ISO 9001: 2015

ISO 14001

ISO 9001:2015 specifies requirements for a quality management system when an organization:

A) Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

B) Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO has indicated its aims for the standard but the certification and accreditation industry will have a huge influence over whether they will be successful. It may be possible for some organizations to do very little to maintain their certification. For others it may create an opportunity to increase and improve performance. Some choices still remain.

 

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.

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.

ISO 9001 is based on the plan-do-check-act methodology and provides a PROCESSS-ORIENTED APPROACH 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

Changes introduced in the 2015 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include the introduction of new terminology, restructuring some of the information, an emphasis on risk-based thinking to enhance the application of the process approach, improved applicability for services, and increased leadership requirements.

Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015 revision as soon as possible. However, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three-year transition period from the publication date of ISO 9001:2015.

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 processes
  • Improve the efficiency of processes
  • Continually improve
  • Organize a QMS
  • Create satisfied customers, management, and employees