Introduction

ISO is an independent, non-governmental international organization with a

membership of 162 national standards bodies.Through its members, it brings together
experts to share knowledge and develop voluntary, consensus-based, market relevant
International Standards that support innovation and provide solutions to global
challenges. The ISO story began in 1946 when delegates from 25 countries met at the
Institute of Civil Engineers in London and decided to create a new international
organization ‘to facilitate the international coordination and unification of industrial
standards’. On 23 February 1947 the new organization, ISO, officially began
operations.Since then, we have published over 22380 International Standards covering
almost all aspects of technology and manufacturing.Today we have members from
162 countries and 786 technical committees and subcommittees to take care of
standards development. More than 135 people work full time for ISO’s Central
Secretariat in Geneva, Switzerland.

What are standards?

International Standards make things work. They give world-class specifications for
products, services and systems, to ensure quality, safety and efficiency. They are
instrumental in facilitating international trade. ISO has published 22380 International
Standards and related documents, covering almost every industry, from technology, to
food safety, to agriculture and healthcare. ISO International Standards impact everyone,
everywhere.
How does ISO develop standards?
Our standards are developed by the people that need them, through a consensus
process. Experts from all over the world develop the standards that are required by their
sector. This means they reflect a wealth of international experience and knowledge.
ISO Standards in Action
Learn about how International Standards work in the real world, address shared
challenges and the things that matter most for people, the environment and business.
What are the benefits of ISO International Standards?
ISO International Standards ensure that products and services are safe, reliable and
of good quality. For business, they are strategic tools that reduce costs by minimizing
waste and errors and increasing productivity. They help companies to access new
markets, level the playing field for developing countries and facilitate free and fair global
trade.
We're ISO: we develop and publish International Standards

ISO creates documents that provide requirements, specifications, guidelines or

characteristics that can be used consistently to ensure that materials, products,
processes and services are fit for their purpose. We've published 22380 International
Standards, which you can buy from our members or the ISO Store. Bringing real and
measurable benefits to almost every sector imagineable, standards underpin the
technology that we rely on and ensure the quality that we expect.

How we develop standards

Like a symphony, it takes a lot of people working together to develop a standard.

ISO’s role is similar to that of a conductor, while the orchestra is made up of
independent technical experts nominated by our members. The experts form a technical
committee that is responsible for a specific subject area. They begin the process with
the development of a draft that meets a specific market need. This is then shared for
commenting and further discussion. The voting process is the key to consensus. If that’s
achieved then the draft is on its way to becoming an ISO standard. If agreement isn’t
reached then the draft will be modified further, and voted on again. From first proposal
to final publication, developing a standard usually takes about 3 years.

The flow-chart below details the main stages in the process.

Key principles in standard development :
1. ISO standards respond to a need in the market
ISO does not decide when to develop a new standard, but responds to a request
from industry or other stakeholders such as consumer groups. Typically, an
industry sector or group communicates the need for a standard to its national
member who then contacts ISO. Contact details for national members can be found
in the list of members.
2. ISO standards are based on global expert opinion
ISO standards are developed by groups of experts from all over the world, that
are part of larger groups called technical committees. These experts negotiate all
aspects of the standard, including its scope, key definitions and content. Details can be
found in the list of technical committees.
3. ISO standards are developed through a multi-stakeholder process
The technical committees are made up of experts from the relevant industry, but
also from consumer associations, academia, NGOs and government. Read more
about who develops ISO standards.
4. ISO standards are based on a consensus
Developing ISO standards is a consensus-based approach and comments from all
stakeholders are taken into account.

ISO 9001 Requirements and Structure

The ISO 9001 requirements provide a set of standard elements that will guide you in
the implementation of a Quality Management System (QMS). The requirements are
designed to be applicable to any company in any industry – both production and service
based, and as such the requirements tell you what elements are mandatory in a QMS,
but not how to implement these necessary elements. The ISO 9001 requirements are
broadly separated into eight sections (called ISO 9001 clauses), five of which contain
mandatory requirements for a QMS: general Quality Management System requirements
(clause 4), Management Responsibility (clause 5), Resource Management (clause 6),
Product Realization (clause 7), and Measurement, Analysis and Improvement (clause
8). All elements of these five clauses are mandatory with the exception of the Product
Realization section, which allows for a company to exclude portions that are not
applicable. Clauses 1 through 3 include no requirements, but instead deal with the
scope of the standard, references to understand the standard better, and terms and
definitions.

Quality Management System

This section deals with general requirements for a QMS, as well as all
documentation requirements. It also includes the requirements for the necessary Quality
Manual, Control of Documents, and Control of Records.

Management Responsibility

The section on Management Responsibility outlines the requirements for customer

commitment and focus, and the important Quality Policy and Quality Objectives. The
elements of planning in the QMS are covered, along with the need to define
responsibility, authority and communication in the company. Finally, the requirements of
the management review, including the mandatory inputs and outputs for the review, are
included.

Resource Management

The short section on resources covers the requirements for management to provide
resources, including infrastructure, work environment and human resources. The
importance of competence, awareness and training for human resources is
emphasized.

Product Realization

This section is the only part of the structure where a company can choose to
exclude sections of the requirements (such as excluding the design requirements if your
company does not do design work). The requirements deal with planning for product (or
service), starting with determining and reviewing the product requirements, design and
development and purchasing, which leads to the provision to create and supply the
product or service. The final requirements deal with the control of any equipment used
to monitor or measure the product or service.

Measurement, Analysis and Improvement

The last section deals with how you know your QMS is working and improving. The
Monitoring and Measurement section outlines requirements for assessing customer
satisfaction, Internal Audit, and monitoring the product and processes. The section
deals with how to control non-conforming product, since this will happen in any
business, and how you will analyze and improve, including corrective and preventive
actions.

Some Difficulties in Implementation

The greatest difficulty of implementing the standard requirements is to ensure that

the resulting collection of policies, procedures, processes and records meets the needs
of the company and their customers, while still allowing for improvement of the system.
Improvement of the system is one of the main reasons for implementing a QMS, as it
benefits the company in the long run.

The facts about certification

Certification can be a useful tool to add credibility, by demonstrating that your

product or service meets the expectations of your customers. For some industries,
certification is a legal or contractual requirement.

ISO does not perform certification

At ISO, we develop International Standards, such as ISO 9001 and ISO 14001, but
we are not involved in their certification, and do not issue certificates. This is performed
by external certification bodies, thus a company or organization cannot be
certified by ISO. However ISO's Committee on Conformity Assessment (CASCO) has
produced a number of standards related to the certification process, which are used by
certification bodies. Read more about CASCO Standards.

Choosing a certification body

When choosing a certification body, you should:

 Evaluate several certification bodies.

 Check if the certification body uses the relevant CASCO standard
 Check if it is accredited. Accreditation is not compulsory, and non-accreditation
does not necessarily mean it is not reputable, but it does provide independent
confirmation of competence. To find an accredited certification body, contact the
national accreditation body in your country or visit the International Accreditation
Forum.
Displaying your certificate
Remember, when labelling a product or system as certified to an ISO standard:
Don't say: "ISO certified" or "ISO certification" DO say: "ISO 9001:2015 certified" or
"ISO 9001:2015 certification" (for example).

Industrial Safety

Reducing Robot Risk: How to Design a Safe Industrial Environment

The increase in industrial automation (IA), and particularly the use of industrial robots,
is increasing the chance of an unexpected interaction between a human operator and a
piece of other mobile equipment or moving machine. The onus is on designers to
implement appropriate and often overlapping safety precautions to avoid consequences
ranging from interruptions in production to injury or even death. While safety is
paramount, designers must still design and keep an eye on both initial costs and total
cost of ownership. This article will discuss best practices in plant safety and review
some of the techniques and products used to establish and maintain a safe industrial
environment and their applications.

Factory safety affects everyone in the organization

Safety in an industrial plant is a multi-faceted topic that requires involvement from all
levels of the organization, from the shop floor to the executive suite. Ideally, a safe
factory is designed from the ground up, but many plant buildings predate the
widespread adoption of automation, the use of industrial robots, and the rise of the
Industrial Internet of Things (IIoT) technologies.

Numerous national and international safety standards apply to different types of

industrial machinery, safety equipment, and production processes. Among these are:

 ANSI/RIA 15.06 (Robot and Robot System Safety)

 ISO 13856-1:2013 (Safety of machinery: Pressure sensitive protective devices)
 ISO 13849-1 (Safety of machinery: Safety related parts of control systems)
 ANSI B11.19-2003 (Safeguarding Equipment and Protecting Employees from
Amputations)
 CSA Z432-16 (Safeguarding of Machinery)

Designers must take time to familiarize themselves with the applicable specifications
before they begin.
The preferred approach in developing a safe factory environment has several layers.
The process begins with a comprehensive identification, evaluation, and analysis of the
hazards, and an assessment of their relative importance.

There are several ways to reduce the risk posed by the hazards thus identified.
Examples include:

 Decreasing the potential severity of harm

 Improving the possibility that the harm can be avoided
 Reducing the number of personnel with access to the hazardous area, or their
duration of exposure

After the initial analysis, the next stage is to develop a Hazard Control Hierarchy that
ranks these measures in order of effectiveness and preference for each risk. ISO
12100:2010 (Safety of machinery – General principles for design) is the primary
standard addressing the concept and methodology of tiered risk reduction.

The preferred solution is to eliminate the risk completely or substitute a safer alternative
that minimizes the opportunity for unexpected human-machine interactions (Figure 1).
An example is installing an automated material handling system to replace a manual
loading operation.

If that is not feasible, the next most desirable course of action is to add safeguarding
devices that prevent a hazardous event from occurring. If such a device is activated, it
typically initiates an automatic operation without human input; a machine is shut down,
or a robot is disabled until an operator performs a manual reset. Examples of such
devices include light curtains, interlocks, and pressure mats.

Other options are less desirable because they require human action as part of hazard
avoidance: these options include visual or audio alarms, enhanced safety training, and
protective equipment such as face shields, ear plugs, or gloves.
Figure 1: A hazard control hierarchy ranks protective measures by their impact and
implementation. (Image source: SICK)

For retrofitting existing work areas, active safeguarding devices have another
advantage: speed of installation. They can be added without redesigning the work flow
or training personnel in new safety procedures, both of which can take months to
implement.

Design a multi-layer approach to work-cell safety

The modern industrial work cell uses a multilayer approach to safety: designers must
combine active measures such as safety mats, light curtains, and lasers with visual and
audible warning indicators (Figure 2). The desired result is that an operator receives
warning of a potentially unsafe situation; if they then venture into harm’s way, several
independent devices shut down operations before disaster can strike.

Figure 2: A variety of safety devices is used in an automated work cell so that if

someone ventures into harm's way, several independent devices can shut down
operations. (Image source: Digi-Key) Increasingly, an industrial network links these
devices; the data is used to track and log incidents, as well as identify areas for future
improvement. A discussion of some of the main safety devices and their application
follows.

Safety mats: a traditional, but still effective solution

A safety mat is a cost-effective means of preventing a human or wheeled machine from

entering an unsafe area. Typically, a safety mat uses an open switch that closes when a
specified minimum weight presses on the mat. The switch closure results in a signal to
the mat controller that initiates a stop signal to the machine being guarded.

Omron Automation and Safety’s UM5-4836 is a good example: it employs two

conductive plates made of 24 gauge steel that together form the switch (Figure 3). An
activation force of 30 kilograms (66 lbs) closes the switch. The mat includes an
integrated four-wire cable that allows a controller to monitor for fault conditions such as
a permanently open connection or physical damage.

Figure 3: the Omron UM series safety mat system includes the mat, controller, and a
variety of trim pieces to secure the mat to the floor. (Image source: Omron)

Multiple mats can be wired in series to form a safety zone around a machine. The safety
zone combines with a mat safety controller such as Omron’s MC3, MC4, or MC6: the
MC6 can accommodate up to six individual mat zones.

Dating back to the 1950s, safety mats have long been the standard form of area
protection in the factory. Be aware, however, that as an electro-mechanical technology,
safety mats are subject to physical, environmental, and operational abuse, and the
contacts can wear out with long-term repeated use. Still, safety mats are widely used in
modern highly automated factories.

A light curtain prevents access to hazardous areas

A safety light curtain is a suitable choice if the designer needs to isolate a hazardous
machine or cordon off an area behind an “invisible wall” (Figure 4). A light curtain
consists of a set of photoelectric transmitters that project an array of synchronized,
parallel infrared light beams to a matching receiver unit. When an opaque object
interrupts one or more beams in the sensing field, the receiver detects the event, and
the light curtain sends a stop signal to the guarded machine.

The transmitter module contains LEDs that emit sequenced pulses of infrared (IR) light.
The pulses are modulated – pulsed at a specific frequency – and the corresponding
phototransistors in the receiver are designed to detect only the designated pulse and
frequency. This technique improves the rejection of external light sources.

Figure 4: A light curtain can discriminate between a workpiece and a human operator
(a) by performing muting control for each beam axis. It can also include a blanking
action (b), so permanent obstacles are ignored. (Image source: Panasonic Industrial
Automation)

In an application such as a conveyer belt, the light curtain incorporates a muting

function that causes the line to stop only when an unexpected object passes through it,
but not when a product passes through.
If the muting transmitter/receiver pair detects the presence of a product on the conveyer
belt (Figure 4a), it can disable a defined number of channels to prevent a false trigger. A
human operator, however, can still interrupt one of the active channels and cause an
alarm. When the muting system detects that the product has passed, it reenables the
muted channels.

Additionally, a blanking function can disable channels (Figure 4b) that are always
blocked, by a piece of equipment, for example.

The SF4B series of light curtains from Panasonic Industrial Automation includes
multiple products optimized for different applications. The “H” series devices are
intended to detect hand-sized objects, with a vertical spacing between beams of 20 mm
(0.8”). For example, the SF4B-H28(V2) has 28 transmit/receive channels that form a
curtain 500 millimeters (mm), or 21.7 inches (“) high. This product has an operating
range from 0.3 meters (m) to 9 m.

With a 10 mm (0.4”) spacing, “F” series products protect against smaller objects such as
fingers. The SF4B-F79(V2) features 79 transmit/receive pairs for a protective height of
790 mm (31.1”) and has a range of 0.3 m to 7 m.

The SICK C4C-SA03030A10000 transmitter and its matching C4C-

EA03030A10000 receiver combine to form a 300 mm (11.8”) light curtain with a
maximum range of 15 m (49 feet). The company also offers a range of
transmitter/receiver pairs with protective heights up to 900 mm (35.4”).

A laser scanner allows design flexibility in area protection

In the last couple of decades, laser technology has also begun to help improve safety
on the factory floor. A safety laser scanner can provide three-dimensional protection of
an area, and offers the designer increased flexibility to tailor the system response by
specifying different warning and safety bands, also known as zones, around the hazard
(Figure 5).
Figure 5: A laser scanner allows the designer to set up multiple safety zones with
different response levels. (Image source: SICK)

Once an object or person is detected in the outer warning zone, the scanner sends a
warning signal to an audible or visible indicator that notifies them of a potential hazard.
When the person or object enters the inner safety field, the laser scanner sends a signal
to stop the hazardous motion of the robot or machine. The zones are programmable
and can be changed dynamically by an input to the safety scanner.

Safety laser scanners use time-of-flight technology. The transmitter emits a pulsed laser
beam that is reflected by an intruding object and detected by the receiver. The time
between transmission and reception is proportional to the distance between the scanner
and the object.

An integrated rotating mirror deflects the pulsed laser beam and enables the unit to
perform a fan shaped scan of the surrounding area. The real-time measurement data
can be transmitted over a networked interface for further analysis if needed.

SICK’s S32B-2011BA safety laser scanner, for example, uses a laser diode to produce
a near-infrared pulse with a wavelength of 905 nanometers (nm). This device is part of
SICK’s S300 family and features a protective range of 2 m and a warning range of 8 m.
Another S300 device, the S32B-3011BA, features an expanded protective range of 3 m.

The OS32C Area Scanner from Omron Automation and Safety features a monitoring
field of up to 270˚ and includes two separate warning zones, plus a safety zone (Figure
6). The OS32C can communicate via the industrial EtherNet/IP protocol: it can be
monitored by ODVA EtherNet/IP-compliant products such as programmable logic
controllers (PLCs) or industrial human-machine interface (HMI) modules. A variety of
data including system status, zone status, and measurement details can be transmitted.
Figure 6: Omron’s OS32C family of area scanners features multiple programmable
zones (Image source: Omron Automation and Safety)

Until recently, laser scanners have been considerably more expensive than safety mats.
But lower cost laser safety scanners are becoming available, and the return on
investment (ROI) for safety scanners compares well to older technologies from a total-
cost-of-ownership (TCO) perspective. The TCO analysis particularly favors a laser
scanner in a high traffic area where a safety mat might have to be periodically replaced.

Other safety components help to “connect the dots”

The main safety devices discussed above are used in conjunction with other safety
components that might not be as technologically sophisticated, but play a vital role in
plant safety. Among these are items such as emergency switches, door interlocks, light
towers, and cable-pull actuators. Designers can find out more about these products on
Digi-Key’s Safety Components page.

Conclusion

Designing a safe industrial environment requires a multi-layer approach which employs

multiple strategies to guard against unwanted human-machine interactions.

The key is to first prevent personnel and equipment from entering potentially dangerous
areas. Safety mats, light curtains, and safety laser scanners play an important role in
detecting intrusions and shutting down machines automatically without the necessity of
human interaction.

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