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ISO 9001:2015 Quality Management System

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.

The standard has been written using a new high-level structure found in all new management systems standards allowing for easy integration with other standards within an organisation’s management system.

The most significant change to ISO 9001:2015 is the Annex SL high-level structure. In addition, several terms have changed, including the use of “products and services” in place of “product”, a shift to “improvement” as opposed to “continual improvement” and “purchasing” and “outsourcing” will be replaced with “external provision of products and services”. The new standard also speaks about the identification and of needs and expectations concerning ‘interested parties’. There is a greater emphasis on the production of desired outputs and process management in general. Risk is another frequently discussed change within the new standard. What was once referred to as ‘preventative action’ has evolved to require organizations to employ risk-based thinking. Further to these changes, there is no longer a requirement for a quality manual, however, while documentation procedures will be less prescriptive, requirements for documentation of information will be more explicit.

Who Should Use ISO 9001:2015 – Quality Management System Revision?

ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

  • Organize processes
  • Improve the efficiency of processes
  • Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.

What Topics Does ISO 9001:2015 Cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:

  • Requirements for a quality management system, including documentation of a quality manual, document control, and determining process interactions
  • Responsibilities of management
  • Management of resources, including human resources and an organization’s work environment
  • Product realization, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Objectives of the ISO 9001 Revision

The new ISO 9001:2015 is meant to:

  • Provide a stable requirements framework for the next ten years.
  • Address recent changes in quality management practice, in technology and in the increasingly complex and dynamic work environment to improve practical relevance.
  • Be sufficiently generic, yet remain relevant to all types and sizes of organizations, regardless of their industry or sector.
  • Maintain the present focus on an effective process management.
  • Apply the "high level structure" (uniform structure, core texts and definitions) to ensure structural compatibility with other management standards, such as the environmental management standard ISO 14001 and the energy management standard ISO 50001.
  • Simplify the implementation in organizations and the conformity assessment.
  • Simplify phrasing to ensure identical understanding and consistent interpretation of the requirements.

What are The Benefits of ISO 9001?

ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.

Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:

  • Organize a QMS
  • Create satisfied customers, management, and employees
  • Continually improve