Friday Facts – What is ISO 9001?

June 3, 2016Data Loggers & Systems Blog, ISO RegulationsBy Lorrie Switzer

ISO 9001 is an internationally recognized standard that provides guidance in creating, and maintaining, a Quality Management System (QMS) within your company. This standard can be applied to any size company, across all industry sectors. It requires an organization to meet its own requirements, along with those of its customers and regulators. A QMS should be a system that is repeatable, measurable and constantly improving. Following this approach will enable your company to provide a better product that is supported by detailed procedures. QMS have the ability to integrate and unite the diverse aspects of a company into a unified core with a common purpose.

ISO 9001 is a relatively short document – only 27 pages long. The requirements are broken into eight sections:

Section 1: Scope – Specifies that the company needs to meet the requirements of customers and regulatory agencies. Employees are required to follow the policies and procedures while continuously improving the processes.
Section 2: Normative Reference – Provides references to ISO 9000 to constitute the terms of ISO 9001
Section 3: Terms and Definitions – defines the terms used throughout the standard
Section 4: Quality Management System – This section describes the general requirements, covering everything from the quality manual documentation, control of documents and records, identifying the sequence and interaction of processes, implementing actions through to achieving the planned results
Section 5: Management Responsibility – This standard requires management to commit to the QMS
Section 6: Resource Management – This provides the criteria needed to perform a job in a competent manner and in a safe environment
Section 7: Product Realization – Defines the steps required for product development – from the initial design all the way through delivery to the end user
Section 8: Measurement, Analysis and Improvement – Improving the QMS through scheduled internal audits, monitoring of customer satisfaction, control of non-conforming product, analyzing data, and corrective and preventive actions

Also required by ISO 9001 is a documented Quality Policy, a Quality Manual, and the numerous records required throughout the standard.

About the author

Lorrie Switzer

Lorrie Switzer is the Continuous Improvement Manager for Mesa’s biological indicator manufacturing facilities in Omaha, NE and Bozeman, MT. Since joining the company in 2010 (as a temporary employee in Assembly & Packaging), she has worked her way through various positions in the Quality Assurance department, ultimately helping to create her existing position. Lorrie holds a B.S. in International Business from Teikyo Post University.