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ISO 9001

Quality Management System

ISO 9001 is a global Quality Management System (QMS) standard. Certification confirms an organization’s commitment to improving quality, delivering more efficient operations, and improving customer satisfaction.

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What Is ISO 9001?

ISO 9001 is a global standard for quality management that shows customers you’re serious about consistently delivering excellent products and services. Certification to ISO 9001 demonstrates that your business meets a recognized level of quality expectations, and which is recognized across the U.S. and internationally.

Achieving ISO 9001 certification can offer a competitive advantage by enhancing quality management and meeting customer expectations. It helps you streamline operations, increase customer satisfaction, and meet industry regulations—all critical factors that contribute to your organization’s success and market differentiation.

In 2023, over 26,800 U.S. businesses earned this certification, putting the United States among the top ten countries globally for ISO 9001 certification.

Learn more about how the standard works, what’s required for certification, and how it supports long-term success in our in-depth ISO 9001 Guide.

Looking to achieve ISO 9001 certification? We’re a trusted, U.S.-based ANAB-accredited certification body committed to making the certification process simple and stress-free for your business.

what is iso 9001

ISO 9001 Explained

This video answers the main questions that you may have about ISO 9001.

What Are the Benefits of ISO 9001?

There are many benefits to achieving ISO 9001 certification:

Enhanced Customer Satisfaction

Enhanced Customer
Satisfaction

Employee Engagement

Employee
Engagement

Improved Quality Management

Improved Quality
Management

Better Decision Making

Better
Decision-Making

Continuous Standardisation

Consistency &
Standardization

Increased Efficiency

Increased
Efficiency

Continuous Improvement Culture

Continual
Improvement Culture

Regulatory Compliance

Regulatory
Compliance

Risk Management

Risk
Management

Strong Supplier Relationships

Strong Supplier
Relationships

Global Recognition

Global
Recognition

Market & Competitive Advantage

Market &
Competitive Advantage

What Industries Need ISO 9001 Certification?

ISO 9001 is a quality management system standard that can benefit organizations across various industries. It offers a flexible framework that can be adapted to suit specific industry needs and business goals.

While ISO 9001 certification is voluntary, certain industries find it particularly valuable or even necessary due to regulatory requirements, customer expectations, or competitive advantages.

These include (but are not limited to):

  • Manufacturing: Improving product consistency and quality.
  • Technology & Software: Enhancing efficiency and customer satisfaction.
  • Construction & Engineering: Improving project management and safety.
  • Professional Services: Delivering better service experiences.
  • Healthcare & Medical Devices: Helping businesses meet strict regulations.
  • Logistics & Supply Chain: Streamlining operations and increasing reliability.
  • Automotive: Maintaining high standards of production and safety.
  • Education & Training: Promoting effective educational practices.
  • Food & Beverage: Helping to provide food safety and quality.

Why Choose Amtivo for ISO 9001 Certification?

Our team of experts are with you every step of your certification journey. Here’s why you should choose Amtivo:

  • Our ANAB accreditation guarantees that your ISO 9001 certificate is recognized worldwide.
  • We proudly hold a 4.8/5 rating on Feefo, reflecting our commitment to excellence.
  • Our US-based auditors offer fast, expert service, using their local insight to provide tailored solutions.
  • We offer transparent pricing with no additional charges for administration or registration.
  • Our flexible contracts ensure you’re not locked into long-term commitments.
  • An impressive 94% of Amtivo clients are ‘likely’ or ‘very likely’ to recommend us.
why choose amtivo - ISO 9001

The ISO 9001 Certification Journey

Get in touch for a free quote from one of our experienced team to get your ISO 9001 quality management certification journey underway. Our quotes will reflect your organization's specific requirements.

STEP 1
STEP 2
STEP 3
STEP 4
Help You Prepare

Our team will get in touch to outline the process and explain the plan for your initial assessment. We can also signpost you to any resources that you might find useful on your journey to becoming certified.

Identify Gaps

Referred to as a “Stage 1 Assessment”, our auditor will conduct an initial review of your management system to determine your readiness for the certification audit, known as the “Stage 2 Assessment”. The Stage 1 Assessment will include reviews of the management system documentation and allocation of resources. It will also determine if management reviews, and internal audit processes are established and confirm the appropriate scope of the management system.

Gaps in your system will be documented as “Areas of Concern” that should be addressed prior to the Stage 2 Assessment. 

In-Depth Review

When you are ready, an auditor will conduct a “Stage 2 Assessment” to establish if your organization meets the standard’s requirements. This is an in-depth review of each of your processes to verify the implementation and effectiveness of the management system. Where requirements are not met, the auditor will issue a nonconformity.

Nonconformities must be addressed prior to certification being granted. Once the responses for nonconformities are accepted, the auditor can recommend certification.  

Certification Issued

Following a review by our Compliance Team, a decision will be made as to whether your certification can be issued. Once certification is granted, we will conduct audits at least annually to ensure continued conformance to the requirements of the standard.  

For more details about the certification process please click here.

The ISO 9001 Certification Journey

Get in touch for a free quote from one of our experienced team to get your ISO 9001 quality management certification journey underway. Our quotes will reflect your organization's specific requirements.

STEP 1
Help You Prepare

Our team will get in touch to outline the process and explain the plan for your initial assessment. We can also signpost you to any resources that you might find useful on your journey to becoming certified.

STEP 2
Identify Gaps

Referred to as a “Stage 1 Assessment”, our auditor will conduct an initial review of your management system to determine your readiness for the certification audit, known as the “Stage 2 Assessment”. The Stage 1 Assessment will include reviews of the management system documentation and allocation of resources. It will also determine if management reviews, and internal audit processes are established and confirm the appropriate scope of the management system.

Gaps in your system will be documented as “Areas of Concern” that should be addressed prior to the Stage 2 Assessment. 

STEP 3
In-Depth Review

When you are ready, an auditor will conduct a “Stage 2 Assessment” to establish if your organization meets the standard’s requirements. This is an in-depth review of each of your processes to verify the implementation and effectiveness of the management system. Where requirements are not met, the auditor will issue a nonconformity.

Nonconformities must be addressed prior to certification being granted. Once the responses for nonconformities are accepted, the auditor can recommend certification.  

STEP 4
Certification Issued

Following a review by our Compliance Team, a decision will be made as to whether your certification can be issued. Once certification is granted, we will conduct audits at least annually to ensure continued conformance to the requirements of the standard.  

For more details about the certification process please click here.  

Implementing ISO 9001

Elevating your Quality Management System (QMS) to meet ISO 9001 standards is a collective effort involving a variety of departments. Training courses are essential to prepare your teams and support them in understanding this certification. Amtivo offers a variety of ISO 9001 training courses to meet your needs. 

Our courses are created by quality management experts and cover implementation strategies, auditing techniques and continuous improvement practices. 

ISO 9001 FAQs

Is ISO 9001 Certification relevant for small businesses?

Absolutely! ISO 9001 is highly relevant for small businesses.

While often associated with larger organizations, small businesses can gain significant advantages from certification, including improved operational efficiency, enhanced customer credibility, better risk management, and access to new markets.

The standard is designed to be scalable and adaptable to businesses of any size. It helps small companies build efficient processes, reduce costs, and increase customer satisfaction.

Many small businesses find that the discipline of ISO 9001 helps them compete more effectively with larger competitors.

Will ISO 9001 certification improve how my business operates?

Achieving ISO 9001 certification can improve your business operations. Implementing its requirements will typically help you find more efficient ways to manage your processes, maintain quality, and boost customer satisfaction.

The standard can help identify areas for improvement, streamline operations, and lead to better overall performance.

Is Certification just a box-checking exercise, or does it add value?

ISO 9001 certification typically adds real value when appropriately implemented rather than being treated as just a box-checking exercise.

By embracing the standard’s framework for continual improvement, organizations can drive quality throughout their business. They typically experience tangible benefits, including better operational efficiency, increased customer satisfaction, and improved competitiveness.

What happens once my business is certified?

Congratulations! Once you are certified, you can display an official certification badge. For more information, see our certification logo usage guidelines.

How long does certification last?

Your ISO 9001:2015 certification will last three years and is subject to mandatory assessments to verify compliance. To become recertified to the standard, your organization must complete a recertification assessment at the end of three years.

How often are we audited after certification?

After you achieve ISO 9001 certification, you will be audited annually through surveillance audits to ensure your management system continues to meet the standard’s requirements. Some businesses choose to have a 6-month surveillance cycle.

After three years, you must undergo a recertification assessment to renew your certification.

Can you support us with recertification?

Of course! During a reassessment audit, we’ll check that your business meets all the requirements of the ISO 9001 standard.

While this audit will be as detailed as the original certification audit, it will take less time. Your company will continue to enjoy all the benefits of having a long-term relationship with us.

What kind of support will I get from Amtivo?

We offer support at every stage in your certification journey. Amtivo can help to support you in the following ways:

  • Expert Auditors: Our auditors can support you through the certification journey, from the initial audit to recertification.
  • Training: While we don’t offer consultancy, we provide a range of training options, including implementation and awareness training, to help your team understand ISO 9001 requirements.
  • Ongoing Support: Our team can answer questions, provide resources, and offer support throughout the process.
  • Certification Badges: Once you have achieved certification, promote your success using our digital certification logos and badges.
Who conducts the certification audit—is it remote or in-person?

ISO 9001 assessments are conducted by independent, qualified auditors who are experts in your industry and accredited to perform certification assessments.

  • Stage 1 is a documentation review, which may be conducted remotely.
  • Stage 2 is an on-site assessment, where the auditor visits your location to verify the implementation and effectiveness of your management system.
What happens if we don’t meet the requirements right away?

Don’t worry—if you don’t meet ISO 9001 requirements during your Stage 1 audit, you’ll receive a report highlighting any issues.

At this stage, you won’t be required to submit a corrective action plan. Instead, any nonconformities or areas of concern will be recorded and reviewed again at Stage 2.

This gives you the opportunity to address any gaps before your final audit. If the same issues are still present at Stage 2, you’ll then need to complete a Nonconformance Report, provide evidence of how you resolved the issue, carry out a root cause analysis, and prepare a plan to address it.

Your auditor will review your actions and supporting evidence before certification can proceed. If further information or steps are needed, they will let you know.

Will you help us close any gaps before certification?

As an ANAB-accredited certification body, we can’t help fix gaps before certification. However, we can provide valuable resources, such as our free ISO 9001 checklists, to help you spot gaps in your processes.

We also offer training courses, so your team can fully understand the requirements of ISO 9001.

During the Stage 1 Audit, our auditor will review your documents and highlight any issues so you can address them before your certification audit.

If you need hands-on help, we have a list of independent consultants you can contact.

What is ISO 9001:2015?

ISO 9001:2015 is the most up-to-date version of the standard for quality management.

If you’d like to learn more about the standard itself, check out our ISO 9001 Guide.

What are the key principles and ISO 9001 requirements?

ISO 9001 contains the followig key principles of quality management:

  • Customer Focus
  • Leadership
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence-Based Decision Making
  • Relationship Management

Download our ISO 9001 key requirements guide to find out more.

Can ISO 9001 certification help grow your business?

There are three ways in which becoming ISO 9001 certified can grow your business:

  • By increasing your quality standards, you can tap into new, larger customer pools. Many industry professionals seeking external services may use ISO qualifications to differentiate competing organizations and help inform their decisions. By becoming certified, you could increase your chances of winning new business.
  • Because ISO 9001 focuses on improving process efficiency, your organization can begin to save money. By providing a platform for better organization and communication and placing your clients’ needs at the center of operations, your organization can avoid wasting money on actions clients don’t really need.
  • As your organization grows, new employees can be trained to adopt and maintain efficient processes and quality practices. Becoming ISO 9001 certified can help your organization become process-based so it isn’t reliant on just key individuals who may not always be present, proving its capability to succeed.
What factors affect the ISO 9001 certification return on investment?

Making a return on investment when implementing and maintaining an ISO 9001-certified QMS can depend on several factors:

  • How long it takes for your organization to become certified
  • Maintenance of your QMS after certification
  • How your organization displays its certification in marketing and PR materials
  • The level of new business gained after ISO 9001 certification
How do I get started with a Quality Management System?

As a business, you already have many processes and procedures in place to build a basis for your Quality Management System (QMS). An external consultant can provide guidance to help you implement your full system.

Amtivo is an independent certification body, so it cannot provide consultancy services. However, we can provide training on this standard to help your team learn about the requirements for ISO 9001 certification and many other useful tools to support you on your certification journey, before becoming certified.

We offer implementation training and awareness training for multiple ISO standards. See further information on our ISO 9001 training, contact our team.

Can ISO 9001 be integrated with other standards?

Absolutely! ISO 9001:2015 has been created under the Annex SL structure. This structure shares the same features across multiple standards for documentation, policies, procedures and processes.

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