ISO 9001 Certification or ISO 17025 Certification?

 


Both ISO 9001:2015 and ISO 17025:2017 are quality management systems(QMS).ISO 17025 Accreditation is only for calibration and testing laboratories whereas ISO 9001 can be applied to any organization.

ISO 17025:2017 is an Accreditation and ISO 9001:2015 is Certification.

 

What is Accreditation?

Accreditation is the third-part attestation to a conformity assessment a formal, independent verification that a program or institution meets established quality standards and is competent to carry out specific conformity assessment tasks further for others by providing certificates.

 

What is Certification?

Certification is the verification of the particular quality required by the specific standard to incorporate it in the product/services.

 

What is ISO 9001?

ISO 9001 is a globally accepted international standard that specifies requirements for a quality management system (QMS). Organizations use this ISO 9001 standard to demonstrate the ability to consistently, efficiency to their products and services that meet customer and regulatory requirements by maintaining continual quality improvement. For this reason, ISO 9001 is a standard that a company is certified in.ISO 9001 Certification can be applied to any type of organization.

 

ISO 9001 certification applies to an entire organization by setting an effective Management tool for Quality Management systems but does not include technical content to show that test/inspection data are reliable.

 

What is ISO 17025?

ISO/IEC 17025 Certification is the highest standard quality management system (QMS) for calibration laboratories. They intend this standard for the competence, impartiality, and consistent operation of testing and calibration laboratories to generate accurate test results. ISO 17025 accreditated lab's test Certificates are accepted globally with the need for further testing.

 

Suppliers, those who need reliable competence calibration backed by a quality management system should seek ISO 17025 Accreditation. And that accreditation should come from a recognized body under the ILAC’s mutual recognition agreement or MRA. 

 

Also, Check >>> ISO 17025 Certification in Dubai

 

Similarities between ISO 9001 Certification  and ISO 17025 Certification

There are a minimum set of QMS requirements that are similar between both the standard for the application. These are:

  • Continual Improvement as per new technology
  • Management reviews and their involvement
  • Implement Control process and policies
  • Documentation of records by management system
  • Corrective actions in case of faults and errors
  • Risks and opportunities handling tool
  • Records control by providing security
  • Regular conduct of Internal audits

 

How They Can Benefit Your Lab’s Experience

If your lab is looking to work with an accredited calibration laboratory then it would benefit you to find a company that is a registered company with ISO 17025 accredited laboratory and follow basic requirements of ISO 9001. They will be able to apply risk-based thinking to manage risks and drive improvement more efficiently for your lab.

 

Do We Need ISO 9001 or ISO 17025?

For companies that do more than just laboratory services, it’s become common to get certified to ISO 9001 Certification. And ISO 17025 Certification can be achieved for calibration testing of laboratories to maintain their competency in the market value. The ISO 9001 quality system is different from ISO 17025 in terms of purpose, emphasis, and criteria, and certain sort of their compliance. The two can standards line up in some areas, but they are separate, and achieving one does not mean you’ve met compliance with the other regulations.

 

Implementation of ISO 9001 can be beneficial for your lab for maintaining in general QMS and it doesn’t have to comply with ISO 17025:2017. Keep in mind that your laboratory doesn’t necessarily need ISO 9001, but it’s an asset when pursuing ISO 17025 accreditation certification.

 

ISO 17025 CERTIFICATION PROCESS

To make the ISO 17025 Certification process simple and quick. Hiring a consultant will guide you and your business through the following steps to achieve ISO 17025 Certification by providing.

  1. Gap Analysis Training 
  2. Testing  
  3. Documentation & Test Report
  4. Process Audit
  5. External Audit
  6. Certification and beyond

 

 

 

 

 

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