ISO 17025 Clause 8 Management System Requirements Explained for Testing and Calibration Laboratories

If your lab wants to show off the quality and reliability of its results, getting a handle on ISO 17025 Clause 8 is pretty much non-negotiable. Clause 8 spells out the management system requirements you need to document, roll out, and keep up with to back up your commitment to the ISO 17025 standard. We’re talking about stuff like documentation, management review, internal audits, and what to do when things need fixing or improving.

Clause 8 actually gives you a bit of freedom in how you set up your management system, so you can tailor things to your own lab’s workflow. This section also covers how you handle documents and records, deal with risks and opportunities, and jump in with corrective actions when necessary.

Whether you’re just dipping your toes into ISO 17025 or you’re already knee-deep in your system, understanding Clause 8 helps you earn customer trust and stay in line with international standards.

🎥 Watch: ISO 17025 Clause 8 Management System Requirements Explained

In this video, I walk through Clause 8 of ISO/IEC 17025:2017, which outlines the management system requirements for testing and calibration laboratories. As a certified ISO/IEC 17025 assessor, I’ll explain what assessors look for during audits and how to effectively implement these requirements in your lab. Whether you’re new to Clause 8 or need a refresher, this video provides practical tips and examples to help you stay compliant and confident.

Key Takeaways

• Clause 8 lays out what you need for a solid management system.
• You’ve got options on how to set up and document your system.
• Getting these pieces right goes a long way toward lab reliability and quality.

Brief Overview of ISO/IEC 17025 and Clause 8

ISO/IEC 17025 is the global standard labs use to show they know what they’re doing and can deliver valid results. It helps you get a quality management system in place for your lab’s day-to-day work.

You might see it called ISO 17025, IEC 17025, or ISO/IEC 17025:2017—just different ways people refer to the same set of requirements for testing and calibration labs. The 2017 version is what everyone’s using now.

This standard covers both management and technical requirements, but Clause 8 is where you’ll find the main rules for management systems.

Clause 8 wants you to:

• Set up and document a management system
• Keep your system running and current
• Show your lab is committed to all the requirements

One big focus in Clause 8 is keeping records straight and controlling documents. Your staff need to be able to get the right info when they need it—no hunting around for missing files.

Here’s a quick table with the areas Clause 8 covers:

Key Area	Description
Document Control	Manage internal and external documents
Records Control	Keep accurate, traceable records
System Maintenance	Regularly review and update processes
Staff Access	Ensure proper access to documentation

Clause 8 basically helps you get your lab running in an organized way, so quality and reliability aren’t just buzzwords—they’re actually part of your daily routine.

Who Should Read This Post

If you’re working in a lab or handling lab quality management, you’ll probably want to stick around. Doesn’t matter if you’re new to ISO 17025 or you’ve been at this for years—there’s something here for you.

You’ll get the most out of this post if you’re:

• A lab manager, supervisor, or technician
• Getting ready for ISO 17025 accreditation
• Part of an internal audit team
• Responsible for lab quality control
• Involved in keeping management systems up to date

And hey, if you work with accreditation bodies or consultants, there are some nuggets in here for you too.

If you’re a student in a technical or quality management program, this post gives you a decent intro to ISO 17025 Clause 8.

Anyone helping document, review, or roll out management system policies in a lab setting might find this handy as well.

Table: Is This Post for You?

Role/Job	Should You Read?
Lab Manager	Yes
Quality Team Member	Yes
Auditor	Yes
Student	Yes
Consultant	Yes

If Clause 8 or lab management systems are anywhere on your radar, you’re in the right place.

Reference to Previous Clauses Covered

When you’re dealing with ISO 17025, you can’t really skip over how Clause 8 connects with the earlier sections. Each previous clause sets you up for what’s expected in your lab’s management system.

Here’s a quick rundown of what those earlier clauses are all about:

Clause Number	Main Topic	What It Focuses On
4	General Requirements	Impartiality, confidentiality
5	Structural Requirements	Organization of the lab, roles, responsibilities
6	Resource Requirements	Personnel, equipment, facilities, systems
7	Process Requirements	Lab methods, sampling, handling test items

Clause 4 wants your lab to be impartial and keep info confidential. You need that foundation before you even think about management practices.

Clause 5 lays out how your lab should be set up and who’s responsible for what. That clarity is the backbone for later management system stuff.

Clause 6 is all about resources—trained staff, proper equipment, the works. If you don’t have this sorted, your management system isn’t going to fly.

Clause 7 covers how you do testing or calibration, handle samples, and make sure your technical results are solid. The systems you introduce in Clause 8 are what manage and check all those processes.

Overview of Clause 8: Management System Requirements

Clause 8 is basically the heart of ISO 17025 when it comes to lab management. It guides you on creating, documenting, and keeping up the systems that help you meet the standard’s requirements and show you’re competent.

Purpose of Clause 8

Clause 8’s main job? Making sure your lab sets up a management system you can actually rely on. This system should support everything you do—testing, calibration, keeping things impartial, and staying technically sharp.

For labs going for accreditation, nailing Clause 8 helps build trust with clients and stakeholders. Your management system should help you manage risks, keep tabs on quality processes, and show you’re always trying to improve. You can use an independent QMS or line things up with ISO 9001, but either way, you need proper documentation, clear procedures, and defined roles.

List of Subclauses (8.1–8.9)

Clause 8 breaks down into nine subclauses, each covering a different part of your management system (QMS):

Subclause	Topic
8.1	Options for a management system
8.2	Management system documentation
8.3	Control of management system documents
8.4	Control of records
8.5	Actions to address risks and opportunities
8.6	Improvement
8.7	Corrective actions
8.8	Internal audits
8.9	Management reviews

Each subclause helps you keep your lab’s procedures organized, monitored, and always on the path to improvement. Things like managing records, dealing with nonconformities, checking methods, and using reference materials all tie back to these requirements.

Importance of Documentation and Audit Preparation

Let’s be honest—document control is a big deal in Clause 8. You need to create, manage, and protect records for everything: sampling, method validation, equipment calibration, you name it.

Auditors will want to see your records during assessments, so your procedures and results have to be traceable and organized. Up-to-date documentation, plus clear records of corrections and improvements, show your QMS is more than just paperwork—it actually works.

Regular internal audits and management reviews help you spot gaps and make sure you’re staying impartial. They also prove your QMS keeps up with requirements and keeps getting better, so your testing and calibration stay reliable.

8.1 Options for Management System Implementation

You’ve got two main ways to set up your lab management system under ISO 17025: Option A and Option B. Both get you to the standard’s requirements, but they have their own structures and documentation quirks.

8.1.1 Establishing a Management System

You need to create, document, and keep up a management system. This system backs up your lab’s work and shows your results meet quality standards. It also helps you demonstrate you’re hitting every part of ISO 17025 Clause 8.

Your management system should cover all the basics—policies, processes, records. It organizes stuff like internal audits, corrective actions, risk management, and regular management reviews. All of that supports steady, reliable lab performance.

8.1.2 Minimum Requirements (Option A)

Option A has you build a management system that hits all the ISO 17025 Clause 8 requirements, but you don’t have to go full ISO 9001. Your system just needs to show how you achieve quality, make improvements, and handle complaints.

Key areas? Document control, record keeping, corrective actions, internal audits. Your management activities should always back up your test or calibration results. Here’s a quick table for Option A focus areas:

Area	Required?
Internal Audits	Yes
Document Control	Yes
Complaint Handling	Yes
Preventive Action	Yes
Continual Improve.	Yes

When to Use Option A

If your lab isn’t already following ISO 9001, or your customers don’t care about ISO 9001 certification, Option A usually makes the most sense. It’s a good pick if you just want to meet ISO 17025 with the least fuss and paperwork.

Option A lets you shape your management system to fit the lab environment without a ton of extra documentation. Smaller or less complicated labs tend to find this route more manageable.

Documentation Requirements for Option A

With Option A, you need documentation that covers everything in Clause 8 of ISO 17025. There’s no official template, but you do have to spell out your policies, processes, procedures, and evidence for each required activity.

Most labs put together documents like:

• A quality manual or summary
• Procedures for document and record control
• Records of audits, reviews, and corrective actions
• Policies for handling complaints and feedback

Make sure you keep documents updated, review them regularly, and that everyone can actually get to what they need.

8.1.3 ISO 9001 Integration (Option B)

Option B is handy if you already have an ISO 9001:2015 (or ISO 9001) management system in place. You just need to prove your ISO 9001 setup covers every ISO 17025 Clause 8 requirement.

This is especially useful if your organization is already ISO 9001 certified at the company or site level. You can avoid running two systems in parallel—just use the same processes and documentation for both standards.

When to Use Option B

If your lab is already ISO 9001:2015 certified, Option B is almost always the easier path. When your main business runs on ISO 9001, or your clients want it, you can streamline compliance and cut down on duplicate audits and paperwork.

Shared quality systems between production and lab activities? Option B helps you keep everything under one roof and running smoothly.

Differences in Audit Focus: Option A vs. Option B

With Option A, audits dig into how your system meets each Clause 8 requirement. Auditors want to see procedures and evidence that tie straight to ISO 17025.

For Option B, auditors check your ISO 9001 system to see if it ticks all the ISO 17025 management boxes. The ISO 9001 certificate alone isn’t enough, but you can point to ISO 9001 documents and processes as proof.

A quick comparison:

Audit Focus	Option A	Option B
Direct ISO 17025	Yes	Indirect via ISO 9001
Separate Docs Needed	Yes	Sometimes only references
Combined Audits	No	Often possible

Reference to Annex B: Further Guidance

Annex B in ISO 17025 gives extra help for using your ISO 9001 system to meet ISO 17025. It lays out how the two standards connect and where there might be gaps.

Check Annex B if you want to compare specific requirements. It offers tips on integrating management systems and helps you avoid missing anything important. It’s honestly a lifesaver when you’re trying to keep both standards in line.

8.2 Management System Documentation

Good management system documentation is what keeps you on track for ISO 17025 Clause 8.2. You need to set up, record, and keep policies, objectives, and evidence that back up your lab’s competence and day-to-day work.

Policies and Objectives (Quality Policy and Objectives)

Your lab should have a quality policy that actually means something and matches your goals for competence and service.

Set quality objectives you can measure, and that make sense for both ISO 17025 and your own operations. These objectives help point everyone in the right direction.

Your policy should:

• Show commitment to solid professional practices.
• Make sure your results are valid, every time.
• Meet what customers and regulators expect.

Top management needs to get this policy out there, make sure people get it, and that it’s not just some poster on the wall.

Documentation Evidence Needed

Document your procedures, instructions, and records that support your management system.

Common documentation includes:

• Policies and objectives
• Process maps or flowcharts
• Standard operating procedures (SOPs)
• Records of review and updates

Keep evidence of what you’re actually doing—like meeting notes, audit records, and management review minutes. This shows you’re following your own processes and that your system isn’t just a paper tiger.

Addressing Competence, Impartiality, and Consistency

Your documents need to show how your lab stays competent, impartial, and consistent.

Training records, qualification requirements, and proficiency test results all point to competence.

For impartiality, keep conflict of interest forms and review risks that might mess with unbiased work.

You keep things consistent by sticking to standard procedures, doing regular audits, and keeping supervision records.

These records let you prove to auditors that your lab walks the talk—not just on paper, but in real life.

Communicating Policies at All Levels

Everyone in the lab needs to know and actually use your policies.

Share your quality policy and objectives in meetings, training, bulletins, intranet, or just post them where folks can see them.

Check if people understand by talking to staff or running quick surveys.

Management should:

• Make policies available where staff work
• Remind people about the big points regularly

Clear communication really does help build a culture where quality and responsibility aren’t just buzzwords.

Linking Documentation (Quality Manual, Procedures)

Make sure your main policy docs—like your quality manual—connect directly to your procedures and work instructions.

A solid documentation setup might look like:

• A quality manual that gives the big picture
• Linked procedures for main processes (sampling, testing, reporting, etc.)
• Work instructions for the nitty-gritty tasks

Example structure:

Document	Content
Quality Manual	Overview and policies
Procedures	Key process steps
Work Instructions	Detailed, task-level guides

This kind of structure makes it way easier for staff to find what they need and helps you keep everything organized and current.

Accessibility for Personnel

Everyone who needs management system documents—policies, procedures, whatever—should be able to get to them without jumping through hoops.

Store documents in a central spot: an intranet, document control software, or well-organized physical files all work.

Only let authorized staff edit or update documents, to keep things under control. For everyone else, make sure they have read-only access or paper copies. And don’t forget to show people how to find and use the latest versions.

Example Templates and Documentation

Templates make it easier to keep your management system documentation consistent and up to snuff.

Some handy templates:

• Quality policy statements
• Objective tracking logs
• SOP forms
• Audit plans and checklists
• Training records

Sample SOP template:

Section	Content
Title	SOP title
Purpose	Why the procedure matters
Scope	Where/when it applies
Roles	Who is responsible
Procedure	Step-by-step instructions
Records	Forms used and records kept
Review Date	When to review/update SOP

Templates help you avoid missing important info and keep things looking uniform—which ISO 17025 definitely expects.

8.3 Control of Documents

When you control your documents well, your lab stays consistent, reliable, and on the right side of ISO 17025. Good document management means you’re less likely to make mistakes, you’ve got the right info when you need it, and your system doesn’t get out of date.

Definition of Internal and External Documents

Internal documents come from inside your lab—think procedures, instructions, forms, your quality manual, and policies. External documents are anything from outside: standards, regulations, official test methods, customer requirements, or technical documents.

Keep these two types separate. It makes updates easier and ensures you’re only using documents from the right sources. A list or register helps you track what’s internal and what’s external.

Label and classify documents clearly. No one wants to waste time hunting for the right version. Both internal and external docs matter for keeping your management system solid.

Document Control Requirements

Document control is all about the rules and routines you use to manage important info. You want to make sure documents get reviewed, approved, distributed, and updated as needed. You also need to keep them accessible, safe, and protected from random edits or loss.

Some key points:

• Assign document control to specific roles
• Store and back up documents properly
• Track changes and modifications
• Make documents easy to find for those who need them

Clear document control procedures lower the risk of people using old or wrong info, and make audits a lot less stressful.

Approval Prior to Issue

Before you put any document into use, get it formally approved. That means someone with the right knowledge and authority checks it for accuracy, compliance, and relevance.

This usually involves reviewing drafts, catching errors, and making sure it lines up with ISO 17025. Record who approved it, when, and any comments.

Only release approved documents for lab use. This step helps you avoid mistakes and keeps your processes legit.

Periodic Review and Updates

Review documents regularly to keep them current and useful. Set up a schedule—once a year or every two years is common. These reviews help you catch updates in standards, new techniques, or changing customer needs.

Document when you review, who did it, and make updates as soon as you spot something out of date. If an external document changes, like a new ISO standard or customer spec, update your records right away.

Letting old info linger can lead to mistakes and nonconformities. Regular reviews and quick updates help you dodge those headaches.

Revision Status and Change Identification

Knowing the current revision status of every controlled document is pretty much non-negotiable. You want everyone confident they’re looking at the latest version, not some outdated relic. Most labs stick with version numbers, revision dates, or a running change history right on the document.

A revision history table at the front or back of the doc? That’s always handy. Typical columns might look like this:

Revision	Date	Description of Change	Approved By
1.0	2025-03-15	Initial issue	J. Smith
1.1	2025-05-10	Updated section 3	T. Chen

Highlighting updates or using tracked changes can be a lifesaver—staff spot what’s new at a glance. Clear revision IDs cut down on confusion, and honestly, they just make life easier when you’re trying to keep everyone on the same page.

Availability at Point of Use

Docs need to be right where people use them. If you’re running tests, the procedure should be at the workstation—not buried in someone’s inbox. That way, no one’s guessing or scrambling for instructions.

Physical docs often live in binders or folders close to the action, while digital files sit in a shared system, database, or intranet. Set up access controls so only the right folks can tweak or even see certain docs.

When people can grab what they need fast, stuff just runs smoother. Less risk, fewer mistakes, better compliance—it’s just practical.

Unique Identification

Every controlled doc needs its own identity—think document number, title, version, or some combo. Like, “SOP-004, Rev. 2” makes it obvious which one you’re dealing with.

Giving each doc a unique tag helps you keep track, especially when you’re juggling several versions or similar procedures. It’s a simple way to avoid mix-ups.

Keeping a master list of these IDs (spreadsheet, database—whatever works) makes searching and audits way less painful.

Preventing Use of Obsolete Documents

Obsolete docs? They have to go. When you roll out a new version, pull the old one from use and either archive or destroy it. Mark outdated docs with “Obsolete” stamps, watermarks, or digital tags so no one uses them by accident.

Your control process should spell out exactly how you handle outdated stuff. If you need to keep old docs for legal or reference reasons, stash them somewhere separate and clearly label them as not current.

Examples of Document Control Practices

Here are some real-world ways to keep your docs in check:

• Stick a controlled cover sheet on with approval signatures.
• Maintain a master list or index showing each doc’s status and revision.
• Set up access controls in your document management system.
• Flag obsolete docs—stamp them, watermark them, whatever works.
• Use version control software to stay on top of changes.
• Physically swap out hard copies when you update something.

8.4 Control of Records

Controlling records is a big deal in ISO 17025. It’s all about keeping your data solid, reliable, and audit-ready. Good record management also keeps confidential info safe and makes reporting way simpler.

Types of Records (Quality vs. Technical)

In your lab, you’re dealing with both quality records and technical records.

Quality records are proof you’re sticking to your quality system—think audit reports, management reviews, complaints, corrective actions, that sort of thing.

Technical records are all about the nitty-gritty of testing and calibration—raw data, calculations, calibration results, observations, final reports.

If you organize these well, finding stuff later (especially during an audit or investigation) is way less stressful.

Records Management Requirements

You need a documented procedure for how you create, manage, and control records. No way around that.

Records have to be complete, accurate, and up to date. Protect them from getting lost, changed without permission, or damaged.

Your system should let you audit and trace any changes. Only people with the right permissions should be able to edit, and everything needs to be tracked.

Legibility

Records need to be legible. If you’re writing by hand, make it clear—no messy corrections or smudges that hide info.

Mistake? Just put a single line through it, write the fix, and add your initials and the date. That way, nothing’s hidden and anyone can follow what happened.

Identification, Storage, Backup, Retrieval, Retention, Disposal

Label records so you can actually find them later. Date, unique ID, and who’s responsible—those are the basics.

Storage has to protect records from stuff like water, fire, pests, or unauthorized snooping. For digital records, make sure you’ve got backups and solid cybersecurity in place.

When someone needs a record, they shouldn’t have to dig for ages—quick retrieval matters.

Retention policies need to say how long you keep each record and why. When it’s time to get rid of them, do it securely, following any privacy or confidentiality rules.

Retention Periods and Confidentiality

Retention times aren’t one-size-fits-all.

Quality records usually stick around for at least five years. Technical records often hang on for however long you and your client agreed, plus any regulatory period.

Keep records locked down—only authorized folks should see or edit them. If something’s confidential, add extra layers like passwords or locked cabinets to keep it private.

Difference Between Quality and Technical Records

Quality records show your system works and you’re meeting ISO 17025. Stuff like corrective actions, management review notes, and training logs fall here.

Technical records back up your actual lab work—test printouts, calibration certs, raw data, worksheets, and so on.

You’ve got to manage both, but each serves its own purpose under the standard.

Example Records and Retention Policies

Some typical examples:

Record Type	Example	Retention Period
Quality Record	Internal audit report	5 years
Quality Record	Training records	Duration of employment + 2 years
Technical Record	Raw test data	3 – 5 years, or as agreed
Technical Record	Calibration certificates	5 years, or as agreed

Always double-check local laws or contracts—sometimes you’ll need to keep things longer (or shorter), or add stricter access, depending on what’s in the record and who it’s for.

8.5 Actions to Address Risks and Opportunities

Clause 8.5 in ISO 17025 is all about spotting and dealing with risks and opportunities in your lab. If you want to keep results solid and push for improvement, this is where you start.

Considering Risks and Opportunities

You’ve got to look at everything—technical work, processes, equipment, people, data handling—when you’re thinking about risks and opportunities.

Risks are anything that could mess with your results (accuracy, reliability, timeliness). Opportunities are the flipside—ways to boost efficiency, add value, or build trust.

Don’t just focus on the big stuff. Little things like equipment maintenance, staff skills, or sample mix-ups matter too.

Getting input from everyone—not just managers—makes it easier to see what’s really going on and where you could do better. Open chats help make risk-thinking part of the culture, not just a checkbox.

Planning and Integrating Actions

Once you spot a risk or opportunity, plan what you’ll do about it. That might mean changing a procedure, assigning someone new responsibilities, or setting up a new check.

Say you keep having issues with sample labeling—maybe you roll out staff training and add a double-check step. If there’s a new software opportunity, figure out how to test and roll it out.

Make sure whatever you plan fits your lab—no need to overcomplicate things. It just has to work.

Your plan should cover what you’re doing, who’s on it, how and when it’ll happen, and how you’ll know if it worked.

Documenting Risks and Opportunities (Risk Register)

ISO 17025 doesn’t force a specific risk register, but honestly, having one helps keep track. A simple table or spreadsheet works—columns for:

Risk or Opportunity	Area/Process Affected	Possible Outcome	Action Planned	Owner	Status	Review Date

Update it as you spot new stuff or finish actions. It’s not just for auditors—it helps you remember what you’ve tried and what still needs work.

Risk Mitigation and Effectiveness Evaluation

When you tackle a risk, that’s mitigation. Maybe it’s more training, new checks, or a tech upgrade. Afterward, check if it worked—look at records, ask staff, monitor your indicators.

If your fix didn’t do the trick, try something else. This isn’t a one-and-done thing; you’ll be tweaking as your lab, tech, and environment change.

Management Review Input Requirement

Clause 8.5 says you need to review all this during management review. Pull together a summary—what you found, what you did, and what happened.

Management uses this info to make calls on resources or changes. It’s also how they spot trends and set priorities. If the risk controls aren’t working, time to rethink the approach.

Example Risk Scenario

Scenario: Your lab rolls out a new water testing procedure.

Risks: Staff might use the wrong technique, leading to bad results. Equipment could be uncalibrated for the new method.

Opportunities: New testing could bring in more clients or speed up analysis.

Actions: You start with focused staff training, update procedures, and run parallel tests for quality. Plus, you schedule regular check-ins on client feedback and turnaround times.

Follow-up: After three months, client satisfaction is up and no false results have popped up. You add these findings to your risk register and discuss them at the next management meeting.

Proportionality and Opportunities for Improvement

Not every risk or opportunity needs a huge response—seriously, don’t overthink it. Your actions should be proportional to the actual risk. If it’s just a minor, low-impact risk, maybe all you need is a quick tweak to a checklist. But if it’s something major, you’ll probably want to take several actions or keep an eye on it long-term.

If you overreact to every little thing, you’ll burn out your team and waste resources. But if you ignore the big stuff, that’s when results or your reputation take a hit.

Opportunities for improvement matter just as much as risks. When you spot a better way of doing things, don’t just file it away—put it into practice. ISO 17025 bakes this mindset right in, pushing labs to keep getting more reliable and efficient.

8.6 Improvement

Clause 8.6 of ISO 17025 really leans into continual improvement. You need processes that actually find, evaluate, and do something about opportunities for your lab to get better.

Identifying and Implementing Opportunities for Improvement

Improvement isn’t a one-and-done deal. You have to keep looking for ways to make your processes, procedures, and results better over time. It’s not just about fixing mistakes; it’s about chasing changes that make your lab more accurate, efficient, or maybe just a bit safer.

Try holding regular team chats about what’s working and what’s not. Another solid move is tracking your goals and comparing them to what’s actually happening. If you spot a gap, come up with a plan to close it.

It helps to keep a running list of planned improvements—who’s doing what, and by when. Tables make it easier to keep everyone on the same page:

Opportunity	Action	Responsible	Target Date	Status
Faster sample pickup	Revise courier schedule	Lab Manager	1 Aug 2025	In Progress
Fewer labeling errors	Staff training	QA Officer	15 Jul 2025	Scheduled

Review these regularly so nothing falls through the cracks.

Sources of Improvement (Audits, Feedback, Corrective Actions)

Your best sources for improvement ideas? Audits, feedback, complaints, and corrective actions. Internal audits can shine a light on weak spots in your methods or documentation. If you treat audits like a learning tool—not just a box-ticking exercise—you’ll get a lot more out of them.

Customer feedback is gold. Sometimes your team misses things that customers spot immediately. Both compliments and complaints can point you toward what needs work.

When something goes off the rails (test failures, complaints, etc.), dig into the root cause and actually fix it. Keep detailed records of corrective actions and check back to see if they did the trick.

Seeking and Analyzing Customer Feedback

Customer feedback can highlight needs you didn’t realize existed or problems you hadn’t noticed. Don’t just wait for complaints—go out and ask for feedback after you deliver results. Quick follow-up emails or phone calls can make a big difference.

Once you get feedback, sort it into buckets, like:

• Turnaround time
• Technical accuracy
• Communication quality
• Ease of ordering

Spreadsheets or tracking software help you spot patterns. If several customers mention the same thing, that’s your cue to prioritize it.

Share the highlights (good and bad) with your team in meetings. It’s a nice way to keep everyone focused on the customer and always improving.

Methods for Gathering Feedback

There’s no single “right” way to gather feedback. The classic approach is a customer survey—email it out or stick it on your website. Keep it short and to the point, with specific questions about their experience.

You could also try:

• Direct phone calls
• Comment cards with reports
• Online review forms
• In-person meetings or exit interviews

Track how you collect feedback—some folks prefer email, others don’t mind a call. You can even ask for feedback during audits or set up a dedicated email address. Just make sure your contact info is obvious on all reports and documents.

As you collect data, check your response rates and tweak your approach to encourage more participation.

Example Documentation of Improvements

Documenting improvements isn’t optional. Keep records of every improvement you consider or put into action. Include the basics:

• What the improvement is
• Where it came from (audit, feedback, error report, etc.)
• What you did about it
• Timeline
• Who’s responsible

Here’s how a record might look:

Date: 10 Jun 2025
Opportunity: Reduce errors in sample labeling
Source: Internal Audit
Action: Staff retrained on labeling; double-check added to process
Responsible: QA Supervisor
Status: Completed 18 Jun 2025

Store these records where you can actually find them when audit time rolls around. Whether you use digital logs or paper files, just be consistent. Good documentation keeps your lab ready for inspections and shows a clear trail of ongoing improvement.

8.7 Corrective Actions

Clause 8.7 of ISO/IEC 17025 lays out what you need to do when your lab finds a nonconformity. The standard walks you through everything from first spotting the problem, investigating it, fixing it, documenting, and making sure you really solved it.

Requirements When Nonconformities Occur

When you find a nonconformity, act fast. A nonconformity just means something didn’t meet your lab’s procedures, methods, or requirements. It can mess with your results, shake customer confidence, or even threaten your accreditation.

You need a clear process for these situations. Confirm what went wrong, check the impact, and record every detail. Assign responsibility for each step so nothing slips through the cracks.

Prompt action is key. Track each nonconformity from start to finish for accountability and real improvement.

Reacting, Controlling, Correcting, Addressing Consequences

When you spot a nonconformity, jump on these four steps:

1. React immediately: Stop or contain the nonconforming work so it doesn’t spread.
2. Control: Make sure it doesn’t get used or delivered by accident.
3. Correct: Actually fix the problem—maybe that means redoing a test, adjusting equipment, or retraining staff.
4. Address consequences: Check if the nonconformity affected anything else (other processes, clients, results) and follow up as needed.

These steps help limit the fallout and show customers you handle issues in a systematic way. Fast action keeps small problems from snowballing.

Root Cause Analysis and Implementation

If you want to avoid the same mistakes, you’ve got to figure out why the nonconformity happened in the first place. That’s root cause analysis. It’s not enough to just patch things up—you need to dig into why it happened.

Popular methods include the 5 Whys, fishbone diagrams, and process mapping. Pull in the right people and focus on facts, not guesses.

Once you know the cause, pick an action that actually fixes the root. That’s the only way to keep the problem from coming back.

Reviewing Corrective Actions and Updating Risks

After you put a corrective action in place, make sure it actually worked. Don’t just assume the fix did the job.

Check back—look at records, data, maybe repeat tests or audit the activity. If you uncover new risks or weak spots, update your risk register or controls. This all loops back to continual improvement and helps prevent future nonconformities.

Making Changes to the Management System

Sometimes, dealing with a nonconformity shows your processes or documents need an update. Maybe you need to revise a procedure, retrain staff, or add a new control.

Handle all changes with a controlled, documented process. Record what changed, why, and who signed off. Make sure staff know about the changes and actually understand them.

This way, you’re not just slapping on a quick fix—you’re making real, system-wide improvements.

Documentation Requirements (Corrective Action Forms/Logs)

Document every step of the corrective action process. Include:

• Clear description of the nonconformity
• Actions taken to fix it and prevent it from happening again
• Who was involved and when
• Proof that the fix worked

Use corrective action forms or logs to keep things organized. A typical form might have columns for date, description, responsible person, actions, and follow-up. Good records give you traceability and make audits less stressful.

Date	Nonconformity Description	Responsible	Actions Taken	Verification/Follow-Up
2025-07-01	Incorrect test result	J. Smith	Retested, retrained	All retests correct

Integration into Management Review

Make sure you cover corrective actions and how well they worked during management reviews. Use these reviews to spot trends, repeated issues, or weak spots in your processes.

It’s a good way to check if your corrective action system is actually effective. Management reviews also give leadership a chance to steer resources or suggest bigger changes for improvement.

If you skip this step, you risk repeating mistakes. Including corrective actions in management reviews shows you’re serious about ISO 17025 and continual improvement.

8.8 Internal Audits

Internal audits are your main tool for checking if your management system really matches ISO/IEC 17025 and your own procedures. They help you spot gaps, fix problems before they grow, and keep trust in your lab’s processes.

Requirement for Planned Internal Audits

Plan your internal audits—they shouldn’t just happen whenever someone remembers. Build an audit schedule ahead of time.

Your plan should cover every part of your management system, from technical to management activities. Make sure you’re checking both ISO 17025 and your own lab’s requirements.

Having a schedule helps you find issues before they become headaches. Regular audits are key to keeping up with continual improvement.

Auditing to Internal and ISO/IEC 17025 Requirements

During audits, check your lab against both ISO/IEC 17025 clauses and your own processes. Review how well staff follow your documented procedures and the standard itself.

Auditors need to be trained and competent. If you can, use auditors who aren’t directly involved in the area being checked—it keeps things more objective.

Compare what’s actually happening to both the standard and your policies. Note any deviations, even the small ones. Solid records make it easier to track and fix compliance issues.

Establishing an Audit Program (Frequency, Scope, Criteria)

When you’re setting up your audit program, figure out how often you’ll review each area. High-risk activities or those with a history of issues probably need more frequent checks. It’s not a one-size-fits-all thing—some stuff just needs a closer eye.

Define the scope for every audit. Scope just means what processes, shifts, or parts of the operation you’re actually going to look at.

Set out clear criteria for each audit. These might be:

• ISO/IEC 17025 clauses
• Your lab’s quality manual
• Specific procedures or job instructions

Honestly, a table makes life easier when you’re organizing your audit program:

Area Audited	Frequency	Scope	Criteria
Sample Handling	Twice a year	All Shifts	Procedure #SH-01, 7.4
Calibration	Once a year	All Techs	Procedure #CAL-02, 7.7

Reporting Results to Management

After each internal audit, get those results to lab management quickly and clearly. Include the good, the bad, and especially any nonconformities—don’t sugarcoat it.

Management should get enough info to understand what worked and what needs fixing. Give them a summary of the big stuff, but keep the details handy in your audit report for follow-up.

Always include who did the audit, the date, which areas got checked, and any spots that need action. No one likes surprises later.

For additional guidance on implementing an effective laboratory quality system, the ILAC G13 document provides an excellent foundation. Download ILAC G13

Implementing Corrective Actions Promptly

If your audit turns up a nonconformity or weak spot, don’t wait around—jump on corrective action fast. Dragging your feet just invites bigger headaches and puts your compliance at risk.

Set up a process so every finding gets addressed. Assign someone to own each corrective action and set real deadlines (not just “ASAP”).

Keep tabs on how fixes are going and double-check that they actually worked—sometimes a follow-up audit helps. Keep records showing you handled complaints and audit results according to your system. Auditors love that kind of proof.

Documentation Requirements (Audit Plans, Reports, Checklists)

Good documentation is the backbone of any solid internal audit. You’ll want to prepare and control a few key documents:

• Audit plans: Lay out what you’ll audit, when, and who’s doing it.
• Audit reports: Capture results, findings, and any recommendations.
• Checklists: Help auditors stay on track and not overlook important stuff.

Keep all your records organized and easy to find, especially for those external audits. Only use approved versions—no freelancing with old forms.

Importance of Integrating Audit Results into Management Review

Make audit results a must-have input for your management review meetings. That way, leadership can make smarter decisions about changes or improvements.

Reviewing audit outcomes shows where your system’s humming along and where it needs a tune-up. It keeps key findings from falling through the cracks and pushes for real corrective or preventive action.

When you connect audits with management review, you create a feedback loop that keeps improvement part of your lab’s DNA.

8.9 Management Review

Management review in ISO 17025 is basically when lab leadership steps back and takes a hard look at how the management system is really working. The process has specific inputs and should end with actions that help your lab hit its goals and fix issues.

Purpose and Frequency of Management Reviews

Management reviews keep your lab’s management system fresh and effective. These regular check-ins help you catch problems, spot trends, and find ways to get better. It’s a chance to see how things are going and react to changes from customers or regulators.

The standard doesn’t lock you into a set schedule, but most labs do a review at least once a year. If you’re dealing with a lot of changes or drama, you might want to meet more often. The point is to actually schedule these reviews, document them, and make sure something useful comes out of them.

Required Inputs for Management Review

Before each review, gather solid, meaningful data. That means pulling info from audits, customer feedback, and performance stats. Cover things like quality objectives, corrective actions, and complaints.

Using a checklist or template helps you stay consistent and not miss anything important. If you prep clean, clear info ahead of time, your meetings will actually get somewhere.

Changes in Internal/External Issues

Always think about what’s changed in your lab’s world since the last review. Maybe you’ve shifted your organizational structure, changed staff roles, or adjusted your business focus. External stuff—new regulations, market shifts—matters too.

If you ignore these changes, your system can end up with gaps. Jot down what’s new before each review, so you can keep your management system up to date and your lab in the game.

Fulfillment of Objectives

During the review, check if you actually hit your lab’s objectives. Compare results to your targets—turnaround times, error rates, customer satisfaction, that kind of thing. If you missed a goal, talk about why and figure out what to change.

Tracking progress and learning from misses keeps you moving forward. Record what worked, what didn’t, and what you’ll try next.

Suitability of Policies/Procedures

Management review is the perfect time to ask: do our policies and procedures still make sense? Sometimes tech changes, new staff, or new rules mean your docs need an update. Make sure people are actually following procedures and that they’re still practical.

Ask staff for their input—they’re the ones using these policies every day. They’ll spot the pointless steps or confusing parts. Keeping documents useful cuts down on mistakes.

Status of Previous Actions

Before each review, check up on what happened with last time’s action items. A simple table works:

Action Item	Responsible	Due Date	Status
Update SOP 101	Jane D.	2025-05-01	Completed
Review customer log	Mark R.	2025-06-01	In Progress

Talk about anything that’s still open or where you missed the mark. That way, stuff doesn’t slip through the cracks.

Internal Audit Results

Bring up internal audit findings at every management review. Audits show in black and white how well your system is working. Go over both the wins and the weak spots.

If you see the same issues popping up, or if there are big non-conformities, make sure someone owns the follow-up. Using real audit data helps you fix root causes—not just slap on a Band-Aid.

Corrective Actions

Use management review to look at all the corrective actions since your last meeting. Focus on whether those actions actually solved the problem. Are you seeing the same issues again, or did you really fix them?

Lists or simple charts can help you spot patterns. If something keeps coming up, maybe it’s time to tweak your process or offer more training. Tackling these at the system level keeps things moving in the right direction.

External Assessment Results

Talk about any feedback from external assessments—like those fun accreditation visits. Pay attention to non-conformities flagged by outsiders and how you handled them.

Look at any recommendations they gave and figure out if you need more changes or resources. Following up well on external assessments shows you care about quality, not just ticking boxes.

Changes in Work Volume/Type

Has your workload changed? Are you doing more tests, different types, or maybe dropping some services? Bring this up during management review.

Ask if your resources still fit your workload. Maybe you need more training, new equipment, or a tweak to your procedures. Keeping your lab balanced prevents burnout and keeps quality high.

Feedback and Complaints

Collect feedback and complaints from clients, stakeholders, and staff—then actually look at them. Group them by topic to spot trends. During the review, talk about what you did to address them.

Are complaints going down? Did your fixes work? Use this info to drive improvement and show people you’re listening.

Effectiveness of Improvements

Always look back at improvements you’ve tried. Did they make things better? Did error rates drop, or are you just spinning your wheels? Ask your staff for their take too.

If something flopped, talk about what to tweak or try next. This keeps your system from getting stale and helps you focus on real progress—not just paperwork.

Adequacy of Resources

Check if you’ve got enough staff, training, working equipment, and supplies. If you’re short anywhere, mistakes and delays start creeping in.

Use management review to call out any resource gaps and brainstorm fixes—maybe hiring, new gear, or a budget bump. Keeping resources in line with your workload is just common sense.

Risk Identification Results

Talk about risks that could mess with your lab’s goals—equipment breaking down, people leaving, or new sample types. Review how well your risk controls worked since the last meeting.

Did any risks get worse, or did new ones show up? Write down your game plan and see if your earlier fixes actually helped. Staying on top of this keeps problems from snowballing.

Assurance of Validity of Results

Use the review to check if your lab’s results are still solid. Look at quality control charts, proficiency testing, and repeat test data.

If a process failed, talk about what you did to fix it. Make plans for stubborn issues. Keeping an eye on validity protects your lab’s reputation and avoids bad results.

Other Relevant Factors (Training, Monitoring)

Don’t forget about staff training, performance monitoring, or new technology. If you rolled out new equipment or procedures, discuss how that went—warts and all.

List out recent trainings and see if they made a difference. If monitoring flagged weak spots, talk about next steps. Covering these extras in management review just makes your system stronger.

Required Outputs for Management Review

Management reviews need to end with clear, documented outputs. ISO 17025 expects you to record decisions, plans, and actions for improvement. That might mean updating policies, objectives, or resources.

Put together an action plan with names and deadlines. Keep records of what you decided—auditors love seeing that stuff actually gets done.

Effectiveness of Management System

Use the review to honestly talk about how well your whole management system is working. Is it meeting customer needs, supporting compliance, and helping you get better?

Call out ongoing strengths and weaknesses. Use the discussion to figure out where your system adds value and where you need to focus next. That’s how you steer future improvement.

Improvement of Laboratory Activities

Check if lab activities—testing, calibration, reporting, communication—are up to standard. Take a look at any new quality issues or wins.

Listen to suggestions from staff or clients. Bring in changes that make work smoother and results more reliable. Focusing on this at every review just makes your lab better.

Provision of Resources/Need for Change

During review meetings, talk honestly about whether you’ve got enough resources for what’s coming. Think people, facilities, software, tools—the whole package.

If you’re short or planning changes (like offering more tests), write down what you’ll do. This keeps things running and lets you handle growth or change without chaos.

Example Management Review Meeting Minutes and Action Tracking

Honestly, meeting minutes are kind of the backbone of good management reviews. You’ll want to capture who showed up, what you all talked about, any decisions, and who’s on the hook for follow-up.

Here’s a basic format that works:

Date	Topic	Discussion Summary	Decision/Action	Responsible	Due Date
2025-07-02	Equipment update	Reviewed overdue calibration	Schedule service	Pat T.	2025-07-31
2025-07-02	Staff training	Need new safety course	Arrange training	Lisa B.	2025-07-15

Hang onto these after each meeting and update them when you meet again. It keeps things moving and makes it a lot easier to chase up actions next time.

Practical Tips and Resources

Meeting ISO 17025 Clause 8 isn’t just about ticking boxes—it’s about building solid habits around documentation, using tools that actually help, and finding support when you need it. Templates, regular audits, and a bit of expert advice can make life way easier and keep you out of trouble.

Importance of Documentation and Record-Keeping

If you ask me, documentation is the backbone of Clause 8. You’ll need to keep records—think management system processes, training logs, audits, and corrective actions. Standard operating procedures, forms, logs, you name it.

Good records can save your skin during audits and help you keep up when standards change or someone new joins the team. It’s just less hassle when everything’s labelled, up to date, and easy to find—whether you’re digital or old-school with paper. Make sure you’ve got some sort of review and disposal schedule, too, as your document control says.

Resources from RJ Quality Consulting

RJ Quality Consulting has a bunch of resources to help labs get ISO 17025 sorted. You’ll find downloadable guides for setting up your management system, document control, and prepping for audits.

Their stuff is pretty practical, not just theory. You get step-by-step instructions that actually fit how real labs work, plus white papers, sample policies, and checklists for Clause 8. They keep their resources up to date, too, so you’re not stuck with old info. Honestly, it’s handy whether you’re just starting out or you’ve been at this for years.

Free Consultation Offer

RJ Quality Consulting even offers a free, no-strings-attached consultation. You can get an expert to look over your management system and chat about what’s working and what’s not, especially when it comes to Clause 8.

Got questions? Bring them. They’ll tailor advice to your lab, and you can book the session online for a time that suits. It’s a pretty good way to avoid rookie mistakes and tighten up your compliance game.

Quality Manual and Procedures Templates

Your quality manual is kind of your system’s heart. RJ Quality Consulting (and a few others) offer templates you can tweak for your own lab.

The templates cover document control, training, review processes, and corrective actions—step-by-step, with examples. Starting with a template saves you a ton of time and helps you hit all the Clause 8 must-haves.

Table: Sample Sections in a Quality Manual Template

Section	Description
Document Control	How to manage, revise, and store docs
Training Records	Keeping track of staff qualifications
Internal Audits	Scheduling and reporting audit results
Corrective Actions	Documenting problems and solutions

Don’t forget to review, update, and actually tailor these templates to match what your lab does—one size never really fits all.

Internal Audit/Gap Analysis Tool

Clause 8 says you need internal audits, so don’t skip this. An audit tool or checklist makes it way easier to check off every requirement. RJ Quality Consulting and others have free or cheap checklists you can grab.

They break Clause 8 into bite-sized questions. Assign tasks, jot down what you find, and track actions—simple. These tools help you catch problems early and prep for the real deal when accreditation auditors come around.

You can tweak most checklists for your own methods. They’re usually spreadsheets or PDFs, so you can keep tabs on progress and hang onto records for next time.

Links to Related Posts/Videos

Sometimes you just want to watch a quick video or skim a blog post instead of digging through the standard. RJ Quality Consulting curates a list of articles, guides, and explainer videos on management systems, document control, and corrective actions.

Some of the most useful videos break down stuff like “Understanding ISO 17025 Clause 8,” “How to Perform an Internal Audit,” and “Tips on Document Control for Labs.” They’re straightforward and use real-life examples—way less dry than reading the standard.

Blog posts are great for catching up on changes or new best practices. Bookmark a few or subscribe so you’re not constantly searching when something comes up.

Conclusion

Clause 8 in ISO 17025 is all about making sure your lab’s management system keeps things reliable and results trustworthy. If you really get what it’s asking for, you’ll have a much easier time staying compliant and feeling confident in your processes.

Recap of Clause 8’s Significance

This clause is honestly the core of how you organize and run your lab for quality and consistency. You need to document, develop, implement, and keep reviewing your management system. That means a quality manual, document control, and regular internal audits.

You get a choice: Option A lets you build your own system, while Option B lets you line up with ISO 9001. Either way, you’re showing you take ISO 17025 seriously.

When you nail Clause 8, you can actually prove your performance and build trust. And those regular audits and reviews? They’re not just paperwork—they help you spot what’s working and what’s not, so you can keep improving and show you’re meeting international standards.

Encouragement to Review Other Clauses

Don’t forget—Clause 8 is big, but the rest of ISO 17025 matters too. Earlier clauses cover things like impartiality, confidentiality, and making sure your staff actually know what they’re doing.

Looking at the whole standard helps you see how everything fits together. You’ll spot weak spots faster and can close gaps before they become problems. Honestly, the more you know about each clause, the better you’ll understand how the whole thing works.

If you get familiar with all the parts, it’s easier to support your team and keep your lab running smoothly. It’s all connected, so a full-picture approach just makes sense.

Invitation to Comment or Reach Out

Got thoughts or questions on Clause 8 or ISO 17025 in general? Don’t be shy—drop a comment or reach out. Every lab’s got its own quirks, and sharing what works (or what doesn’t) helps everyone out.

Maybe you’ve noticed differences in how labs handle things, or maybe you’re looking for advice that’s actually practical. When you share, you help the whole quality community get better.

Use the comments below or send a message directly. Real-world examples and tips are always appreciated.

Contact Information and Resource Links

Need more help? Here’s how to get in touch:

Method	Details
Email	support@examplelab.com
Phone	+1-234-567-8901
Website	www.examplelab.com

And if you want to dig deeper, check out these resources:

• ISO/IEC 17025:2017 Standard
• Official ISO 9001 Information
• Download ISO 17025 clause-by-clause guide (PDF)

Seriously, don’t hesitate to reach out or use those links if you need more details or just want to talk through your implementation.

Frequently Asked Questions

So, ISO/IEC 17025:2017 Clause 8 lays out what labs need to do for their management system. It’s about documentation, clear responsibilities, procedures, confidentiality, and always pushing for improvement.

What are the essential components of a Quality Management System as outlined in ISO/IEC 17025:2017?

Your QMS under Clause 8 should cover documented policies, procedures, and records that prove your lab can deliver valid results. You’ll also need internal audits, management reviews, document control, and a way to handle corrective actions.

It covers risk management, competence, resource management, and impartiality—just make sure you tailor it to what your lab actually does.

How does an organization document its management system to comply with the requirements of Clause 8?

You’ll need to develop, document, implement, and keep your management system up to date. That means writing a quality manual or something similar that spells out policies, objectives, and how you’re meeting the requirements.

Keep records to show you’re following procedures and hitting the standards. Good documentation helps you track changes, who’s responsible, and how you’re improving.

What procedures must be established to meet the ISO/IEC 17025:2017 management system requirements?

Write down your procedures for internal audits, management reviews, corrective actions, and what to do with nonconforming work. Also, cover how you handle documents and records, deal with risks and opportunities, and make sure your staff are competent.

Having clear, consistent processes keeps you in line with the system and helps you actually improve quality over time.

How is management’s responsibility defined in the context of ISO/IEC 17025:2017?

Management needs to show real commitment to developing and improving the QMS. They assign roles and pick someone to keep an eye on compliance.

They also make sure the QMS goals fit with the lab’s bigger objectives, and that everyone knows what they’re responsible for when it comes to quality and impartiality.

What is the process for continual improvement under the management system requirements of ISO/IEC 17025?

Look for ways to get better by reviewing audit results, customer feedback, and performance data. When you spot nonconformities, fix them and check if your fix actually worked.

Continual improvement is all about regular management reviews and using a structured approach to keep making your processes—and your results—better.

How does ISO/IEC 17025:2017 address the issue of confidentiality within the management requirements?

You’ve got to set up solid policies and procedures that actually protect customer info and stop it from leaking out. It’s on both staff and management to really get what their part is in keeping data under wraps.

Audits and reviews look at confidentiality, so it’s something you can’t just gloss over—it’s woven right into the management system, and you’ve got to stay on top of it.

🔗 Explore the Full ISO/IEC 17025 Clause Series

As part of our complete walkthrough of the ISO/IEC 17025:2017 standard, we’ve created a dedicated blog post and video for each major clause. If you’re just joining the series or want to revisit another topic, you can explore the related posts below:

Clause	Title	Link
Clause 4	General Requirements	ISO 17025 Clause 4
Clause 5	Structural Requirements	ISO 17025 Clause 5
Clause 6	Resource Requirements	ISO 17025 Clause 6
Clause 7	Process Requirements	ISO 17025 Clause 7
Bonus	Technical vs. Nontechnical Requirements	Bonus Video