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All documents as shown here are included in the package, and many more!

A total of 38 SOPs are included in the package. 18 of them are shown here.

Forms help to make computer system validation consistent and effective

Understanding and Implementing ISO 17025

Strategies and Tool Kits for Laboratory Accreditation

 

ISO 17025 Accreditation Package

Training, Strategies and Tools for Fast, Trouble Free Laboratory Accreditation

With audio seminar and free on-line updates

For chemical testing laboratories

For mechanical, optical and electronic testing and calibration labs

Now with two Options for Ordering

  • CD
  • Web Download

 

Version 4 just introduced

Testimonials, References and Sample Pages

So far we have received very positive feedback from users of the package. To learn how the package helped to get ISO 17025 accreditation, click here.

To see the table of contents and example pages of the Quality Manual, an SOP and 2 pages of a checklist, download a zip file (sample pages are in PDF format, the products comes with word and/or PDF formats)

Intro

Training tools, strategies for compliance and tools for implementation

ISO 17025 can be used by testing and calibration laboratories as a standard to develop and establish a Quality System in the laboratory and for the assessment by their clients or by third parties. The standard is also being used as a criterion for laboratory accreditation.

This package helps you to

  • Get a detailed  good understanding on ISO 17025 requirements
  • Develop a strategy and quality manual
  • Implement the strategies in the most cost-effective way with 40+ Best Practice Documents such as SOPs, checklists, forms, templates

.

Version 4.0 just released

New or updated features/documents in version 4 include

  1. SOP: Document Management and Control (S-105) UPDATE
  2. SOP: Auditing Suppliers (S-128) NEW
  3. SOP: Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237) NEW
  4. SOP: Developing an effective Supplier Program to Assist Regulated
    Users (S-251-01) NEW
  5. SOP: Validation of Spreadsheet Applications (S-264) NEW
  6. SOP: Scanning of Paper Records for ISO17025 Compliant Archiving.
    (S-316-0
    2) NEW
  7. SOP: Electronic Audit Trail - Specifications, Implementation and
    Validation (S-322) NEW
  8. SOP: Internal Audits for ISO 17025 (S-507) NEW
  9. SOP: Conducting Laboratory Management Reviews (S-510) UPDATE
  10. SOP: Review and Approval of Analytical Test Results (S-512) UPDATE
  11. SOP: Purchasing Laboratory Services (S-514-02) UPDATE 
  12. SOP: Qualification/Calibration of Analytical Equipment (S-632) NEW
  13. Laboratory Quality Manual (M-169) UPDATE
  14. Step-by-Step Implementation (M-517)  UPDATE
  15. Checklist: SOPs for ISO 17025 (E-115-02) NEW
  16. Checklist: Sampling and Sample Handling (E-179) NEW
  17. Checklist: Handling (Certified) Reference Material (E-180) NEW
  18. Worksheet: Laboratory Audits (E-184) UPDATE
  19. Example: Project Plan and Schedule for ISO 17025 Accreditation (E-240) UPDATE
  20. Documenting Audit Performance – Individual Items (K-1113) NEW 
  21. Documenting Audit Performance – Summary Results (K-1114) NEW
  22. Spreadsheet Inventory (K-1332) NEW
  23. Excel Spreadsheet to Estimate Costs for ISO 17025 Laboratory Accreditation (K-1544) NEW
  24. Sample Collection Form (K-1611) NEW
  25. Test Example – Regular Testing of a Balance for Calibration (-3303) NEW

Package Overview

  1. A one hour audio presentation with Q&As: Understanding and Implementing ISO 17025: Requirements, Strategies and Tool Kits for Laboratory Accreditation
    (Train yourself and others on requirements and best practices)
  2. Quality Manual: ISO 17025, 65 pages
  3. ISO 17025: Step by Step Implementation
  4. Two checklists: ISO 17025 and Laboratory Audits
  5. 57 SOPs, e.g., for document control, complaint handling, corrective and preventive actions, management reviews, facilities and environmental conditions, sampling, sample handling, validation of software and computer systems, validation of methods, qualification of equipment, maintenance of laboratory equipment, training of laboratory personnel, auditing of laboratories, control of non-conforming tests and calibration, measurement uncertainty, measurement traceability, validation and use of Excel and computer systems
  6. 30+ Forms/Templates
  7. 7 Reference papers related to laboratories
  8. 30+ most frequently asked question and answers related to laboratory quality systems
  9. Two years online support. Buyers can ask questions at any time.
  10. Guides from official organizations that help to implement ISO 17025 (some are links)
  11. Two years free on-line updates

Target Audience

  • Testing laboratories: chemical analysis, mechanical, electronic testing
  • Calibration laboratories: chemical, mechanical, electronic, optical
  • Laboratory management
  • Technical managers
  • QA managers and personnel
  • Analytical scientists
  • Validation specialists
  • Metrology groups
  • Consultants
  • Training centers
  • Suppliers of laboratories
  • Teachers

Format/Price/Ordering

  • Format and Pricing
    - 1) CD for $699.-
    - 2) Web download for $649.-
    Prices include shipping and two years on-line updates
    VAT will be added for EU countries.
  • Size: More than 500 pages, when printed
  • Availability: Worldwide, shipment within one working day after order entry and payment has been received
  • Ordering: (SSL secured, recommended for payment by credit card)
    - Electronically
    from this this web site (SSL secured)
    - Regular mail or fax using the form in PDF
    or MS Word format

Free Online Updates

On-line updates - keeps you on top of ever changing regulatory and quality standard requirements

Requirements for laboratory quality systems are quite dynamic. What was enough yesterday is not enough any more today and what was necessary last year may not be any more next year.

A book can give the background, the fundamentals and an overview on regulations and inspection practices at a particular point in time - but updates reflecting on-going changes are practically limited to a 3 to 5 year time frame.

The Internet with it's instant publication power can give this update on a much more frequent basis, but is not so popular to learn the fundamentals. The real solution is a combination of both: get the start up package for the fundamentals and procedures and the Internet for the updates. That's why we offer two years free on-line updates with the purchase of the ISO 1705 accreditation package.

Updates include:

  • New requirements related to laboratory quality systems
  • New guidelines from official organizations and industry task forces
  • Interpretations what the new requirements mean for laboratories and how to respond
  • New SOPs, checklists and examples, related to laboratory quality systems, if necessary
  • Updates of all documents, if required

Registration is automatically with each package purchase from Labcompliance

Click here to go to the update site (requires access information).

All in One

All in one - makes your work efficient and keeps your budget under control

ISO 17025 Accreditation can be a complex task. This gets even more complex and even confusing when information is obtained from different sources. Frequently they give a high level overview talking about generic compliance but none gives a full picture and details that are required for quick implementation.

This package is a single source covering all aspects. It is written by a single author who has more than 10 years practical international experience and understands all aspects of quality in laboratories and quality standards from ground.

The author has been ranked as number one presenter at various international conferences and the package answers all questions typically raised at these conferences

  • Which laboratories should comply with ISO17025?
  • We are ISO17025 accredited, is this enough for GMP and GLP inspections?
  • What are the management requirements of ISO17025?
  • What are technical requirements of ISO17025?
  • What is the benefit for pharmaceutical laboratories?
  • We are already certified for GLP, what do we have to do for ISO17025?
  • How much does ISO17025 implementation and accreditation cost?
  • What is the most effective way to get ISO17025 accreditation?
  • How to select an organization for accreditation?

Detailed Contents

1. Laboratory Quality Manual (M-169) UPDATE

ISO 17025 requires that the laboratory should define its management system, including a policy statement in a quality manual. This 64 pages example quality manual helps to build your own. It has all elements that are required to develop, implement, maintain and continually improve the quality system and operational efficiency at lowest cost.

2. Audio seminar: Understanding and Implementing ISO 17025 (UPDATE)

Understanding and Implementing ISO 17025: Requirements, Strategies and Tool Kits for Laboratory Accreditation. In a one our seminar Dr. Ludwig Huber gives an overview on the standard  and he guides the audience through a logical step-by-step process on how to get ISO 17025 accreditation in the most cost-effective way.

3. Step-by-Step Implementation (M-517) UPDATE

This document guides owners of ISO 17025 accreditation projects through the complete process from planning to implementation and on-going maintenance and improvements.

4. Standard Operating Procedures (SOPs)

In ISO 17025 environments routine operations should follow written procedures. They help to implement processes and and technical controls in a consistent manner. The ISO 17025 Accreditation Package includes 49 example SOPs for chemical analysis laboratories, 38 SOPs for  mechanical, electronic and optical testing and calibration laboratories.

  1. Document Management and Control (S-105) UPDATE
  2. Writing and Distribution of Electronic SOPs (S-107) 
  3. Corrective and Preventive Actions (S-114)
  4. Auditing Suppliers (S-128) NEW
  5. Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237) NEW
  6. Maintenance of Equipment (S-241)
  7. Requalification of Equipment (S-244)
  8. Developing an effective Supplier Program to Assist Regulated
    Users (S-251-01) NEW
  9. Retirement of Computer Systems (s-261)
  10. Validation of Macro Programs and other Application Software. (S-263)
  11. Validation of Spreadsheet Applications (S-264) NEW
  12. Quality Assessment of Software and Computer System Suppliers.(S-274)
  13. Retention and Archiving of Electronic Records (S-315)
  14. Scanning of Paper Records for ISO17025 Compliant Archiving. (S-316-02) NEW
  15. Data Back-up and Restore. (S-317)
  16. Access Control to Computers and Data (S-320)  
  17. Electronic Audit Trail - Specifications, Implementation and
    Validation (S-322) NEW
  18. Generation and Maintenance of SOPs for Laboratories (S-504)
  19.  Internal Audits for ISO 17025 (S-507) NEW
  20. SOP: Gap Analysis for ISO 17025 (S-508)
  21. Conducting Laboratory Management Reviews (S-510) UPDATE
  22.  Auditing Laboratories for ISO 17025 Compliance. (S-511-02)   
  23. Review and Approval of Analytical Test Results (S-512) UPDATE
  24. Training for Laboratory Personnel (S-513)
  25. Purchasing and Receipt of Laboratory Supplies (S-514)
  26. Purchasing Laboratory Services (S-514-02) UPDATE 
  27. Quality Assessment of Laboratory Suppliers (S-515)
  28. Quality Assessment of Laboratory Service Providers (S-515-02)   
  29. Laboratory Complaint Handling for ISO 17025  (S-520-01)   
  30. Improving the Effectiveness of the Laboratory Management System (S-520-11) 
  31. Laboratory Facilities and Environmental Control (S-520-16)  
  32. Review of Requests, Tenders and Contracts (S-521)  
  33. Subcontracting of Testing and Calibration (S-522)
  34. Providing Services to Customers (S-524)
  35. Control of Non-conforming Testing and/or Calibration Work (S-525)
  36. Identification and Control of Laboratory Records (S-526)
  37. Recording and Archiving of Records for ISO 17025 (S-527)
  38. Sampling for Analytical Testing. (S-531)
  39. Preparation of Laboratory Working Standards (S-532)
  40. Handling of Laboratory Test Samples (S-534)
  41. Measurement Uncertainty in Chemical Analysis (S-536)
  42. Measurement Traceability for ISO 17025 (S-538)  
  43. Maintenance of Laboratory Equipment (S-541)
  44. Selection of Analytical Methods and Procedures (S-605) 
  45. Validation of Analytical Methods (S-612)
  46. Validation of Chromatographic Methods (S-613)
  47. Transfer of Analytical Methods (S-614)
  48. Ongoing Performance Control of Analytical Equipment (S-621)  
  49. Verification of Standard Methods (S-623)
  50. Handling (Certified) Reference Material (S-625)
  51. Qualification of Analytical Equipment (S-632) NEW
  52. Calibration of Analytical Balances (S-641)
  53. Qualification of Refrigerators (S-644)
  54. Validation of Laboratory Computer Systems (S-656)
  55. Reporting Analytical Data for FDA and ISO 17025 Compliance (S-672)
  56. Validation of Software and Computer Systems for ISO 17025 (S-690)
  57. Using Software and Computer Systems for ISO 17025 (S-691)

6. Checklist / Worksheets/Examples

Checklists and worksheets are key to identify missing procedures and technical controls for computer system validation. The Package includes two Checklists/Worksheets

  1. Checklist: SOPs for ISO 17025 (E-115-02) NEW
  2. Checklist: ISO 17025 Accreditation (E-178)
  3. Checklist: Sampling and Sample Handling (E-179) NEW
  4. Checklist: Handling (Certified) Reference Material (E-180) NEW
  5. Worksheet: Laboratory Audits (E-184) UPDATE
  6. Checklist: Measurement Uncertainty in Chemical Analysis (E-186)  
  7. Checklist: Measurement Traceability in Chemical Analysis (E-187)  
  8. Example: List with Required Laboratory Procedures for ISO 17025 (E-198)
  9. Example: List with Required Laboratory Records for ISO 17025 (E-199)
  10. Example: Project Plan and Schedule for ISO 17025 Accreditation (E-240) UPDATE
  11. Checklist: Using Computer Systems in ISO 17025 Environments (E-610)

7. Forms and Templates

Forms help to implement ISO 17025 efficiently and even more importantly, consistently acres your organization. Labcompliance forms are offered in word format for easy customization. The Package includes 15 forms

  1. Documenting Audit Performance – Individual Items (K-1113) NEW 
  2. Documenting Audit Performance – Summary Results (K-1114) NEW
  3. Spreadsheet Inventory (K-1332) NEW
  4. ISO 17025 Laboratory Gap Analysis Project Team (K-1541)
  5.  Worksheet for ISO 17025 Gap Analysis Documentation (K-1542)
  6. Excel Spreadsheet to Estimate Costs for ISO 17025 Laboratory Accreditation (K-1544) NEW
  7. Project Plan for ISO 17025 Gap Analysis (K-1545) 
  8. Remedial Actions to Fill Gaps for ISO 17025 (K-1546)
  9. Sample Collection Form (K-1611) NEW
  10. Reporting Individual Components Contributing to Measurement Uncertainty (K-1661)
  11. Documenting Recovery Studies for Uncertainty Evaluation (K-1662)
  12. Documenting Combined Standard and Expanded Uncertainties (K-1663)
  13. Test Example – Regular Testing of a Balance for Calibration (K-3303) NEW
  14. Corrective Action Form (K-3511)
  15. Preventive Action Form (K-3512)
  16. Training Requirements (K-3513)
  17. ISO 17025 Accreditation Project Team (K-3514)
  18. Laboratory Records Retention Schedule (K-3515)
  19. ISO 17025 Laboratory Audit Summary (K-3516)
  20. ISO 17025 Laboratory Management Review (K-3517)
  21. Laboratory Employee List (K-3518)
  22. Recording Sampling Data (K-3519)
  23. Equipment Records (K-3520)
  24. Equipment List (K-3521)
  25. Equipment Records (K-3522)

8. Reference Papers

Reference papers are quite useful to get some more back-ground information and more details on various topics. The package includes 6 papers.

  1. CAPA – A Fundamental Quality Subsystem. (A123:)
  2. Definitions: Qualification vs. Verification, Calibration and Validation. (A-154
  3. Equipment Qualification in Practice. (A-234)
  4. Selecting Parameters and Limits for Equipment Operational Qualification.(A-239)
  5. Qualification of Equipment and Computerized Systems. (A-264)
  6. How an Instrument Vendor can help with ISO 17025 Accreditation (A-534) NEW
  7. Preparation and Qualification of Certified Reference Material and Working Standards. (A-633)

8. Thirty Most Frequently Asked Questions and Answers

This section includes more than 30 questions and answers on ISO 17025 accreditation and other quality issues we received during our audio seminars, conference workshops and through e-mail. This section will continually be updated through our package reference website.

9. Two Years Online Support

Package buyers get two years online support. This will allow buyers to ask and receive all types or questions related to ISO 17025 for two years after package purchase. 

10. Guidelines from Official Organizations (some are links to external websites)

The package includes most important guidelines related to topics for Laboratory accreditation.

Official guidelines include

  • Selection and Use of Reference Material
    A Basic Guide for Laboratories and Accreditation Bodies
  • Traceability in Chemical measurement
  • Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories
  • Quantifying Uncertainty in Analytical Measurement, 2nd Edition
  • Measurement uncertainty arising from sampling
  • Use of uncertainty information in compliance assessment

11. On-line Update

Subscribers of the package get two years on-line updates through a password protected website. This includes quality systems and regulatory updates and other new documents such as new guidelines, SOPs, examples and templates.

Testimonials/References

The Feedbacks on the Package have been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored and can be viewed in the Labcompliance archive.

  • Mr. Andrew Glum, Director of Special Products and Quality Manager, Madge Tech, Inc., USA
    The package did exceed my expectations. The ISO 17025 Labcompliance Accreditation package is very insightful, practical, easy to understand, and there are a ton of additional resources offered to download when you have purchased this package for your laboratory accreditation and implementation of ISO 17025. Our Laboratory Manager, myself (quality manager, safety chair, director of special projects), and our Vice President of Operations are all very glad that I chose to buy the Labcompliance package. Just after two implementation meetings, the vice president of operations said "wow, this is actually good", and referring to certain sections of the laboratory quality manual: "this is good stuff!".
    The manual uses a consistent structure and terminology which applies throughout the manual and SOP's which makes it very easy to understand and incorporate into your companies existing quality management system, or to implement for the first time a great laboratory quality management system. I highly recommend the complete ISO 17025 Laboratory Accreditation Package to any company with a testing / calibration laboratory. Trust me, I have done my research and due diligence. This is
    the best one out there; don't waste your time looking for others that could lead you down a wrong path. When you get this package and start reviewing it, you will say to yourself "this is a LOT of work"; but then you will say, "Boy am I glad I bought this!"  (Ref 1085)

  • Mr. Russell Hensel, President, Hensel Environmental Biology Laboratories, USA
    The package did exceed my expectations. It gives us a HUGE head start on the lab start up. The cost is minimal compared to the return. EXCELLENT documentation. (Ref 1048)

  • Dr. Andrew Wotherspoon, National Research Council, Bioanalytical Chemistry,  Canada
    The ISO17025 is a comprehensive resource for all your accreditation needs. Explanations of key points of the accreditation process are well explained and there is extensive supporting material (SOP's etc) to allow an organization to successfully speed along the implementation process. SOP's and Forms are well written and satisfy the principal components of ISO17025 guidelines. Access to the website provides a source to access any updates to documentation. (Ref: 1017)

  • Ms Rona Canilao, Trans World Trading Co, Chief Chemist, Chemical Department, Philippines
    The package did exceed my expectations. It was very helpful on the start-up of our laboratory especially on our documentation system. It is a complete package. The necessary requirements for ISO accreditation are there. (Ref 1086)

  • Kellie Sorrell, Metrology Solutions Inc., Quality Department, Country, USA
    The templates were very useful in starting from the ground floor. Everything really fits together. Website is very helpful. The package did exceed my expectations. (Ref 1013)

  • Peggy Weber; Accelerated Technology Laboratories (ATL); USA,
    Project Manager

    The package did exceed my expectations. The number of documents especially dealing with the IT side of use in Lab environment exceed what I was expecting for the purchase. I wish a couple years ago I knew of this website and access. I do know that I will recommend this to others. (Ref: 1020)

  • Ms.Tiffany Weldin, Quality Systems Director, Primex Farms, LLC, USA
    Documents were thorough and self explanatory. Great Resource!! I would definitely recommend. The package did exceed my expectations, (Ref T-1031)

  • Ms. Brad Whisson, Managing Director, West Minerals Analysis Pty Ltd, Australia
    The package was a good starting point for our ISO17025 compliance program. It ensured that we did not overlook key requirements, and saved a lot of time in providing a framework to build on. The ISO 17025 Accreditation Package download from Labcompliance gave us a head start in our ISO17025 compliance program and significantly decreased the resources required.
    (Ref T-1030)

  • Ms.Kathryn Wadle, Technician, Texas Engineering Exp. Station, Energy Systems Lab (ESL), USA
    The procedure for each clause specified in the ISO 17025 has been clearly identified and documented through SOPs.
    The package did exceed my expectations. (Ref T-1029)

The author

Picture of Ludwig Huber

The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here