ISO 17025 encompasses requirements and guidelines for laboratories to perform testing and calibration.
Hence, ISO/IEC 17025 accreditation is proof of a laboratory’s accuracy, sound management system, and global recognition.
For this article, QSE Academy explains everything your laboratory needs to know about ISO 17025 accreditation.
Afterward, you can look into our toolkits to help you obtain the following rewards of ISO/IEC 17025 accreditation:
- Commitment to quality, accurate, and reliable results
- Prevention of defects
- Improved daily operations
- Cost Savings
- Reduced Waste
- Access to International Marketplace
Why Laboratories Need ISO 17025 Accreditation
ISO/IEC 17025:2005 – General Requirements for the Competence of Testing and Calibration Laboratories can develop and implement management systems of laboratories.
Aside from the benefits we’ve mentioned earlier, here are other reasons why ISO 17025 accreditation is a cost-effective investment:
- Efficient management system.
- Improve measurement accuracy.
- Control operational costs.
- Guarantee customers, stakeholders, auditors, and authorities about your laboratory’s technical competence to perform testing or calibration.
- Reduced customer complaints.
- Yearly assessments to verify that systems are following ISO/IEC 17025 requirements.
- A strategic tool, which results in a competitive edge over competitors.
- Accreditation certificate for marketing and advertising.
How to Select an Accreditation Body?
ISO 17025 accreditation assures that your laboratory can provide quality testing and calibration services. Subsequently, consistent and accurate data.
But before this, you must choose a well-organized accreditation body. Generally, a third-party accreditation body decides whether or not your laboratory complies with the standard.
An accreditation company will perform a comprehensive and complete assessment of your laboratory’s management system to determine compliance with ISO 17025 requirements.
QSE Academy suggests studying the background and credentials of potential accreditation bodies. There are points to consider, so you could select one that is appropriate for the needs of your laboratories.
First, identify whether an accreditation body has qualified assessors that can perform assessments.
Secondly, look into the International Laboratory Accreditation Cooperation (ILAC) to see whether an accreditation body is recognized for its program.
Next, a potential body must give your laboratory a complete description of its accreditation process. This allows you to check if some restrictions or policies may impact your laboratory.
Lastly, know whether the accreditation company is financially stable. This assures your laboratory that the accreditation company is still operating during the validity of your accreditation certificate.
How to Apply for ISO/IEC 170215 Accreditation?
- File Application
Once you’ve picked an accreditation company, your laboratory must become familiar with the body’s practices. In this way, you can determine the right time to apply.
To create a realistic timeframe, you must first identify the scope of your laboratory’s calibration and/or testing.
You should also know whether your laboratory is part of a bigger facility or self-supporting.
Next, determine the status of current management system implementation.
Most importantly, secure documentation of your laboratory’s management system.
- Get a Price Quote
The accreditation body will prepare a price quote for all aspects of the accreditation process. In this way, you can estimate the necessary time, money, and resources.
- Enter Contract
Your laboratory must have an official contract with the accreditation body.
Remember to review the responsibilities of all parties involved, terms and conditions, policies, and financial obligations.
- Prepare for Accreditation
It is easier to prepare for accreditation if your laboratory has implemented an ISO/IEC 17025 management system.
During the implementation, it is expected that your staff members are familiar with the system. Employees should also have ample documentation for assessment. Secure:
- Quality Records – Any records of objective evidence such as files, charts, inspection and testing records, and assessment results.
- Quality Documentation – Documents that explain how to manage quality for testing projects or individual calibration.
- Procedures – Describes how the system functions.
- Work Instructions – Specific job activities that impact the quality of testing or calibration.
- Quality Manual – Outlines how your laboratory follows ISO 17025.
- Document Review
A documented management system guarantees consistent performance by:
- Defining the responsibilities and authority of staff.
- Communicating the system’s objectives, as well as the procedures, work instructions, and policies of the laboratory.
- Promoting constant improvement.
- Incorporating changes.
Most of the time, accreditation bodies seek an uncontrolled copy of a laboratory’s management system documentation.
Your accreditation body will review the documentation to assess whether it fulfills ISO/IEC 17025 requirements. Besides, it will verify that your laboratory has created and implemented the processes for:
- management review
- internal audits
- interlaboratory comparisons
- proficiency testing
- measurement uncertainty
After the review, the accreditation body will deliver a report to your laboratory. If the documentation doesn’t meet all the criteria in ISO/IEC 17025, your laboratory must take corrective action to deficiencies.
QSE Academy suggests submitting your laboratory’s documentation at least four to six weeks before your scheduled assessment. In this way, you can make corrections to nonconformances.
If the body deems the documentation satisfactory, arrangements will be made for the preliminary assessment.
Afterward, the accreditation company will assign an assessment team to conduct a full assessment of your laboratory’s management system.
A lead assessor will coordinate assessment activities. The whole assessment team will check your laboratory’s tests and/or calibrations, as well as personnel, equipment/instruments, and records.
There could be more than one assessor depending on your laboratory’s size. Note that one of them should be experienced in your area of testing or calibration.
Furthermore, the lead assessor will work with your laboratory’s management representative in developing an assessment agenda for the on-site visit.
The lead assessor must confirm accommodation requests and the daily schedule of events.
- Preliminary Assessment
You can request for a dry-run or preliminary assessment of the management system, records, and documentation. This will gauge the laboratory’s readiness for the actual accreditation assessment.
Similarly, this enables an accreditation body to pinpoint flaws or deficiencies in the management system. In effect, your laboratory gets sufficient time to correct any problems before the accreditation assessment starts.
Moreover, this helps the accreditation body in determining the criteria, the appropriate number of assessors, and the necessary timeframe.
The good thing is that you may decide on the extent of the preliminary assessment. Even though this part is optional, QSE Academy suggests conducting this stage to take corrective actions early.
- Entry Briefing or Opening Meeting
The upper management and other parties involved with the laboratory management system will take part in an opening meeting on the scheduled assessment’s first day.
The lead assessor will direct the assessment team in presenting the overview of the assessment process.
Only then can the assessment team review your laboratory’s objectives and scope. They will also confirm resources and schedules.
Aside from that, the team will look into procedures to detect deficiencies or nonconformances.
Your laboratory must appoint guide(s) who can accompany the assessment team through the facility and your procedures.
- Accreditation Assessment
The assessment team will have an on-site visit to observe and witness activities. This aims to gather evidence of technical competence. The team may:
- Inspect written policies, procedures, statements, records, and documents;
- Do one-on-one interviews with staff;
- Select witnesses for tests or calibrations.
The team will record any deficiencies in a nonconformance report.
- Exit Briefing or Closing Meeting
An exit briefing will follow the on-site assessment. This lets the lead assessor recommend your laboratory’s eligibility for accreditation.
The lead assessor will summarize the assessment’s results. These include deficiencies or nonconformities. Your laboratory will get ample time to take corrective action.
- Take Corrective Action
Your laboratory must resolve all nonconformances by taking corrective action. Include a copy of objective evidence to show that you have implemented and completed corrective action. This may include training records, laboratory procedures, and calibration certificates.
Even after the corrective action, the accreditation body may need to do a follow-up assessment to confirm that the nonconformance has been addressed.
Once verified, only then can the lead assessor recommend your laboratory for accreditation.
- Executive Committee’s Decision
The independent body’s executive committee will decide whether your laboratory will get accreditation.
It will review your laboratory’s accreditation documents and recommendations from the lead assessor.
You will be informed if the committee deems that your laboratory has met all of the accreditation requirements.
Afterward, the accreditation body will prepare an accreditation certificate, which includes the body’s logo.
- Certificate of Accreditation
The accreditation certificate assures customers that your laboratory has shown technical competency to conduct calibration and testing services.
You can use this certificate in stationery, promotional literature, marketing, and advertising.
- Surveillance Assessments
Even if you’ve achieved accreditation status, your accreditation body will still perform surveillance assessments.
This is only a partial assessment of your management system. The body will continue assessing objective evidence that your laboratory is still following ISO/IEC 17025 requirements.
Therefore, your laboratory must continue working to improve and maintain the management system.
ISO/IEC 17025 Accreditation Timeline
The accreditation assessment’s duration depends upon the:
- size of the laboratory
- desired scope
- the complexity of testing and/or calibration operations
- number of employees
Most of the time, laboratories may spend six months to one year in preparing for the assessment.
The actual assessment until the issuance of a certificate will take at least eight weeks.
How Much Does Accreditation Cost?
The cost will depend on various factors, especially since laboratories have scopes and characteristics. Here are key aspects of the cost:
- Daily rate
- Overhead expenses
- Travel and accommodations
- Fees for document review
- Fees for preliminary assessment (optional)
- Fees for accreditation assessment
- Miscellaneous fees associated with accreditation, such as travel and accommodations
- Fees for surveillance
Check whether your accreditation body has extra charges for other services such as office preparation.
There are accreditation bodies that will send assessors near your site to avoid excessive travel expenses.
How Can QSE Academy Serve You?
As you can see, your laboratory needs a well-documented management system before you can pursue ISO/IEC 17025 accreditation.
This is where QSE Academy can help.
We have toolkits and packages you can optimize to develop forms, checklists, and documentation.
You could also read our previous blog posts for further tips and explanations.
Message QSE Academy for inquiries and let us help secure your accreditation certificate.