What Is ISO 9001 and how can your business benefit?

ISO 9001 is one of the most useful ISO certifications for a business to obtain. It indicates a well-run company with effective quality management systems in place. ISO 9001 requires outside certification, and in this guide, you will learn how to obtain said ISO certification.

Table of contents

1. What is ISO 9001?

2. Why are quality management systems important?

3. What are the seven quality management principles?

3.1 Customer focus

3.2 Leadership

3.3. Engagement of people

3.4. Process approach

3.5. Improvement

3.6. Evidence-based decision making

3.7. Relationship management

4. Why is ISO 9001 important?

4.1. Benefits of ISO 9001 for your business

4.2. Benefits of ISO 9001 for your clients

5. What are the ISO 90001 requirements?

6. What is an ISO 9001 certification?

6.1. How long does an ISO 9001 certification last?

6.2. How much does it cost to get an ISO 9001 certification?

6.3. Is an ISO 9001 certification mandatory?

What Is ISO 9001?

ISO 9001 is part of the ISO 9000 family of business standards, issued by the acclaimed International Organization for Standardization (ISO). It is a standard for quality management systems (QMS). ISO 9001 is one of the most popular ISO 9000 standards and is also the only one that requires official certification.

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

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

But what kind of quality does ISO 9001 certify? It is not a product-based standard, so it does not prove anything about the quality of the products you produce. Instead, ISO 9001 is used to control and oversee the quality of processes that lead to high quality products. Well-defined and structured processes translate to a strong product. This is what a QMS is for.

ISO 9001 was published in 1987 and currently, over one million companies all across the globe have been ISO 9001 certified. The sheer amount of certified businesses highlights the importance of the standard.

Obtaining an ISO certification simply means that your company has met all necessary requirements detailed in the ISO 9001 standard by the International Organization for Standardization (ISO) and is therefore operating with a functioning and effective QMS.

Why are quality management systems important?

Before covering all the benefits of ISO 9001, you may wonder if a QMS is even important. Simply put, a QMS is important because it is always better to be organized and have a way of holding yourself and your team accountable. In the past, this may have worked without a strict system in place; however nowadays there are so many aspects to consider that you need systems in place. Your goal is to deliver the highest level of quality in every part of your business – from product to management.

With a solid QMS in place, you can organize everything you do, meet requirements effortlessly, and document the process. This way, you improve every aspect of your business and can prevent errors, save money and time, and make continuous improvements.

National standards are becoming more and more outdated and it is important to adapt your practices to international ways of working. That’s where the International Organization of Standardization comes into play. ISO coordinates and develops standards that are globally accepted, creating unity and trust across borders.

What are the seven quality management principles?

The seven quality management principles, or QMPs, are the foundation of any good quality management system. While each principle is relevant and necessary, some organizations may choose to focus on one over another. For example, one might prioritize leadership and improvement, while another prioritizes customer focus and relationship management. You can set your own priorities, which may shift as your company grows and changes over time.

ISO 9001 teaches us that a good quality management approach is a flexible approach. 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.

Each of the seven principles have defined criteria you can use to assess how well you have met your objective.

1. Customer focus

Any good QMS involves developing a good understanding of your customers and their specific needs in order to satisfy them. Gather client and customer feedback data in order to identify gaps so that you can improve. Paying attention to your customers helps you ensure customer 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 to a quality management system. By developing strong leaders that are able to communicate your vision in an accessible way, your company will flourish. Guidance from these leaders 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

Your employees are the lifeblood of your operations, and it is important they feel engaged and motivated. Employee care is part of ISO 9001 and therefore mandatory for anyone seeking ISO 9001 certification.

The benefits of engaging your employees include:

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

Engagement of people can be achieved through open communication and issue discussion. Make sure that every team member feels valued and receives praise for their contributions.

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 where every team works together, leading to better performance.

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

5. Improvement

Making your quality management system better is a constant process. The ISO 9000 standards are about continuous improvement. That means identifying risks, and pinpointing inconsistencies. By weeding out the root cause of an issue, you can improve performance faster.

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 more likely to produce results. Gather 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 your clients and suppliers. By cultivating said relationships and putting an effort into keeping them healthy, you’ll improve performance because you’ll optimize your supply chain.

Aim to see suppliers, customers, investors, and employees as equally important parts of your business. Share information, collaborate, and encourage and recognize where appropriate.

Why is ISO 9001 important?

As a standardization for quality management systems, ISO 9001 helps you gain trust and improve your reputation. Passing an ISO audit means that you’ve done well addressing the seven principles of quality management.

With ISO certification, 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 the best sign of a healthy QMS.

As ISO has published these set guidelines and requirements for ISO 9001:2015,improving your quality management structures is just a matter of following them. The clarity of requirements means there’s no second-guessing or ambiguity.

Benefits of ISO 9001 for your business

Implementing an ISO 9001 quality management system into your organization and following the seven QMPs benefits you in many ways, including:

• More efficient processes
  Streamline your procedures according to ISO 9001 regulatory requirements and watch your efficiency increase.
• Higher chance of 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, meaning your partnership would be valuable.
• Better relationships with suppliers
  Just like ISO certification can attract new partnerships, it can also help your relationships with existing partners by adding a new layer of credibility to your operations.
• International recognition
  On the international level, a certification signals to businesses worldwide that your operations are meeting QMS requirements.
• Higher customer satisfaction
  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.
• More profit
  By opening yourself to an international market or, at the very least, attracting more suppliers and improving your client relationships, you can expect to attract more business.
• Increased employee motivation
  Not only can partners benefit from your organization being certified, better quality management systems translate to higher employee morale.
• 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.
• Continuous improvement
  The road to a better QMS is never ending, as there are always processes to streamline, relationships to improve, and customers to satisfy. Meeting ISO 9001 requirements is not a one-off thing. You need to uphold the new standards, so you can make constant progress.

Benefits of ISO 9001 for your clients

Successfully meeting any of the ISO 9000 standards is a great sign for potential customers. An ISO 9001 certification offers your clients:

• Higher-quality service, signaling that they can trust your business operations.
• A more satisfactory customer experience due to a focus on client-business relationships (QMP 1, QMP 7).
• Fewer issues. Items need to be returned less frequently, as robust quality management systems identify problems much faster and before they can become larger issues.
• An internationally recognized certification of quality.

What are the ISO 9001 requirements?

ISO 9001 requirements are meticulous, with over 350 individual requirements across ten clauses.

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

The 10 ISO 9001 clauses define the standard and its terms and definitions (clauses 1-3) before going into the actual requirements of the standard (clauses 4-10). There is also a 0 clause that talks about the benefits of a QMS and the PDCA (Plan-Do-Check-Act) cycle. 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 help organizations better understand ISO 9001 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 covers 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), and figure out the 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 forward many requirements and responsibilities regarding leadership. Top management needs to be able to:
   
   • Demonstrate leadership and full commitment.
   • Promote a customer focused culture.
   • Establish a quality policy, if you haven’t already.
   • Precisely determine responsibilities and assign authorities.
6. Planning
   Clause 6 focuses on the organization and planning of the QMS by addressing questions of risk management and considering opportunities. Ask yourself: how do you plan to reach set quality objectives?
7. Support and Resource Management
   Enlisting all the resources needed for the QMS, clause 7 asks management to provide:
   
   • Informed, well-trained, competent human resources
   • Adequate infrastructure (e.g. hardware, software, equipment, facilities)
   • A 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; namely monitoring, measuring, analyzing, and evaluating your QMS.
10. Improvement
    The final clause deals with continual improvement and asks you to consider areas that lend themselves to improvement, much like during a Gemba walk. Here you take action to correct any issues, uphold the ISO 9001 standards set, and keep on improving.




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 and 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 assesses the practical application of the requirements of the QMS by questioning employees, examining documentation, and visiting relevant areas.
5. Certification: as soon as the ISO 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 issues that occur.
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.




Maintaining quality management standards guarantees continuous improvement and 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. Your organization’s size and the complexity of your QMS also determine how much money you’ll have to spend.




Ideally, you’ll get a free quote from an accredited body and go from there, all the while considering:



• Whether you want to invest in QMS software that is compliant with ISO 9001 requirements. Such software can support your internal quality management teams.
• Whether you want to handle most of the work with an internal team or whether you require external assistance.
• Whether you wish to apply for a grant to support your ISO certification.




Is an ISO 9001 certification mandatory?




Unless your business partners request that you obtain one, an ISO 9001 certification is not mandatory.




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




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




Passing your ISO audits is easy with Lumiform. With countless digital templates that all your employees can follow on their smartphones, you can easily assess whether your business is compliant with all ISO 9001 regulations.




Frequently Asked Questions

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

• meet industry regulatory requirements.
• meet customer requirements.

Why is ISO 9001 important?

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.

What are the benefits of ISO 9001?

• More efficiency in your processes
• Higher chances of securing new partnerships
• Better relationships with suppliers
• International Recognition
• Higher customer satisfaction
• More Profit
• Increased employee motivation
• Better documentation
• Continuous improvement

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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.