How to Become an ISO 17025 Accredited Laboratory: Step-by-Step Guide for Lab Owners and Managers

If you’re running a lab and want to stand out, ISO 17025 accreditation is a solid way to show you’re serious about quality and competence. To become an ISO 17025 accredited laboratory, you’ll need a robust quality management system, clear documentation for your methods, and you’ll need to get through both internal and external audits successfully. When you meet these requirements, you’re basically proving your lab can deliver results people can trust.

As a lab owner or manager, knowing the steps in the accreditation process really matters. From prepping your documents to fixing gaps, understanding what’s ahead saves you a ton of headaches (and probably some money). Here’s a guide that breaks it down so you can actually get accredited without losing your mind.

Key Takeaways

• You need a documented quality management system
• Do internal audits and management reviews before assessment
• Accreditation shows your lab meets global quality standards

Understanding the Process to Become an ISO 17025 Accredited Laboratory

ISO/IEC 17025 accreditation basically means your lab lines up with international standards for reliability and competence. Getting this stamp of approval helps you show off the quality of your testing and calibration, and honestly, it just makes your lab look good.

What Is ISO/IEC 17025?

ISO/IEC 17025 is the international standard for testing and calibration labs.
It spells out both technical and management requirements, so your results aren’t just accurate—they’re also backed up by solid processes.

This standard is for any lab that does testing, calibration, or sampling, no matter the field.
A lot of businesses and government agencies only accept results from ISO/IEC 17025 accredited labs, since it’s recognized worldwide.

When your lab gets accredited, you’re showing you operate impartially and keep quality consistent.
But don’t get too comfortable—it’s not a “set it and forget it” deal. You’ve got to keep those standards up, year after year.

Key Requirements and Scope of the ISO/IEC 17025 Standard

ISO/IEC 17025 has two big buckets: management and technical requirements.
Management requirements are all about how your lab’s quality system runs.
Technical requirements cover staff competence, equipment, methods, and the actual results you produce.

The standard applies to anything your lab does that leads to reliable test or calibration results.
So you’ll need clear procedures, well-maintained instruments, and staff who actually know what they’re doing.

It also expects you to keep tabs on your results—think calibration, quality control, and proficiency testing.
And you’ll need to look for risks and take steps to keep errors out of your testing and calibration work.

Who Needs ISO 17025 Accreditation?

If your lab does testing, sampling, or calibration and you want people to trust your results, ISO/IEC 17025 is for you.
That goes for independent labs, in-house company labs, and government outfits alike.

Pharma, food safety, environmental, manufacturing—these industries often require accredited labs.
It can help you win contracts, meet regulations, and get recognized across borders.

If your clients expect proof that your results are solid, you’ll need accreditation.
It’s really about showing you know your stuff and hold yourself to high standards.

The Importance Of Proper Documentation And Implementation

You’ll need to keep your documentation up-to-date for everything—processes, your quality system, and all lab activities.
That means SOPs, equipment maintenance logs, staff qualifications, and records of every test or calibration you do.

Having your docs in order keeps your work consistent and makes audits way less stressful.
It’s not just about writing stuff down, either—you’ve got to make sure people actually follow the procedures, day in and day out.

When everyone sticks to documented processes, it’s easier to train new staff, spot problems, and fix mistakes before they get bigger.

Table: Examples of Key Laboratory Documents for ISO 17025

Document Type	Purpose
SOPs	Ensures consistent procedures
Equipment Logs	Tracks maintenance/calibration
Training Records	Shows staff qualifications
Test/Calibration Reports	Records final results

Step 1 – Create All ISO 17025 Required Documentation

Written documentation is at the heart of ISO 17025 compliance. You’ll need to prepare specific documents and records, and they’ve got to stay current and actually reflect what’s happening in your lab.

Overview Of ISO 17025 Required Documentation (Quality Manual, Procedures, Policies)

ISO 17025 calls for a handful of key documents to make up your management system. The big one is the Quality Manual—it lays out your approach to quality assurance, how you’re organized, and what your testing or calibration covers.

You’ll also want a quality policy statement that spells out your commitment to quality management and improvement.
On top of that, you’ll need written procedures and work instructions for all the important stuff: sampling, test methods, equipment care, quality checks, and what to do when things go off the rails.

Here’s what usually goes in the pile:

• Quality Manual
• Policies and objectives
• Procedures for key processes
• Technical records and forms
• Document control and record retention policies

Honestly, keeping a master list of all your controlled documents will save you from a lot of chaos.

Aligning Documentation With ISO 17025 Clause Structure (Clauses 4–8)

ISO 17025’s requirements are laid out in Clauses 4 through 8, each covering a different part of your lab’s operations. If you map your documentation to these clauses, audits and compliance checks get way easier.

• Clause 4: General requirements—think impartiality and confidentiality.
• Clause 5: Structure—how your lab’s organized, who does what.
• Clause 6: Resources—personnel, facilities, equipment, environment.
• Clause 7: Process—your technical activities: testing, calibration, reporting.
• Clause 8: Management system—document control, audits, corrective actions, improvement.

Use headings or references matching the clause numbers in your docs.
It’ll make updates and audit prep a whole lot faster.

How ISO 17025 Templates and Documentation Packages Can Save Time and Ensure Compliance

Trying to write all your documentation from scratch? It’s a slog, especially if you’re new to ISO 17025. Templates and documentation packages designed for the standard can really take the edge off.

Most templates already have the right format, section headings, forms, and sample wording, so you can just tweak them to fit your actual processes.
Plus, checklists make it harder to accidentally skip something important.

A good documentation package can speed things up, cut down on mistakes, and make sure you don’t miss details like retention periods or technical requirements.
If you’re a small lab or just starting out, this is a lifesaver.

ISO 17025 Quality Manual and Procedures Template Package

If you want to make your ISO 17025 journey less painful, check out our Quality Manual and Procedures Template Package.
It’s built for labs of all sizes and helps you get a compliant management system up and running without reinventing the wheel.

• Start with prewritten, customizable documents
• Make sure your docs match ISO 17025 clauses
• Skip the rookie mistakes that trip up audits
• Get templates for policies, procedures, forms, and document control

Want to know more about getting your ISO 17025 docs sorted? Just reach out and we’ll help you get started.

Step 2 – Implement ISO 17025 Documentation and Procedures (Clauses 4–8)

You’ll need to both document and actually use every policy and procedure ISO 17025 calls for. This covers your management system, technical work, and how you show compliance with quality, technical competence, and measurement.

Importance Of Systematic ISO 17025 Implementation

Having a plan is huge. If you go step by step, you’re less likely to miss something or mess up. ISO 17025 touches everything—management, technical work, staff, facilities, and improvement.

A good plan means you won’t leave out any required topics. Clause 4 is about your management system; 5–8 dive into technical details, equipment, and measurement. Every process and policy should live in a controlled document—manuals, SOPs, or instructions.

Keep your docs accessible and current. You’ll want to review them now and then to make sure they still work for your lab.

Tips For Implementing One Clause At A Time

Don’t try to do everything at once. Tackle one clause at a time to keep things clear. Start with management system policies (clause 4)—roles, responsibilities, communication. Then hit documentation for staff competence and training (clause 6), facilities and equipment (clauses 6–7), and technical activities.

Checklists are your friend. Here’s a quick example for Section 5 (Structural Requirements):

Task	Status
Define organizational chart	Complete
Assign roles/responsibilities	Pending

Break big tasks into smaller chunks so you don’t miss anything. Keep the ISO 17025 standard handy and double-check as you go.

Ensuring Alignment Between Procedures and the Standard

Your procedures should match what ISO 17025 actually says—both the wording and the intent. That means your docs need to line up with the requirements for quality, technical qualifications, and measurement uncertainty.

For technical procedures, compare your SOPs with the ISO requirements for calibration, testing methods, and records. Management system docs should lay out how you handle quality goals, audits, corrective actions, and improvement.

Update your documents as soon as the standard changes. Always link policies and docs to the right ISO 17025 clause so audits don’t turn into a scavenger hunt.

Maintaining Records Of Implementation (Logs, Reports, Etc.)

Keep track of everything as you go—training logs, procedure changes, calibration records, management review notes. Good records prove you’re actually meeting ISO 17025 and make audits a lot smoother.

Stay organized by date and type. Digital tools or spreadsheets make searching easier. Set up access controls so only the right people can change important records.

Check your records regularly for gaps. Missing or outdated stuff can cause compliance headaches. Set a retention schedule so you know how long to hang onto each type of document.

Step 3 – Conduct an ISO 17025 Internal Audit/Gap Analysis

Before you even think about applying for ISO 17025 accreditation, you really need to make sure your lab actually meets all the requirements. Running an internal audit and a gap analysis lets you catch problems early—way better than finding out during the official assessment, right?

Why Internal Audits Are Essential Before Applying For Accreditation

Internal audits let you see how well your lab’s processes stack up against ISO 17025. They’re a great way to spot risks, uncover weaknesses, and check if your staff really follows the procedures you’ve written down. When you audit your own systems, you get a much clearer idea of what needs work.

Accrediting bodies want to see that you’ve found issues and actually done something about them. An internal audit isn’t just a box to tick—it’s proof you care about quality and you’re serious about accreditation. If you skip it or do a half-hearted job, you’ll probably run into delays or even fail the assessment. Not fun.

How To Perform an ISO 17025 Gap Analysis

A gap analysis is basically you comparing what you’re doing now with what ISO 17025 says you should be doing. Easiest way? List each clause of the standard in a table or checklist, then compare them to your current procedures, records, and day-to-day practices.

Jot down where your lab doesn’t fully meet the requirements. For instance, if your calibration records are spotty, that’s a gap. Tackle the big stuff first—anything that affects quality, safety, or compliance should be top of the list.

Tools and Checklists Available

Honestly, checklists and templates make life way easier for audits and gap analyses. ISO 17025 checklists break down the requirements into bite-sized points. You’ll find them in Excel, PDF, or as online forms.

If you want a head start, grab our free ISO 17025 internal audit and gap analysis tool here. It’s pretty straightforward—step-by-step guidance for each clause, plus space to document findings and corrective actions. It’s designed to help you actually track compliance and highlight gaps, not just drown you in paperwork.

Documenting Findings And Preparing For Corrective Actions

Be thorough when you document your internal audit and gap analysis results. Capture all findings—good or bad—in a way that makes sense. Short, specific notes work best for each gap or concern. Don’t overthink it.

Try a simple table to keep track of:

• The requirement or clause
• What you found or what’s missing
• Who’s handling the follow-up
• When it should be done

Example Table:

Requirement	Finding	Responsible Person	Target Date
7.8.3 Test Reports	Missing data fields	Lab Manager	July 1, 2025

Assign corrective actions right away and make sure everyone knows what’s expected and by when. Getting on top of this now makes the official assessment way less stressful—and shows you’re serious about compliance.

Section 5: Step 4 – Correct Gaps And Non-Conformities

After you’ve wrapped up your internal audit, it’s time to tackle any issues you found. Fixing gaps and non-conformities is how you get your lab up to ISO 17025 standards—and honestly, it’s how you build a culture that actually improves over time.

Reviewing Audit Findings

Go through all the audit results carefully. Focus on any non-conformities—missing documents, process slip-ups, or requirements you didn’t meet. Match each finding to the right ISO 17025 clause so you’re not just guessing.

Make a list or a table that sums up each issue, where it came from, and how risky it is. Bring your team in on the review; their input is crucial for accuracy (and hey, more eyes never hurt). Make sure everyone understands what’s at stake before you move on.

Here’s an example table you might use:

Finding	ISO Clause	Risk Level	Responsible Person
Missing records	7.5	High	Lab Manager
Outdated SOP	8.3	Medium	QA Officer

Developing and Implementing Corrective Actions

For every non-conformity, figure out a specific corrective action. Start by digging into the root cause—use a 5 Whys analysis or a basic cause-and-effect diagram if that helps.

Write up a corrective action plan: what you’ll do, who’s in charge, and a deadline. Make sure you’re fixing the actual problem, not just slapping on a band-aid. Assign tasks clearly so there’s no confusion about who owns what.

Follow through on the corrective actions. Check in regularly—if something new pops up or the plan isn’t working, adjust as needed. The whole point is to stop the issue from coming back, not just patch it up for now.

Documenting Changes and Improvements

Keep solid records of every action and change for traceability. Update your corrective action plan, tweak procedures, and redo risk assessments as needed. ISO 17025 wants to see exactly how you found non-conformities, what you did about them, and what happened afterward.

Store everything in an organized spot—a corrective action log or a central file works well. Make sure everyone knows where to find the latest procedures and policies. Review these docs regularly to keep improving and to make future audits less of a headache.

Set reminders to double-check that corrective actions actually worked and that nothing new has cropped up. This habit supports strong risk management and keeps your lab compliant without last-minute scrambles.

Step 5 – Conduct an ISO 17025 Management Review

The ISO 17025 Management Review is your chance to step back and see if your lab’s processes are really working and staying compliant. It’s kind of like a health check for your whole system—where are you strong, what needs work, and how do you keep quality moving in the right direction?

Purpose Of The Management Review In ISO 17025

The management review checks if your quality management system is actually working for your lab’s goals. Use this review to see if your processes meet both ISO 17025 requirements and your customers’ needs—or if you’re just going through the motions.

During the review, you’ll look at audit results, customer feedback, nonconformities, and any corrective actions you’ve already handled. You’re trying to spot trends, find problems, and make sure you’re using resources wisely. Top management should confirm that improvements actually happen, not just talk about them.

How To Organize And Document The Review Meeting

Pick a date, a place, and set an agenda. Invite top management, quality managers, and anyone else who’s responsible for the stuff you’ll discuss. Appoint someone to run the meeting and someone to take notes—trust me, you’ll want records.

Preparation checklist:

• Review last meeting’s minutes
• Gather audit reports and nonconformity logs
• Summarize customer complaints and feedback
• List performance metrics and resource needs

Document who attended, what you covered, decisions made, and any action plans. Keep these records handy for future audits. Use a format that makes sense—meeting minutes or summary reports work fine as long as you can trace actions and outcomes.

Recording Minutes, Audit Findings, And Corrective Actions

Keep detailed records for every management review. Write down the date, attendees, key findings, discussions, and what actions you agreed on.

List each audit finding or issue and the evidence you discussed. Assign corrective actions to specific people with deadlines. A table helps keep things organized:

Finding	Action Needed	Responsible Person	Due Date	Status
Calibration overdue	Schedule calibration	Lab Supervisor	07/01/2025	Open
Document control issue	Update procedure	Quality Manager	06/28/2025	Closed

All this makes follow-up easier, shows your progress, and helps satisfy auditors during accreditation checks.

Importance Of Management Commitment

Management really needs to be involved—ISO 17025 expects it. Leaders should provide resources, break down barriers, and push for improvements. When you show up for reviews, you send a message to your team that quality and compliance actually matter.

It’s up to management to make sure corrective actions get done and needed changes happen. This keeps your lab’s goals lined up with ISO 17025 requirements.

Honestly, commitment isn’t just about paperwork—it shapes your lab’s culture. If staff see managers care, they’re way more likely to follow procedures, report issues, and keep standards high.

Step 6 – Schedule Your Accreditation Assessment

Ready to move forward with ISO 17025 accreditation? Time to set up your formal assessment with an authorized accreditation body. This is where your lab’s readiness gets put to the test, and you’ll find out if anything else needs fixing before you become officially accredited.

How To Contact an ISO 17025 Accreditation Body

First, figure out which accreditation body fits your lab. National bodies like ANAB, A2LA, or NATA are common options, depending on your country and field. Head to their website and check out their contact methods—usually you’ll find online forms, email, or a phone number.

Get your basic lab info ready: what types of tests or calibrations you do, your quality manual, and your main contact person.

Reach out using their preferred method. Be upfront that you want to apply for ISO 17025 accreditation. Some bodies will ask for specific documents right away, like a filled-out application or a summary of your lab’s scope.

Once you send your request, the accreditation body will review your info and let you know the next steps. Expect an application package and a breakdown of fees.

For laboratory owners, managers, and quality professionals seeking comprehensive information and official guidance on ISO/IEC 17025 accreditation, the International Laboratory Accreditation Cooperation (ILAC) offers a wealth of valuable resources. Their dedicated ISO/IEC 17025:2017 Resources page provides access to essential documents, guidance materials, and frequently asked questions to support laboratories on their accreditation journey.

Whether you’re just starting the process or looking for clarification on specific requirements, ILAC’s resources can help you better understand the standard and ensure your laboratory meets all necessary criteria for accreditation.

Preparing For The Assessment (Documentation, Staff Readiness, Facilities, Etc.)

Pull together all your quality management documents—quality manual, procedures, records, internal audit results. Double-check that everything’s current, complete, and easy to find.

Gather your staff and go over their roles and responsibilities. Hold a quick training or refresher so everyone knows what’s expected and can answer questions about their work and lab processes.

Take a walk around—make sure your facilities, testing areas, and equipment look good, are safe, and are in working order. Handle any maintenance, calibration, or safety issues before the assessment team arrives.

Have your supporting records ready—calibration certificates, control charts, proficiency testing results, supplier evaluations. Assessors might ask for any of these.

Create a checklist or schedule so nothing slips through the cracks. Assign team members to handle document presentation, answer questions, and guide the assessors around.

What To Expect During The Assessment Process

The accreditation assessment is usually an on-site visit from the accreditation body’s team. They’ll review your documentation, talk to your staff, and watch your lab in action.

Expect assessors to observe testing or calibration, check equipment, and verify traceability of measurements. They’ll ask about your quality system and daily operations—just answer honestly and provide the records they request.

Assessors might point out areas for improvement during the visit. They’ll keep notes on all findings and go over them with you before they leave.

The whole process can take anywhere from a day to several days, depending on your lab’s size and what you do. Stay open, communicate, and have your documents handy—it’ll make things go much smoother.

Responding To Any Findings Or Non-Conformities Post-Assessment

Once the assessment wraps up, the accreditation body sends over a report that lays out any findings or non-conformities. They’ll usually give enough detail so you know exactly what needs fixing.

Tackle each finding by putting together a corrective action plan. Lay out the steps you’ll take, who’s handling what, and when you’ll have it done. Hang onto documentation for everything you do—it’ll come in handy.

Some non-conformities might mean you need to update policies, tweak a process, run more staff training, or beef up your records. Don’t just patch the surface issues—dig into the root cause so it doesn’t pop up again later.

Send your evidence of corrections and improvements to the accreditation body for them to review. Keep your records clear and organized so it’s obvious your lab checks all the boxes.

Conclusion

Recap The Step-By-Step Process

Getting ISO 17025 accreditation isn’t exactly a walk in the park, but the steps are pretty clear. First, you’ll want to get familiar with the standard’s requirements and see how your current lab setup stacks up. Spot the gaps and make a plan to close them.

Next up: update your management system docs—think quality manuals, procedures, records, the whole lot. Training your team is a big deal too; everyone needs to be on the same page with the new procedures. Run an internal audit, fix whatever pops up, and then you’re ready to apply for the official assessment.

After the assessment, respond to any feedback you get. Once everything’s up to scratch, you’ll get your accreditation certificate. Staying accredited means regular reviews and ongoing improvements, so it’s not a “set it and forget it” deal.

Emphasize The Value Of Thorough Preparation And Documentation

Honestly, solid prep and good documentation make all the difference with ISO 17025. If you’re missing documents or something’s off, it can slow you down or even derail the whole process. Keep everything current and easy to find—it’ll save you headaches later.

It helps to start with clear templates for policies and procedures. Track every update and keep your docs under version control. Make sure your team actually follows the procedures and gets records done right after each activity (not three days later, when details are fuzzy).

When auditors show up, tidy records make your lab look competent and on top of things. Being prepared speeds things up, and honestly, it just makes daily work smoother too.

Available Resources

You don’t have to navigate this alone. With years in the lab accreditation world, our team gets the real-life challenges lab owners and managers face. We’ve built solutions that work for small, mid-sized, and big labs alike. As a certified ISO/IEC 17025 Assessor I understand what you will be going through, not only in the preparation of the assessment, but the actual assessment process itself.

Our documentation packages come with ready-to-use templates for quality manuals, procedures, and forms. We keep these up to date with the latest ISO 17025 requirements. Got technical questions or stuck on an audit finding? Our experts are here to help you through it. The best type of documentation package you can use, is they type created by an ISO 17025 experience assessor, and that is what you get with our templates. Plus, you get ongoing email support.

Whether you want hands-on help or just need solid templates to get rolling, our support can save you time and help you dodge those expensive mistakes.

ISO 17025 Documentation Templates

Reliable documentation is a game-changer when you’re working toward ISO 17025. A well-organized documentation package saves you time and makes sure you’re not missing anything critical. Ours includes controlled templates, step-by-step procedures, checklists, and forms—built specifically for testing and calibration labs.

Every file is fully editable, so you can tweak procedures for your lab’s unique needs. There’s an instruction guide included, too, to help you adapt everything smoothly. With these docs, you’ll show your auditors you’ve got a solid and compliant management system.

Here’s what you get out of the package:

• Way less time spent writing new procedures from scratch
• No more worrying about missing required policies or records
• Support for meeting ISO 17025:2017 standards
• Training’s easier with clear, ready-to-use formats

Having these resources on hand helps you avoid the usual gaps that can bog down your accreditation timeline.

Book A Free 45-Minute Consultation

Sometimes you just need real answers for your specific situation. Book a free 45-minute call and let’s talk through your needs. No hard sell—just practical advice for your accreditation plans.

During the call, we can:

1. Review where you’re at right now
2. Spot any gaps in your system
3. Share tips for internal audits and management reviews
4. Clarify what documentation and evidence assessors expect

By the end, you’ll have a list of clear next steps. Booking’s easy—just use the online calendar or shoot over your availability by email. This call could save you hours of spinning your wheels.

Frequently Asked Questions

ISO 17025 accreditation means dealing with strict documentation, training, and quality control. Labs need to keep up with ongoing requirements, prep for audits, and make sure staff actually understand safety, technical, and procedural expectations.

What are the initial steps to apply for ISO 17025 accreditation?

Start by reviewing the ISO 17025 standard and see how your current lab practices measure up.
Next, develop or update your quality management system and pull together all related procedures.
Reach out to an accreditation body in your region to get the application process rolling.

What documents are required to obtain ISO 17025 accreditation for my laboratory?

You’ll need a quality manual, standard operating procedures, test methods, and equipment calibration records.
Also, have proof of staff qualifications, internal audit reports, corrective actions, and management review meeting results ready to go.

How can a laboratory prepare for an ISO 17025 audit?

Run an internal audit using an ISO 17025 checklist and sort out any non-conformities you find.
Make sure all your procedures are current and everyone’s actually following them.
Train your staff on the requirements and help them feel confident answering auditor questions honestly and clearly.

What training do staff members need for a lab to qualify for ISO 17025 accreditation?

Your team should understand the ISO 17025 standard and their roles in the quality system.
They’ll need technical training for their jobs, plus training in recordkeeping, safety, and handling equipment.

What are the common pitfalls labs face during the ISO 17025 accreditation process?

Labs often struggle with unclear documentation, not following written procedures, or sloppy quality control records.
Sometimes, training records get overlooked or corrective actions don’t get handled quickly enough.

How often must a laboratory renew its ISO 17025 accreditation?

Most accreditation bodies ask labs to renew every two years. On the odd years, you will receive a surveillance assessment, which, besides the first one, is an off-site documentation review.
Every cycle, your lab goes through a re-assessment audit and needs to show it still meets the requirements of the standard.

If you need more detailed guidance, check out RJ Quality Consulting’s ISO 17025 Clauses Explained or consider booking a consultation with a qualified ISO/IEC 17025 assessor by clicking the box below.