Download Contact / Inquires

Home Basic Rules for All Industries

Basic Knowledge
Basic Rules for All Industries
Implementation Basics

Traceability Laws and Regulations Vital for Every Industry

Technological
This page introduces basic rules, laws and regulations related to traceability and quality
Innovations and Laws
management that apply to every industry, such as automotive, electronic device, food, and
and Regulations
pharmaceutical. Standards and laws such as ISO 9000/9001 and the Measurement Act are
familiar in the fields of quality management and production control. They play important
Technological Innovations
and Development of a roles in traceability as well.
Traceability System
Basic Rules for All Industries Definition of the Term Traceability:
Definition of Traceability: ISO 9001
ISO 9000
Automotive Industry
Food and Pharmaceutical
Industry Basic Safety Standard Concerning
Electronic Control: IEC 61508

Definition of the Term Traceability: ISO 9000

The International Organization for Standardization (ISO) has defined traceability as follows in
ISO 9000:

Meaning
Traceability is the ability to trace the history, application, use and location of
an item or its characteristics through recorded identification data.

There are two important requirements to meet this definition:

You must clearly specify the identification unit (individual or by lot) of the object under
consideration (raw material, part, or product).
You must identify the object under consideration and record necessary information to
allow tracing forward/back.

Download

Definition of Traceability: ISO 9001

The quality management system of the International Organization for Standardization (ISO)
is generally called the ISO 9000 series or ISO 9000 family and ISO 9001 is the most
important standard in this family. A quality management system (QMS) is defined as "part of
a management system intended to lead and manage an organization regarding quality."

ISO 9001 is an international standard based on the essence extracted from many successful
cases regarding business improvement. Its purpose is to maximize profits by promoting
business based on consistent rules concerning not only manufacturing processes or
products, but also throughout the business from purchase to manufacturing, shipment, and
service. We can say that it is the best guideline for improving routine work by eliminating
problems such as inefficient procedures or repeated mistakes. By obtaining ISO 9001
certification, the company can also achieve social credibility and increase the trust of
customers.
 Download

Two Concepts of Traceability

ISO 9001 specifies traceability in two sections: Measurement traceability and Identification
and traceability. Since the topic of this page is traceability in the entire supply chain, this
section describes identification and traceability.

Overview of Identification and Traceability

ISO 9001 states the following requirements regarding identification and traceability:

Use suitable means to identify outputs when it is necessary to ensure the

conformity of products and services.
Identify the status of outputs with respect to monitoring and measuring
requirements throughout production and service provision.
Control the unique identification of the outputs when traceability is a
requirement, and retain documented information to enable traceability.

These can be summarized as follows:

Select suitable means for identification (representation format and

representation method) throughout the processes from production to retail to
allow identification of outputs such as finished products and information in
every process. Record and store the information properly.

Identification is an especially important concept in these requirements. This identification

means a common recognition shared among the entire production processes or the entire
supply chain. Assume that you have a chip used for manufacturing a TV, for instance. The
basics of identification are to ensure that this chip is recognized as the same one whether it
exists by itself or is built in a product, and to allow everyone to know the current status of
the chip, whether it has passed inspection or is under inspection, or in what process it is
being worked on.

For that purpose, a traceability system identifies objects by using a representation format
such as serial numbers or lot numbers, as well as the transfer medium such as labels and RF
tags.

When all people related to the supply chain, including consumers, can recognize the status
of the product and objects and information has been linked, tracing forward/back can be
done easily. This ensures the quality and safety of the product.
 Download

Basic Safety Standard Concerning Electronic Control: IEC

61508

A lot of electronic control systems have been introduced to the manufacturing sites, such as
industrial robot control using programmable logic controllers (PLCs) which is indispensable
for factory automation (FA). IEC 61508 is a functional safety standard for such electronic
and electrical systems. IEC 61508 was established by the International Electrotechnical
Commission (IEC). It is a generic term for the functional safety standards concerning
electrical, electronic and programmable electronic systems in all industries.

Its basic idea is to ensure safety and prevent accidents and disasters by adding functional
equipment to protect human life, health, and environment (region) from hazardous events. Traceability Textbook
IEC 61508 is the base of all functional safety standards. ISO 26262, which is the functional
safety standard concerning automotive electrical/electronic systems, is also derived from Download
IEC 61508.

Laser Marker MD-X series

High Quality at High Speed

Download

1D/2D Code Reader

SR-2000 series
One reader for
any code, anywhere,
any speed
Download

Download

Technological Innovations and Laws and Technological Innovations and Laws and
Regulations Regulations
Technological Innovations and Automotive Industry
Development of a Traceability
System

Home

1-888-539-3623
 Download Contact / Inquires
Products

Sensors Process Controls / Process Sensors Laser Marking Systems / Continuous Inkjet
Printers
Measurement Sensors Static Eliminators / Ionizers Microscopes / 3D Surface Profilers
Measurement Systems Vision / Barcode Scanner Handheld Mobile Computers
Safety Controls

Copyright (C) 2020 KEYENCE CORPORATION. All Rights Reserved. Corporate Overview Privacy KEYENCE