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Quality Management

ISO 9001

ISO 9001:2015 is the International Standard for Quality Management Systems.

ISO 9001: Quality Management Systems (QMS)

What is ISO 9001?

ISO 9001 is defined as the internationally recognised standard for Quality Management Systems (QMS). It is the most widely used QMS standard in the world, with over 1.25 million certificates issued to organisations in 178 countries. 

ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. In simple terms, ISO 9001 certification provides the basis for effective processes and effective people to deliver an effective product or service time after time.

The key to any successful business is strong quality control. If you want your operations to thrive, your potential consumer base must be confident that the goods or services you offer meet or exceed expected standards. ISO 9001 is a quick and easy way for potential consumers to see if your company has put the time and effort into making sure your product or service is the best it can possibly be.

The standard follows the common structure provided by Annex SL. ISO 9001:2015 is compatible with other management systems, such as ISO 14001, making it effective and efficient to integrate management systems.

Looking to implement an ISO 9001 management system? Not sure where to start? Take a look at our ISO 9001 Implementation Guide here.
 

The 10 Clauses of ISO 9001:2015

The ISO 9001:2015 standard is structured into 10 clauses. 

  • Clauses 1-3 (Introductory): Scope, Normative References, and Terms and Definitions.

  • Clause 4 - Context of the Organisation: Understanding internal and external issues relevant to the QMS, and the needs and expectations of interested parties.

  • Clause 5 - Leadership: Requirements for top management's involvement, establishing quality policy, and assigning roles and responsibilities.

  • Clause 6 - Planning: Addressing risks and opportunities, establishing quality objectives, and planning for changes.

  • Clause 7 - Support: Requirements related to resources (people, infrastructure, environment), competence, awareness, communication, and documented information.

  • Clause 8 - Operation: Planning and control of operational processes, requirements for products and services, design and development, control of externally provided processes, production / service provision, release of products / services, and management of nonconforming outputs.

  • Clause 9 - Performance Evaluation: Monitoring, measurement, analysis, evaluation, internal audit, and management review.

  • Clause 10 - Improvement: Addressing nonconformities and taking corrective actions, and continual improvement of the QMS.

Benefits of ISO 9001 Certification

Customer satisfaction icon

Customer satisfaction

Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.

Reduced operating costs icon

Reduced operating costs

Continual improvement of processes and resulting operational efficiencies mean money saved.

Improved stakeholder relationships icon

Improved stakeholder relationships

Improve the perception of your organization with staff, customers and suppliers.

Legal compliance icon

Legal compliance

Understand how statutory and regulatory requirements impact your organisation and its customers.

Improved risk management  icon

Improved risk management

Greater consistency and traceability of products and services means problems are easier to avoid and rectify.

Proven business credentials icon

Proven business credentials

Independent verification against a globally recognised industry standard speaks volumes.

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Win more business

Procurement specifications often require certification as a condition to supply, so certification and verification opens doors.

The 7 Quality Management Principles

ISO 9001 is built upon a set of fundamental principles that guide an organisation's approach to quality management and any organisation can benefit from it. 

  1. Customer focus: Organisations must strive to meet and exceed customer needs and expectations, continuously monitoring feedback for improvement.

  2. Leadership: Top management plays a crucial role in establishing unity of purpose and direction, creating an environment where people are engaged in achieving quality objectives.

  3. Engagement of people: Competent, empowered, and engaged people at all levels are essential to enhance the organisation's capacity to create and deliver value.

  4. Process approach: Managing activities as interconnected processes helps achieve consistent and predictable results more effectively and efficiently. This often ties into the Plan-Do-Check-Act (PDCA) cycle.

  5. Improvement: Continuous improvement is a permanent objective of the QMS, enabling organisations to adapt to changes and enhance performance.

  6. Evidence-based decision making: Decisions should be based on the analysis and evaluation of data and information, leading to greater objectivity and improved outcomes.

  7. Relationship management: For sustained success, organisations should aim to manage their relationships with interested parties, such as suppliers, to optimise their performance.

Why become ISO 9001 certified?

  • The Annex SL structure provides a common language between ISO management systems that streamlines the path to compliance related certifications.

  • The focus on risk identifies areas of concern in advance and allows you to allocate resources where they are most needed.

  • The leadership requirement engages upper-level management and brings quality assurance more in line with overall business objectives.

  • The performance evaluation and self-governance components can foster innovation and deliver enhanced value for stakeholders whilst delivering business credibility.

  • The emphasis on organisational context within the ISO 9001 standard looks at quality management from a big-picture perspective.

Upcoming Transition To ISO 9001:2026

As part of ISO’s review cycle, ISO 9001 (Quality Management Systems) and ISO 14001 (Environmental Management Systems) are currently being revised, with updated versions expected in 2026. 

These revisions go beyond routine updates, they address the changing demands of today’s business landscape, including increased focus on risk management, sustainability, and digitalisation. 

Find out more here, and sign up to InTouch for updates as and when they're available. 

Steps to Certification

  1. Step 1

    Complete a Quote Request Form so we can understand you and your business. We will then use this to personally prepare a proposal for your certification and define what is known as your 'scope of assessment'.

  2. Step 2

    We will then contact you to book your assessment with an NQA assessor. It consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been operational for a minimum of three months and has been subject to a management review and a full cycle of internal audits.

  3. Step 3

    Following a successful stage two audit, a decision is made. If positive, your certification will be issued by NQA, with both a hard and soft copy of the certificate awarded. Certification is valid for three years and maintained through surveillance audits (years one and two) and a recertification audit in year three.

See more details

Quality Management Toolkit

ISO 9001 FAQs

Quality Management Training

ISO 9001 Implementation Guide

ISO 9001 to ISO 27001 Gap Guide

Integrated Quote Request Form

Annex SL Comparison Tool

Gap Analysis

Need a Consultant?

Download Certification Logos

Is Your Management System Integrated?

MVIS Bartco Case Study

Affinity Water Case Study

  • What Are the Benefits of ISO 9001 Certification? 

    The QMS system presented in ISO 9001 can help a business produce reliably high quality products, improve customer satisfaction, boost operational efficiency, manage risk, and more. Like other types of ISO certification, ISO 9001 certification shows your company's stakeholders that you care about quality control and effective management. With ISO 9001 certification, you may even get more business, since many international companies will only work with ISO-certified partners. 

    Who Should Get ISO 9001 Certification? 

    ISO 9001 certification has the potential to benefit businesses in a wide variety of industries, including automotive, aerospace, construction, electronics, medical device manufacturing and more. ISO 9001 presents guidelines for Quality Management Systems that apply to all business models. Operations of any size can get certified. In fact, NQA works with small businesses and highly recognized brands. 

    All businesses interested in meeting and exceeding quality control metrics and expanding business horizons should consider ISO certification. 

    How Does ISO 9001 Certification Work? 

    To earn ISO 9001 certification, you must implement the standard and complete a two-visit Initial Certification Audit. After earning the initial certification, you must complete yearly surveillance and re-certification audits every three years to maintain your certification. 

    An accredited third-party certification body like NQA must complete the audits. In addition, you must be able to prove that your QMS has been operational for at least three months and has undergone a management review and a full cycle of internal audits before you can earn ISO 9001 certification. 

    How Much Does ISO 9001 Certification Cost? 

    The cost of ISO 9001 certification varies based on a number of factors, including audit duration, business size, risk and how close you are to meeting ISO 9001 requirements when you start implementing the system. You should also expect to pay for copies of the standard, any process changes that are necessary to meet ISO 9001 requirements and employee training, if necessary. 

    The best way to find out how much ISO 9001 certification will cost your organization is to request a quote from NQA by using our online form or calling 0800 052 2424. 

    Request a quote 
  • What Are The ISO 9001 Revisions From 2015 And What’s Coming In 2026? 

    Annex SL is the single biggest change to the ISO 9001:2015 document. Annex SL is a standard structure that applies to all ISO management systems standards. 

    As part of ISO’s review cycle, ISO 9001 (Quality Management Systems) and ISO 14001 (Environmental Management Systems) are being revised, with updated versions expected in 2026.  

    Find out more here.  

    Does ISO 9001 Require A Management Rep? 

    ISO 9001 does not require a management rep. However, NQA will still need a nominated contact for all matters related to certification and the organization of certification visits. NQA does not expect this to impact our relationship with our clients. 

    Do All The Elements Of ISO 9001 Management Review Have To Be Covered In One Meeting? 

    All the elements of ISO 9001 management review can be covered in separate meetings. However, the requirement is to have a management review process, which may be a meeting or meetings, but could also take the form of other events or documentation. The requirement is to “…retain documented information as evidence of the results of management reviews.” 

    How Does ISO 9001 Documentation Work? 

    There are various ways of approaching ISO 9001 risk and result documentation. You could use a risk register and mitigation actions or identification of risk points on a process flow, recognizing that your procedures are carried out in a particular way to reduce risk. 
     
  • What Would ISO 9001 Consider A Risk In The Exporting Business? 

    An example of a risk is completely and accurately completing the export documentation. Full licenses need to be in place. Price fluctuations may also be a risk or an opportunity. 

     Are Risks Control Parameters In ISO 9001? 

    Risks will influence the control parameters needed to reduce or mitigate that risk. 

    How Do You Refer To Sources Of Inputs In ISO 9001? 

    The process requirements are the same as those in the 2008 standard. However, the 2015 standard enhances and makes the determination of inputs and outputs and the importance of processes more explicit. 

    Sign up to InTouch for updates on the 2026 version as and when they're available.  

    Can Risks Be Managed Using The ISO 14001 Approach? 

    The same approach can be used, although the specific risks may differ from those managed using ISO 14001

    Do You Need To Identify Risks For Every Process In ISO 9001? 

    Yes, you do need to identify your risks for every process in ISO 9001 in some way. If your processes are documented, it is also useful to document the risks. 

    Should You Create Visual Process Maps? 

    ISO 9001 does not require that you map processes as a visual document, but it would be very helpful if you did so. 

    What Is The Difference Between Management And Support Oriented Processes? 

    Management-oriented processes relate directly to the overall system, e.g., management review. The support processes support the system, e.g., training and competence, document control, and calibration. 

    Should You Use A Joint Risk Approach For ISO 9001 And ISO 27001? 

    You should use whatever approach makes sense and is effective for your needs. A joint risk assessment approach for ISO 9001 and ISO 27001 may make sense, depending on your needs. 

    What Should A Documented Business Risk Register For ISO 9001 Look Like? 

    NQA does not promote specific templates. It would undoubtedly be helpful to include internal and external interested parties. The primary purpose of a risk register is to help the organization identify its own needs. 

     
  • Will ISO 9001 Auditors Look For More Robust Systems Now? 

    The only ISO 9001 requirements that have been reduced are those for documented information. There are still very specific requirements for documented evidence (records). Any management system, whether highly documented or not, needs to be robust to be effective. 

    What's The Difference Between "Maintained" And "Retained" Information In ISO 9001? 

    You "maintain" elements of the system, e.g. infrastructure, and "retain" documented evidence, i.e. records.  

    How Can You Engage Senior Management In A More Risk-Based Approach? 

    Approach the system's requirements from a risk perspective, using the vocabulary of risk but not necessarily the word “risk," and you will very likely get a positive response. The management review or internal audit process might be a good place to start. 

    How Do You Measure Leadership In ISO 9001? 

    Visibility, inclusiveness and good communications are all examples of leadership in ISO 9001. Employees should be aware of vision, mission, strategy and policy, if leadership is effective. 
  • How Does NQA Track The Transition To ISO 9001? 

    Our Assessors and Client Executives will work closely with our clients to track their progression towards the new standard. You should speak to your Client Executive to establish exactly where you are in the transition process. 

    How Do The Changes To ISO 9001 Updates Affect Integrated Systems? 

    The introduction of Annex SL will aid the integration process for ISO 9001, ISO 14001, and ISO 45001. However, due to the different publication dates, you must consider transition dates and plans carefully. 

    Is ISO 9001:2015 The Most Complicated Version Of ISO 9001? 

    ISO 9001 is not necessarily complicated, but it is professionally challenging. It requires much more high-level professional judgement than in previous versions. 

    Do You Have To Re-Number Your QMS To Match ISO 9001? Can You Use Your Existing QMS And Expand Sections To Cover The New Criteria? 

    You do not have to renumber your QMS. There is no requirement to number your documentation as per the standard. However, you may well find it necessary and useful to expand your documentation to address the additional 2015 and 2026 requirements. 

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