Best Practice Approaches
MOTIVA publishes a series of information videos on laboratory accreditation. As each is developed, it is added to the list shown on this page. The videos are in .mp4 format. They are an excellent start point to learn about accreditation and how to prepare and implement a laboratory quality system conformant to ISO/IEC 17025. As each webinar provides someone with the learning they need, they may come back to this page and download the documents and forms needed.
Sample Documents and Procedures
These documents are provided free of charge to anyone who wishes to create a quality manual that conforms to ISO/IEC 17025. They may also be used for part of the creation of quality manuals required by the other technical competence standards used by Inspection Bodies (ISO/IEC 17020), Product Certification Bodies (ISO/IEC 17065), Proficiency Testing Providers (ISO/IEC 17043), and Reference Material Producers (ISO Guide 34).
The manual and its associated procedures are based on the approach identified in MOTIVA training courses for the creation of a conformant quality system for these types of technical conformity assessment bodies (CABs). The approach is based on tried and true strategic planning processes. In essence, the quality policy is expanded into "Key Result Areas" which are the objectives at the beginning of each of ten chapters and the remainder of each chapter is dedicated to the processes by which the laboratory meets the objective of that chapter.
Laboratories, Inspection Bodies and other types of CABs may make use of these approaches in their own QMS by simply downloading the documents and implementing them directly. These approaches represent best practice in CAB QMS implementation. These documents are presented in pdf format for ease of downloading.
- MOTIVA Sample Quality Manual. This document forms the basis of the MOTIVA Quality Manual Template Course and provides a straighforward approach that meets or exceeds current requirements for quality system components. It includes a comprehensive quality policy and a sample document structure. Note that it is not written in the clause structure of any of the technical competence standards. There are other quality manual templates offered on the web that are structured in that fashion.
- MOTIVA Sample Code of Ethics. This document details a code of ethics for implementation within a laboratory that meets or exceeds the impartiality requirements, including conflict of interest and confidentiality requirements of ISO/IEC 17025 and the other technical competence standards.
- MOTIVA Sample Document Control and Control of Records Procedure. This document details an comprehensive approach for the control of laboratory documents and records. It is based primarily on the control of paper based documents and electronic records. It meets or exceeds the requirements in ISO/IEC 17025 for these two disciplines as detailed in clauses 4.3 and 4.13 as well as the associated clauses for the other technical competence standards. Its companion Master Document List Form (described below) is also available in PDF or EXCEL.
- MOTIVA Sample Continual Improvement Procedure. This document details a comprehensive continual improvement approach for use in CABs that wish to meet or exceed the requirements detailed in the applicable clauses of the technical competence standard that governs their own operation. This approach allows for the identification of non-conformances, potential-non conformances, and opportunities for improvement from all of these source clauses and describes a congruent approach to addressing them as prescribed more and more in later revisions of the technical completence standards. It contains all the elements required for a CAB to track all non-conformances, potential non-conformances and opportunities for improvment from identification through root cause analysis (where this is actually required) to solution and follow up. Included are suggested forms and root cause analysis techniques specifically aimed at supporting CAB operations. Simple yet effective approach that is the basis of the MOTIVA Root Cause Course and the other continual improvement disciplines. Meets or exceeds all the requirements of all technical competence standards, including ISO/IEC 17025 clauses 4.9, 4.10, 4.11 and 4.12.
- MOTIVA Sample Feedback Procedure. This document contains a comprehensive approach in acquiring and addressing feedback, both positive (compliments) and negative (complaints) in a single procedure that includes sample forms that can be used by lab staff from reception to determination of impact on operations. Simple yet effective approach that is the basis of the MOTIVA training in this specific QMS discipline. Meets all the requirements of ISO/IEC 17025 clauses 4.7 and 4.8 and the applicable clauses in the other technical competence standards. Based, in part, on ISO/PAS 17003 - Conformity assessment — Complaints and appeals — Principles and requirements.
- MOTIVA Sample Conflict of Interest and Confidendiality Guideline. This document contains a comprehensive committment that has been referenced in the Sample Code of Ethics regarding integrity. This guideline is separate from both the Sample Quality Manual and the Sample Code of Ethics, but is refered to in the Sample Code of Ethics which allows for committment to both the Code and these Guidelines by staff signature. This approach meets all the requirements of ISO/IEC 17025 clauses 4.1 and 4.2, and the applicable clauses of the other technical competence standards regarding these issues. Based, in part, on ISO/PAS 17001 - Conformity assessment — Impartiality — Principles and requirements and ISO/PAS 17002 - Conformity assessment — Confidentiality — Principles and requirements.
- MOTIVA Sample Internal Audit and Management Review Procedure. This document forms the basis of the MOTIVA Internal Audit Course and provides a straighforward approach that meets or exceeds the requirements provided in applicable clauses of all the technical competence standards, ISO/IEC 17025. The procedure describes a process based approach for internal auditing and contains reference to the forms needed for such activity.
- MOTIVA Sample Job Hazard Assessment Procedure. This document forms the basis of the MOTIVA Job Hazard Assessment Course and provides a straighforward approach that meets or exceeds current OHSA guidelines regarding the need to inform laboratory staff of potential hazards and have them participate in appropriate solutions.
Laboratories may make use of these forms in their own QMS by simply downloading them and implementing them directly. These approaches represent best practice in laboratory QMS implementation.
Continual Improvement Form. This form tracks an identified departure from the quality system (whether or not it has already occured) or a potential improvement, from identification through assessment of impact, root cause analysis (where necessary), development and implementation of solution, to follow up (again, where necessary). This form is used in the MOTIVA Internal Audit Course. It is also available in Word format here.
Feedback Form - This form tracks both positive and negative feedback from any person or organisation with respect to any aspect of the operation of the laboratory. It is also available in Word format here.
Internal Audit Forms. This set of forms allows for a laboratory to conduct an internal audit conformant to ISO/IEC 17025, clause 4.14, using a process based approach. These forms are used in the MOTIVA Internal Audit Course. It is also available in Word format here.
Master Document List. While this appraoch to controlling documents has been phased out of the newest versions of standards such as ISO/IEC 17020 and 17065, it still lives in 17025 and it provides a very simple approach to controlling the documents within a management system. If we understand that the entire aim of document control is to ensure that only the most appropriate version of a document is available to everyone who may need it, then the Master Document List approach described in 4.3.2 of ISO/IEC 17025 is a pretty straightforward way to do that. No thinking required, just list them and track them. This form allows a laboratory to list the status and location of all internally-generated documents and all externally-generated documents, including the formats of laboratory forms. It also allows the laboratory quality system personnel to record the authorities for creating and authorizing documents, tracking review dates, and indicating when a document needs to be reviewed again to determine its continued suitability in the laboratory management system. It is also available in its Excel format here.
- Job Hazard Assessment Form. This form allows a laboratory to record the outcomes of its own job hazard assessment activities and implement a conformant process with regard to mitigating risk associated with specific lab functions. This Version allows continuing examination of risk as conditions change over time after the initial steps have been taken. This form are used in the MOTIVA Job Hazard Assessment Course and is available in Excel format here.
Design and Build a Laboratory (or other CAB) QMS
MOTIVA publishes a self examination document, leading to the most appropriate steps to the design and implementation of a QMS. This work can be the set of steps from determining the need for a QMS right through to applying for accreditation from an ILAC signatory body.
Download it here and determine where your CAB is now. Determine how long it will take and what effort your CAB will have to undertake to have a conformant QMS in placc.
This document does not promote any consulting services, but it does shed strong light on what it takes to succeed in this effort. As MOTIVA staff can attest, it can be a long and lonely journey - but it need not be.