What Is ISO Certification? (And How To Get Certified)
International Organization for Standardization (ISO) certification establishes credibility and trust among consumers, clients and other business partners. In today’s international marketplace, such a designation validates that an organization adheres to global standards of quality assurance, manufacturing and business. For enterprise organizations, understanding what ISO certification entails can help to optimize business practices and inspire confidence in their interested parties. In this article, we define ISO certification, explain why a business might want to pursue it and provide a step-by-step guide for earning a particular certification.
What is ISO certification?
ISO certification is a credential that validates a business’s fulfillment of requirements relating to quality process standards as defined by the International Standards Organization. The ISO is a non-governmental organization that determines specifications for products, services and systems for quality and efficiency.Its history dates back to the mid-twentieth century, when international delegates met in London to create a new standardization for international cooperation and organization. The ISO now has almost 23,000 published standards throughout 164 countries, and companies earn ISO certifications to prove their quality standards to the world.Standards set forth by the ISO are valuable with regard to international trade as the organization has strict requirements concerning goods. Its ultimate goal is to improve industrial welfare worldwide, increasing levels of safety and security for all.Credentialing takes place through external bodies, as the ISO itself doesn’t perform certification. There are also multiple ISO certifications. The credentials relate to specific industries, including but not limited to:
- Agriculture
- Food safety
- Healthcare
- Manufacturing
- Occupational health and safety
- Risk management
- Technology
Each certification has its own set of standards and requirements. Some of the most common types of ISO certification are:
- ISO 9000: One of the most common certifications is the ISO 9000, a grouping of standards that relates to quality management systems (QMS) and helps companies meet the needs of customers and other interested parties. It’s the most basic form of what the ISO has set out to accomplish.
- ISO 9001: Companies choose the ISO 9001 to establish product conformance to standardized requirements. In this case, the product also refers to services, materials, hardware and software, and this certification relates more to the product a company supplies rather than the entity itself.
- ISO 13485: The ISO 13485 is a sector-specific certification for the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
- ISO 14001: Relating to requirements for an environmental management system, the ISO 14001 is growing more prevalent because of consumer opinions concerning the impact of corporations on the environment. Entities with this certification control the effects of their general activities on both flora and fauna.
As the need for standardization grows, so do the circumstances in which to apply them. The scope of the ISO has broadened to include multiple additional areas and certifications, including OHSAS 18001, AS9100, ISO ITAR, lean manufacturing and R2 certification.
Why get ISO certified?
Obtained from third parties, ISO certifications function as proof that a business abides by the standards set forth by the ISO. As such, they help to instill confidence in clients and other interested parties that the business conducts itself efficiently and strives for high quality.ISO certifications also prove a company’s commitment to important business objectives such as customer satisfaction and production. Some public and private sector entities even request that companies attain ISO certification before they agree to conduct business with them.
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How to get ISO certified
Most companies that seek ISO certifications are those that ship globally, meaning it’s necessary for them to adhere to trade agreements in various countries. For such businesses, the certification of global standards is nearly a requirement, so the ISO 9001 is crucial for their success. The following steps explain how an entity can earn an ISO 9001 certification, along with an official audit:
1. Develop a quality management system
The first step to earning an ISO certification is to develop a QMS unique to the business. Identify core business processes, study them and determine where to make improvements. Work with managers and teams at all levels and document their processes. Then, using the standards set by the ISO, develop a QMS that works most effectively. Create a document outlining the new process and distribute it to all levels of the business.
2. Implement the new quality management system
The next step is to initiate the new QMS and monitor its progress. Ensure that procedures at all levels get carried out as outlined by the new documentation. If the new system requires new processes, make sure that teams receive training with new methodologies in mind. It often helps to create a reporting system so that managers and individual team members can submit issues as they arise. Review and address these issues as needed.
3. Schedule an external audit
After some time has passed and all problems have gotten addressed, schedule an audit with a certified body. During this process, an expert auditor assesses the new QMS at all levels, looks for potential problems and determines whether it meets ISO standards. Keep in mind that the auditor may require access to formal documentation, to compare it to the actual work conducted.
4. Register the quality management system
If the company passes inspection, it can register its QMS for certification. To do so, the company gathers all of the documentation and submits it to the certifying party for review. Once the documentation passes review, the company earns its certification. Standards often change over time. To maintain certification, the QMS requires auditing every three years. Upon passing, the company also earns recertification after each audit.
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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.
At ISO, we develop International Standards, such as ISO 9001 and ISO 14001. 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.
Certification – the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements.
Accreditation – the formal recognition by an independent body, generally known as an accreditation body, that a certification body operates according to international 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 provides independent confirmation of competence. However, accreditation is not compulsory, and non-accreditation does not necessarily mean the certification body is not reputable. To find an accredited certification body, contact the national accreditation body in your country or visit International Accreditation Forum CertSearch.
International organizations in cooperation with ISO for accreditation
The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel etc.
ILAC is the international organization for accreditation bodies operating in accordance with ISO/IEC 17011 and involved in the accreditation of conformity assessment bodies including calibration laboratories (using ISO/IEC 17025), testing laboratories (using ISO/IEC 17025), medical testing laboratories (using ISO 15189), inspection bodies (using ISO/IEC 17020) and proficiency testing providers (using ISO/IEC 17043).
ISO does not perform certification
ISO does not perform certification or issue certificates, and it does not permit anyone to use the ISO logo in connection with certification. Certification is performed by external certification bodies, thus a company or organization cannot be certified by ISO.
Making a complaint in relation to a claim of certification
ISO takes complaints related to the misuse of the ISO logo or false certification to ISO management system standards seriously.
Complaints should be addressed to the certification body that certified the organization. You can identify the certification body by examining the statement of certification, the certification mark used by the organization, or by requesting a copy of the certificate to the ISO standard.
If the above steps cannot be followed, please send us an email with full details of the issue and how we can contact you. While ISO cannot guarantee a resolution or assume any liability, it can help facilitate dialogue between the parties involved and work towards a positive outcome.
A response to your complaint will be sent to you within 14 days.
