The ISO 9001 certification is the global reference in terms of quality management systems (QMS). Whether you run a small business, an SME or a large group, this international standard offers a structuring framework for optimizing your processes, strengthening customer satisfaction and gaining competitiveness. This comprehensive guide explains in detail what the ISO 9001 standard is, how to obtain it, the concrete benefits for your organization and the latest regulatory developments, including the 2024 amendment, which now includes climate actions.
Definition of the ISO 9001 standard
What is quality management?
The ISO 9001 standard defines the criteria for an effective quality management system (QMS). This system corresponds to a set of processes, procedures and resources implemented to achieve the quality objectives of an organization. It is the international reference standard to help businesses improve customer satisfaction and the quality of their products and services.
This standard is part of the ISO 9000 family, which also includes:
- ISO 9000 : vocabulary and essential principles of quality management
- ISO 9001 : requirements for the certification of the quality management system
- ISO 9004 : guidelines for improving organizational performance
The quality management system according to ISO 9001 is based on a process approach and a way of thinking based on risks and opportunities. This approach makes it possible to identify, understand, and manage interconnected processes as a coherent system.
History and evolution of the ISO 9001 standard
The ISO 9001 standard has undergone several major developments since its creation to adapt to the contemporary challenges of organizations:
The structure of the ISO 9001:2015 standard
The 2015 version of the ISO 9001 standard is structured around 10 chapters organized according to the HLS (High Level Structure) structure:
- Field of application : defines the scope of application of the standard
- Normative references : list the essential documents
- Terms and definitions : specify the terminology used
- Organization context : understanding of the organization and its challenges
- Leadership : management commitment and quality policy
- Scheduling : actions in the face of risks and opportunities, quality objectives
- Support : resources, skills, awareness, communication
- Carrying out operational activities : planning, design, production
- Performance evaluation : surveillance, internal audit, management review
- Improvement : non-conformities, corrective actions, continuous improvement
This HLS structure is common to all ISO management system standards, which facilitates the integration of several standards (quality, environment, health and safety) into a single management system.
Differences with other ISO standards
The ISO 9001 standard focuses specifically on quality management, while other ISO standards address various aspects of business management:
Although each standard has its own specificities, they all share the HLS structure, thus facilitating their integration into a global management system.
The 7 principles of quality management
The ISO 9001 standard is based on seven fundamental principles that form the backbone of the quality management system:
- Customer focus : understand the current and future needs of customers, meet their requirements (including those related to climate issues) and strive to exceed their expectations. This principle places customer satisfaction at the heart of the quality system.
- Leadership : establishing the purpose and guidelines, creating conditions in which staff are involved to achieve quality objectives. Visible management commitment is essential.
- Staff involvement : competent, authorized and involved people at all levels of the organization. The organization benefits from the skills and commitment of each individual.
- Process approach : activities managed as correlated processes that function as a coherent system. This approach provides consistent and predictable results.
- Continuous improvement : permanent focus on improving performance. The organization maintains its current level while creating new opportunities.
- Evidence-based decision making : decisions based on the analysis and evaluation of data and information. This objective approach limits bias and intuition.
- Management of relationships with interested parties : managing relationships with suppliers, partners and other interested parties for sustainable and mutually beneficial success, taking into account their expectations concerning, in particular, climate-related actions.
Amendment 2024 now includes a complementary dimension linked to climate actions, strengthening the link between quality and environmental responsibility.
Why get ISO 9001 certification?
Competitive and commercial advantages
ISO 9001 certification offers numerous competitive advantages that justify the initial investment:
- Improving brand image : certification is an international recognition of the level of quality, reinforcing credibility with customers and partners
- Access to new markets : many public and private tenders require ISO 9001 certification as a prerequisite, thus opening up new business opportunities
- Increased customer satisfaction : the establishment of a quality management system improves the reliability of products and services, thus reducing non-conformities and complaints
- Differentiation from the competition : in some sectors where certification is not widespread, it is a significant distinctive advantage
According to an ISO study, 84% of certified companies notice an improvement in customer satisfaction within two years of certification.
Internal organizational benefits
In addition to commercial advantages, the ISO 9001 approach brings concrete organizational benefits:
- Optimizing processes : identification and elimination of redundancies, wastes and operational inefficiencies
- Cost reduction : reduction in non-conformities, rejects, rework and non-quality costs (estimated between 5% and 15% of turnover for non-certified companies)
- Strengthening the quality culture : raising awareness and involving staff in the continuous improvement process
- Better risk management : identification and proactive treatment of potential risks affecting processes and quality
- Clarification of responsibilities : precise definition of roles, responsibilities and interactions between the various functions
- Capitalization of know-how : formalization and maintenance of critical business knowledge
International recognition and credibility
With more than one million certified organizations in 170 countries, the ISO 9001 standard enjoys unparalleled global recognition:
- Harmonized international standard, recognized in all sectors and on all continents
- Common language between business partners facilitating inter-company relationships
- Trust factor for international customers and global supply chains
- Facilitator for export and cross-border trade relationships
This international recognition is a major asset for companies with international ambitions or working with foreign partners.
The ISO 9001 certification process
Preliminary steps to certification
Before engaging in a certification audit, several steps are required to prepare the organization:
- Initial diagnosis : assessment of the gap between existing practices and the requirements of the ISO 9001 standard (gap analysis)
- Awareness-raising and training : preparation of management and staff to the principles of quality management and the requirements of the standard
- Defining the perimeter : precise determination of the activities, products, services and sites concerned by certification
- Documentary system design : development of the quality policy, process mapping and essential procedures
- Implementing the system : effective application of the provisions defined in the documentary system
- Internal Audit : verification of the conformity and effectiveness of the system in relation to the requirements of the standard
- Management review : evaluation of the system by management and improvement decisions prior to the external audit
The time required for this preparatory phase generally varies between 6 and 18 months depending on the size and complexity of the organization, as well as its initial level of maturity in terms of quality.
Conduct of the certification audit
The certification is issued by an accredited certification body (such as AFNOR Certification, Bureau Veritas, SGS, etc.) which carries out an audit in two stages:
Documentary audit (step 1)
- Review of the documentary system to verify its compliance with the requirements of the standard
- Assessment of the maturity of the system and its relevance to the context
- On-site audit planning by identifying areas of focus
On-site audit (step 2)
- Verification of the effective application of the quality management system
- Interviews with management and staff at all levels
- Observation of practices and review of registrations
- Identification of strengths and possible non-conformities
In the event of major non-conformities, a period is granted to correct them before the certificate is issued. For minor non-conformities, an action plan may be sufficient.
Certificate monitoring and renewal
ISO 9001 certification is not final and requires regular monitoring:
- Validity period : 3 years
- Surveillance audits : annual audits to verify the continuity of compliance (covering part of the system)
- Renewal audit : complete audit at the end of 3 years to extend the certification
This cyclical dynamic ensures the continuous improvement of the system and avoids the risk of obsolete practices.
Costs associated with the certification process
The costs of ISO 9001 certification vary according to several factors:
For a company with 40-50 employees, the average costs can be estimated as follows:
- For a company already committed to a quality approach : €3,500 to €5,000 for the certification process alone
- For a company without a prior quality approach : in addition to the certification cost, there are the costs of an internal quality manager and/or an external consultant, knowing that the complete implementation may require 15 to 20 days of intervention
Note: since the 2015 version, the audit process has been similar for ISO 9001 and ISO 14001, allowing combined audits and reduced costs for businesses seeking dual certification.
The key requirements of the ISO 9001:2015 standard
Organization context (chapter 4)
Chapter 4 of the standard sets out the foundations of the quality management system:
- Understanding the organization and its context (4.1): analysis of external (market, regulation, technology) and internal (culture, performance, organization) issues affecting the ability to achieve the expected results of the QMS
- Understanding the needs and expectations of interested parties (4.2): identification of interested parties (customers, employees, employees, suppliers, suppliers, shareholders, authorities) and their relevant requirements
- Determining the field of application (4.3): clear definition of the scope of the QMS, with justification of the requirements that are not applicable
- Quality management system and its processes (4.4): identification of the necessary processes, their interactions, interactions, resources, responsibilities, risks and opportunities
It is in this chapter that the 2024 amendment added the obligation to determine whether the issues arise from climate change.
Leadership and commitment (chapter 5)
Chapter 5 highlights the critical role of management:
- Leadership and commitment (5.1): visible and active involvement of management, promotion of the process approach and through risks, allocation of the necessary resources
- Quality policy (5.2): development and dissemination of a quality policy adapted to the context and strategic guidelines, serving as a framework for the objectives
- Roles, responsibilities and authorities (5.3): definition and clear communication of responsibilities for quality at all levels of the organization
Leadership is a fundamental pillar of an effective quality management system.
Quality system planning (chapter 6)
Chapter 6 concerns the strategic planning of the QMS:
- Actions in the face of risks and opportunities (6.1): identification and methodical treatment of risks and opportunities that may affect the QMS
- Quality and planning objectives (6.2): establishment of measurable objectives, consistent with the quality policy, with planning of actions to achieve them
- Change planning (6.3): control of QMS changes by considering their purpose and potential consequences
This proactive approach reinforces the robustness of the system in the face of uncertainty.
Support and resources required (chapter 7)
Chapter 7 deals with the resources necessary for the operation of the QMS:
- resources (7.1): humans, infrastructures, working environment, monitoring and measurement equipment
- Skills (7.2): determination and acquisition of the necessary skills for persons performing work that affects the performance of the QMS
- Awareness raising (7.3): people's awareness of the quality policy, the objectives and their contribution to the effectiveness of the QMS
- Communication (7.4): determination of relevant internal and external communications concerning the QMS
- Documented information (7.5): creation, updating and control of the necessary documents and records
This section ensures that the organization has the appropriate means to achieve its quality objectives.
Carrying out operational activities (chapter 8)
Chapter 8 is the operational core of the standard:
- Operational planning and control (8.1): planning, implementing and controlling the processes necessary for the provision of products and services
- Product and service requirements (8.2): determination and review of customer, legal and regulatory requirements
- Design and development (8.3): control of the design process to ensure that products and services will meet requirements
- Control of processes, products and services provided by external service providers (8.4): control of purchases and subcontracting
- Production and service provision (8.5): control of the conditions of implementation, identification and traceability, customer property
- Release of products and services (8.6): conformity check before delivery
- Control of non-compliant output elements (8.7): identification and treatment of non-compliant products
This chapter ensures that operational processes are controlled to deliver compliant products and services.
Performance evaluation (chapter 9)
Chapter 9 concerns the measurement and analysis of the system:
- Monitoring, Measurement, Analysis, and Evaluation (9.1): definition of the elements to be monitored and the methods of analysis, in particular customer satisfaction
- Internal Audit (9.2): planning and conducting internal audits to assess the compliance and effectiveness of the QMS
- Management review (9.3): periodic evaluation of the QMS by management to ensure its relevance, adequacy and effectiveness
This feedback loop is essential for system improvement.
Continuous improvement of the QMS (chapter 10)
Chapter 10 finalizes the improvement loop:
- Generalities (10.1): identification and selection of improvement opportunities
- Non-compliance and corrective action (10.2): reaction to non-conformities, analysis of the causes and implementation of actions to avoid their recurrence
- Continuous improvement (10.3): continuous improvement of the relevance, adequacy and effectiveness of the QMS
This chapter embodies the principle of continuous improvement at the heart of the quality approach.
Amendment 2024: Integrating climate change
New climate requirements
In February 2024, ISO published Amendment 1 to ISO 9001:2015, introducing explicit climate change requirements for the first time. This evolution marks a turning point in the history of the standard by integrating environmental considerations directly into the quality framework:
- Amendment to Chapter 4.1 (Organization Context) : organizations must now explicitly determine whether their external and internal issues are the result of climate change
- Addition of a note to Chapter 4.2 (Interested Parties) : clarifying that interested parties may have specific requirements relating to climate change
These changes reflect the growing importance of climate issues in the strategies of organizations and the need to integrate these considerations into the quality management system.
Implementation schedule
The integration of these new requirements follows a gradual schedule to allow organizations to adapt:
- February 2024 : Official publication of Amendment 1
- February 2024 - February 2026 : Transition period for organizations already certified
- Starting in March 2026 : Mandatory application of new requirements during certification and renewal audits
During the transition period, certified organizations must prepare for the integration of these new requirements into their quality management system.
Impact on certified organizations
The 2024 amendment will have several concrete implications for ISO 9001-certified organizations:
- Expanded context analysis : need to identify climate issues relevant to the organization, such as:
- Climate regulations (carbon tax, emission allowances)
- Physical risks (extreme weather events)
- Energy transition challenges
- Changing customer expectations for sustainability
- Taking into account new interested parties : integration of stakeholders specific to climate issues:
- Environmental NGOs
- Local communities
- Environmental authorities
- Investors attentive to ESG criteria
- Extending the scope of regulatory monitoring : monitoring of legislative developments in the field of climate at the national and international levels
- Review of risks and opportunities : integration of climate factors into the risk analysis of the quality system
- Development of specific skills : training and awareness-raising on climate issues for the personnel concerned
For companies already committed to an environmental approach or certified ISO 14001, this evolution will facilitate the integration of quality and environmental management systems.
The following table shows the main differences between the traditional ISO 9001:2015 approach and the new requirements of Amendment 2024:
Sectors of activity and specificities
The ISO 9001 standard applies to any type of organization, but some sectors have specific characteristics in its implementation:
Each sector adapts the standard to its specific challenges while respecting the general framework of quality management.
Best practices and success factors
The success of an ISO 9001 certification process is based on several key factors identified by practitioners and certification bodies:
- Visible management commitment : the success of a quality approach depends fundamentally on the active and visible involvement of management, which must lead the project and allocate the necessary resources to it
- Pragmatic and adapted approach : an effective quality management system should be adapted to the culture, size and specificities of the organization rather than applying generic models
- Staff involvement : awareness-raising and training of staff at all levels are essential for the ownership of the approach and its effective implementation
- Proportionate documentation : contrary to popular belief, the ISO 9001:2015 standard does not impose excessive documentation but requires relevant and useful documented information
- Value-added approach : processes should be designed to provide real added value rather than to meet only the requirements of the standard
- Integration into the global strategy : the quality management system must be aligned with the organization's strategic goals to avoid being perceived as a parallel approach
These best practices make it possible to avoid the classic pitfalls and to optimize the benefits of ISO 9001 certification.
ISO 9001 FAQ
What are the differences between ISO 9001:2015 and ISO 9001:2008?
The 2015 version introduced several major changes compared to the 2008 version:
- Structure HLS (High Level Structure) aligned with other ISO management system standards
- Introduction of the risk and opportunity approach in place of preventive actions
- Strengthening the role of management with more active and empowered leadership
- Greater documentary flexibility with the concept of documented information
- Increased consideration of the organization's context and interested parties
- Organizational knowledge management as an essential resource
- Life cycle thinking in the design of products and services
These developments have made the standard more adaptable to different sectors and types of organizations, while strengthening its strategic focus.
Is ISO 9001 certification mandatory?
No, ISO 9001 certification is a voluntary process. However, it can become a contractual requirement in several situations:
- Public tenders : some public contracts require certification as a selection criterion
- Customer-supplier relationships : many large companies impose it on their suppliers
- Regulated sectors : some sectors (aeronautics, automotive, medical) consider ISO 9001 as a minimum prerequisite
Although not mandatory, certification is often a decisive competitive advantage and sometimes a condition of access to certain markets.
How long does it take to get ISO 9001 certification?
The processing time generally varies between 6 and 18 months depending on several factors:
- Size and complexity of the organization : number of sites, diversity of activities
- Maturity of the existing quality system : organizations that are already structured vs. starting from scratch
- Resources allocated to the project : dedicated team vs. partial resources
- Involvement of management and staff : ownership and commitment
- Recourse to external support : specialized consultants
Here is a typical calendar for a medium-sized SME:
A hasty approach risks leading to a superficial system that does not provide the expected benefits.
What are the pitfalls to avoid when implementing ISO 9001?
The most common mistakes when implementing ISO 9001 include:
- Underestimating the necessary involvement of management : an approach solely carried out by the quality manager is doomed to failure
- Create excessive documentation that is disconnected from real practices : the documentary “gas factory” remains the classic pitfall
- Consider certification as an end in itself rather than a continuous improvement tool
- Neglecting staff training and awareness to the process approach and to the quality philosophy
- Entrust the project only to external consultants without internal ownership
- Copy generic templates without adapting to the specific context of the organization
- Separating the quality system from operational activities daily
These errors generally lead to an inefficient system, perceived as a bureaucratic constraint rather than a lever for improvement.
How does the ISO 9001 standard relate to other ISO standards?
Thanks to the common HLS structure, the ISO 9001 standard can easily be integrated with other ISO standards in an integrated management system:
System integration makes it possible to pool resources, simplify documentation and ensure the consistency of approaches.
Does the 2024 amendment involve environmental certification?
No, the 2024 amendment does not require comprehensive environmental certification like ISO 14001. It simply requires organizations to take climate issues into account in their context analysis and the management of interested parties.
This evolution introduces a “climate dimension” into the quality management system, but:
- Does not require an assessment of environmental aspects
- Does not impose carbon footprint measurements
- Does not require an emissions reduction plan
ISO 9001 certification remains focused on quality management, even if it now introduces a consideration of climate issues in this framework. For a comprehensive environmental approach, ISO 14001 certification remains the reference.
What is the difference between an internal audit and a certification audit?
Internal and certification audits differ in several key aspects:
The two types of audit are complementary in a certification process: the internal audit prepares and continuously improves the system, while the external audit validates its compliance.
Conclusion: ISO 9001, a strategic investment for businesses
The ISO 9001 standard continues to evolve to meet the contemporary challenges of organizations. With the 2024 amendment integrating climate issues, it confirms its central place in the ecosystem of management standards, while adapting to current societal concerns.
For organizations of all sizes, it is much more than just a certification:
- A structuring framework for the organization of processes
- A lever for improving customer satisfaction
- A tool for reducing non-quality costs
- A vector for mobilizing teams
- An internationally recognized commercial asset
The process approach, customer orientation and risk management that characterize the ISO 9001 standard remain fundamental principles of effective management, now enriched with an environmental dimension.
To deepen your knowledge of the ISO 9001 standard or to engage in a certification process, do not hesitate to consult qualified experts or to contact accredited certification bodies who can assist you in this strategic process for the sustainable development of your organization.
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