ISO Quality Management Principles

Far and away, one ISO standards towers above all others in terms of sheer number of certificates and overall influence in manufacturing.  

That standard is ISO 9001, with more than 1.6 million sites certified worldwide. 

First published in 1987, ISO 9001 is built around helping companies organize and continuously improve the efficiency of their quality processes. It also forms the basis for other industry standards such as IATF 16949 for automotive quality and AS9100 for aerospace quality management systems. 

The goal: deliver compliant, high-quality products that satisfy customers and provide a foundation for the long-term success of the company.  

In today’s article, we explore the seven quality management principles that are the basis for ISO 9001, including: 

1. Customer focus 
2. Process approach 
3. Leadership 
4. Engagement of people 
5. Continuous improvement 
6. Evidence-based decision making 
7. Relationship management

1. Customer Focus

ISO 9001 puts customer satisfaction front and center, recognizing that the primary goal of quality management is to meet and even exceed customer expectations. 

Clause 4.2 of ISO 9001 details requirements around understanding the needs of interested parties, chief among them being customers. Under ISO 9001, manufacturers must: 

• Identify customer requirements and link them to your organization’s objectives 
• Evaluate and adjust processes to ensure they result in products that meet customer expectations 
• Communicate customer needs with the organization regularly 
• Monitor customer satisfaction to drive process and product improvements 
• Be proactive in managing customer relationships 

Companies that are able to do this are the ones that are most successful. By designing their processes around creating safe, high quality products, they also lay the foundation for improved profits and a strong brand reputation. 

2. Process Approach

Like other ISO standards, ISO 9001 emphasizes the Plan-Do-Check-Act (PDCA) process approach to improving customer satisfaction. This process requires organizations to: 

• Systematically define their processes (plan) 
• Track and manage those processes effectively (do) 
• Monitor performance consistently (check) 
• Improve processes based on data and information (act) 

PDCA represents a continuous cycle that promotes continuous improvement of processes and products. The clauses of ISO 9001 all fit into different steps of the PDCA process, as shown in the table below. 

PDCA Step	ISO 9001 Clauses
Plan	Context of the organization   Planning
Do	Support  Operation
Check	Performance evaluation
Act	Improvement

Clause 5 on leadership is unique in that it fits in with every step of the PDCA process, since leaders should be involved in all aspects of quality management 

3. Leadership

In recent years, there has been an increased emphasis on management involvement across all ISO standards. That’s because without leadership participation, any quality effort is doomed to failure. Leadership involvement is also key to coordination and communication, helping facilitate a more effective quality process overall.  

Because of this, ISO 9001 Clause 5 centers entirely on leadership, detailing requirements, such as: 

• Setting the direction in terms of communicating the organization’s quality policy and objectives 
• Promoting the PDCA process and risk-based thinking 
• Taking accountability for ensuring that the quality management system delivers results 
• Providing resources and support to facilitate continuous improvement 

Leaders are responsible for creating a shared vision and culture of quality in the organization, one where management sets a positive example, empowers others and recognizes their contributions. 

4. Engagement of People

ISO 9001 recognizes that an engaged workforce is the backbone of value creation in organizations today. People at all levels must be involved with quality, with a focus on skill-building, empowerment and recognition. This, in turn, improves team satisfaction and contributes to a shared culture of quality where everyone’s work matters.  

Key actions here include: 

• Communicating to individuals why their role is important to quality 
• Having open discussions where you solicit feedback and invite people to share their knowledge and experience 
• Measuring employee satisfaction and taking action based on the results 

5. Continuous Improvement

Continuous improvement is a requirement for success in today’s ever-evolving manufacturing landscape. A focus on improvement makes manufacturers better able to adapt to change and even innovate in the face of new risks.  

This quality management principle focuses on: 

• Effective root cause analysis combined with corrective and preventive action 
• Having a specified process for reacting to and documenting nonconformities 
• Deploying improvement projects and tracking their results 
• Making use of ongoing monitoring and measurement to inform continuous improvement projects and objectives 

6. Evidence-Based Decision Making

Far too often, it’s the loudest voice in the room that ends up driving decisions. ISO’s focus on data-driven decision making, on the other hand, provides for more objective decisions that the organization can have confidence in. Not only does it improve decision making, it also provides a mechanism to review and challenge decisions, as well as to demonstrate the effectiveness of previous decisions. 

Action points around evidence-based decision making include: 

• Monitoring manufacturing KPIs 
• Sharing accurate, reliable data with relevant parties 
• Analyzing data in a timely manner and making sure people know how to evaluate it 

7. Relationship Management

ISO acknowledges the importance of managing relationships with all interested parties, such as: 

• Customers 
• Employees 
• Investors 
• Partners 
• Suppliers 
• Society overall 

Specific emphasis is placed on management relationships with suppliers. The reason is that supplier management is critical to being able to meet customer needs and expectations. In the context of supplier management, action items should focus on: 

• Monitoring supplier performance and providing them feedback 
• Sharing information and resources to create value 
• Enlisting suppliers to collaborate on improvement projects 

Using Technology to Strengthen Quality Management Standard (QMS) and Become ISO 9001 Compliant

Technology has a key role to play in terms of safeguarding compliance with ISO 9001 requirements at every step of the PDCA process. 

For example, digitizing standard operating procedures (SOPs) can help you ensure that all of your processes are documented and updated, which is a key focus of ISO audits.  

Quality tools such as connected worker platforms, too, promote more effective, efficient ISO compliance with: 

• Plant floor checklists for monitoring processes and generating data to drive decision making, continuous improvement and leadership involvement 
• Issue tracking to document and handle nonconformities effectively 
• Dynamic training tools to increase workforce competency and engagement

Effective quality management is a multi-faceted process involving a wide variety of stakeholders, making technology a critical enabler of success. Even for manufacturers who do not certify to the standard, following ISO quality management principles can help improve performance and competitive standing in the industry.