International Organization for Standardization
ISOThe International Organization for Standardization (ISO) is a global body that develops and publishes standards for products, services, and systems.
The International Organization for Standardization (ISO) is an independent, non-governmental body. It creates standards to ensure the quality, safety, and efficiency of products, services, and systems. ISO has members from the national standards bodies of over 160 countries. The standards it develops are voluntary and based on global expert consensus.
On the shop floor, ISO standards provide a framework for managing processes. The most common standard in manufacturing is ISO 9001, which specifies requirements for a quality management system (QMS). Other relevant standards include ISO 14001 for environmental management and ISO 45001 for occupational health and safety. Adhering to these standards helps manufacturers produce consistent products, reduce waste, and improve workplace safety.
Achieving ISO certification is a multi-step process. A manufacturer first performs a gap analysis to see how its current processes compare to the standard's requirements. Then, it develops and documents procedures, trains employees, and implements the new system. The process includes conducting internal audits to check for compliance.
Finally, an accredited third-party certification body performs an external audit. If the manufacturer meets all requirements, it receives certification. This certification often is a requirement to become a supplier for companies in industries like automotive, aerospace, and medical devices. Maintaining certification requires periodic surveillance audits.
An electronics manufacturer wants to supply circuit boards to a medical device company. The customer requires ISO 9001 certification. The manufacturer documents its soldering and inspection procedures, implements a system for corrective actions, and successfully passes an external audit to earn the certification.
Does ISO certify companies?
No, ISO develops the standards. Independent, external certification bodies audit companies and grant certification.
What is the most common ISO standard for manufacturers?
ISO 9001 is the most widely used standard. It outlines the requirements for a quality management system.
Is ISO certification required by law?
ISO standards are voluntary. However, many customers and regulatory bodies require certification as a condition of doing business.
How long does it take to get ISO 9001 certified?
The timeline varies based on a company's size and existing processes. It typically takes between 6 and 18 months to prepare for and pass the certification audit.
What is involved in maintaining ISO certification?
Certified companies must undergo regular surveillance audits by their certification body to ensure they continue to meet the standard's requirements. They must also conduct their own internal audits.
Quality Management System
QMSA Quality Management System (QMS) is a set of documented policies, processes, and procedures for achieving consistent product quality.
Standard Operating Procedure
SOPA Standard Operating Procedure (SOP) is a document with step-by-step instructions for performing a routine task.
Corrective and Preventive Action
CAPACorrective and Preventive Action (CAPA) is a structured process for investigating, fixing, and preventing quality problems.
Good Manufacturing Practice
GMPGood Manufacturing Practice (GMP) is a system of rules and procedures that ensures products are consistently made and controlled according to quality standards.
Traceability
Traceability is the ability to track a product's history, location, and components from raw materials to the final customer.