What is ISO 9001?

• Customer focus: Creating a culture of quality will help meet and exceed customer expectations. This means treating every complaint or non-compliance as a chance to learn and deliver more value.
• Leadership: The leadership team plays a key role in boosting quality. With aligned strategies and collaboration, pursuing quality objectives is easier.
• Engagement of people: Employees also play a key role in quality management. ISO 9001 empowers the entire team to engage with quality processes and continuous improvement.
• Process approach: Improving processes through an EQMS system can remove silos, link workflows across departments, and help produce consistent results.

Improvement: The most successful companies focus on continually improving their processes. This could mean streamlining root-cause investigations, improving complaints handling, or making documentation processes more efficient.

• Enhanced customer satisfaction: Certification shows that an organization is serious about quality. Improved products, complaints handling, and decision-making can all positively impact customer satisfaction.
• Improved operational efficiency: More focus on processes as part of ISO 9001 can help an organization improve efficiency.
• Better risk management: An EQMS allows an organization to standardize its risk assessments and better handle any non-conformance events.
• Increased credibility and competitiveness: The internationally recognized ISO 9001 certification adds a level of credibility to a business. 
• Continuous improvement: ISO 9001 focuses on continuous improvement. This ensures an organization is always running efficiently, helping it maintain a competitive edge.

Certification elevates quality management to a higher level, adding credibility, improving customer relationships, enhancing productivity, and giving a competitive edge.

To become ISO 9001 certified, an organization needs to focus on a set list of requirements. 

• Scope and application: The scope statement provides a detailed description of the business’s activities, including its products, regulatory requirements, locations, and facilities.
• Context of the organization: This shows the organization in the wider industry landscape and might include political considerations, changes in legislation, environmental issues, and more.
• Leadership and commitment: Business leaders need to take a hands-on approach to managing quality. This should be evidenced through an organization’s policies, meeting minutes, and other documentation.
• Planning: An organization should take a risk-based approach to planning. This involves setting and measuring quality objectives, procedures for updating the QMS, and policies for responding to risks and opportunities.
• Support: As well as outlining personnel, locations, and logistics, the organization should provide information on maintaining monitoring and measuring resources. It will also outline training requirements and quality policies.
• Operation: This outlines the processes in place to meet quality requirements — from design to delivery. It will also include any external processes (such as those from suppliers) and policies for handling non-conformances.

Performance evaluation: Understanding how the organization will collect and monitor feedback is key to ISO 9001. A robust internal audit program should also be established to evaluate the effectiveness of the QMS.

To achieve ISO 9001 certification, take these steps:

• Understand the guidelines: Take time to read through the requirements.
• Create a customer-centric plan: Keep the focus on customer satisfaction.
• Execute leadership training: Ensure leaders understand their role in the quality process.
• Roll out team training: Team members should also understand how their work relates to quality and any new processes.
• Measure and track data: Implement a system for collecting and measuring data as it relates to quality objectives.

Implement a QMS: Implement an EQMS to keep all processes, documents, policies, and insights in one place.