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?
(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?
1 what quality documents do they have for their laboratory/organization?
• Manual
• Procedure
• Policy
• Program
• 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
• 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?
• 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?
• 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?
• 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
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
Clause 4.7
1 Do you
have the procedure of customer servicing including:
•
Confidentiality?
• Security?
• Visitors?
• Packaging & delivery?
• 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?
• 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
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
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
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
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
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
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
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
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
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
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
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?
• 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
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?
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
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
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?
• 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
• 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
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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