This article will give a detailed discussion on ISO standards
It is expected that after reading, one should understand:
- ISO Standards: What are ISO Standards and What is ISO Certification?
- How to Obtain ISO Certification
- Common ISO Standards in Different Industries
- Benefits of ISO Certification
- And Much More...
Chapter One: What are ISO Standards, What is ISO Certification?
What are ISO Standards?
ISO standards are a list of goals that cover thousands of management practices as well as technological and manufacturing processes with the intention of providing a better life and safety for citizens of the world. Established in 1947, the International Organization for Standardization (ISO) has had the primary goal of discovering the best ways to complete simple and complex common practices.
One of the first challenges for the ISO was the development of a uniform set of measurements, which led to the acceptance of the metric system as a worldwide standard. Gradually, over the years, the goals of the ISO expanded into a wide variety of areas. Today, ISO standards cover the manufacturing and production of clothing and WIFI networks as well as a wide variety of complex and intricate industrial procedures.
The choice of the letters ISO relates to the Greek word for equal, Isos (ίσος). The ISO exists as a world organization for the good of all peoples of the world. Its 163 nation membership meets regularly to examine various changes in manufacturing and industrial processes. At the general meetings, various standards that have been developed by ISO committees and experts are presented for discussion and approval.
Documents published by the ISO include specifications, guidelines, and characteristics that companies use to ensure materials, products, processes, and services are of the highest quality and acceptable. Regulatory and enforcement agencies use the standards as a means of determining the quality of a product or service. Having an ISO certification indicates to customers, providers, clients, suppliers, and business partners that the presented products are of the highest quality, safe, durable, and environmentally compliant.
The International Organization for Standardization began as a conference that met in 1946 in London that was attended by 65 representatives from 25 nations to plan post war development and recovery. With 67 original technical committees and teams of experts, ISO was established in 1947. As of November 2022, the organization has published over 24,500 international standards and has 811 technical committees and subcommittees.
What is ISO Certification?
An accreditation known as ISO certification verifies that a company has met the requirements related to quality processing standards. If a company operates internationally, an ISO certification broadens the company’s client base and creates a positive image. The display of an ISO certification announces to the world that a company is trustworthy, reliable, and produces quality products.
The first ISO standard was ISO/R 1:1951, which was published to set a reference temperature for industrial length measurements. ISO/R 1:1951 still exists but has been updated multiple times with the last publication being ISO 1:2002. A major step forward for ISO standards came in 1987 when it published ISO 9001, which was the first quality management standard. As environmental concerns grew during the 1980s and 1990s, ISO published ISO 14001 as its first step of dealing with the issues of pollution and environmental contaminants.
Certain industries benefit from having an ISO certification. Healthcare organizations have ISO certification to let patients know that they are committed to proper treatment of their patients and are patient centered. Hotels, restaurants, and other hospitality groups use an ISO certification to prove their dedication to their guests.
Construction companies, engineering firms, manufacturing, and technical services all strive to have an ISO certification as proof of the quality of their work and businesses. When customers are making decisions to purchase or invest in an organization, they are more than likely to invest in a company with an ISO 9001:2015 certification, which is a quality management system certification. Companies that have gotten an ISO 9001:2015 have already been approved by several other regulatory agencies.
The process for being ISO certified means that a company has been evaluated by a third party and has shown that they conform to the ISO requirements for quality, efficiency, effectiveness, and consistency. A company with an ISO certification guarantees that they manufacture quality products that will be delivered on time.
As ISO standards change and are adjusted, businesses update their policies to match the changes. The ultimate goal of the ISO is to raise the standards for safety, quality, and security for everyone while improving industrial welfare.
Chapter Two: How to Receive an ISO Certification
When a company receives an ISO certification, it has been audited by an independent third party that verifies that the organization complies with the most recent quality process requirements established by the International Organization for Standardization. The ISO does, however, maintain a Committee on Conformity Assessment (CASCO) that oversees certification process requirements.
The Committee on Conformity Assessment develops international standards and documentation for conformity assessment bodies (CAB) and accreditation bodies (ABs). CABs verify that ISO requirements have been fulfilled, such as testing practices, inspections, evaluations, examinations, auditing, assessment, and other industrial and business practices.
An accreditation body is an accreditation service that provides third party recognition of the competence of an organization to perform a specific function. Since ISO standards are constantly changing and being added, organizations that perform accreditation have grown to meet the increasing demand. ABs can be laboratories, inspection groups, and certification bodies. They determine the technical proficiency and integrity of an organization.
A company first establishes and documents its management system by following procedures that guarantee that it can uphold quality requirements. ISO consultants are usually hired to assist in this process and guide a company through each of the various steps of the process. Actions taken to get an ISO certification include:
Creating a Management System
In a self evaluation, a business will define procedures and examine those procedures to check for improvements. All levels of management will document their procedures for compliance with ISO requirements. Once procedures are documented, documentation should be distributed for acceptance and approval.
Implementation of the System
In order to implement the system, it is important to check that the agreed processes are completed as they are specified in the documentation. For the success of the system, teams must receive proper training in regard to performing and maintaining new methodologies. Effective and detailed reporting systems, management review meetings, objective monitoring, statistical methods, inspection, testing, corrections, and preventative actions, as well as other reporting activities are used to collect measurable data to determine efficiencies. During in process reviews, necessary steps should be taken to ensure improvements.
Checking the Efficacy of the System
After a period of adjustments and evaluation, a third party organization should be contacted to do an audit to assess efficacy of the system. All levels of the system will be audited to search for issues and determine compliance with ISO requirements and procedures. The auditor will make observations, conduct interviews, and review sample documents to make a determination as to the management system's strengths and weaknesses and report them. Once the report is completed, remedial or proactive actions will be implemented to overcome deficiencies.
Identify the System.
After the audit, management system documentation will be submitted for evaluation. The external auditor assessment ensures that the management system is implemented successfully and that the system's requirements are met. ISO accreditation will be received after the assessment documents are completed. As ISO standards evolve and change, the management system will need to be audited every three years to maintain its certification. After each audit, the business receives recertification.
Selecting an ISO Consultant
Hiring an ISO consultant is a critical part of getting ISO certification and requires careful scrutiny. ISO consultants receive intensive training in regard to standard requirements and their implementation. They sort through documents and observe processes to assist companies in their desire to achieve ISO compliance.
As an ISO consultant processes data, they will suggest ISO standards that are most beneficial for an organization. After determining specific ISO standards, a consultant will complete a gap analysis to determine the difference between present practices and the necessary ones to meet the requirements of the chosen ISO standards.
Focused on Results
ISO consultants create a timeline for the implementation of ISO standards, which includes process improvements, internal audit times, training, and other key performance indicators (KPIs) in accordance with the budget and established dates for the organization to successfully complete its certification. To optimize an organization's potential for future success and ISO certification, process changes and implementations are carefully chosen and evaluated.
Reason to Hire a Consultant
The process of qualifying for an ISO certification is daunting and intricate with several activities that are new to organizations. A consultant serves as a guide to help the management team understand the process. Using their expertise, a consultant analyzes all aspects of an organization to develop a timeline for meeting ISO requirements. The determination of the level of assistance and resources depends on an organization's starting point. The roles of a consultant include:
- Advisory: interpreting standards and assisting managers on how to implement them
- Management: managing the implementation
- Implementation: adding resources to complete plans
- Ongoing support: planning routine and on-going activities
The philosophy, concepts, and ideals of every organization is different. The experience and knowledge of an ISO consultant places them in a position to adapt their services to match the needs of an organization. There isn’t a standardized formula for placing a company in the position to be ISO certified. Consultants customize their practices to meet the needs of their clients actual.
Cost and Schedule
The price of ISO consulting services vary according to an organization's size, the demands of implementation, the degree of employee cooperation, and the timeframe. Smaller businesses require more time and pay less while larger organizations have ISO training, a procedure that takes time and is more expensive. The cost of an ISO consultant includes training, audits, and other operations.
The resume of an ISO consultant provides a clear picture of their success and qualifications. They support organizations at various stages and are trained in management, counseling, consulting, and internal audits. Their credibility rests on their success rates, previous projects, client satisfaction, industry experience, and case studies. All ISO consultants present a plan of action with references to other organizations that they have guided and assisted.
Relevance and Experience
Consultants help guide management with implementation and serve as an advisor and internal auditor. Different skills are required with each step of the ISO certification process, which include launching an ISO effort and updating and maintaining it. An ISO consultant is judged by the caliber of their work, their clients, and the degree of client satisfaction.
Crucial factors to consider:
- Experience in the industry: This includes a knowledge of the sector of business to be served and its primary activities.
- Knowledge of management systems: All consultants are trained in management systems, which is a requirement of ISO to qualify as a consultant.
- Support for certification bodies: Having knowledge of various certification bodies is the main function of a consultant and is part of their being certified by ISO.
Chapter Three: Common ISO Standards in Different Industries
Each sector of ISO standards has its own numbering system with the most used sectors being ISO 9001, quality management, and ISO 14001, environmental management. After ISO 9001 and ISO 14001, the ISO numbering system gets very specific and detailed.
ISO 9001: Quality Management Systems
ISO 9001 standard is used by organizations as a means to raise the quality of their goods and services and satisfy consumer expectations. The ISO 9001 standard outlines the requirements of a quality management system (QMS), which is globally recognized. More than a million businesses and organizations in over 170 countries have received ISO 9001 certification.
The fundamentals of ISO 9001 include a strong customer focus, top management involvement and motivation, the process method, and continuous improvement. Its quality management principles provide a thorough explanation of each of its concepts. ISO 9001 ensures that clients receive dependable, high-quality goods and services.
The various aspects of the ISO 9001 standard provides a structure and a set of guidelines that guarantees that a company will be managed with common sense to satisfy consumers and stakeholders. The guidelines of ISO 9001 provide an outline for success for customers, employees, and company management.
Industry Specific Applications of ISO 9001
The ISO 9001 has quality management system standards based on ISO 9001 that are designed for specific industries and businesses. These consist of:
- ISO 13485: is for companies that design, produce, install and service medical devices and is used for auditing purposes.
- ISO/TS 54001:2019: applies to electoral services provided by an electoral body.
- ISO/IEC/IEEE 90003:2018: software engineering rules for the application of ISO 9001:2015 to computer software.
ISO 45001: Occupational Health and Safety
ISO 45001 is an international standard that outlines the requirements for an occupational health and safety management system. It is used to safeguard staff members from illnesses and accidents related to the workplace. ISO 45001 certification is structured to assist in eliminating elements that could endanger employees and companies. The International Labor Organization (ILO) estimates that every day, more than 7,600 individuals die due to illnesses or accidents at work.
An ISO group made up of professionals in occupational health and safety are working to create a global standard that could save three million lives annually. Additionally, OHSAS 18001 and the ILO's labor standards, conventions, and safety recommendations were part of the development of ISO 45001, along with other occupational health and safety standards.
ISO 45001 is applicable to all types and sizes of companies. Using the OH&S management system, a company can integrate health and safety standards for the wellness/wellbeing of workers. Additionally, organizations are obligated to adhere to local and national safety and health regulatory requirements, such as those in the United State that are outlined by the Occupational Safety and Health Administration (OSHA).
ISO 14001: Environmental Management Systems (EMS)
The ISO 14001 management system standard specifies the requirements for establishing and maintaining an EMS and contains an outline of guidelines for environmental control, impact minimization, and legal compliance. Studies show that up to 70% of office waste is recyclable, but only 7.5% of it ends up in a recycling facility. In conjunction with ISO 14001 is ISO 14004, Environmental Management Systems - General Guidelines, that covers the principles, systems, and supporting procedures, which covers the development, use, maintenance, and improvement of an EMS system.
Private, not-for-profit, and governmental organizations can use ISO 14001. The certification process provides a framework for putting into effect sustainable practices that are beneficial to all businesses in any sector or field. The implementation of ISO 14001 requires that a company consider all environmental issues that are relevant to its operations, such as use of resources, efficiencies, air pollution, water and sewage issues, waste disposal, soil contamination, and issues in regard to climate change. As with all ISO management system standards, ISO 14001 stresses the need for on-going development of environmental policies and procedures.
ISO 14001 has recently undergone revisions that include the elevation of the status of environmental management in an organization's strategic planning process with increased leadership involvement and stronger dedication to a proactive response to improving environmental performance.
Adherence to the managerial practices of ISO 14001 has proven successful for businesses in decreasing water and energy use, having improved regulatory compliance, and improvement in environmental performance. The approach of ISO 14001 is to identify, manage, monitor, and control environmental challenges. ISO 14001’s goal is to conserve the environment by providing advice on renewable energy as opposed to fossil fuels.
ISO 13485: Quality Management Systems for Medical Device Manufacturing
ISO 13485 covers the manufacture of products that are designed for use in the diagnosis, prevention, and treatment of illnesses or other medical disorders and includes instruments, machines, implants, and in vitro reagents. Specifically created for the manufacture of medical equipment, ISO 13485 is a management system standard that is based on the ISO 9001 process model. The goal of ISO 13485 is to standardize medical device regulatory criteria and includes specifications for how medical devices are manufactured, installed, and maintained.
Organizations that develop, manufacture, install, and maintain medical equipment are the target group for ISO 13485 and can be used by certification organizations to support auditing procedures. Organizations that are ISO 13485 certified are considered to be more reliable and trustworthy. ISO 13485 is edited and updated every five years in accordance with new standards and market demands.
ISO 22000: Food Safety Management Systems
The goal of ISO 22000, which is focused on food safety management systems, is to help organizations in the food industry with improving their overall performance in terms of food safety. The requirements of ISO 22000 are meant to provide food safety throughout the world.
ISO 22000 can be implemented by any organization in the food industry from farms and producers to restaurants. Having an ISO 22000 certification tells clients and customers that a business has a food safety management system in place and assures customers that they are protected.
The implementation of ISO 22000 includes having interactive communication and system management, prerequisite programs, and Hazard Analysis and Critical Control Points (HACCP) principles. All relevant food safety threats will have been recognized and controlled at each stage of food processing with open communication throughout the process.
Clear and concise communication assists customers and suppliers regarding the requirements for handling food. ISO 22000 integrates and supplements the main components of ISO 9001 to offer an efficient framework for the creation, implementation, monitoring, and improvement of a documented Food Safety Management System (FSMS)
Proven and widely used HACCP practices, and good manufacturing principles are prerequisites to an ISO 22000 certification. HACCP has gained international recognition for improving food safety. Its programs and practices are put in place to address the concerns for production environments and their place in the creation of safe food products. The requirements for ISO 22000 call for food producers to incorporate all applicable statutory and regulatory requirements for food safety in their food safety system.
ISO 27001: Information Security Management Systems
ISO 27001 standard is used as a framework for maintaining an organization’s confidentiality, integrity, and privacy while adhering to local and national regulatory requirements. The protection of organizational information, such as customer and employee data, confidential brand data, and proprietary processes, is covered under the guidelines of ISO 27001 accreditation. It is a process based approach to starting, implementing, running, and maintaining ISMS.
In the electronic age, there has been ever growing concern regarding detailed information and data held by businesses, companies, and medical groups. In an effort to stem the release of personal data, nations are passing stringent legislation and requiring adherence to strict guidelines. ISO 27001 is a response to governmental actions.
The implementation of ISO 27001 is an ideal way to address consumer concerns and legal obligations as a way to prepare for potential security threats such as cybercrime and data breaches. A commitment to upholding an industry's best practices in information security is demonstrated by achieving ISO 27001 accreditation. The process of accreditation provides a company with a professional assessment of its information security.
ISO 50001: Energy Management Systems
ISO 50001 was created to address energy usage, preserving resources, and improving the bottom line through the use of effective energy management. The framework of ISO 50001 is used to develop policies for more efficient use of energy, set goals and methods to achieve those goals, use data to understand and make decisions about energy use, measure results, assess implemented policies, and continuously improve energy management.
An organization's commitment to continuous energy management improvement is demonstrated by an ISO 50001 certification. The certification process enables companies to radically enhance their energy management program and guarantees compliance with local, national, and international regulatory standards.
ISO 50001 standard benefits businesses of all sizes and offers a workable strategy for reducing energy use through the creation of an energy management system (EnMS). Resource management will become more efficient, which will lead to fewer regulatory reporting requirements by lowering claims, returns, reprocesses, and rejections.
For the implementation of ISO 50001, energy monitoring systems may be required depending on the type of business and its energy needs. Although energy savings is the goal of ISO 50001, significant costs savings is an additional benefit through improved energy efficiency.
Chapter Four: Benefits of ISO Certification
ISO documentation outlines specifications, guidelines, practices, and processes that companies can use to ensure materials, products, methods, and services are of the highest quality. Standards for information security, food safety, risk management, environmental performance, and quality management assist in improving a company’s image and its integrity. Implementation of ISO standards ensures quality, consistency, and safety.
The benefits of ISO accreditation:
- Reliability: An ISO accreditation shows a company’s dependability to customers, suppliers, business partners, and the government as well as its dedication to the quality, safety, and durability of its goods and services. Included in ISO accreditation is a demonstration of adherence to and meeting the requirements of international laws and regulations as well as a commitment to excellence.
- Enhanced efficiency: To adhere to ISO standards, companies describe, record, and track their processes to determine their goals and track their development. ISO accreditation provides companies with the knowledge to optimize their operations and boost performance. Following the ISO process helps people to work effectively and efficiently, as well as to adopt new working methods quickly and successfully.
- Superior quality : ISO standards enable companies to improve the quality of their services and manage projects efficiently to reach new markets. The display of the ISO emblem promotes consumer confidence since it is associated with reliability and high quality. Compliance with ISO standards gives clients faith and confidence in a company’s goods and services.
- Better quality control: ISO complaint management and client satisfaction monitoring standards keeps clients and customers happy and reduces consumer complaints, an important advantage of ISO certification, according to research.
- Increased income: ISO certification allows a company to market its quality, which leads to an increase in revenue and sales. Large businesses demand that suppliers have an ISO certification, which is crucial for businesses looking to expand into international markets. ISO standards have become more important as world markets become more interconnected in regard to the movement of goods, services, and logistical technologies. The finest performance outcomes occur in businesses that consistently strive to enhance operations.
- Risk mitigation: The ability to anticipate hazards and turn them into opportunities is a key advantage of ISO standards. The requirements guarantee and awareness of methods for risk management and risk reduction. When issues do develop, businesses are prepared to handle them and recover quickly.
- Sustainability: In recent years, sustainability has become a major concern for companies as they focus on how their operations will affect future generations. ISO standards assist by showing an organization's commitment to addressing environmental and social issues. Businesses save money, boost their reputation, and address environmental issues by examining how they use their resources and energy as well as the quality of their waste management practices.
- Innovation: A practical outcome of ISO certification is a business’ ability to see its processes and develop new and innovative ways to approach problems. The energy and system improvement provided by ISO certification opens communications and empowers all members of an organization.
- Applies to all business sizes and types: A primary goal of the ISO is to help companies improve, regardless of their size, function, and sector. If the world is to properly deal with the issues of climate change and industrial pollution, it needs a set of standards as a guide and touchstone, which is what the ISO provides.