Online Regulatory Compliance Training, FDA, Risk, and Compliance: The ISO 9001:2015

The ISO 9001:2015 is the latest revision to the set of ISO standards, and is considered a major update to the existing standard. The ISO consists of a set of standards, implementing which an organization can bring about improvements into the auditing of its Quality Management Systems.

First, an understanding of Quality Management System

A Quality Management System is defined by the ISO as a set of procedures, processes and policies an organization requires to plan and execute into its central business area, meaning areas that affect the organization's ability for meeting customer requirements. The ISO has different quality management standards for different areas. For example, the ISO 13485 series is meant for bringing in processes into the medical devices industry, the ISO 20252 for market research, and so on.

The ISO issues standards that are numbered by the unique and distinctive field to which they belong. The ISO standards thus signify a simple and commonsensical way to approach a particular business.

First change in seven years

The ISO keeps significantly updating requirements to meet current market best practice. This is done because market best practices evolve and change over time. Accordingly, the ISO 9001 standard, which relates to Quality Management Systems, has undergone its first change since 2008 in 2015.

Called the ISO 9001:2015; the latest offering from the ISO brings in several changes into the previous version. Some of the core areas in which the ISO 2015 differs from ISO 2008: