In today’s world, business is done on a global scale. With so many moving parts around the world, how can businesses – and consumers – be sure that the goods and services they purchase or use meet quality expectations? The answer is standardization. Businesses throughout the world rely on specific standards to achieve quality and consistency in industries of all kinds.

To facilitate the standardization of things, the International Organization for Standardization (ISO) was created. The ISO serves as an independent, non-governmental body, composed of representatives from standards bodies in 169 different countries.

The work of the ISO helps businesses establish safety, efficiency, and even sustainability protocols. But perhaps the most important standard for both businesses and consumers is ISO 9001.

ISO 9001 is essential in helping businesses of all kinds to establish a quality management system (QMS). Its latest version, ISO 9001:2015, further improves quality management standards. Today, we’ll take an in-depth look at what ISO 9001 means, the latest updates in ISO 9001:2015, and how achieving it can benefit your business.

What is ISO 9001?

ISO 9001 sets a framework of quality management principles needed for a business to establish a quality management system. Implementing a QMS allows an organization to satisfy consumer expectations by consistently delivering high-quality products. These standards are internationally applicable to businesses of all kinds.

The quality management principles of ISO 9001 include:

Customer Focus

Whether your customers are consumers or other businesses, a strong focus on the customer’s needs is paramount to success. Adherence to this principle leads to greater customer satisfaction and repeat business.

Leadership

Strong leadership is required to maintain a dedication to quality management. With the right leadership, the organization is unified in purpose and communication is clear between all levels.

Engagement of People

To be successful, all members of the organization must be competent, motivated, and empowered to do their best work. This principle ensures all are aligned towards the same goals of quality, enhancing trust and collaboration.

Process Approach

Consistent quality is achieved when there is an inherent understanding of the process required to achieve it. Identifying, understanding, and managing interrelated processes as a system is imperative to achieving quality goals.

Improvement

Achieving quality is only part of the process. Successful organizations must also seek improvement of their processes. The Plan-Do-Check-Act methodology is critical to continuous improvement.

Evidence-Based Decision Making

Organizational decision-making should be predicated on thorough analysis and evaluation of available data. While decision-making necessarily involves some uncertainty, decisions should be made objectively, and with as much data to back up the decision as possible.

Relationship Management

Maintaining positive relationships within your business network is crucial to success. Understanding and respecting the goals of suppliers, distributors, end consumers, and anyone else involved with your organization, increases value and overall performance.

What is ISO 9001:2015?

ISO 9001:2015 builds upon the framework laid out in the original ISO 9001. Released in 2015, the update makes some notable changes and additions to ISO 9001. These include:

Structure

The 2015 edition of ISO 9001 adopts the high-level structure format used by many other ISO standards. Adapting to this new structure makes it easier to integrate other standardizations into your organization.

Emphasis on Risk-Based Thinking

The current update of ISO 9001 encourages companies to take a proactive approach to risk management. By practicing risk-based thinking, companies can identify and prevent issues before they become a threat to quality objectives.

Context of the Organization

Understanding your market and operating environment allows you to tailor your QMS specifically to your needs.

Leadership Involvement

ISO 9001:2015 increases its emphasis on the role of leadership in quality management. Management is expected to take accountability for the implementation, effectiveness, and availability of resources for the QMS.

Documented Information

A renewed emphasis on keeping and maintaining access to documentation determined as crucial to the quality management system.

Benefits of ISO 9001:2015 Compliance

Adopting ISO standards brings numerous benefits to an organization. Some of these include:

Enhanced Product Quality

Establishing a QMS ensures uniform and consistent product quality. This instills confidence in your partners, knowing that your product is free of defects.

Improved Customer Satisfaction

Adhering to quality standards ensures that your product meets customer expectations. When customers get what they pay for, they are likely to repeat their business and even recommend you to others.

Increased Operational Efficiency

By implementing the process approach, your business can identify and correct inefficiencies that would otherwise increase cost and waste. Improved efficiency leads directly to increased profitability.

Structured Approach to Decision-Making

Collecting and utilizing data in decision-making ensures that your company-level decisions are based largely on quantifiable evidence. It takes the guesswork out of problem-solving.

Increased Employee Engagement and Accountability

An emphasis on training programs to enhance your workforce’s skills gives employees a greater investment in the organization. The more employees feel like an important part of the business, the greater their quality of work.

Continuous Improvement Through Plan-Do-Check-Act

A pivotal component of ISO 9001:2015 is the Plan-Do-Check-Act (PDCA) methodology. PDCA is a development cycle that ensures the adoption of a process approach, producing continual improvement. It also ensures that processes have the resources they need to be completed, as well as identifying opportunities for improvement.

Plan

PDCA starts with planning the objectives and processes needed to achieve the customer’s requirements. Planning also involves determining the potential risks that might impact the quality of the product.

Do

This stage sets the plan into motion. It manages resources and establishes control over the processes necessary to execute the plan.

Check

To achieve consistent quality, you must monitor and measure performance against the quality and standards that have been set.

Act

Continual improvement is one of the primary goals of ISO 9001:2015. After measuring performance, steps must be taken to improve any areas that fall short of quality goals.

How to Become ISO 9001:2015 Certified

Becoming ISO certified is not a requirement for doing business, but as outlined above there are many benefits to adopting this standard for business. Above all, it adds credibility to your organization in the eyes of suppliers, partners, and customers.

In order to become certified, you’ll need to pass an accreditation audit by a certified body. This can be done by following a 5 step process.

Dedication of Leadership

In order to begin this process, company leadership must fully buy into establishing a QMS. This starts by fully understanding the requirements of ISO 9001:2015. Once leadership is invested in the process, a gap analysis must be conducted to gauge the company’s current status with respect to the standards, and where the company currently falls short.

Development and Implementation of the QMS

Documentation of the processes required to meet quality standards must be established. The terms of the QMS will be tailored to your unique business needs. This part of the process also involves training your employees on QMS standards.

Internal Audit

Once the QMS has been integrated into your business operations, it’s wise to conduct an internal audit to identify any areas that do not align with the ISO 9001:2015 standards. Companies like Manex have partnered with numerous organizations to carry out internal audits.

Certification Body Audit

When your internal audit shows you are at an acceptable level of compliance, it’s time to reach out to a certification body. The certification body will audit your operation in two stages. Stage 1 will audit your documentation. Stage 2 will involve an on-site audit.

Continual Improvement

Upon completion of a successful audit by the certification body, you will receive ISO 9001:2015 certification. However, it is important not to rest on your laurels. Continual improvement is paramount to sustained quality management. Following the Plan-Do-Check-Act methodology will help you keep on top of quality while identifying areas for improvement.

What if I Hold a Previous ISO 9001 Certification?

For organizations that already hold a prior ISO 9001 certification, you must achieve the ISO 9001:2015 to continue certification. As of 2018, any older ISO 9001 certifications are no longer valid. Only ISO 9001:2015 certifications are currently valid.

In addition, individual certifications must be renewed every three years. This is why continual improvement and adherence to your QMS must be maintained.

Conclusion

As you can see, adopting ISO 9001:2015 means more than simply passing a certification exam. It is a multifaceted approach to running a business, dedicated to quality and constant improvement that requires a total commitment from an organization, from leadership down through the entire workforce.

At Manex, we specialize in helping manufacturing organizations throughout the Bay Area and the greater Sacramento region achieve compliance with ISO 9001:2015, as well as many other standards.

Our industry professionals can help you document and implement a QMS, conduct gap analysis, conduct training, and much more. Let us help your organization to achieve its quality goals. Contact Manex at info@manexconsulting.com today to get started on the road to ISO 9001 certification.