What is ISO? Requirements

What is International Organization for Standardization (ISO)?

The International Organization for Standardization (ISO) was set up in 1946. It is headquartered in Geneva, Switzerland. It is an international and non-governmental organization, which sets quality standards for different processes and industries. It comprises members from all national standards organizations.

ISO works towards promoting proprietary and also for promoting standards for industries. Its mission is the worldwide promotion and development of standardization and related activities with a view to facilitate the international exchange of goods and services and develop cooperation in the spheres of intellectual, scientific, technological, and economic activities.

The results of the ISO technical work are published by International Standards. International Organisation for Standardisation (ISO) defines a standard as a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.

Prior to the creation of the ISO, different countries or regions used to develop and adopt different criteria to evaluate similar types of products and technologies. In such a scenario, it became difficult for producers/organizations to sell their products around the world, and consequently, it had a direct effect on the international trading process.

Moreover, industries were required to be linked to each other directly or indirectly, as no industry can function independently. For example, bolts are required by the aviation industry for manufacturing airplanes and other equipment used in this sector.

Similarly, nuclear plants required control rods and steam generators. Rapid development, globalization, and the increasing penetration and interdependence of industries and technology have led to the requirement for the establishment of standards that can be accepted worldwide.

An important characteristic of ISO standards is that they are quite generic in nature. Since all individual countries formulate their own standards on the basis of ISO standards, care must be taken in interpreting their applicability to the concerned industry or organization. For instance, ISO 9000 is a series or family of standards for quality assurance and management.

ISO 9000 standards have been adopted by around 45 countries as their own national standards. The national standards may be named differently, but they contain exactly the same text as the original ISO 9000 standards. In India, the equivalent standard of ISO 9000 is the Bureau of Indian Standards (BIS) 14000 series.

In the United States, ANSI and ASQC have adopted and published ISO 9000 standards and they are known as ANSI/ISO/ASQC Q9000 series. If an organization desires to achieve an ISO 9000 certification, it must conform to its requirements.

ISO 9000:2015

ISO 9000 standards were issued in 1987. They are based on the BS 5750 standard, the first management quality system standard that was developed by the British Standards Institute. Since they were first developed, they have undergone various revisions in 1994, 2000, 2008 and in 2015. The current version of ISO 9000 is ISO 9000:2015.

The ISO 9000 family of quality management standards can be used by organizations for the following purposes:

  • Providing guidance and tools to those organizations that want to ensure the quality of their products and services

  • Meeting customer requirements consistently

  • Improving quality on a continuous basis

ISO 9000 standards on quality management and quality assurance have been developed to ensure effective documentation required for maintaining efficient quality systems. These standards are generic and can be applied to any organization of any size.

There are four standards in the ISO 9000 family—ISO 9000:2015, ISO 9001:2015, ISO 9004:2018, and ISO 19011:2018. Each standard has been created for a different purpose. These standards are shown in Table:

Standards in the ISO 9000 Family

ISO 9000:2015Quality Management Systems—Fundamentals and Vocabulary (definitions)
ISO 9001:2015Quality Management Systems—Requirements
ISO 9004:2018Quality Management—Quality of an Organization— Guidance to Achieve Sustained Success (continuous improvement)
ISO 19011:2018Guidelines for Auditing Management Systems

Together, these four standards in the ISO 9000 series form a complete quality management system. These standards can be used for national and international trade. The requirements for quality management systems in organizations are contained in the ISO 9001:2015 standard.

Organizations try to get certifications to improve their credibility and demonstrate that their products/services meet the expectations of their customers. In some industries and organizations, it might be a legal/regulatory or contractual requirement to acquire certification. It must be specifically stated that ISO as an organization does the work of setting standards only.

It does not perform certification and does not issue certificates on its own. This work is done by certain external certification organizations. However, ISO has created a Committee on Conformity Assessment (CASCO) to produce various standards related to the certification process. The bodies that issue certificates must follow the CASCO standards.

In common parlance, the ISO 9000 certification is not a necessity but customers’ demand for certified products and services has made it quite significant. Initially, ISO 9000 standards were formulated to be used in the case of contracts where the suppliers were required to demonstrate their capability to meet requirements.

The main idea behind this was to encourage customers to buy certified products/services as they are no longer required to verify the product on receiving it. It also serves as a convenient means to ensure that the suppliers adhere to the requirements of ISO 9000 standards.

Customers and third parties can use standards and certifications to determine the capability of the organization to provide products that meet their requirements in addition to the regulatory requirements.

It is not mandatory to acquire certifications but having a valid certification helps organizations in reducing the cost of customer-sponsored audits and verifying the capability of its suppliers. Certifications also help customers to effortlessly and successfully trade with organizations that do not have much credibility in the market.

ISO 9000 standards have evolved beyond their primary functions and now serve as a concrete basis for developing and implementing quality management systems such as Total Quality Management (TQM).


ISO 9001:2015 (Quality Management Systems-Requirements)

ISO 9001:2015 is the most widely used quality management system standard. It is the actual standard for the purpose of ISO certification. However, other standards are used to acquire more detailed and elaborate information. All the standards under the ISO 9000 series are complementary in nature. The current version of ISO 9001 is ISO 9001:2015.

The previous version was ISO 9001:2008. The most important change that has been made in ISO 9001:2015 is that it is based on risk-based thinking rather than on a preventive action as in the case of its 2008 version. The ISO 9001:2015 standard is a complete operational tool that can help in improving the performance of an organization.

Some key features and benefits of ISO 9001:2015 are as follows:

  • ISO 9001:2015 standards help in managing a business in an operationally resilient manner.

  • ISO 9001:2015 standards help in achieving long-term success.

  • ISO 9001:2015 standards help in ensuring customer satisfaction.

  • ISO 9001:2015 standards can be adopted by businesses of any size.

  • ISO 9001:2015 standards are generic and flexible.

  • ISO 9001:2015 standards help facilitate continual improvement

  • ISO 9001:2015 standards help organizations in achieving competitive advantage.

  • ISO 9001:2015 standards serve as the basis for other sector-specific standards such as the ISO 13495 standard for medical devices, ISO 16949 for the automotive sector, AS/EN 9000 for aerospace, and ISO 14001 for the environment.

  • ISO 9001:2015 is based on a High-Level Structure (HLS).

  • ISO 9001:2015 can be integrated with any existing ISO management system.

  • ISO 9001:2015 adopts risk-based thinking.

  • ISO 9001:2015 has fewer prescriptive requirements for documentation and organizations can decide the need and format of documented information.

  • ISO 9001:2015 does not use the terms ‘documents’ and ‘records’; now, it uses the term ‘documented information’. Documented information refers to the information that needs to be controlled and monitored.

  • ISO 9001:2015 defines the term ‘knowledge’ and also defines the requirements for managing organizational knowledge using four phases that are similar to the Plan-Do-Check-Act (PDCA) cycle. Quality Manual and Management Representative (MR) are no longer mandatory as per this standard.

It has been decided by ISO that all the current and future quality and management systems standards must contain ten main clauses, as shown in Figure:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Continual Improvement
Figure 7.1: Ten Main Clauses of ISO Standards

ISO 14001:2015

ISO 14001 is the international standard developed by ISO and it specifies the actual requirements for an Environmental Management System (EMS). It was published for the first time in 1996. The latest version of this standard is ISO 14001:2015.

It is the most widely used EMS in the world. More than 14000 organizations have been ISO 14001 certified in the UK alone and more than 3 lakh organizations globally (approximately 171 countries) have acquired ISO 14001 certification.

This standard applies to those environmental aspects which are under the control of an organization. This standard prescribes a framework that any organization can use to formulate and maintain its EMS in accordance with environmental performance requirements. It is a voluntary standard. Using a combination of ISO 9001 and 14001 standards is extremely beneficial for an organization.

ISO 14001 helps organizations achieve commercial success without neglecting their responsibilities towards the environment. ISO 14001 standard helps an organization in meeting legal and regulatory requirements related to the environment and the ever-increasing customer expectations at the same time.

Adopting this standard helps organizations to improve their environmental performance by protecting the environment and preventing pollution.

This standard can be adopted by any organization belonging to any sector that wishes to establish, implement, maintain, and improve anEMS. Organizations that are ISO 14001:2015 certified provide assurance to the management and employees and other stakeholders of the organization that the organization is taking essential steps for measuring and improving the environmental impact.

Achieving an ISO 9001 certification also helps the organization in assuring itself that its activities and policies are in conformance with the environmental policy and ISO 14001:2015. All the requirements stated in ISO 14001:2015 standards must be incorporated into any EMS.

The table presents the clauses of ISO 14001:2015 standard:

Clause
0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organisation
5. Leadership
6. Planning
7. Support
8. Operations
9. Performance Evaluations
10. Improvement

Some major advantages of adopting an EMS are as follows:

  • Better environmental management
  • Reduction in wastage
  • Efficient energy use
  • Increased efficiency
  • Decreased cost of running businesses
  • Better image of the organization
  • Access to more business opportunities
  • Increased trust from the side of the stakeholder and customer
  • Increase in the trust of customers and other stakeholders
  • Increase in adherence to legal obligations
  • Increase in the ability of an organization to perform better

IATF 16949:2016

In the US, General Motors, Ford Motor Company, and Fiat Chrysler Automobiles US are called the ‘Big Three’. In 1994, the Big Three automobile manufacturers developed the QS 9000 standard, which was the first QMS standard meant for the automobile sector. This standard was managed by the Automotive Industry Action Group (AIAG).

QS 9000 was meant to be adopted by organizations that were involved in the supply of automotive production materials, heat treatment, etc. The purpose of this standard was to provide a single standard and certification for all assessments, standards, and certifications in the automotive sector supply chain.

QS 9000 was the first standard for the automobile sector. It was declared obsolete in December 2006. QS 9000 was replaced by TS 16949:1999, which was further replaced by the IATF 16949 standard in 2016.

The IATF 16949:2016 is an international QMS standard specifically developed for the automotive industry by the International Automotive Task Force (IATF) in association with the Automotive Industry Action Group (AIAG). It is one of the most widely used quality management system. It was published on 3rd October 2016 by the IATF.

ATF 16949 standard is used by organizations for the development of a Quality Management System that supports continual improvement, helps in defect prevention, and reduces variation and waste in the supply chain. Organizations can create their own unique QMS by using a combination of IATF 16949 standards along with the applicable customer-specific requirements.

Such QMS requirements can be used for automotive production, service, and/or accessory parts. IATF 16949:2016 is aligned with the structure and requirements of the ISO 9001:2015 standard and must be implemented along with ISO 9001:2015 standard.

For organizations in the automobile sector, it is important to register to IATF 16949 standard because all the organizations that are registered with this standard need to develop their suppliers’ QMS. This ensures that the suppliers conform to the IATF 16949 standard. Implementation of this standard ensures that the customers of the organization are able to receive good quality products and services, which manifest in the form of various business benefits.

IATF 16949:2016 is based on seven key principles:

  • Customer focus
  • Engagement of people
  • Evidence-based decision making
  • Improvement
  • Leadership
  • Process approach
  • Relationship management

The characteristics or features of the IATF 16949:2016 standard are as follows:

  • Defines how organizations can meet customer requirements and the requirements of other stakeholders at the same time

  • Emphasizes continual improvement

  • Mandates that the organizations define their objectives and continuously work towards achieving them

  • Focuses on defect prevention

  • Includes important tools of the automotive industry such as Advanced Product Quality Planning (APQP), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Measurement Systems Analysis (MSA), and Production Part Approval Process (PPAP)

  • Helps in reducing variation and waste in the supply chain

  • Mandates that policies related to corporate responsibility must be documented and implemented

ISO 45001:2018

The ISO 45001 standard was released by ISO in 2018. This standard is known as Occupational health and safety management systems – Requirements with guidance for use. It is the most recent and widely-used international standard for occupational health and safety (OH&S).

This standard has replaced OHSAS 18001:2007, which was the previous standard for workplace health and safety. Organizations that are currently certified to the OHSAS 18001 standard have been given a time of three years to transit to the ISO 45001 standard. Organizations are not mandated to acquire a certification of this standard.

ISO 45001:2018 standard has been designed to provide an effective set of processes for improving workplace health and safety in supply chains. This standard can be used by organizations and industries of all sizes. With the introduction of the ISO 45001 standard, it is expected that workplace injuries and illnesses can be reduced measurably.

The International Labour Organization (ILO) estimated in 2017 that each year approximately 2.78 million fatal accidents take place at workplaces. In other words, every day, approximately 7700 people die due to workplace injury or illness.

Apart from this estimate, the ILO has also estimated approximately 374 non-fatal work-related injuries and illnesses each year. As a result of these injuries and illnesses, many people remain absent for extended periods of time. It means that people working in modern workplaces have to endure serious consequences even as a result of doing their jobs.

Across the world, ISO 45001 is used to provide guidance to governmental organizations, industry, and other stakeholders in order to improve worker safety. The standard provides a framework that can be used in all factories irrespective of their location.

David Smith, who was the chairperson of the committee that developed ISO 45001 quoted, “It is hoped that ISO 45001 will lead to a major transformation in workplace practices and reduce the tragic toll of work-related accidents and illnesses across the globe.”

The new standard is quite promising and it is expected that its implementation will help in providing a safe and healthy work environment for all workers and visitors across the world. This standard helps organizations in continually improve their health and safety-related policies, practices, and standards.

ISO 45001 is developed on an HLS structure and can be perfectly integrated with other HLS-based standards such as ISO 9001 and ISO 14001, which are the standards for QMS and EMS, respectively. Organizations that have already implemented these standards will be able to implement ISO 45001 quite easily.

The benefits of implementing ISO 45001:2018 are as follows:

  • Integrable with various ISO standards

  • Senior management can assess the OH&S risks and opportunities

  • Management sets objectives related to OH&S and strives for continual improvement

  • The adoption of standards enables monitoring and review of the safety performance of the organization

  • The organizations may be inclined to conduct worker health promotion campaigns

  • Implementation of the ISO 45001 standard is considered a demonstration of the organization and related stakeholders’ commitment to the protection of employees from accidents, injuries, and illnesses

  • Adoption of this standard helps in reducing the downtime that might be caused due to the absence of workers due to OH&S hazards

  • Adoption of this standard helps in reducing the chances of prosecution due to faulty OH&S standards

  • Adoption of internal process controls such as risk-based management of contractors helps in encouraging a safety culture and protecting business

  • Internal and external audits help an organization in evaluating and demonstrating the effectiveness of the OH&S systems and processes

  • The participation of employees to identify health and safety factors that can lead to continuous improvement

  • Employee participation in OH&S helps in increasing the organization’s reputation, employee retention, increased motivation levels, and increased productivity

  • Adoption of the PDCA cycle makes the standard eligible to be applied in the whole management system as well as each individual element of the management system.

  • Top management plays an important role in the implementation and management of the OH&S systems

The ISO 45001 standard audits can be conducted at three levels namely: internal audits, external audits, and certification audits.

The table presents the clauses of the ISO 45001:2018 standard:

Clause
0. Introduction
1. Scope
2. Normative References
3. Terms of Definition
4. Context of the Organisation
5. Leadership
6. Planning
7. Support
8. Emergency Preparedness
9. Performance Evaluation
10. Improvement

Other Emerging Standards

Till now, you have studied a few key standards that are used internationally. Apart from these, there are a wide variety of standards that are used across the globe for different purposes such as quality management, environment management, and information security.

The standards-setting and development bodies such as ISO keep on developing new standards and revising the previously-established standards to check whether they are appropriate for contemporary times. For instance, the ISO has mandated that all the international standards must be reviewed at least once in every five years by all the ISO member bodies.

The process of developing a new national standard begins after the National Standards Body (NSB) of a country determines that there is a market need for the proposed standard.

After determining such market needs, the national standards body may adopt one of the following courses:

  • Develop a national standard for domestic use

  • Adopt the national standard of another country developed by its NSB if it permits and by paying the required copyright fees

  • Adopt any existing similar standard

The process of developing a new international standard is somewhat more elaborate. For developing a new international standard, one or more NSBs need to submit a proposal to ISO [and International Electrotechnical Commission (IEC)/ International Telecommunication Union (ITU)].

In the proposal stage, the new standard proposed is assessed for market demand and then submitted for a three-month vote to the NSB of the Technical Committee (TC) or the Sub Committee (SC) to decide whether it should be taken up or not. In order to develop a proposed standard, the NWIP must gain a simple majority from the participating members of the TC/SC and at least five members must actively support the proposal.

If the NWIP acquires the required number of votes, the NWIP moves to the preparatory stage. In this stage, the TC/SC sets up a working group to prepare a working draft, which is finalized as a result of all members’ consensus. This draft is then sent to the parent committee of the working group and is put up for consensus building.

At the stage where the initial draft is with the TC/SC, it is drafted as per the ISO format and is prepared in the form of a Committee Draft (CD), which is distributed to the members of the TC/SC for comment.

CDs are prepared successively till all the members agree upon one CD. The final CD that is finalized by consensus of all the members is submitted in the form of a Draft International Standard (DIS).

In the inquiry stage, the DIS is submitted to the ISO. At this stage, the DIS is circulated to all ISO members for voting and commenting which has to be completed within three months. ISO members and the members of the committee that developed the draft are then asked to vote for the DIS.

The DIS will gain acceptance and approval only if 2/3rd of the votes of the members of the drafting committee vote in favor and not more than 1/4th of the total number of votes are negative. If the DIS meets these criteria, it is developed in the form of an FDIS (Final Draft International Standard) after voting. On the other hand, if it fails to meet the criteria, it is returned to the TC/SC that has submitted it for further study and revision.

At the approval stage, the FDIS is circulated to all the ISO members for the final voting within two months. The voting, acceptance, and approval criteria for FDIS are the same as for DIS. If the FDIS vote satisfies the criterion, it is approved in the form of an International Standard (IS) and if the FDIS vote fails to meet the given criteria, it is returned to the TC/SC that has submitted it for further study and revision.

At the publication stage, the approved FDIS, i.e., the international standard (IS) is sent to the ISO CS (Central Secretariat) for publishing the international standard.

Some of the important FDIS that have been finalized by ISO (which would most probably go on to become important standards) and some of the published standards (as of October 2019) are listed in Table:

A. FDIS
FDIS/StandardDescription
ISO/PRF 643Steels — Micrographic determination of the apparent grain size (Revision of ISO 643:2012)
ISO/FDIS 14620-2Safety requirements — Part 2: Launch site operations 2019-11-26 (Revision of ISO 14620-2:2011)
ISO 20766-20Liquefied petroleum gas (LPG) fuel systems components — Part 20: Filter unit
ISO/FDIS 15585Hard coal — Determination of caking index
ISO/PRF 23169Paints and varnishes — On-site test methods on quality assessment for interior wall coatings
ISO/PRF 15836-2Information and documentation — The Dublin Core metadata element set — Part 2: DCMI Properties and classes (Revision of ISO 15836:2009, ISO 15836:2009/ Cor 1:2009)
ISO/FDIS 7870-1Control charts — Part 1: General guidelines
ISO/FDIS 10276Nuclear energy — Fuel technology — Trunnion systems for packages used to transport radioactive material 2019-11-07 (Revision of ISO 10276:2010)
ISO/FDIS 16321-3Eye and face protection for occupational use — Part 3: Additional requirements for mesh protectors
ISO/FDIS 14966Ambient air — Determination of numerical concentration of inorganic fibrous particles — Scanning electron microscopy method 2019-11-12 (Revision of ISO 14966:2002, ISO 14966:2002/Cor 1:2007)
ISO/FDIS 10015Quality management — Guidelines for competence management and people development 2019-11-04 (Revision of ISO 10015:1999)
ISO/FDIS 24444Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)
ISO/PRF TS 50044Energy saving projects (EnSPs) — Guidelines for economic and financial evaluation
ISO/IEC PRF TR 24772-1Programming languages — Guidance to avoiding vulnerabilities in programming languages — Part 1: Language-independent guidance (Revision of ISO/ IEC TR 24772:2013)
B. Standards Published
StandardDescription
ISO 10642:2019Fasteners — Hexagon socket countersunk head screws with reduced loadability
ISO 21745:2019Electronic record books for ships — Technical specifications and operational requirements
ISO 10679:2019Steels — Cast tool steels
ISO 8267-2:2019Aircraft — Tow bar attachment fittings interface requirements — Part 2: Regional aircraft
ISO 6626-3:2019Internal combustion engines — Piston rings — Part 3: Coil-spring-loaded oil control rings made of steel
ISO 1018:2019Hard coal — Determination of moisture-holding capacity
ISO 3631:2019Citrus fruits — Guidelines for storage
ISO 12944-5:2019Paints and varnishes — Corrosion protection of steel structures by protective paint systems — Part 5: Pro- tective paint systems
ISO 10962:2019Securities and related financial instruments — Classification of financial instruments (CFI) code
ISO/TS 25107:2019Non-destructive testing — NDT training syllabuses
ISO 20264:2019Stationary source emissions — Determination of the mass concentration of individual volatile organic compounds (VOCs) in waste gases from non-combustion processes
ISO 14064-1:2018Greenhouse gases — Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals
ISO/IEC/IEEE 21841:2019Systems and software engineering — Taxonomy of systems of systems
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