What is ISO Certification & How to Get Certified

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What Is ISO Certification?

The International Standards Organization (ISO) is a nongovernmental organization created by a group of delegates from 26 countries to develop international standards that businesses can use to adhere to industrial specifications and requirements. To comply with these standards, businesses have to become certified through various ISO certifications, which demonstrate that a company is meeting specific quality assurance and manufacturing standards. In other words, ISO certifications ensure that the products and services provided by an organization are safe, reliable, and of excellent quality.

In 1951, the very first ISO standard, ISO/R 1:1951, was published to set a reference temperature for length measurements. Today, ISO has 22,700 International Standards spanning almost all areas or steps of business processes, including science and technology, engineering, and information security. Currently, its members include standards bodies from 167 countries, all of whom contribute to building policies and quality standards that are effective and can be implemented worldwide.

ISO works in cooperation with the International Accreditation Forum (IAF), which is the world association of Conformity Assessment Accreditation Bodies, and the International Laboratory Accreditation Cooperation (ILAC), which is the international organization for accreditation bodies that comply with ISO/IEC 17011. 

In this article, we will dive into more details of ISO certification, including how it is defined, what it includes, and how one can obtain the certification for its organization.

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Overview of ISO Certifications

ISO certification serves as a seal or validation by a third party (accredited certification bodies) for the services or products offered by an organization. It shows consumers and stakeholders that the company runs on an international standard, developed by the International Organization for Standardization (ISO), and consistently produces high-quality goods.

Each ISO certification has a different focus, and standard criteria, such as:

  • ISO 15189: For quality management.
  • ISO 17020: For reliability and risk assessments.
  • ISO 17025: For competence of testing and calibration of laboratories. 
  • ISO 17034: For everything from property value to traceability.
  • ISO/IEC 17065: For ensuring competence of an accreditation body.

These ISO certifications consist of different components that define their features and use cases for the certification procedures. Let’s use ISO 9001:2015 as an example. The standard has three components:

  • ISO: It refers to the International Organization for Standardization, which develops customer focus quality standards to certify businesses and organizations for quality assurance and management systems.
  • 9001: The number is written after ISO, which shows the classification of the standards. For example, the standards within the ISO 9000 refer to quality management. ISO 9001 is the certification to meet quality management principles by organizations.
  • 2015: It represents the year in which the particular version of the standard was launched. An organization has to follow the latest modified version of the standard to keep its certified status. 

How ISO Certifications Work

To demonstrate how ISO certifications work, let’s use the example above once more. ISO 9001 lays out specific requirements for a quality management system (QMS), a formalized system that documents the processes, procedures, and responsibilities necessary to create high-quality products or services. An organization’s QMS should meet the standards defined by ISO 9001 to show to customers and stakeholders that it is complying with regulatory requirements and maintaining consistent quality of goods and services. It offers a “process approach” (management of different individual activities as interconnected processes) to manage more than 20 processes.

If an organization is ISO 9001 certified, it shows that the company’s quality management system adheres and conforms to all requirements laid out under the standard. 

Figure: An illustrative diagram of all the elements of ISO’s Quality Management.

How to Learn More About ISO Certification

The most accurate and updated information on the ISO certification processes can only be found on its official website. However, many accreditation bodies or teaching platforms also provide information on all the regulatory requirements of ISO. 

Additionally, you can find many publications on the ISO website that detail specific standards. Training courses and webinars, templates for documentation, and guidance notes are even provided by some organizations to help you out with all the stages of ISO accreditations.

How to Get ISO Certification

The ISO certification process and the first-time certification audit can take around three years. During this period, you will need to conduct a list of assessments such as document control, internal audits, and management review meetings to ensure the standard is in place. 

However, implementing ISO standards help organizations in multiple ways. Some of the benefits of ISO standards are:

  • Continual improvement in management system standards and processes.
  • Meet customer expectations and deliver customer satisfaction.
  • Enhanced productivity.
  • Increased credibility and recognition on international platforms.
  • Increased revenue and competitive advantages
  • More efficient process
  • Minimized risk exposure
  • Consistent business operations.

But, how can you get ISO certification?

Here’re the steps required to obtain ISO certification for your organization.

1. Update and Check Your Systems

First, develop a relevant management system for your organization and decide which ISO standards you want your organization to be certified under. Each ISO standard has different requirements that need to be fulfilled to gain accreditation.

You need to perform the following activities at this stage:

  • Define and document your business objectives and processes.
  • Create a team of employees and management to oversee the ISO certification initiative.
  • Assign a leader to direct the process and ensure the proper implementation of the ISO standards.
  • Conduct a gap analysis between the current management system and the ISO QMS. Work with an ISO consultant or certification provider to help you out with the implementation of the process.
  • Analyze and minimize the risks in your processes to achieve the targeted output.
  • Train your assigned team and personnel about ISO standards and ensure everyone is updated with the latest information.

2. Test and Close Compliance Gaps

  • Implement the new and updated system.
  • Train your employees on how the new system works.
  • Check if there are still any gaps left after the implementation of the updated process and if the system is working efficiently. 
  • If there are still gaps, take corrective actions.
  • Meanwhile, the internal auditor should also evaluate the system and ensure that all the ISO requirements are met and no corrective actions are required.
  • From the beginning of the process, document everything.

3. Choose a Certification Body

  • Select a certification company that is CASCO accredited. The company assigns a team for you that consists of a registrar, third-party assessor, independent, lead auditor, and other personnel to help you with your certification processes.
  • Gather all necessary documentation required to provide the evidence to the lead auditor for the implementation of each requirement.

Lease High-quality Lab Equipment with Excedr

Certification by ISO signifies that a management system, a service, a manufacturing process, or a documentation procedure has met all the quality assurance and requirements laid out under a specific standard. The 22,700 ISO standards are developed to ensure consistency and quality in global organizations in security, safety, and quality control areas. 

The ISO standard benefits both the stakeholders and organizations in many ways. Organizations that are ISO certified can boost their reputations in the global market and increase productivity while ensuring that customers receive high-quality products and services. Earning ISO accreditation is a multi-step process that takes years. It starts from updating and checking your system to inviting external accredited auditors to test the implementation of the standard requirements in your organization and offer ISO certifications. 

In addition to being a time-intensive process, ISO certification is also an expensive procedure. However, ensuring and checking every requirement by yourself from your side may reduce the expenses and time of your accreditation.

For labs, one approach is to produce reliable and accurate data for their product, which can be achieved by using effective procedures, expert personnel, and the use of quality reagents and equipment.

Excedr’s leasing program can help you meet and maintain the strict regulatory and customer requirements outlined in ISO certifications by providing you with top-notch, highly-advanced equipment leases, from analytical equipment and clinical equipment to life sciences and biotech instruments.

Choosing to lease equipment from Excedr can be much more effective and affordable than purchasing each piece of equipment outright. You avoid a huge down payment, extend your cash runway, and conserve working capital that can be reinvested in your business. Additionally, we ensure that the equipment is operating efficiently by including comprehensive service coverage. Excedr can help your lab get the technology and equipment it deserves. With the right equipment, you can accelerate your R&D and achieve milestones faster! Get your customized leasing solution now.