ISO 9001

ISO 9001:2015 Quality Management System -Requirements

ISO 9001:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Origin of ISO 9001

ISO 9001 was first published in 1987 by ISO (International Organization for Standardization). The current version of the standard - ISO 9001:2015 - was published on 30th September 2015 and replaces the previous edition, ISO 9001:2008 which will be retired on 27 September 2018.

Since ISO 9001 was first published in 1987, it has been adopted by over one million organizations in more than 160 countries. 

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The new specification contains an increased emphasis on leadership and the systems approach to management, both of which are critical in any effective quality management system 

Leadership 

A Quality Management System requires strong top-level commitment with active involvement from top management. The responsibility for carrying out the activities required by ISO 9001 rests with all members of staff throughout the organization. All need to be aware of their contribution to the quality management system, and of its importance in achieving the organization's goals.

Systems Approach 

The structure of ISO 9001:2015 uses process-based language to describe the relationships between customers, organizations, suppliers, regulators, and other interested parties. This approach supports an integrated approach to managing processes that are interrelated.

How ISO 9001 was developed?

ISO Management Systems Standards are developed by experts drawn from many countries through a consensus-based process. The standards provide for flexible adaptation to specific organizational needs and are available worldwide to all nations. These standards assist customers in their goal of achieving quality excellence while allowing suppliers to develop efficient processes to meet customer and applicable statutory and regulatory requirements.

ISO 9001 provides a framework that integrates the needs of customers, the organization, suppliers, regulators, and other interested parties to achieve quality excellence.

ISO 9001 is available in several versions according to the nature of the organization's product or service.

How Organization adopts ISO 9001?

An organization must demonstrate its ability to consistently provide a product or service that meets customer and applicable statutory and regulatory requirements. This requires the organization to have effective quality management systems in place, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. In short, ISO 9001:2015 demonstrates an organization's commitment to quality excellence.

Benefits of ISO 9001:2015

ISO 9001: 2015 includes requirements and guidance to help organizations ensure that their documented information is accessible and provides traceability of requirements to documentation and records. There are also additional requirements for the management of documents, which will be particularly useful in helping customers demonstrate the ISO 9001 Quality Management System is the safest approach to quality management. 

The system demonstrates successful results in manufacturing, hospitals, schools, and other industries. To obtain certification all company processes are put to inspection. A total of 12 key areas are evaluated by an authorized registrar to obtain certification for companies that comply with ISO 9001:2015.

For example, to obtain certification for ISO 9001:2015-based quality management system, the company's processes are inspected by an authorized registrar. The company would need to prove that it successfully satisfies all twelve key areas of requirement laid out in the standard. A total of 100% compliance with each individual requirement is required before companies can receive certification, ensuring an accurate assessment of the organization's quality management system.

The twelve key areas are: 

4) Quality Management System 

5) Improvement 

6) Documented Information 

7) Product Realization 

8) Measurement, Analysis, and Improvement 

9) Resource Management 

10) Product Realization 

11) Servicing 

12) Continual Improvement

Latest version ISO 9001:2015 application:

Guidelines for the Application of ISO 9001:2015 provide a step by step instructions on how to apply for certification, and how to maintain it. The new standard also allows companies to focus more on organizational performance and less on documentation procedures, which means there's less pressure when it comes to writing reports and having records. 

This approach supports an integrated approach to managing processes that are interrelated and continuous and ensures sustainable performance improvement by emphasizing the importance of leadership, strategy, planning for its implementation, communication within the organization, and review of results on a regular basis. As a result, there is a greater focus on risk management and on continual improvement.

The new standard provides a clearly defined framework for the organization, which means you can immediately identify areas of process weakness and quickly put a plan together to correct them.

Since its first edition published in 1987, hundreds of thousands of organizations have adopted ISO 9001 as their quality management system. The global demand for this standard has been evident through its widespread use across different industry sectors and geographical boundaries.

Standard continues to evolve in line with changes in business practices, technology, and customers' expectations. The introduction of the 2015 edition is a major change for this standard, which will have a significant impact on organizations that apply it or seek certification. 

Why does your organization need ISO 9001-Quality Management System?

The quality management systems can be applied to several sectors, but for many, it is the basis of an accreditation scheme that enables organizations to demonstrate their competence to perform specific tasks. For example, ISO 9001 is very common in the manufacturing industry and it defines requirements for designing, planning, implementing, operating, and improving quality management systems. ISO 9001 requires documented quality management system. 

ISO 9001 is one of the most widely used standards in the world. More than one million companies across 160 countries have sought certification to ISO 9001, which provides a stamp of approval that they meet customer satisfaction through effective quality management systems.

The new standard emphasizes an integrated approach to managing processes. It also acknowledges the importance of leadership, strategy, planning for its implementation, communication within the organization, and review of results on a regular basis to ensure long-term success.

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