ACC-LAB(E) - Procedure for the Accreditation of Testing Laboratories by Industry Canada
Appendix III - Assessor Rating Guide
Use of the Assessment Rating Guide
1. Elements to be assessed in this Rating Guide
- Section 4 (Management Requirements)
- Section 5 (Technical Requirements)
2. Key to Column Headings used in this Rating Guide
- Item (unique identifier for use in assessment support software and database applications)
- Clause (specific clause cited from ISO/IEC 17025)
- Heading of the summary of requirement used in the standard ISO/IEC 17025
- Clause number referenced in the standard ISO/IEC 17025
e.g.:Scope of Management System
4.1.3ensure management system covers activities in the testing laboratory's permanent facility, sites away from its permanent facilities, or temporary/mobile
- Requirements (specific detail from the standard associated with an observation)
- Numbered requirements (1O, 2O, 3O);
- 1……meets requirement
- 2……does not meet requirement
- 3……requirement is not applicable to this testing laboratory
- Bulleted requirements (Yes, No, N/A);
- Yes…meets requirement
- No… does not meet requirement
- N/A… requirement is not applicable to this testing laboratory
- Numbered requirements (1O, 2O, 3O);
- Comments (assessor notes on the observation raised – specific details)
Assessor Rating Guide
4.0 MANAGEMENT REQUIREMENTS
A.01 4.1 Organisation
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Testing laboratory Registration
4.1.1 |
ensure the testing laboratory can be held legally responsible | O O O |
| 02 | Testing laboratory Requirements
4.1.2 |
ensure the testing laboratory carries out its testing and calibration activities in a manner that meets the requirements of ISO/IEC 17025:1999, and the needs of the client, regulatory authorities or recognition organizations | O O O |
| 03 | Scope of Management System
4.1.3 |
ensure management system covers activities in the testing laboratory's permanent facility, sites away from its permanent facilities, or temporary/mobile facilities | O O O |
| 04 | Conflict of Interest
4.1.4 |
when part of an organisation, ensure the testing laboratory defines the responsibilities of key personnel to identify potential conflicts of interest | O O O |
| 05 | Management and Technical Personnel
4.1.5a |
ensure management and technical personnel have the authority and resources needed to carry out duties | O O O |
| 06 | Undue Pressure
4.1.5b |
ensure arrangements are in place so that management and personnel are free from internal and external commercial, financial and other pressures that might adversely affect the quality of their work | O O O |
| 07 | Client Confidentiality
4.1.5c |
ensure there are policies and procedures related to client confidentiality, including electronic storage and transmission of results | O O O |
| 08 | Operational Integrity
4.1.5d |
ensure the testing laboratory has policies and procedures to avoid involvement in activities that compromise the confidence in its competence, impartiality, judgement or operational integrity | O O O |
| 09 | Organisation Chart(s)
4.1.5e |
ensure the organisation defines the relation of all staff including the interrelation between management, technical operations, support services and the quality system and, if applicable, the position of the testing laboratory within the parent organisation | O O O |
| 10 | Responsibility and Authority
4.1.5f |
define the responsibility and authority of all personnel who manage, perform or verify work affecting the quality | O O O |
| 11 | Testing laboratory Supervision
4.1.5g |
ensure adequate supervision of personnel for calibration and testing activities | O O O |
| 12 | Technical Management
4.1.5h |
identify technical management that has overall responsibility for technical operations and resources | O O O |
| 13 | Quality Manager
4.1.5i |
appoint a member of staff as quality manager who has defined authority and responsibility for implementing and overseeing the quality system, with direct access to the highest level of management at which decisions are made | O O O |
| 14 | Managerial Substitution
4.1.5j |
ensure designated staff are available to substitute for key managerial personnel, where practical | O O O |
A.02 4.2 Quality System
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.2.1 |
document policies and procedures related to the quality system and ensure they are communicated, understood and implemented | O O O |
| 02 | Quality Manual
4.2.2, 4.2.3, 4.2.4 |
maintain a quality manual that:
|
O O O
Yes No N/A |
| 03 | Quality Policy Statement
4.2.2 |
ensure the quality policy statement includes:
|
O O O
Yes No N/A |
A.03 4.3 Document Control
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.3.1 |
ensure procedures to control all quality system documentation (internal and external documentation) are established and maintained; | O O O |
| 02 | Approval and Issue
4.3.2 |
ensure documents are reviewed and approved by authorised personnel prior to issue, and are periodically reviewed to ensure continuing suitability; | O O O |
| 03 | Master List
4.3.2.1 |
maintain a readily available master list (or equivalent) of all quality documentation, which documents current revisions and distribution; | O O O |
| 04 | Availability
4.3.2.2 |
ensure all quality documentation is available where required | O O O |
| 05 | Obsolete Documents
4.3.2.2 |
ensure obsolete documents are removed, or those retained for either legal or knowledge preservation purposes are suitably marked | O O O |
| 06 | Identification
4.3.2.3 |
ensure all quality documentation is uniquely identified by:
|
O O O
Yes No N/A |
| 07 | Document Changes
4.3.3.1 |
ensure changes to documents are reviewed and approved by the same function that performed the original review, or a designate | O O O |
| 08 | Altered or New Text
4.3.3.2 |
ensure the altered or new text is identified in the document or the appropriate attachments, as practical | O O O |
| 09 | Handwritten Amendments
4.3.3.3 |
define procedures and authority for handwritten amendments to documents, and formal reissue | O O O |
| 10 | Computerised Amendments
4.3.3.4 |
establish procedures for changes to and control of computerized documents | O O O |
A.04 4.4 Review of Requests, Tenders and Contracts
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.4.1 |
ensure policies and procedures related to review of requests, tenders and contracts are established and maintained; the procedures shall ensure:
|
O O O Yes No N/A |
| 02 | Records of Review
4.4.2 to 4.4.3 |
maintain records of reviews, that include:
|
O O O
Yes No N/A |
| 03 | Notification of Client
4.4.4 |
ensure client is informed of any deviations from the contract | O O O |
| 04 | Contract Amendments
4.4.5 |
ensure the same contract review process is repeated, and amendments communicated to all personnel | O O O |
A.05 4.5 Subcontracting of Tests and Calibrations
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Competency
4.5.1, 4.5.4 |
ensure that subcontractors are competent (e.g., comply with ISO/IEC 17025:1999) and maintain records of competent subcontractors used | O O O |
| 02 | Client Approval
4.5.2, 4.5.3 |
ensure client approval has been obtained before work is subcontracted, unless specified by the client or regulatory authority | O O O |
A.06 4.6 Purchasing Services and Supplies
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.6.1 |
document policies and procedures related to:
|
O O O
Yes No N/A |
| 02 | Verification
4.6.2 |
ensure all purchased supplies that affect the quality are not used until verified compliant with specifications, and maintain records | O O O |
| 03 | Purchasing Documents
4.6.3 |
ensure purchasing documents are reviewed and approved for technical content prior to release | O O O |
| 04 | Approved Suppliers
4.6.4 |
maintain records of investigation of suppliers and a list of all approved suppliers | O O O |
A.07 4.7 Service to Client
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.7 |
ensure policies and procedures are in place for co-operation with clients | O O O |
A.08 4.8 Complaints
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.8 |
document policies and procedures for the resolution of complaints from clients or other parties | O O O |
| 02 | Records
4.8 |
maintain records of complaints, investigations and corrective actions | O O O |
A.09 4.9 Control of Nonconforming testing and/or Calibration Work
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.9 |
ensure policies and procedures related to work or results that do not conform to procedures or client requirements are implemented; the procedures shall ensure:
|
O O O
Yes No N/A |
A.10 4.10 Corrective Action
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Policies and Procedures
4.10 |
document policies and procedures and designate appropriate authorities for implementing corrective actions; the procedures shall include:
|
O O O
Yes No N/A |
A.11 4.11 Preventive Action
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Action Identification
4.11.1 |
ensure needed improvements and potential sources of non-conformances are identified | O O O |
| 02 | Action Plans
4.11.1, 4.11.2 |
ensure preventive action plans are developed, implemented and monitored for effectiveness | O O O |
A.12 4.12 Control of Records
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Procedures
4.12.1 |
document procedures related to control of quality and technical records:
|
O O O
Yes No N/A |
| 02 | Record Integrity
4.12.1 |
ensure all records are:
|
O O O
Yes No N/A |
| 03 | Technical Records
4.12.2 |
ensure testing laboratory retains technical records of:
|
O O O
Yes No N/A |
| 04 | Record Information
4.12.2 |
ensure records maintained contain sufficient information to:
|
O O O
Yes No N/A |
| 05 | Recording
4.12.2.2 |
ensure observations, data and calculations are recorded at the time they are made and be identifiable to the specific task | O O O |
| 06 | Corrections to Records
4.12.2.3 |
ensure any changes to the original records are made so that:
|
O O O
Yes No N/A |
| 07 | Corrections to Electronic Records
4.12.2.3 |
ensure measures are taken to avoid loss or change of original data stored electronically | O O O |
A.13 4.13 Internal Audits
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Requirements
4.13 |
ensure internal audits are periodically conducted to verify operations comply with all elements of the quality system and requirements of ISO/IEC 17025:1999; ensure that:
|
O O O
Yes No N/A |
A.14 4.14 Management Reviews
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Objectives
4.14.1 |
ensure the appropriate level of the testing laboratory management periodically carries out management review of the quality system, based on predetermined schedule and procedure, to ensure continuing suitability and effectiveness and to introduce necessary changes or improvements | O O O |
| 02 | Contents
4.14.1 |
ensure the contents of the management review include:
|
O O O
Yes No N/A |
| 03 | Actions Taken
4.14.2 |
ensure actions are carried out within an appropriate and agreed time scale | O O O |
| 04 | Records
4.14.2 |
maintain records of management reviews and actions taken | O O O |
5.0 TECHNICAL REQUIREMENTS
B.01 5.2 Personnel
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Qualifications
5.2.1 |
ensure personnel performing specific tasks are qualified on the basis of education, training, experience and/or demonstrated skills | O O O |
| 02 | Trainees
5.2.1 |
ensure staff being trained have adequate supervision | O O O |
| 03 | Training Program
5.2.2 |
ensure there is a training program that documents policies and procedures for establishing goals and identifying training needs and provision of training | O O O |
| 04 | Employees
5.2.3 |
ensure personnel are employed or contracted by the testing laboratory, and ensure contracted personnel are supervised, competent and work in accordance with the quality system | O O O |
| 05 | Job Descriptions
5.2.4 |
document current job descriptions for managerial, technical and key support staff | O O O |
| 06 | Authorised Personnel
5.2.5 |
ensure management has authorised specific personnel to:
|
O O O
Yes No N/A |
| 07 | Records
5.2.5 |
ensure testing laboratory maintains records for all technical personnel (including contracted personnel) for:
|
O O O
Yes No N/A |
B.02 5.3 Accommodation and Environmental Conditions
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Technical Requirements
5.3.1 |
ensure that technical requirements for accommodation and environmental condition are documented | O O O |
| 02 | Facility
5.3.1 |
ensure the testing laboratory or off-site facility(ies) accommodation and environmental conditions do not compromise the quality of results | O O O |
| 03 | Monitoring
5.3.2 |
ensure testing laboratory monitors, controls and records environmental conditions, where applicable | O O O |
| 04 | Termination
5.3.2 |
ensure tests and/or calibrations are terminated when results are jeopardised by the environmental conditions | O O O |
| 05 | Incompatible Activities
5.3.3 |
ensure there is effective separation between areas of incompatible activity | O O O |
| 06 | Access
5.3.4 |
ensure access to office and testing laboratory areas is controlled | O O O |
| 07 | Housekeeping
5.3.5 |
ensure housekeeping measures are adequate | O O O |
B.03 5.4 Test and Calibration Methods and Method Validation
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Methods and Procedures
5.4.1 |
ensure testing laboratory uses appropriate methods and procedures for calibrations and tests including, where appropriate, estimation of uncertainty and statistical techniques for analysis of data | O O O |
| 02 | Equipment Instructions
5.4.1 |
ensure testing laboratory uses appropriate instructions for the operation of equipment, where the absence of the instructions would affect the work | O O O |
| 03 | Method Deviations
5.4.1 |
ensure that deviations from the test and calibration methods are:
|
O O O
Yes No N/A |
| 04 | Method Selection
5.4.2 |
ensure testing laboratory selects test and/or calibration methods that:
|
O O O
Yes No N/A |
| 05 | Non-Client Specified Method Selection
5.4.2 |
for non-client specified methods, ensure the testing laboratory informs the client of the method chosen, and selects methods that are either:
|
O O O
Yes No N/A |
| 06 | Inappropriate Methods
5.4.2 |
ensure testing laboratory informs the client if the method proposed by the client is inappropriate or out of date | O O O |
| 07 | Testing laboratory-Developed Methods
5.4.3 |
ensure testing laboratory developed methods are planned, and assigned to qualified personnel | O O O |
| 08 | Non-standard Methods
5.4.4 |
when methods used that are not covered by standard methods, ensure that:
|
O O O
Yes No N/A |
| 09 | Method Validation
5.4.5 |
ensure the method validation includes:
|
O O O
Yes No N/A |
| 10 | Range and Accuracy
5.4.5 |
verify that the testing laboratory ensures the range and accuracy of the test and/or calibration results are relevant to the clients' needs | O O O |
| 11 | Uncertainty of Measurement
5.4.6 |
ensure testing laboratory has a procedure to estimate the uncertainty of measurement that includes relevant uncertainty components and uses appropriate methods | O O O |
| 12 | Calculations and Data Transfers
5.4.7 |
ensure calculations and data transfers are checked in a systematic manner | O O O |
| 13 | Computers or Automated Equipment
5.4.7 |
ensure for computers or automated equipment used:
|
O O O
Yes No N/A |
| 14 | Protection of Data
5.4.7, 5.10.7 |
ensure procedures for protection of data are established and include:
|
O O O
Yes No N/A |
B.04 5.5 Equipment
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Operation
5.5.1 to 5.5.4 |
ensure all equipment (including that outside the testing laboratory's control) required for the test and/or calibration procedure is:
|
O O O
Yes No N/A |
| 02 | Records
5.5.5 |
ensure records of equipment are maintained and include:
|
O O O
Yes No N/A |
| 03 | Procedures
5.5.6, 5.5.10, 5.5.11 |
ensure procedures for the management of measuring equipment are established and include:
|
O O O
Yes No N/A |
| 04 | Out of Service
5.5.7 |
ensure equipment subjected to overloading or mishandling, gives suspect results, or shown to be defective or outside of specified limits is taken out of service, and is:
|
O O O
Yes No N/A |
| 05 | Calibration Status
5.5.8 |
ensure equipment calibration status is identified, where practicable | O O O |
| 06 | Return to Service
5.5.9 |
ensure that if equipment goes outside the direct control of the testing laboratory, it is checked and validated before being returned to service | O O O |
| 07 | Adjustments
5.5.12 |
ensure equipment is safeguarded from adjustments that would invalidate results | O O O |
B.05 5.6 Measurement Traceability
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Calibration Program
5.6.1, 5.6.2 |
ensure the testing and/or calibration testing laboratory has a calibration program for its measurement and test equipment | O O O |
| 02 | Traceability
5.6.2 |
verify the calibration program ensures the measurements from the testing laboratory are traceable to SI units:
When using internal calibration source, ensure there is an unbroken chain linking to the primary standards of the SI units. When using external calibration source, ensure:
|
O O O
Yes No N/A |
| 03 | Traceability
5.6.2 |
where measurement traceability cannot be strictly made to International System (SI) units, establish traceability by use of:
|
O O O
Yes No N/A |
| 04 | Reference Standards and Reference Materials
5.6.3 |
ensure the testing and/or calibration testing laboratory has procedures for the:
|
O O O
Yes No N/A |
B.06 5.7 Sampling
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Procedures and Plan
5.7.1 |
ensure procedures for sampling are available at the location where required, and include:
|
O O O
Yes No N/A |
| 02 | Deviations
5.7.2 |
ensure client-requested deviations from the sampling plan are documented and communicated to the appropriate personnel | O O O |
| 03 | Records
5.7.3 |
ensure testing laboratory has procedures for recording sampling data and operations; records to include:
|
O O O
Yes No N/A |
B.07 5.8 Handling of Test and Calibration Items
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Procedures
5.8.1 |
document procedures for test and/or calibration item management:
|
O O O
Yes No N/A |
| 02 | Identification
5.8.2 |
ensure testing laboratory has a system for identifying test and/or calibration items | O O O |
| 03 | Deficiencies
5.8.3 |
ensure any abnormalities and deficiencies upon item receipt are recorded; if in doubt about suitability of item, ensure that client is contacted and instructions are recorded | O O O |
| 04 | Facilities
5.8.4 |
ensure testing laboratory has appropriate facilities to maintain item integrity, and the protection of secured items | O O O |
| 05 | Environmental Conditions
5.8.4 |
ensure required environmental conditions for items are maintained, monitored and recorded, as appropriate | O O O |
B.08 5.9 Assuring the Quality of Test and Calibration Results
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Quality Control
5.9 |
ensure testing laboratory has planned quality control procedures for monitoring data validity; monitoring may include but is not limited to:
|
O O O
Yes No N/A |
| 02 | Quality Control Data
5.9 |
ensure that the planned quality control data are reviewed, recorded to detect trends, and, where practicable, statistical techniques are applied | O O O |
B.09 5.10 Reporting the Results
| ITEM | CLAUSE | REQUIREMENT | 1 2 3 COMMENTS |
|---|---|---|---|
| 01 | Test Reports and Calibration Certificates
5.10.2, 5.10.6, 5.10.8 |
provide test reports and calibration certificates that contain:
|
O O O
Yes No N/A |
| 02 | Test Result Interpretation
5.10.3 |
where necessary for the interpretation of results, ensure test reports include the following:
|
O O O
Yes No N/A |
| 03 | Calibration Result Interpretation
5.10.4 |
where necessary for the interpretation of results, ensure calibration certificates include the following:
|
O O O
Yes No N/A |
| 04 | Compliance Data Records
5.10.4.2 |
ensure testing laboratory maintains records of measurement results and associated uncertainties, when these items are omitted from the reported statement of compliance | O O O |
| 05 | Statement of Compliance
5.10.4.2 |
ensure uncertainty of measurement is accounted for when statements of compliance are made | O O O |
| 06 | Repairs and Adjustments
5.10.4.3 |
ensure calibration results before and after adjustments/repairs are reported, if available | O O O |
| 07 | Calibration Intervals
5.10.4.4 |
ensure calibration certificates or labels do not recommend calibration intervals unless requested by the client or legally regulated | O O O |
| 08 | Opinions and Interpretations
5.10.5 |
ensure testing laboratory documents the basis upon which opinions and interpretations have been made, when applicable | O O O |
| 09 | Amendments
5.10.9 |
issue, as necessary, revised test reports and calibration certificates that:
|
O O O
Yes No N/A |
| 10 | Simplified Reporting
5.10.1 |
when results are reported in a simplified way (i.e. for internal clients, or in the case of a written agreement with a client), ensure any information normally reported to the client is maintained |