ISO 9001 is one of the many certifications from ISO, the International Organization for Standardization. It ensures that a company has achieved an international standard for quality management.
This certification is part of a group of five standards, the ISO 9000 family. For example, ISO 9002 and 9003 were alternative models to 9001. The former did not cover product creation, while the latter did not address how the product was produced. Nevertheless, both were incorporated into ISO 9001 in the 2000 revision.
The purpose of the certification is to help organizations of all sizes and sectors improve their performance, meet customer expectations, and demonstrate their commitment to quality.
The requirements of ISO 9001 dictate how to implement a Quality Management System (QMS). The most recent updates to the certification also define how to continuously maintain and improve this management.
How ISO 9001 Came About
The history of ISO 9001 can be traced back to the 1950s. At that time, government departments in the United States and the United Kingdom sought to define standards for purchasing military materials.
To ensure the excellence of the acquired equipment, suppliers were required to meet a series of quality assurance requirements. Thus, NATO AQAP, MIL-Q, and Def Stans standards were created—all focused on quality management for the military sector.
This changed in 1979 when quality management moved from the military field to the general industry. The catalyst for this was the BS 5750 standard from the BSI Group (British Standards Institution), the UK’s technical standards body.
Based on this technical standard, ISO 9001 emerged in 1987, a model to demonstrate quality assurance in all areas of a company. At the time, this included design, development, production, assembly, and customer service.
ISO’s creator, the International Organization for Standardization, was established in 1947 from a proposal by the newly-formed United Nations (UN). Representatives from 25 countries met to create ISO, then a new body for creating global standards.
Today, ISO’s technical committee meets every five to eight years to review the ISO 9001 standard. The goal is to ensure it remains relevant to the demands of companies worldwide, resulting in a continuous improvement cycle.
Benefits of ISO 9001 Certification
About 1.2 million companies had ISO 9001 certification by the end of 2022, the last time the organization released updated data. Certification is highly sought after by organizations from various fields due to its numerous benefits.
Here are the main benefits of having ISO 9001 certification:
- Greater chance of winning contracts. Whether your company is looking to secure a public or private contract, certification guarantees greater credibility (and sometimes it is a mandatory requirement).
- More satisfied customers. One of the criteria for achieving certification is “customer focus.” This means your organization needs to put them first, leading them to renew their subscriptions or return to buy from you again.
- Better management. The International Organization for Standardization requires a business’s top leadership to work with its employees to ensure they follow the QMS. They are also responsible for ensuring the system achieves its intended results.
- cA comprehensive view of your processes. The process to obtain ISO 9001 involves analyzing your company’s overall context. This allows you to set clear objectives and identify new business opportunities.
- Reduction of problems. Avoid defects in your products or errors in your services. With a quality system, you will have established processes to improve problematic products or inefficient services.
- More satisfied and secure employees. After implementing ISO 9001, employees will feel more secure working in an organization with well-defined processes and organized management.
- Continuous improvement. The certification process leads the company to create a culture of excellence that should permeate all facets of its operation. This creates the goal of meeting and even exceeding consumer expectations.
- Reduced costs. All your processes will be aligned and better understood by everyone in the organization. This increases productivity and efficiency, reducing internal expenses.
Principles of ISO 9001
For quality to find a place in your organization’s heart, some principles developed by the International Organization for Standardization specialists must be followed.
Here are seven points highlighting what is necessary to achieve greater consistency in your processes, better performance, and more satisfied customers.
Learn about the fundamental principles for any organization implementing ISO 9001:
1. Customer focus
Customers are the main focus of any successful business. For an organization to grow, it must meet customer expectations. An essential step in getting there is seeking customer feedback.
By listening to both negative and positive opinions, it will be possible to better understand what does not comply with the processes. Work to correct your flaws and improve your weak points.
Following this principle, your organization is likely to create a loyal customer base, improve its reputation, and maintain a healthier relationship with stakeholders.
2. Leadership
Strong leadership with a clear vision of the company’s future is another crucial factor for implementing ISO 9001. This allows for greater coordination of processes throughout the organization.
Effectively communicating this vision also ensures that all your teams work towards the same goals. This clarity tends to increase employee motivation and result in greater productivity.
The International Organization for Standardization requires the company’s top management to communicate quality management processes to employees. They are also responsible for ensuring the goals for improving procedures are met.
3. Engagement of people
Systems like ISO 9001 require contributions from top management and the entire organization. Everyone needs to be engaged, sharing their knowledge and experience with the rest of the team in the pursuit of excellence.
It is also essential that everyone understands their role in the company’s success and feels valued for their contributions.
According to ISO, the benefits of having engaged employees include:
- Greater personal development, with more participation in initiatives and better use of creativity
- Increased satisfaction levels
- Increased employee trust in the organization
- Attention to company values and culture
4. Process approach
This item addresses the importance of having a process-oriented culture. This allows managing the organization’s activities by identifying key procedures.
It is encouraged to adopt a philosophy of creating plans, providing the necessary resources, and managing interactions between different stages more effectively. This way, you can focus your efforts on seizing improvement opportunities as they arise.
Another advantage is the possibility of more fruitful collaboration between different departments. As a result, your organization can demonstrate greater efficiency and effectiveness to its partners and other stakeholders, increasing trust in your operations.
5. Continuous improvement
Continuous improvement should be your organization’s main objective, not only during the implementation of ISO 9001 but also after obtaining certification. To do so, it is necessary to implement processes to identify risks and opportunities to resolve non-compliance issues.
Use all learning opportunities to develop and improve your processes. Through this, you can increase your performance and improve customer satisfaction.
The main benefits of a continuous improvement philosophy include:
- Greater focus on investigating and determining the root cause of problems, followed by preventive and corrective actions
- Better ability to predict and react to internal and external risks
- Increased ability to recognize new opportunities
- Evidence-based decision making
Your decisions should be based on objective information and data analysis. In other words, no defining strategies based on subjective evaluations or personal hunches.
For example, a hospital wanting to implement a new surgical technique should seek information from scientific research, clinical trials, and treatment outcomes. This ensures maximum patient safety, which would not be the case if the decision were based only on anecdotal evidence or expert opinions.
6. Evidence-based decision making
Your decisions should be based on objective information and data analysis. In other words, no defining strategies based on subjective evaluations or personal hunches.
For example, a hospital wanting to implement a new surgical technique should seek information from scientific research, clinical trials, and treatment outcomes. This ensures maximum patient safety, which would not be the case if the decision were based only on anecdotal evidence or expert opinions.
7. Relationship management
Few things are as important for long-term success as cultivating good relationships with stakeholders, especially with suppliers. ISO also highlights the importance of partner networks in an organization’s success.
This also means balancing short-term financial gains with long-term strategies that bring mutual benefits to your organization and stakeholders. By improving your business relationships, you pave the way for expansion and growth.
How to implement ISO 9001
Despite developing and publishing the standard, the International Organization for Standardization does not participate in the certification process. To obtain certification, a company must contact an independent certification body.
When choosing a certification body, it is important to check if it uses a relevant CASCO (ISO committee for conformity assessment) standard. In the USA, for example, there are various accredited certification bodies recognized by the American National Standards Institute (ANSI) and the National Institute of Standards and Technology (NIST).
ISO also recommends verifying if the body is accredited, which serves as a form of competence certification. You can check who holds accreditation on the International Accreditation Forum website.
To implement ISO 9001, you can follow these seven steps:
- Work with top management. The company’s top management needs to be committed to implementing the quality management system. You will only succeed if they allocate the necessary resources for its implementation.
- Understand the ISO 9001 requirements. It is necessary to read the entire standard document and review the requirements contained in its sections. Your organization will need to comply with the seven principles listed above: customer focus, leadership, engagement of people, process approach, continuous improvement, evidence-based decision making, and relationship management.
- Conduct a gap analysis. Perform an internal audit to identify gaps between your organization’s current practices and ISO 9001 requirements. Create an action plan with steps to improve your processes.
- Implement a quality management system. Develop policies, procedures, and strategies to guide the implementation of a quality culture in your company. Create a quality manual, define measurable objectives, and communicate them to all employees.
- Monitor your performance. Establish key performance indicators (KPIs) and conduct internal audits to identify areas where your company can improve.
- Seek certification. Once your QMS has been operating for three to six months, it’s time to start the ISO 9001 certification process. Contact an accredited body and begin the certification process.
- Focus on continuous improvement. Your improvement process only begins with certification but certainly does not stop there. Continue monitoring your performance and identifying improvement opportunities. Develop your QMS to ensure it remains effective.
Conclusion
ISO 9001 certification is an essential milestone for any organization seeking excellence in quality management. By adopting the principles and requirements established by ISO, companies not only ensure compliance with international standards but also promote a culture of continuous improvement.
This results in greater customer satisfaction, more efficient processes, more engaged employees, and consequently, a more competitive market position. Implementing ISO 9001 is a strategic investment that brings significant short- and long-term benefits, consolidating a reputation for commitment to quality and operational excellence.
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