For some of the best understanding, we have added some links to external website.

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.


ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.

As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.

Guidance on transitioning from ISO 9001:2008 to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).

What topics does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as:

  • Requirements for a QMS, including documented information, planning and determining process interactions
  • Responsibilities of management
  • Management of resources, including human resources and an organization’s work environment
  • Product realization, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include:

  • The introduction of new terminology
  • Restructuring some of the information
  • An emphasis on risk-based thinking to enhance the application of the process approach
  • Improved applicability for services
  • Increased leadership requirements

The Seven Principles of ISO 9001:2015
The Seven Principles of ISO 9001:2015

How do I get started with ISO 9001:2015?

Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.

As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.

Previous versions of ISO 9001

Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000, and again in 2008. The latest revision was published in September 2015.

  • ISO 9001:1994 included changes to improve the control of design and development clause, as well as provide other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003.
  • The ISO 9001:2008 revision sought to clarify issues raised during the application of ISO 9001:2000.

ISO 9001 timeline
ISO 9001 Timeline


ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.

Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:

  • Organize a QMS
  • Create satisfied customers, management, and employees
  • Continually improve their processes
  • Save costs

In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years in actual expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three critical components of the system’s success: training, communication and respect, and efficiency.


ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:

  • Follows the guidelines of the ISO 9001 standard
  • Fulfills its own requirements
  • Meets customer requirements and statutory and regulatory requirements
  • Maintains documentation

Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements.

Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:

  • Registrar’s costs for ISO 9001 registration, surveillance, and recertification audits
  • Current level of conformance with ISO 9001 requirements
  • Amount of resources that the company will dedicate to this project for development and implementation
  • Amount of support that will be required from a consultant and the associated costs

Read “What’s the cost?” for a checklist you can use to assess the costs of certifying to ISO 9001.

Note: ASQ does not issue ISO 9001 certification.

Courses in the ISO 9001 Standard

Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.

Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.


You can also search articlescase studies, and publications for ISO 9001 resources.

ISO 9001:2015 Standard

The 2015 revision to ISO 9001, the international standard specifying requirements for quality management systems, is available for purchase in these formats:

Example Quality Manual

Need to write a quality manual that conforms to ISO 9001:2015? Download an example quality manual and read about how to create one.



Case Studies


  • ISO 9001:2015 Overview As you get ready to implement or transition to ISO 9001:2015, it’s helpful to get a high-level overview of the standard before jumping in.
  • ISO 9001:2015 – 15 Things You Must Know Now In this video interview, Paul Palmes discusses the ISO 9001 revision and key points organizations must consider as the draft international standard progresses through the development process.
  • Team Builds ISO 9001 QMS on Wiki Learn how Geometrica, a dome manufacturer based in Texas and Mexico, involved its entire organization in documenting its quality management system for ISO 9001 certification using a Wiki.
  • More ISO 9001 videos


  • Improving Your QMS While Certifying to ISO 9001 Author Milt Dentch shares how organizations can go beyond ISO 9001:2015 compliance to substantially improve their quality management systems and the bottom line.
  • Guidance on Conforming to ISO 9001:2015 Author Milton Dentch provides guidance on conforming to ISO 9001:2015.
  • Lean ISO 9001 ISO 9001 expert Mike Micklewright walks through how and why documentation systems get out of control, what’s wrong with an overly lengthy documentation system, and how to get it back in control and make it more user friendly with the 5S lean tool.
  • More ISO 9001 webcasts


For some of the best understanding, we have added some links to external website.


The Conformité Européene (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.


A CE Mark is a symbol that must be affixed to many products before they can be sold on the European market. The mark indicates that a product:

  • Fulfills the requirements of relevant European product directives
  • Meets all the requirements of the relevant recognized European harmonized performance and safety standards
  • Is fit for its purpose and will not endanger lives or property

Conformité Européene Mark (CE Mark)
Conformité Européene Mark (CE Mark)

The presence of CE marking further indicates that appropriate technical documentation supporting the use of the mark is available and can be provided by the manufacturer, importer, or person responsible for placing the product on the EU market upon request.


CE marking does not provide any specific information to the consumer. It is not a quality assurance declaration, it does not show evidence of third-party testing, and it should not be confused with any independent certification mark of the type issued by international or European notified test bodies.

Certain directives include an option for the responsible organization to provide a declaration of conformity stating that a product fulfills the requirements of the applicable directives. However, if challenged, the appropriate evidence must be supplied to support the self-declaration claim. Other directives, particularly those pertaining to products affecting health and/or safety, such as pressure vessels, will require a specific certificate from a notified body.


Affixing a CE Mark to a product is considered a means to certify for authorities within the EU member states that the product meets all appropriate EU requirements.

There is an EU requirement that products not in conformity with the provisions of the directives are not allowed to circulate in the territories of the member states; appropriate action should be taken to remove these products from sale and use within the specific state. One example is the recent import of toys from China to the UK which, when examined, were found to contain a high level of poisonous toxins that endanger life.

The importer and/or manufacturer must take steps to comply with safety provisions, produce the appropriate records, and decide on the necessary procedures to maintain production in conformity with directives. The CE Mark must be affixed to demonstrate conformity with the provisions of the directives.

Specific directives have comprehensive safety objectives, but they leave the manufacturer to make decisions on how these may be achieved.

Where more than one CE Mark directive pertains to a product and a transitional period allows the manufacturer a choice of which to apply, the marking indicates conformity only with those directives applied by the manufacturer. In this case the directives that have been applied must be identified in the documents or notices accompanying the product. Where the manufacturer does not list those directives that have been applied, the authorities will assume that a declaration of conformity is available for all applicable directives.


Any organization manufacturing or selling products in the EU should be aware of its obligations when it comes to demonstrating conformity to requirements and directives:

  1. The CE Mark must be affixed to demonstrate conformity with the provisions of the directives.
  2. In the event of a challenge, a report from a notified body may be submitted showing conformity of the equipment. This allows the manufacturer working with a notified body to show conformity with the safety objectives.


Concerning gloves PPE users (Directive 89/656 dated 30.11.1989 and the associated texts).

Obligations are fixed in the PPE users” Directive 89/656 dated 30.11.1989 and the associated texts.

Employers of people using PPE must insure that they analyse and assess, in collaboration with the various internal committees, the weaknesses of the protection systems.

In accordance with the definition above, they select personal protective equipment with the appropriated level of protection necessary in view of the potential danger and risk likely to be incurred.

They provide personal protective equipment free of charge and conforming to the legal requirements, i.e.:

  • CE marked ;
  • with user information attached to each pair of glove;
  • with a declaration of conformity given to the user during the purchase phase.



CE Marking type-Examination certification


Concerning  Gloves PPE manufacturers (“PPE design” Regulation 2016/425/UE).


CE marking is based on the following texts: “PPE design” Regulation 2016/425/UE

Manufacturers must place PPE gloves on the market that comply with the essential requirements of European Regulation 2016/425/EU.


For this purpose, they are required to:

A – Characterize the product / Define the risks

PPE certification Rules – PPE Gloves

Certification rules Category I Category II Category III
CLASSIFICATION Minor risks  Other risks Lethal or irreversible risks
EXAMPLES Gardening glove  Glove for mechanical risks  Glove for chemical risks
  • Technical file of the PPE
  • Declaration of conformity
  • User instruction
  • CE marking
Category I


  • UE type examination by a Notified Body (module B)
Category II


  • Annual PPE surveillance by a Notified Body (Module C2 ou D)
  • Affix the number of the Notified Body on the marking



B – Choose the PPE gloves standard

Hand Protection Classification
EN ISO 374-1
Protective gloves against dangerous chemicals and microorganisms – Part 1: Terminology and performance requirements for chemical risks
EN ISO 374-5
Protective gloves against dangerous chemicals and microorganisms – Part 5: Terminology and performance requirements for micro-organisms risks
EN 388
Protective gloves against mechanical risks
EN 407
Protective gloves against thermal risks (heat and/or fire)
EN 421
Protective gloves against ionizing radiation and radioactive contamination
EN 511
Protective gloves against cold
EN 659
Protective gloves for firefighters
EN 1082
(part 1 to 3) Protective clothing – Gloves and arm guards protecting against cuts and stabs by hand knives
EN ISO 10819
Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand
EN ISO 11393-4
Protective clothing for users of hand-held chain-saws – Part 4: Test methods and performance requirements for protective gloves
EN 12477
Protective gloves for welders
EN 13594
Protective gloves for motorcycle riders – Requirements and test methods
EN ISO 13997
Protective clothing – Mechanical properties – Determination of resistance to cutting by sharp objects
EN 14328
Protective clothing – Gloves and armguards protecting against cuts by powered knives – Requirements and test methods
EN 16027
Protective clothing – Gloves with protective effect for association football goal keepers
EN 16350
Protective gloves – Electrostatic properties
EN 16523
(parties 1 et 2) Determination of material resistance to permeation by chemicals
EN 16778
Protective gloves – The determination of Dimethylformamide in gloves
EN 18889
Protective gloves for pesticide operators and re-entry workers – Performance requirements
EN ISO 21420
Protective gloves – General requirements and test methods

D- Safety gloves marking system

All gloves marked CE guarantee a high level of protective, comfort and durability established on the basis of the following marking standards :
  • Gloves must comply with the requirements of the European Regulation. The compliance is established by the implementation of harmonized European standards applicable in all the countries of the European Community.
  • In addition to the CE marking, the international standards enforce a secondary indication allowing the identification of the protection afforded by the gloves.



EN 388 – WXYZα (P)


EN511 – XYZ


EN ISO 374-1

gant de sécurité EPI - EN 388 gant de sécurité EPI - EN 511 gant de sécurité EPI - EN ISO 374
  • Abrasion resistance : W
  • Blade cut resistance : X
  • Tear resistance : Y
  • Puncture resistance : Z
  • Cut resistance TDM : α
  • Impact protection : P Optional
  • Convective cold: X
  • Contact cold: Y
  • Water penetration: Z
Permeation resistance

+ letters corresponding to the tested chemical

  • A: methanol
  • B: acetone
  • C: acetonitrile
  • D: dichloromethane
  • E: carbon disulphide
  • F: toluene
  • G: diethylamine
  • H: tetrahydrofurane
  • I: ethyl acetate
  • J: n-Heptane
  • K: sodium hydroxide 40%
  • L: sulphuric acid 96%
  • M: nitric acid 65%
  • N: acetic acid 99%
  • O: ammonium hydroxide 25%
  • P: hydrogen peroxid 30%
  • S: hydrofluoric acid 40%
  • T: formaldehyde 37%

EN 1082


EN ISO 374-5



PPE Gloves - EN 1082 gant de sécurité EPI - EN ISO 374 gant de sécurité EPI - EN 407gant de sécurité EPI
  • Burning behaviour: U
  • Contact heat: V
  • Convective heat: W
  • Radiant heat: X
  • Small splashed of molten metal: Y
  • Large quantities of molten metal: Z

EN 421



gant de sécurité EPI - EN 421 gant de sécurité EPI - EN 659

EN ISO 11393-4


EN 13594

gant de sécurité EPI - EN ISO 11393 gant de sécurité EPI - EN 13594

EN ISO 18889

gant de sécurité EPI - information gant de sécurité EPI - EN ISO 18889


PPE Glove design

Gants de sécurité EPI