What is the Purpose of ISO 9001?
ISO 9001 (or, to give it its full title ISO 9001:2015, Quality management systems – requirements) is an internationally recognized standard that sets out the requirement for an ISO Quality Management System (QMS).
It was initially developed by the British Standards Institute and is known as BS 5750. It became an international standard in 1991 when published under the auspices of the International Standards Organization (ISO).
While originally product-focused (and mainly of interest to manufacturing businesses), it has evolved through several iterations into a standard focused on managing the processes that make up an organization’s activities. As such, it is now globally applicable to all kinds of organizations.
The purpose of the Standard is to provide a framework for an organization to develop a management system that will …
- Consistently meet customer requirements, that is, consistently provide a product or service that meets specification or other agreed/recognized criteria, and
- Enhance customer satisfaction through continual improvement of the management system.
Fundamental to fulfilling achieving these objectives are two features …
- A Quality Policy – the intentions and direction of an organization as formally expressed by its top management and consistent with the context of the organization, and
- Quality Objectives – measurable targets, generally specified for relevant organizational functions, levels, and processes – focused on improvements.
External Auditors will persistently pay great attention to these four issues.
For more, visit ISO 9000, Quality management systems – Fundamentals and vocabulary
What is the Purpose of a Quality Management System?
Quality is fundamentally about an organisation’s ability to consistently provide products and services that meet customer requirements.
Adopting a quality management system is a strategic decision for an organisation that goes beyond the ability to provide a quality product or service. It can help to improve the organisation’s overall performance and provide a sound basis for sustainable improvement initiatives.
Is ISO 9001 a Widely Used Standard?
Third-party certification bodies confirm that organizations meet the requirements of ISO 9001. In 2021 (the latest year for which ISO has published figures), over one million organizations worldwide, covering 1.5 million sites, were independently certified to ISO 9001, making it by far the most widely used management system standard in the world today.
What does the year mean in ISO 9001?
The year in ISO 9001, such as “2015” in ISO 9001:2015, indicates the year in which that version of the standard was published or last updated. It reflects when the specific revision of the standard was officially released by the International Organization for Standardization (ISO). Each revision may include updates or changes to reflect new industry practices, technologies, or concepts in quality management.
What is the most recent ISO 9001 version?
The latest version of ISO 9001 is ISO 9001:2015. It replaced the previous version, ISO 9001:2008.
Is ISO 9001 Still Relevant?
The relevance of ISO 9001 certification has repeatedly been questioned over the years, yet it persists. Some may argue that the standard needs to be updated and more relevant to the current business environment. However, despite the changes in business practices and technology, the core principles of the ISO 9001 standard remain relevant and come with many benefits for different stakeholders.
What kinds of organizations can benefit from implementing ISO 9001?
All the requirements of ISO 9001:2015 are generic and are intended to apply to any organization, regardless of its type or size or the products and services it provides.
What Does it Mean to Have ISO 9001 Certification?
For organizations, ISO 9001 certification means that they have a quality management system (QMS) that complies with the requirements of ISO 9001. By having it, the organization shows that it is committed to providing its customers with products and services that meet its requirements and those of relevant regulatory bodies and to continually improving its processes.
Having ISO 9001 certification as an auditor signifies that the auditor is recognized for their competence in understanding and applying the ISO 9001 standard, as well as conducting effective audits of Quality Management Systems (QMS).
What are the Benefits of Having ISO 9001 Certification?
All organizations certified to ISO 9001 by an accredited Certification Body will enhance their:
- Customer satisfaction: The standard focuses on customer satisfaction, arguably every organisation’s top priority. With technological advancements, customer expectations and demands have increased, and organizations must continually improve their processes to meet these demands. The ISO 9001 standard’s emphasis on customer satisfaction provides a framework for organizations to continually improve their processes and meet customer needs.
- Reputation: Be taken seriously as a prospective supplier as the holder of ISO 9001 Certification, which is based on the independent assessment of an accredited certification body.
- Qualifications for pre-tender and tender opportunities, especially from the public sector.
- Status: Be on equal terms with the ‘big’ boys’ – the size of your organization won’t hold you back.
- Risk management. While not a requirement, it is implemented by most certified organizations as the basis of quantifying threats of all kinds to the business and then proactively dealing with them. With the increasing complexity of business operations, risk management is more critical than ever. The ISO 9001 standard’s emphasis on risk management provides a framework for organizations to identify and manage risks effectively.
- Objectives and improvement: Obligations focus on setting targets for improvement and then planning and implementing them in a timely manner.
- Processes and procedures: Organizations must continually improve their processes to remain competitive and meet customer demands. The ISO 9001 standard’s emphasis on process improvement provides a framework for organizations to identify and address inefficiencies in their processes, leading to increased productivity and reduced costs.
- Internal audits to monitor compliance with requirements and highlight deficiencies.
- Corrective actions to prevent the recurrence of errors – try to make mistakes only once, if at all.
- Informed Board of Directors: The standard emphasizes the importance of data-driven decision-making. In 2023, with technological advancements, organizations had access to vast amounts of data. The ISO 9001 standard’s emphasis on data-driven decision-making provides a framework for organizations to use data effectively to improve their processes and make informed decisions.
- Management satisfaction knowing that the organization is functioning in line with strategic objectives and satisfying customers.
- Minimal costs for maximum gain: The costs of maintaining certification are minimal compared to the potential created by having an ISO 9001-compliant Quality Management System.
- Reduce errors: Fewer costly errors, less rework, replacement of goods and/or services, and increased productivity.
- Fewer customer complaints as fewer errors occur.
- Better retention of customers: again, a consequence of reduced errors.
- Management performance improved as less time was spent apologizing to customers and managing the unnecessary repetition of work.
ISO publishes four standards that focus directly on an organisation’s QMS:
- The management system standard: ISO 9001:2015. This standard is the specification for a QMS.
- The Technical Standard ISO/NP TS 9002:2016 Quality management system — Guidelines for applying ISO 9001:2015. This standard provides extensive knowledge on all aspects of a QMS and has copious examples from which you can draw. Note: This is not a Normative Reference in ISO 9001:2015; therefore, applying it to your QMS is not mandatory.
Is ISO 9001 Certification Necessary?
It depends on your specific needs or circumstances. Here are a few things you might want to consider when making the decision:
Option 1: Defer or drop the ISO 9001 Certification Project. This is the easy option, but here you forego the efficiencies and increased business that implementing and maintaining the Standard can bring.
Option 2: Proceed with the Project using your own resources alone. If your team is knowledgeable about management systems and has been deeply involved previously in implementing and maintaining a management system, this may be a viable option.
Option 3: Proceed with the Project with outside support. Please supplement your resources with the services of a Consultant or, if part of a multinational, the services of experienced colleagues from similar sites.
By the way, when you choose a consultant, please be careful. Engage only a consultant with experience in similar businesses to your own, and check out the references provided (a site visit or two may be helpful).
When is the right time to get ISO 9001:2015 Certified?
You can go forward for Certification too soon. With start-ups, things are in a state of flux for some months or perhaps some years. When we went forward for ISO 29990 Certification (an ISO 9001 family standard specifically for Learning Providers and since replaced by ISO 21001 certification) we were in business for four years.
We needed to wait until processes and the associated procedures had bedded in. All startups do need to wait until that kind of stability is achieved. After all, startups are about ‘running as hard as you can with the ball’ and not about documenting things that are liable to radical change next week!
But once you are satisfied that processes and procedures are bedded in, go for it. You definitely won’t regret it. Your customers, your board, your staff and your bank manager will all thank you for it. And you’ll sleep easier in your bed knowing that your business and the satisfaction of your customers in under control.
Is ISO 9001 Auditor Training mandatory when aiming for certification?
A course in quality management for a Management Representative or others with day-to-day responsibility to maintain a QMS is NOT mandatory. Training is implied as part of developing competence but not a specific stand-alone requirement.
Training is also not mandatory for internal auditors. However, effective internal audits are essential to doing a professional job in maintaining your QMS, preparing for Certification Body audit, and continuously improving your organization’s quality processes.
However, the ISO 9001 does require competence of all personnel whose work affects quality and that certainly includes a course in quality management systems and the auditing of same for audit programme managers and internal auditors.
Where can I get a copy of ISO 9001 and other related standards?
Before establishing a QMS and drafting the various documents for your QMS, you should purchase copies of the pertinent ISO standards, namely:
- The management system standard: ISO 9001:2015. This standard is the specification for a QMS. It sets out the requirements for an auditable QMS. It provides the standard against which QMS certification audits are performed, including the required documentation. An organisation that seeks certification of its QMS is examined against this standard.
- The Technical Standard ISO/NP TS 9002:2016 Quality management system — Guidelines for applying ISO 9001:2015. This standard provides extensive knowledge on all aspects of a QMS, especially for Small and Medium-sized Enterprises and Service Industries (which historically have had difficulty interpreting ISO 9001). It contains copious examples from which you can draw.
You can purchase these standards from the following online stores:
Option 1: Defer or drop the ISO 9001 Certification Project. This is the easy option, but here you forego the efficiencies and increased business that implementing and maintaining the Standard can bring.
Option 2: Proceed with the Project using your own resources alone. If your team is knowledgeable about management systems and has been deeply involved previously in implementing and maintaining a management system, this may be a viable option.
Option 3: Proceed with the Project with outside support. Please supplement your resources with the services of a Consultant or, if part of a multinational, the services of experienced colleagues from similar sites.
By the way, when you choose a consultant, please be careful. Engage only a consultant with experience in similar businesses to your own, and check out the references provided (a site visit or two may be helpful).
Get a copy of our ISO 9001 FAQs eBook to see our complete list of answers to frequently asked questions about ISO 9001.