ISO 17025

ISO 17025 Checklists

ISO 17025 Audit Checklists about Organization

Clause 4.1

1 Does the laboratory management system cover work at its permanent & outside premise and mobile facilities?

2 For those who manage, perform and verify work, are their responsibilities and authorities defined?

3 Are all laboratory employees free from any undue commercial, financial and other pressures that may affect the quality of their work?

4 Are policies and procedures to ensure the protection of client’s confidentiality and proprietary rights established and maintained?

5 Are key positions in this chart defined?

6 Is there an Organization chart available?

7 Does it contain all units (departments) responsible for quality, technical operations and support services?

8 Are the supervision of laboratory staff and assessment of the results adequate and suitable?

9 Management Representative – has this person being appointed?

10 Are his responsibility & authority defined?

11 Is he able to direct access to the top management when quality matters are concerned?

12 Is he competent to ensure?

(a) Compliance to the ISO standard & the company’s specific Quality System.
(b) Implement all relevant requirements?

13 Are there appointed deputies for all key managerial personnel?

14 Are all staff aware of the relevance and important of their activities to the objectives achievement?

Clause 4.2
1 what quality documents do they have for their laboratory/organization?

• Manual
• Procedure
• Policy
• Program

2 Who are responsible for the quality documents?

3 Where are the quality documents located/kept?

4 How do you make sure that staff know and understand the quality policy and quality system?

5 Who is the person responsible for the quality policy?

• Changes
• Approval

6 What are the policy and procedure for reviewing the quality documents?

• How is the procedure for any changes to your quality documents?
• What are the recent changes to the documents?
• How do you inform the staff of the changes?

ISO 17025 audit checklist about document control

Clause 4.3

General terms of document control

• What is the policy & procedure on document control?
• How is document amendment carry out?
• Who is authorized to approve the changes?
• Is there a record of change?
• Is there a distribution list?
• How do you issue out new doc and retrieve the obsolete copy?
• How do you dispose the obsolete copy?
• How do you track the revision number?
• Do you have a doc control number system?
• Where to you keep/file all obsolete copies for future reference?
• How long do you keep them?

4.3.1 General

• Are there documented procedures established and responsibilities defined to control all documents and data that form part of the quality system?

4.3.2 Document Approval & Issue

• Are these procedures defined for: (establishment, review, approval, identification and distribution) of (system-related, operation -related and governing) documents?
• Do policy and procedure documents have unique identifiers?
• Are these documents clearly marked?
• Do all documents carry revision status and date?
• Is it ensured the latest revision of document is available at the relevant places?
• Are obsolete documents: removed from all points of used; clearly marked as obsolete or destroyed; retained for legal or knowledge preservation and identified as such?
• Is all documents review periodically to ensure continuing suitability?

 

4.3.3 Document Changes

• Are procedures and responsibilities for handling changes defined and documented?
• Are all changes to controlled documents reviewed and approved by the same functions that performed the original review?
• If not, are there documented procedures for the designated functions/organizations to follow and do they have access to the background information?
• Are responsibilities and time for storage of quality system documents defined and documented?

ISO 17025 audit checklist about review of Requests, Tenders and Contracts

Clause 4.4

1 Are there documented policies and procedures for contract review?

2 Is coordination between involved organization units clearly defined?

3 Requests, tenders and contracts – are they reviewed for:

a) Correct definition including the methods

b) Documentation

c) Capability and resources such as facilities, manpower, materials, skills, etc.?

4 Are orders and quotations/tenders matched and resolved for any differences before confirmation?

5 Policy on changes to orders – is they defined and follows the procedure?

6 Are reviews to contracts and discussions with the client documented and records maintained?

7 Does the review cover subcontract work by the laboratory?

8 Does the laboratory inform the client of any deviation form the contract?

9 Do you have any documents related to communication with customer on requirements and specification?

10 Where/who update for records, authorized personnel?

ISO 17025 audit checklist about subcontracting of Test & Calibrations

Clause 4.5

1 What are the policy and procedure that they have for subcontracting test & calibrations?

2 Where is the record of evaluation of sub-contractors?

3 How do you communicate with the client about the sub-contracting work and where is the record?

4 How is the policy and procedure on clients’ recommended sub-contracting test/ calibration?

ISO 17025 audit checklist about purchasing Services & Suppliers
Clause 4.6

1 Do you have a policy/procedure for this element?

2 Please show me you record of evaluation

• How do they carry out the evaluation?

• Based on what criteria they do the selection?

• Who is authorized and responsible for the approval?

3 Is there a list of approved suppliers?

• Please show the list?

• How do you monitor their performance?

• If the supplier is below acceptable performance, what are you going to do/action?

• Any record of termination?

ISO 17025 audit checklist about service to the customer
Clause 4.7

1 Do you have the procedure of customer servicing including:

• Confidentiality?
• Security?
• Visitors?
• Packaging & delivery?

2 Do you have any record & could you show

• The feedback from customer?
• The action taken by laboratory related to the feedback from customer?
• Evidence of communication?
• Packaging & delivery record?

 

ISO 17025 audit checklist about complaints
Clause 4.8

1 What are the policy & procedure to resolve complaints?

2 How do you record the complaints?

3 Who’s responsible to do the investigation?

4 How do you handle the complaints? Check the last QMR minute?

5 Who approve the corrective action?

ISO 17025 audit checklist about Control of Non-confirming (NC) Testing and/or Calibration Work
Clause 4.9

1 What are the policy & procedure on the control of non-confirming test?

2 How does the lab handle the NC material/test/instrument?

3 Is there any record on corrective action?

4 Who’s responsible to verify the corrective action?

5 Do the lab notify their client and where is the record?

ISO 17025 audit checklist about Improvement Calibration Work
Clause 4.10

Is there any evidence on continuous improvement of its management system;

• Quality policy?

• Quality objectives?

• Audits results?

• Analysis of data?

• Corrective and preventive actions?

• Management review?

ISO 17025 audit checklist about Corrective Action
Clause 4.11

1 What are the policy & procedure related to corrective action?

2 Who make the analysis of the root cause of the problem, the decision and the action?

3 How does the lab make the selection and implementation of CA?

4 How does the lab monitor the effectiveness of CA?

5 Any additional audit?

6 Where is the record on the corrective action taken?

ISO 17025 audit checklist about Preventive Action
Clause 4.12

1 What are the policy & procedure related to preventive action?

2 What is the lab action plan to ensure the PA is effective?

3 Where is the record on the preventive action taken?

ISO 17025 audit checklist about Control of Records
Clause 4.13

1 What are the policy & procedure related on controlling of the record?

2 How do the lab identify their record?

3 Where is the master list of the record?

4 How the lab controls the accessibility on their record?

5 What is the retention period for the records?

6 How the lab disposes the obsolete copies?

ISO 17025 audit checklist about Internal Audits
Clause 4.14

1 Is the laboratory conduct its internal audit by predetermine schedule and procedure periodically?

2 Do all element of management system are included in the internal audit program (including testing and calibration activities)?

3 Have the audits been carried by trained and qualified personnel?

ISO 17025 audit checklist about Management Reviews
Clause 4.15

1 What are the policy & procedure related to QMR?

2 Where is the QMR minutes and schedule? Check the requirement and the evident of continuous improvement?

ISO 17025 audit checklist about personnel requirements
Clause 5.2

1 What is the policy & procedure related to personnel?

2 Where is the personnel record?

3 Does the lab have any training program and plan?

4 Is the lab personnel competence to do the job?

ISO 17025 audit checklist about Accommodation & Environmental Conditions
Clause 5.3

1 What is the policy & procedure related to accommodation & environmental conditions?

2 Any house keeping program/record?

3 Any record on environment monitoring?

4 Any safety/security procedure and record?

ISO 17025 audit checklist about Test and calibration methods and method validation
Clause 5.4

1 What are the policy & procedure related to test method and method validation?

2 Where is the list of the test method used by the lab?

3 What is the level of the standard test method?

• Standard test method?
• Lab-developed method?
• Non-standard method?

4 Any validation on their test?

5 Does the lab have records related to measurement of uncertainty, validation, verification, conformation of the test method?

6 Who are the authorized personnel related to selection of test method? How does the lab make the selection of test method, calibration and method validation?

7 How the lab control on their data?

ISO 17025 audit checklist about Equipment requirements
Clause 5.5

1 What are the policy & procedure related to equipment?

2 Where is the master list related to the instrument used by the lab?

3 Any preventive maintenance and calibration program?

4 Where are the record, logbook and information (such as manual & handling procedure) related to the instrument?

5 How do the lab label their instrument (such as calibrated, break down, obsolete, under run test etc.)?

6 How does the lab segregate them?

7 How does the lab control the nonconforming instrument?

 ISO 17025 audit checklist about Measurement traceability
Clause 5.6

1 What are the policy & procedure related to measurement trace ability?

2 Where is the list of the apparatus, instrument and/or reference material that need to be calibrated?

3 Where are the record & certificates of calibration and the statement of fit for use?

4 Where is the list standard reference material and relevant standards? Any evidence of trace ability to national/international standard?

ISO 17025 audit checklist about sampling activities
Clause 5.7

1 What are the policy & procedure related to sampling?

2 Do the labs have; method of sampling and the sampling plan?

3 Any other apparatus/instrument could effect on the sample during sampling process?

ISO 17025 audit checklist about Handling of test & calibration items
Clause 5.8

1 What are the policy & procedure related to handling of test/calibration items (handling, transport, storage, maintenance, protection and disposal)?

2 Does the lab have the procedure on nonconforming items and where is the record?

ISO 17025 audit checklist about Assuring The Quality of Test and Calibration Results

Clause 5.9

1 What are the policy & procedure related to assuring the quality of test and calibration results?

2 Do the lab have the record on;

• Calibration
• Proficiency test
• Control chart for IQC?

3 What is the control action taken by the lab?

• Retesting of retention items
• Replicate test
• Comparative test and verification the parameter
• Inter lab cross check

4 How do the lab sure there is sufficient supervision in quality control action?

5 Who are the authorized personnel related to the quality of test /calibration result?

ISO 17025 audit checklist about Reporting the Results
Clause 5.10

1 What are the policy & procedure related to reporting the results?

2 Any standard format of the test report?

3 How do the lab analyzed the test results and to control the nonconforming in reporting the results?

4 Who are the authorized personnel for data checking, report preparation and approval of the test report?

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