ISO 17025
ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" is the document that forms the basis for laboratory accreditation.
Laboratory Accreditation
Laboratory accreditation is the formal recognition by a third party (the accreditation body) that the laboratory meets the requirements of ISO 17025 or its predecessor ISO Guide 25 and is competent to perform calibrations and/or tests within a defined scope.
In the US there are two generally recognized accreditation bodies; A2LA (American Association for Laboratory Accreditation) and NVLAP (National Voluntary Laboratory Accreditation Program). Within the last couple of years additional accreditation bodies have started to issue accreditations. You should check with your customers to make sure they recognize your accreditation body of choice.
Quality System
The quality manual and related documentation are the formal documents that describe a laboratory's quality system. Most laboratories seeking accreditation find that the development of a quality manual that meets the requirements of ISO 17025 and the accreditation body is one of the major stumbling blocks for obtaining accreditation.
Where registration to ISO or QS 9000 can be accomplished with fairly vague statements in the quality documentation, ISO 17025 requires fairly specific statements about how things are accomplished. If you are familiar with ISO/QS 9000 audits, you will find that ISO 17025 assessments are much more detailed and look for much more supporting documentation.
It is my experience as an assessor for A2LA, that laboratories who have worked with a consultant with only ISO/QS 9000 experience are shocked by the required level of detail and either have to rework their quality documentation prior to the assessment, or will receive a significant number of deficiencies (things that need to be corrected prior to accreditation) during the assessment.
Scope of Accreditation
The scope of accreditation is a document, which defines the types of calibrations/tests the laboratory is accredited to perform. It also gives the measuring range and best measurement uncertainty, that the laboratory is allowed to quote for each type of calibration/test under their accreditation. Particularly the development of uncertainty budgets to support the claimed uncertainties is another major stumbling block for many laboratories.
Consulting Services
I offer consulting services to help laboratories put together their application for accreditation, implement an appropriate quality system and develop the necessary uncertainty budgets to become accredited.
Model Quality System
To avoid having to start from scratch every time I work with a new laboratory, I have developed a Model Quality Manual for ISO/IEC 17025 with extensive support documentation.
Using the Model Quality Manual as the basis for the quality system development cuts 3-6 man months out of the development process. By spreading the cost of developing the Model Quality Manual over several laboratories, I can charge a fixed fee for using the Model Quality Manual as the basis for the development, that is only a fraction of what I would have to charge for developing a system from scratch for each laboratory.
I also have clients, who have bought the Model Quality Manual and have modified it themselves to fit their needs.
The manual also comes with an A2LA calibration checklist already filled out in PDF format
Layout
The Model Quality Manual is written in Microsoft Word and each section is a separate file, making it easy to update and tailor the Model Quality Manual to the particular needs of a laboratory.
The sections and headings follow ISO 17025 very closely and in each document, referenced documents are given in italics and people assigned responsibilities are given in bold.
References
There is a list of referenced documents at the end of each section and there are references in the job descriptions to the section where the responsibility/authority is identified.
The documents are generally well cross referenced, making it easy to know where you have to check for impact, when you make changes.
Customization
The manual is written as mail merge documents, enabling me to insert the laboratory name and logo in appropriate places to avoid the cookie cutter look and feel. In the sample documents I have used the fictitious "HN Calibration Laboratories" as the laboratory name.
Support Documents
In the list of support documents * means that I provide a sample document to work from. # means that I provide an empty form or a file with layout. Documents without a prefix is not provided, as I deem them to not lend themselves to the model document approach, such as the data backup procedure, as everybody does it differently.
Sample Documents
The documents linked below are PDF files of the Table of Content and a section of the Model Quality Manual itself, one supporting policy and one supporting procedure, as well as the job description for the Quality Manager and the list of supporting documents.
Model Quality Manual Table of Content
Model Quality Manual Section 04 - Management System
Model Quality Manual Policy 03 - Gifts and Gratuities
Model Quality Manual Procedure 05 - Feedback and Corrective Action
Model Quality Manual Quality Manager Job Description
Model Quality Manual List of Support Documents
Contact me for more information.
Proficiency Testing
One requirement to obtain and maintain accreditation is to participate in proficiency testing. Simply put, proficiency testing is blind measurements where you prove that you can measure correctly within your claimed uncertainty.
I run a proficiency testing service, HN Proficiency Testing. The link takes you to the separate website for that service.
Henrik S. Nielsen
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