ISO 17025 Accreditation Package

Strategies and Tools for Fast, Trouble Free Laboratory Accreditation

With audio seminar and free on-line updates

 

Version 2 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 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 good understanding on ISO 17025 requirements
• Develop a strategy and quality manual
• Implement the strategies with 40+ Best Practice Guides such as SOPs, checklists, forms, templates

Version 2.0 just released

New or updated features/documents in version 2 include

• SOP: Corrective and Preventive Actions (S-114) NEW
• SOP: Gap Analysis for ISO 17025 (S-508) NEW
• SOP: Quality Assessment of Laboratory Suppliers (S-515) NEW
• SOP: Measurement Uncertainty in Chemical Analysis (S-536) NEW
• SOP: Measurement Traceability in Chemical Analysis (S-537)  NEW
• SOP: Handling (Certified) Reference Material (S-625)  NEW
• SOP: Validation of Software and Computer Systems for ISO 17025 (S-690)  NEW
• SOP:  Using Software and Computer Systems for ISO 17025  NEW
• Updated: Laboratory Quality Manual UPDATE
• Updated: Step-by-Step Implementation UPDATE
• Checklist: ISO 17025 Accreditation (E-178) UPDATE
• Checklist: Measurement Uncertainty in Chemical Analysis (E-186) NEW
• Checklist: Measurement Traceability in Chemical Analysis (E-187) NEW
• Checklist: List with Required Laboratory Procedures for ISO 17025 (E-198) NEW
• Checklist: List with Required Laboratory Records for ISO 17025 (E-199) NEW
• Checklist: Using Computer Systems in ISO 17025 Environments (E-610) NEW
• Three new forms

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, 57 pages
3. ISO 17025: Step by Step Implementation
4. Two checklists: ISO 17025 and Laboratory Audits
5. 39 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 computers
6. 12 Forms/Templates
7. 10 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: food, chemical, clinical, environmental, pharmaceutical
• Calibration laboratories
• Laboratory managers
• QA managers and personnel
• Analytical scientists
• Validation specialists
• Metrology groups
• Consultants
• Suppliers of laboratories
• Teachers

Format/Price/Ordering

• Format and Pricing
  - 1) Binder with CD for $649.-
  - 2) Web download for $579.-
  Prices include shipping and two years on-line updates
  VAT will be added for EU countries.
• Size: More than 1000 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 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 the author offers two year free on-line updates with the purchase of the Laboratory Compliance 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

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 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 (UPDATE)

ISO 17025 requires that the laboratory should define its management system, including a policy statement in a quality manual. This 57 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

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 (UPDATE)

This documents 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 39 example SOPs

1. Document Management and Control (S-105)
2. Corrective and Preventive Actions (S-114) NEW
3. GLP Facilities and Environmental Control (S-121)
4. Qualification of Equipment (S-240)
5. Retirement of Computer Systems (s-261)
6. Validation of Macro Programs and other Application Software. (S-263)
7. Quality Assessment of Software and Computer System Suppliers.(S-274)
8. Retention and Archiving of Electronic Records (S-315)
9. Scanning of Paper Records for GxP Compliant Archiving. (S-316)
10. Data Back-up and Restore. (S-317)
11. Generation and Maintenance of SOPs for Laboratories (S-504)
12. SOP: Gap Analysis for ISO 17025 (S-508) NEW
13. Conducting Laboratory Management Reviews (S-510)
14. Auditing Laboratory Systems (S-511)
15. Review and Approval of Analytical Test Results (S-512) 
16. Training for Laboratory Personnel (S-513)
17. Purchasing and Receipt of Laboratory Supplies (S-514)
18. Quality Assessment of Laboratory Suppliers (S-515) (NEW)
19. Laboratory Complaint Handling  (S-520)
20. Subcontracting of Testing and Calibration (S-522)
21. Control of Non-conforming Testing and/or Calibration Work (S-525)
22. Identification and Control of Laboratory Records (S-526)
23. Sampling for Analytical Testing. (S-531)
24. Preparation of Laboratory Working Standards (S-532)
25. Handling of Laboratory Test Samples (S-534)
26. Measurement Uncertainty in Chemical Analysis (S-536) NEW
27. Measurement Traceability in Chemical Analysis (S-537) NEW
28. Maintenance of Laboratory Equipment (S-541)
29. Validation of Analytical Methods (S-612)
30. Validation of Chromatographic Methods (S-613)
31. Transfer of Analytical Methods (S-614)
32. Verification of Standard Methods (S-623)
33. Handling (Certified) Reference Material (S-625) NEW
34. Calibration of Analytical Balances (S-641)
35. Qualification of Refrigerators (S-644)
36. Validation of Laboratory Computer Systems (S-656)
37. Reporting Analytical Data for FDA and ISO 17025 Compliance (S-672)
38. Validation of Software and Computer Systems for ISO 17025 (S-690) NEW
39. Using Software and Computer Systems for ISO 17025 (S-691) NEW

6. Checklist / Worksheets

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

1. Checklist: ISO 17025 Accreditation (E-178) UPDATE
2. Worksheet: Laboratory Audits (E-184)
3. Checklist: Measurement Uncertainty in Chemical Analysis (E-186) NEW
4. Checklist: Measurement Traceability in Chemical Analysis (E-187) NEW
5. List with Required Laboratory Procedures for ISO 17025 (E-198) NEW
6. List with Required Laboratory Records for ISO 17025 (E-199) NEW
7. Checklist: Using Computer Systems in ISO 17025 Environments (E-610) NEW

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. Corrective Action Form (K-3511)
2. Preventive Action Form (K-3512)
3. Training Requirements (K-3513)
4. ISO 17025 Accreditation Project Team (K-3514)
5. Laboratory Records Retention Schedule (K-3515)
6. ISO 17025 Laboratory Audit Summary (K-3516)
7. ISO 17025 Laboratory Management Review (K-3517)
8. Laboratory Employee List (K-3518)
9. Recording Sampling Data (K-3519)
10. Equipment Records (K-3520)
11. Equipment List (K-3521)
12. Equipment Records (K-3522)
13. Reporting Individual Components Contributing to Measurement Uncertainty (K-1661) NEW
14. Documenting Recovery Studies for Uncertainty Evaluation (K-1662) NEW
15. Documenting Combined Standard and Expanded Uncertainties (K-1663) NEW

8. Reference Papers

Reference papers are quite useful to get some more back-ground information and more details on various topics. The package includes 10 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. Qualification of High-Performance Liquid Chromatography Systems.(A-553)
7. Validation of Analytical Methods: Review and Strategy.(A-603)
8. Validation of HPLC Methods.(A-605)
9. Evaluation and Validation of Standard Methods. (A-607)
10. 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 in the Labcompliance archive.

• 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. The package did exceed my expectations.

• 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.

• 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.

• 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

• Ms.Tiffany Weldin, Quality Systems Director, Primex Farms, LLC, USA
  Documents were thorough and self explanatory. Great Resource!! I would definately 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

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 on the advisory board for the European Compliance Academy. 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