, erprobt Nicky ihre Schreibkünste bei Lumiform, indem sie gemeinsam mit dem Startup wächst und sich entwickelt. In ihrer freien Zeit arbeitet sie am liebsten kreativ mit Textilien aller Art, liest gerne, geht ins Theater oder ins Museum, macht Musik und ist beim Schwimmen in den Seen und Gewässern in und um Berlin anzutreffen.

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