ISOBudgets ISO/IEC 17025:2017 Quality Manual Template (3rd Edition) | Audit-Ready System
Price range: $500 through $2,000
Complete ISO 17025 Quality Manual Template for all calibration and testing labs. Create a custom quality management system in less than 30 days. Package includes:
- 1 Quality Manual,
- 11 Procedures,
- 18 Lists & Logs, and
- 25 Forms
- 1 File Folder System
- 1 Accreditation Prep Checklist
Get the ISO 17025 Quality Manual Template
and be audit-ready in 30 days or less.
Want to get your laboratory ISO/IEC 17025 accredited?
If so, you need a quality management system that meets the standard’s requirements.
Creating a system on your own can be time consuming. Most laboratories, that we speak with, spend 6 to 12 months making their own quality management system.
Don’t spend 6 months creating a quality manual. Get the ISO 17025 Quality Manual Template and be audit-ready in 30 days or less.
This is a complete quality management system for ISO/IEC 17025:2017, including:
- 1 Quality Manual,
- 12 Procedures,
- 15 Lists,
- 21 Forms
- A file folder system (to store your documents and records), and
- An action plan checklist (to prepare for ISO/IEC 17025 assessment).
The template gives you a management system that is 90% complete. You just need to review and update it to make it yours. Then, implement the policies and procedures in your lab so you can begin collecting data and records to prepare for ISO/IEC assessment.
Just dedicate 1 hour a day to customizing your quality manual template to complete it in 30 days or less.
What’s Included With theISO 17025 Quality Manual Template
The template gives you everything you need to prepare for ISO/IEC 17025 accreditation. Below, you will find complete breakdown of what is included with the template.
QUALITY MANUAL
Here is a list of the included sections.
- Section 2.0: Introduction – How to Use the Manual
- Section 3.0: Terms and Definitions
- Section 4.1: Impartiality
- Section 4.1: Confidentiality
- Section 5.0: Organization
- Section 6.1: General Resources
- Section 6.2: Personnel
- Section 6.3: Facilities and Environmental Conditions
- Section 6.4: Equipment
- Section 6.5: Metrological Traceability
- Section 6.6: Externally Provided Products and Services
- Section 7.1: Contract Review
- Section 7.2: Selection, Verification, and Validation of Methods
- Section 7.3: Sampling
- Section 7.4: Handling of Items
- Section 7.5: Technical Records
- Section 7.6: Evaluating Measurement Uncertainty
- Section 7.7: Ensuring the Validity of Results
- Section 7.8: Reporting the Results
- Section 7.9: Complaints
- Section 7.10: Nonconforming Work
- Section 7.11: Information Management
- Section 8.1: Management System
- Section 8.2: Management System Documentation
- Section 8.3: Document Control
- Section 8.4: Record Control
- Section 8.5: Risks and Opportunities
- Section 8.6: Improvement
- Section 8.7: Corrective Actions
- Section 8.8: Internal Audits
- Section 8.9: Management Reviews
Procedures
Here is a list of the included procedures.
- SOP 01: Managing Personnel
- SOP 02: Managing Laboratory Equipment
- SOP 03: Intermediate Checks
- SOP 04: Managing Products and Services
- SOP 05: Reviewing Requests
- SOP 06: Verifying & Validating Methods
- SOP 07: Handling Items
- SOP 08: Ensuring Validity of Results
- SOP 09: Handling Complaints
- SOP 10: Handling Nonconforming Work
- SOP 11: Conducting Internal Audits
LISTS
Here is a list of the included lists and logs.
- List 01: Master Document List
- List 02: Distribution List
- List 03: Qualification List
- List 04: Laboratory Training Log
- List 05: Equipment Maintenance List
- List 06: Reference Values and Correction Factors
- List 07: Supplier List
- List 08: Purchase Log (Supplies and Services)
- List 09: Method List
- List 10: Multi-Year PT/ILC Plan (with Risk)
- List 11: Feedback Log
- List 12: Nonconforming Work Log
- List 13: LIMS Management Log
- List 14: Risks and Opportunities List
- List 15: Laboratory Temperature Log (°C)
- List 16: Laboratory Temperature Log (°F)
- List 17: Laboratory Temperature & Humidity Log (°C)
- List 18: Laboratory Temperature & Humidity Log (°F)
FORMS
Here is a list of the included forms and documents.
- Form 01: Impartiality Agreement
- Form 02: Confidentiality Agreement
- Form 03: Read and Understand Log
- Form 04: Competence Requirements Worksheet
- Form 05: Monitoring Personnel Competence Form
- Form 06: Equipment Check-In/Check-Out Log
- Form 07: Intermediate Check Form
- Form 08: Purchase Request Form
- Form 09: Product/Service Inspection Form
- Form 10: Service Request Form
- Form 11: Contract Review Form
- Form 12: Method Development Form
- Form 13: Method Verification Form
- Form 14: Method Validation Form
- Form 15: Public Complaint Handling Process
- Form 16: Corrective Action Form
- Form 17: Internal Audit Plan
- Form 18: Internal Audit Checklist
- Form 19: Laboratory Witnessing Form
- Form 20: Laboratory Tracing Form
- Form 21: Assessment Finding Form
- Form 22: Scope Audit Form
- Form 23: PT Participation Audit Form
- Form 24: Management Review Form
- Form 25: Organization Chart
Why You Should Buy This ISO 17025 Quality Manual Template
Complete Package
This quality management system template includes everything that you need for ISO/IEC 17025:2017, including quality manual, procedures, logs, forms, and folder system. All done for you in one bundle.
Easy to Customize
Create a quality manual fast by just filling in the blanks. Each document has fields that you need to complete and includes suggestions and tips to help customize the manual for your laboratory.
Universal Compatibility
This quality management system is designed to work for all lab types, including: calibration, mechanical, electrical, dimensional, chemical, microbiology, automotive, aerospace, food testing, and more.
Why You’ll Love This ISO 17025 Quality Manual Template
Easy to Customize
This quality management system is very easy to customize because it was designed to be that way. We dedicated a lot of time to optimizing user experience to make sure anyone can use and update this document.
No previous ISO/IEC 17025 experience required. This template includes notes, options, comments, and guidance to help you easily make changes so you can confidently make to the quality manual template yours (without hiring a consultant).
Below, you will learn more about how we make the quality manual template easy to edit and use.
Just Fill in the Blanks
Each document contains brackets and boxes (with suggestions) where you can enter your custom information, such as logos, names, procedures, dates, services, etc. Simply fill in the blanks to make your quality manual for ISO/IEC 17025:2017 accreditation.
Selectable Policy Options
Tailor your quality manual to calibration, testing, dimensional, chemical, or microbiological operations using built-in policy selection blocks.
Simply select the policies you want and delete the one you don’t. We made it easy to customize your quality manual.
Scan-Optimized Documentation
Dense paragraphs and text blocks have been replaced with structured tables, process flowcharts, and scannable requirement lists. The best way to find the information you need fast.
Embedded Expert Guidance & Tips
If filling the blanks isn’t easy enough, every document includes comment boxes full of helpful suggestions, expert advice, and external references to help you customize your quality manual, effectively implement requirements, and prepare for ISO/IEC 17025:2017 accreditation.
It’s like having a professional consultant guiding you through the process!
When you are finished customizing your quality manual template, simply delete all the comments, and you are done. It is that easy!
Smart Spreadsheet Architecture
Logs now include user-friendly features, such as process flow bars, dropdown menus, conditional formatting (e.g. automated calibration due date alerts), and automated risk matrix scoring.
We didn’t just make pretty spreadsheets. We turned boring logbooks into interactive tools that help you solve problems, give obvious alerts, and ensure your records are audit-defensible!
To date, the best spreadsheets I a have ever used!
2-Click Folder System
Struggle keeping your documents and records organized? We designed a structured digital folder system that makes document and record storage and retrieval easy!
Plus, it’s built to limit file retrieval to a maximum of 2-clicks (i.e. 2 subfolders); folder map included.
Simply, copy and paste to folder system to a shared drive or file server and you are ready to go.
Just another way we made your system audit ready!
Easy to Use – Find Information Fast
Don’t create a quality manual that just collects dust! Get a quality manual that you will actually use.
Seriously! We designed this quality manual template to be user friendly and easy to read. I know that you are wondering how we did it, so let me tell you.
1. Short, Actionable Sentences
First, we removed the long useless paragraphs of passive information that put people to sleep and make finding information difficult.
We replaced them with short, actionable sentences so you know exactly what to do.
2. Bold Headers Above Every Section (for Scannable Search)
Second, we added bold headers to every section and sub-section of the quality manual so you can scan the manual and find what you are looking for fast!
3. Lists and Tables
Third, we replaced long sentences that contain multiple requirements with lists and tables. It seems simple, but it works!
Lists and tables are a great way to find, read, and understand information faster.
Simply find the information you need without having to read through large paragraphs
Give it try. You will thank me later.
4. Flowcharts & Infographics
Fourth, we added flowcharts and infographics to help you better understand processes and procedures. They make a great supplement to visually see and understand a process compared only relying on the procedural steps alone. Another simple solution to enhance your workflow and improve consistency!
Check them out. We made these high-end visual aids for you.
5. Color-Coded Text
Fifth, we added color-coded texts to help you find:
- Procedures,
- References,
- Lists,
- Forms, and
- External Documents
It really makes finding information fast and easy.
6. Improved Logs
Sixth, we improved the logs by adding a process flow bar to the top of the log and segmenting entry field with their respective process. This helps users keep their data organized and avoid leaving critical fields blank.
Additionally, we added conditional fields that automatically change color based on date dues, risk levels, and outcomes. Another way to visually see and understand important data fast.
Next, we converted all spreadsheets to tables so you data is now searchable, indexable, and easy filters. We even added named columns so you known what each entry field is no matter how far down you scroll.
Finally, we preloaded logs with default information to help you complete them faster and avoid nonconformities. These include the master document list (with all QMS documents), qualifications and authorizations log (with all required qualifications and authorizations), risks and opportunities log (with common risks and opportunities, including risks to impartiality), and more. Another way to turn “I don’t know what to do” to “Done.”
7. Enhanced Forms
Seventh, we overhauled every form for better data collection that matches the process flow. Plus, we included instructions and tips to help you fill it out without the need to go back and forth with reading the policies or procedure. Also, we added tables, checkboxes, and other advanced features that help keep better records.
8. Organized File Folder System
Eighth, we create a entire folder hierarchy to help you manage your QMS documents, logs, forms, and records. Simply copy and paste the folder architecture to your file server or shared drive and begin organizing your files. It makes storing and retrieving your records easy.
Additionally, we design the system with minimal levels so you never need to click more than twice to find a file. Forget clicking through 14 folders to find a file; never again.
9. Accreditation Checklist
Finally, we developed a complete checklist to ensure you are audit-ready. The checklist makes sure you have completed all quality document, records, and activities necessary to apply for ISO/IEC 17025 accreditation and prepare for your assessment. We made it project management friendly so you can track the status of each task, who is assigned to, and include any notes or instructions want to communicate to your team or keep for your own knowledge preservation.
This checklist is ultimate tool that ensures you successfully complete your audit with minimal nonconformities (i.e. deficiencies).
It’s Designed for Different Types of Labs
I know that you are thinking, “Will this quality manual template work for my laboratory? We are a [Fill in the blank] laboratory.”
The answer is, “Yes, it will.”
Made for These Types of Labs
We designed this quality management system to be compatible with various types of laboratories, including:
- Calibration Labs,
- Dimensional Testing Labs,
- Mechanical Testing Labs,
- Electrical Testing Labs (including EMC),
- Thermodynamic Testing Labs (including NADCAP),
- Chemical Testing Labs (including Materials, Food, Supplement, Pharma, Cannabis, etc.),
- Microbiology Testing Labs (including Food, Supplement, Pharma, Cannabis, etc.),
- Environmental Testing Labs,
- Automotive Testing Labs,
- Aviation & Aerospace Testing Labs,
- Ionizing Radiation & Dosimetry Labs,
- and more.
It does not matter if your activities are performed in-house, in the field, at customer sites, or all the above, this system will work for you.
Includes Options for Unique Lab Activities
This quality manual template includes policy and procedure options to accommodate the different activities accredited labs perform, such as:
- Calibration and(or) Testing with or without sampling,
- In-house and(or) Field Testing/Calibration/Sampling,
- Rented, Borrowed, or Subcontracted Equipment,
- Reference Values and Correction Factors,
- Customer Requested Methods,
- Sampling,
- Measurement Uncertainty Evaluations for Calibration and(or) Testing Labs,
- Simplified Reporting,
- Reporting Requirements,
- Reporting Statements of Conformity,
- Reporting Opinions and Interpretation,
- and more.
Keep the options that match how your lab operates and delete the options that you don’t need. We even include exclusion statements for clauses that are not applicable to your laboratory. It is super easy.
And, if this quality management system is not compatible with your type of laboratory, we will give a 100% money-back refund.
So, you have nothing to lose.
About this Quality Manual Template
Hi, I’m Rick Hogan.
I made this quality manual template for two reasons:
- To help labs that didn’t have the budget to hire a consultant,
- Because I was tired of seeing ugly quality manuals that no one uses (b/c they don’t work).
So, I used my 15 years of experience consulting with various types of laboratories, observations from audit results, and customer feedback to make a quality manual template that is practical, functional, and easy to use.
The main goal is to have a quality management system that:
- Meets ISO/IEC 17025:2017 requirements,
- Meets laboratory specific requirements, and
- That lab personnel will actually use (so lab personnel are competent and not relying on a single subject matter expert).
I know that you may be thinking “That is impossible,” and “No one actually uses the quality manual (except QA).”
Well, I am here to tell you that is not true.
The problem is you don’t have a quality manual that is easy to use and that employees understand. For them, it is easier (and faster) to just ask management (i.e. you) for the answer. Plus, if something goes wrong, they can just blame you and claim no responsibility.
Trust me! I have been there. I spent 22 years managing people and a laboratory.
While it feels good to be the person with all the answers, all of the constant interruptions affect your productivity, quality, and profits. Not to mention, how good is your quality management system if you are the only one who knows it. Think about it. What are your personnel doing when you are not around to answer their questions? The answer is whatever they think is the right thing to do. They never learned to look up the answer for themselves.
So, if you do not like getting interrupted 30 times a day to answer questions employees could find in the quality manual (if they just looked), you may want to consider redesigning or reformatting your quality manual so your personnel can find answers fast.
When the quality management system becomes a tool that they actually use and find what they need, they will stop bugging you for answers.
It could make a BIG difference that…
- Saves you hours of your life,
- Eliminates stress and headaches,
- Improves the quality of work the lab outputs,
- Enhances your company’s brand reputation,
- Improves your lab’s productivity, and
- Increases your top and bottom-line (i.e. revenue and earnings).
After all, you are running a business.
If you think this is impossible, ask me. I have actually managed an ISO/IEC 17025:2017 accredited lab and helped plenty of other labs (internationally) implement systems that got them accredited. Additionally, I have done this recently; not 25 or 30 years ago before the standard existed.
Real-world experience matters!
Make sure that you consider this when selecting a consultant or buying a solution for your laboratory. Many consultants have ZERO experience operating an ISO/IEC 17025 accredited lab.
Knowing requirements is one thing. Knowing how to successfully implement them is an entirely different ball game!
Frequently Asked Questions (FAQ)
How long does implementation take?
By dedicating 1 hour per day to customizing pre-configured fields and establishing/collecting the required records, your laboratory can achieve audit readiness in 30 days or less.
Are the template files fully editable?
Yes. All files are unlocked Microsoft Word (.docx) and Excel (.xlsx) documents. There are no protected documents, locked cells, macros, VBA scripts, or proprietary software requirements.
Is this template compatible with my laboratory’s discipline?
Yes. The 3rd Edition includes selectable options engineered for calibration, mechanical testing, electrical testing, dimensional testing, thermodynamic testing chemical testing, automotive testing, aerospace testing, energy testing, food testing, environmental testing, Ionizing radiation, and microbiology laboratories. If your lab type is not listed, contact us more details.
Does this kit help prepare for the external audit?
Yes. The kit includes an Accreditation Action Plan Checklist that guides you step-by-step through document customization, record collection, internal auditing, management reviews, application submission, and pre-audit preparation.
Get Your Laboratory Ready For Accreditation Buy the ISO/IEC 17025 Quality Manual Template.
This really is a great ISO 17025 quality manual template. It has everything that you need to get ISO/IEC 17025:2017 accredited. All you need to do is download the files, fill in the blanks, select the options applicable to your laboratory, and prepare the records we specified for you. We made it super easy! You’ll be ready for your assessment in just a few weeks.
If you are ready to create a quality management system for your laboratory, click the link below to get your quality manual template today.
| Version | Version 1.0, Version 2.0, 3rd Edition |
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