Quality Management System & ISO 9001:2015 Standard

ISO 9001 Standard addresses a number of aspects associated with quality management. This standard provides guidance and tools for the companies, which need to make sure that their products and services consistently meet the customer requirements and satisfaction.

What Stats are saying about ISO 9001?

• 1.1 million ISO 9001 certificates have been issued from 178 countries and economies

• 42,000 North American organizations have ISO 9001 certification

• 29,000 organizations across the United States have ISO 9001 certification

Structure of ISO 9001 Standard

Before, diving into the deeper discussion, it is important to state that the requirements of ISO 9001 quality management standard are centered on Quality Management System or QMS. This standard is comprised of eight sections, such as:

1. Scope

The scope should define the organizational context of your QMS. This section should clearly explain to the auditors why your organization needs the Quality Management System, what are your business objectives, and what are your quality objectives. You need to demonstrate how you have aligned your business objectives with ISO 9001:2015 requirements.

2. Normative References

This section refers to a document where reference is presented in the proper way to make it look an integral part of the application of the ISO 9001:2015 standard. This standard offers common grounds. It also refers to the ISO 9000, which is the mother series of ISO 9001 standard. This particular section exists in the standard designed for ISO 17025 certification as well.

3. Terms and Definitions

This section explains the terms and definitions related to the Quality Management System. The section “terms and definitions” is comprised of:

• Terms related to the persons or people

• Terms related to the organization

• Terms related to activity

• Terms related to the processes

• Terms related to the system

• Terms related to the requirement

• Terms related to results

• Terms related to data, information, and document

• Terms related to customer

• Terms related to characteristics

• Terms related to the determination

• Terms related to action

• Terms related to audit

4. Quality Management System

Everyone needs to deal with quality. We can easily judge if something is good or bad in terms of quality. But, when it comes to the definition of quality, most people struggle a lot to define quality in the proper way. Hence, it is clear that defining quality from the business perspective is not an easy task. Quality Management System is a framework that helps the businesses organize the quality functions and operating properly so that quality can be maintained continuously.

5. Management Responsibility

ISO 9001:2015 has greatly emphasized the roles and responsibility of top management. Unlike the previous version of this standard, the current version of ISO 9001 Quality Management Standard has insisted on the involvement of the top management. The senior management should interact with the employees and assess quality performance frequently. If it is required, the senior management should arrange several meetings with the employees who are associated with quality management processes.

6. Resource Management

This section explains the importance of resource management. A quality management system needs various resources, such as human resources, money, tools etc. Therefore, it is important to hire experts for each department. The main aim of these departments is to contribute to the overall improvement of the performance of the QMS.

7. Product Realization

This section, “Product Realization” defines the planning process of some controls, such as:

• The quality objective controls

• Regulation controls

• Necessary processes, documents, and resource controls

• Product acceptance controls

• Customer-oriented process controls

• Design controls

• Purchasing controls

• Process controls

8. Measurement, Analysis, & Improvement

This section defines the importance of measurement. Since continual improvement is one of the major requirements of ISO 9001:2015 Standard, the performance of the Quality Management Standard should be measured regularly. It will help an organization understand and improve their current situation.

Whenever an organization is looking for ISO 9001 Certification, they must go through these eight sections.