Background
In 1987 the International Standards Organization (ISO) introduced ISO 9000, a quality management system that gave organizations a group of standards to implement quality controls in a consistent and systematic manner. As part of the ISO 9000 series, the ISO 9001 standard outlines how to meet quality and regulatory requirements and a methodology for process improvement, cost savings, and customer satisfaction. This standard can be certified or audited, which incorporates accountability within an enterprise. ISO’s practice of ongoing process improvement includes periodic revision of the standards, of which ISO 9000-2015 is the current version.
The concept of Total Quality Management (TQM) is a critical aspect of the ISO 9000 philosophy. TQM focuses on customer relationships, employee engagement, effective communication, and continuous process improvement. ISO 9001-2015 includes the criteria to establish these quality principles in businesses and organizations. ISO’s signature approach to TQM is for each organization to define quality objectives based on their own business needs and requirements, establishing more meaningful outcomes.
The current version of the standard was released in September 2015 and confirmed in 2021. Some fundamental changes were made to address the rapidly changing technological updates in recent years and achieve organizational goals more effectively. Included in the changes were:
- Overall revised structure of the standard
- Terminology changes from “products” to “products and services.”
- Terminology changes from “customers” to “interested parties.”
- Concept of Risk-based thinking
- Terminology changes from “documents” and “records” to “documented information.”
- Concept of Organizational knowledge
- Benefits of ISO 9001-2015
All types and sizes of organizations have implemented ISO 9001 standards. Small businesses to mid-size to large corporate entities and non-profits are using the standards to ensure the quality management of their product and service offerings. These organizations are enjoying a wealth of benefits as a result.
Once the standards are implemented, an organization’s systems and performance become streamlined and efficient. Processes are repeatable, and predictable outcomes provide opportunities for great product and service delivery, creative employee contribution, and significant cost savings.
Being ISO certified or compliant is a selling point for many enterprises giving them a competitive advantage over other companies vying for new business. The reputation of the ISO standards is well established and has clout.
When prospects evaluate a company’s products or services, the ISO 9001-2015 certification carries weight because many businesses make it a requirement for their vendors. The value of that designation can increase the bottom line substantially.
An essential update to the standard in the 2015 version is a focus on leadership in the organization. The principle requires the organization’s leadership to have a more active role in the quality management of the business – more leadership by example. These leaders exhibit a commitment to the industry and the quality management system’s tenets.
Continuous process improvement is a natural result of the ISO 9001-2015 implementation. Organizations have controls in place to evaluate and update processes ongoing. Process improvement is facilitated by emphasizing strong communication within the organization, primarily through employee feedback.
Who Can Use ISO 9001-2015?
The beauty of this quality management system is that it can be adapted and used by any entity. Small businesses find it as effective as mega-corporations do. It works in a non-profit or for-profit organizations as well as academic institutions. The standard is designed to be customized for a business or organization based on their individual needs and desired outcomes.
The ISO 9001-2015 standard can help prepare a business for the audit process. As the organization establishes or updates its quality management processes, it must also institute regularly scheduled internal audits. These internal audits ensure that the organization is operating based on established processes like a checks and balances system. Audits are also conducted to maintain certification to the standard.
Businesses and organizations may choose to implement ISO 9001-2015, in part, to satisfy customer requirements and statutory and regulatory requirements. Many companies make ISO 9001 compliance a condition for new and ongoing business relationships.
Process Approach
The use of a process approach provides consistency in operations. Measurable inputs and outputs result in a better understanding of the various types of requirements. These processes help organizations identify objectives and create metrics that, in turn, lead to more effective performance goal setting for employees.
The standard promotes continuous process improvement with regularly scheduled internal audits and communication feedback mechanisms. Potential issues are identified more quickly and can be resolved proactively.
Efficient inputs and predictable outputs are targeted outcomes for QMS. When these processes are in place, high performance and cost savings result.
A process approach enables organizations to stay on top of requirements of all kinds – customer or regulatory. Ongoing monitoring of processes provides good data that can be used to identify potential risks or issues and make evidence-based decisions.
Applying ISO 9001 to Ongoing Quality Operations
ISO 9001 is designed to use either manufacturing or service-based businesses and organizations. Earlier versions of the standard referenced manufacturing, making it somewhat difficult to translate the concepts to service industries. However, the current version changed the language and clarified the intent to include both.
Instead of a methodology that prescribes specific processes and procedures, ISO-compliant organizations must apply the standard and methods according to their particular business requirements and objectives. They must define what the standards mean to their business model, build processes, identify risks, and document information accordingly.
ISO 9001 uses 7 Quality Management principles to drive the framework for performance improvement.
Customer focus – organizations must strive to be aware of customer needs and requirements, both present and future, and exceed expectations.
Leadership – implementation and ongoing use of the processes begin at the organization’s top. Strong leadership engages employees and motivates success in every area of the business.
Engagement of people – when everyone is involved, accountable, and committed to the organization’s objectives, people feel valued and are more open creatively.
Process approach – as discussed above, repeatable processes and predictable outcomes are suitable for the bottom line and customer and employee retention.
Improvement – continuous improvement as an ongoing objective yields tremendous benefits to the organization
Evidence-based decision-making – using sound data and facts to make informed decisions that are most likely to be on point.