Customers increasingly want a guarantee from businesses that the products and services the customers are buying have gone through quality management best practices. Adopting the ISO 9001 standard is one step towards offering a quality assurance guarantee.
ISO 9001 is the most well-known international standard for Quality Management Systems (QMS), published by the International Organization for Standardization (ISO). ISO standards are the most widely used performance and quality standards worldwide.
ISO 9001 is part of the ISO 9000 family of quality management standards. The current version is ISO 9001:2015, meaning it was released in 2015. The key benefit is to help your business prevent quality issues that could affect customers, employees, business partners, and even your industry.
The standard defines requirements for creating a robust quality management system. The QMS is a uniform, well-organized, process-driven approach to governing quality and control objectives to ensure continual improvement.
Implementing ISO 9001, however, is a challenging task. This article will give you a thorough understanding of the basics of the standard before you begin.
What Is ISO 9001?
ISO standards handle a range of business concerns. 9001 specifically focuses on quality management system standards for enterprise-wide quality assurance.
The ISO 9001 quality management system also defines requirements for meeting customer needs and overall customer satisfaction rather than just adhering to product specifications. That’s because the quality of your products depends, ultimately, on whether and how well they meet customer needs.
ISO 9001 encourages a process-oriented management strategy by reviewing more than 20 processes. By following the suggestions of the standard, a company can ensure that it offers high-quality products and services.
8 Key principles of ISO 9001
At the center of ISO 9001 are eight fundamental quality management principles.
1. Customer Focus
ISO 9001 evaluates an organization’s objectives and initiatives to meet customer requirements and exceed customer expectations. This principle applies to product performance as well as customer service. Customer complaints must be systematically logged and corrective action taken.
2. Leadership
Organizations succeed when their leaders establish and maintain work environments that engage people across the company to achieve quality objectives. Leadership at all levels must be aligned to drive a quality-minded culture.
3. Involvement of People
Engagement of people is one of ISO 9001’s most essential principles. The arrangement allows employees to be more empowered, competent, dependable, and better able to help you achieve your quality objectives and meet customer needs.
Engaging your employees also means you should respect them as individuals. Recognize their achievements, help them with personal and professional development, and constantly communicate with them. The way for your company to succeed is to retain competent employees by engaging with them.
4. Process Approach
An organization will operate more efficiently when leaders manage and control the business processes, linking them together to form a single system. Adopting this process approach of inputs and outputs will help your company achieve more predictable and consistent results. It will also help people focus their efforts on crucial improvement processes.
5. System Approach to Management
The process approach is part of the system approach. Individual process performance will improve when you understand, analyze, and manage interrelated processes to develop a cohesive system. You’ll continue to be successful when your business processes are managed as one cohesive quality management system.
6. Continual Improvement
Continual improvement is an ongoing effort to identify new opportunities and enhance your company’s products, services, and processes. It involves constant evaluation of customer needs and process improvement activities. In response to quality gaps, identifying the root cause and implementing sustainable corrective actions are crucial to quality assurance.
7. Factual Approach to Decision-Making
Competent staff members should analyze and evaluate all available data and information using the appropriate tools and methods during the decision-making process. All this data, however, should be accurate, reliable, and secure because objective facts and proper data analysis drive the best business decisions.
8. Relationship Management
Successful companies establish relationships with relevant partners, including business associates, vendors, investors, and resellers, to ensure the continuity of the supply chain.
What are the benefits of following the core principles of ISO 9001?
The International Standard for Quality Management Systems offers numerous benefits if you’re ISO certified. These quality management principles are at the core of ISO 9001, encompassing customer focus, process approach, and continuous improvement.
- ISO 9001 Implementation: Implementing ISO 9001 enables organizations to meet customer requirements and exceed customer expectations, enhancing customer satisfaction and loyalty.
- Engagement of People: ISO 9001 builds a more competent and motivated workforce by engaging and respecting employees and strengthening the Quality Management System (QMS).
- Process Approach: The process approach ensures efficient management of business processes, resulting in predictable and consistent outcomes while focusing on critical improvement processes.
- Quality Assurance: The ISO 9001 standard promotes a culture of quality assurance, fostering data-driven decision-making and continual improvement.
- Relationship Management: Maintaining solid relationships with stakeholders throughout the supply chain is crucial, as ISO 9001 emphasizes relationship management.
- Evidence-Based Decision Making: ISO 9001 stresses the importance of analyzing data for informed, evidence-based decision-making.
- Continuous Improvement: The PDCA (Plan-Do-Check-Act) cycle encourages organizations to identify new opportunities, address nonconformities, and implement corrective actions for continuous improvement.
- Market Share and New Opportunities: ISO 9001 helps organizations respond rapidly to new opportunities, expand market share, and meet regulatory requirements.
What Are the Requirements of ISO 9001?
To achieve and maintain an ISO 9001 certification, businesses must meet requirements based on the critical areas of the quality management system. Internal audits use these requirements as an ISO 9001 checklist to help your company comply with the ISO standard.
The seven requirements of the ISO 9001 standard are:
Context of the Organization
Clause 4 of ISO 9001 specifies the goal and strategic direction of your company’s quality management system. It addresses the following topics:
- Identify the internal and external factors influencing your quality;
- Identify your company’s stakeholders, such as employees, suppliers, and other stakeholders;
- Recognize your consumers’ preferences and needs.
Leadership
ISO 9001 recognizes that a successful quality management system depends on your organization’s top management’s commitment. As a result, Clause 5 compels your management team to accept responsibility for:
- Developing a quality management system;
- Creating quality guidelines and goals;
- Communicating these guidelines and goals to personnel accountable for the quality of the company’s products and services;
- Performing periodic evaluations.
Planning
A successful quality management system uses a risk-based approach and implements strategies to handle risks and opportunities. As a result of Clause 6, businesses must:
- Record possible threats, noting their severity and likelihood of occurrence;
- Make plans to avoid or mitigate unfavorable consequences;
- Integrate strategies to improve desired outcomes.
Support
Clause 7 of the ISO 9001 standard demands that your organization offers appropriate resources to execute an effective quality management system. This involves making resources available for:
- Efficient working environments,
- Strong infrastructure,
- Effective human resources management.
Operation
The ISO 9001 operation section, Clause 8, defines your organization’s work to produce and supply products and services to your clients.
Your procedures should outline the following:
- The specifications and quality goals of your goods or services;
- The procedure manuals, papers, and tools your staff require to produce goods or services successfully;
- Monitoring, inspection, or testing required to verify the quality of your products or services;
- The guidelines governing the production and preservation of your records.
Performance Evaluation
Clause 9 of ISO 9001 mandates your company to measure and analyze its operations, then document the results to:
- Show that it meets the standards of the ISO 9001 standard;
- Check if it is using all components of its quality management system;
- Encourage continuous improvement in quality management throughout the organization.
Improvement
The standard’s final clause emphasizes continual improvement inside a corporation. Measures should be implemented to:
- Improve services and goods for the company’s benefit;
- Improve client satisfaction by better matching consumer demands;
- Identify situations when processes fail to meet their objectives and adjust them accordingly.
Why Is ISO 9001 Important?
ISO standards are recognized worldwide. Doing business globally is much easier when dealing with a standard set of established practices and expectations. Even if your company is entirely domestic, understanding ISO 9001 regulations and how they might apply to your company is valuable.
A quality management framework also helps you increase market share, implement quality fundamentals, and drive improvement activities. It’s a valuable roadmap to becoming a world-class organization. The internal and external audits required for maintaining ISO 9001 certification hold your organization accountable for its quality management principles.
Improve Quality Management with ROAR
The ISO 9001 standard requires internal audits but does not allow for self-assessment. Instead, your organization’s compliance must be audited by a certified body. Nor can you rest on your laurels after certification; you’ll need to recertify every few years.
Compliance audits for ISO and other regulatory frameworks can be time-consuming and challenging. Understanding requirements, conducting internal audits, and organizing the necessary documents can be overwhelming.
Instead of using spreadsheets, adopt RiskOptics ROAR to streamline activities for all your compliance frameworks. Cross-mapping standard requirements across multiple compliance frameworks reduces your team’s workload.
It is a single source of truth that ensures your organization is prepared for your next audit. Policies and procedures are revision-controlled and easy to find in the document repository. Workflow management features offer easy tracking, automated reminders, and audit trails. Insightful reporting and dashboards provide visibility to gaps and high-risk areas.
RiskOptics makes it easier to achieve ISO 9001 compliance. Schedule a free demo and begin your worry-free journey.