WHAT IS ISO 9001:2015 – QUALITY MANAGEMENT SYSTEMS?

ISO 9001 is defined as 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.

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 many topics, such as:

Requirements for a QMS, including documented information, planning 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 ISO 9001 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:

Adequate resourcing of the organization’s processes / activities to support its scope and strategic direction, taking into consideration the identified risks, including people, infrastructure and equipment.

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

Increased leadership requirements

Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.