Professional Documents
Culture Documents
When writing a quality manual according to ISO/IEC 17025, remember that assigning
responsibilities and appropriate authority work hand in hand.
In the context of quality management, this may involve giving a quality manager
authority on quality matters over a line management superior. The superior, in
supporting the quality policy, should respect this authority.
The quality manual will need to give an alternative, such as a deputy or another
point of reference when a post holder or a member who has a responsibility is
not available.
Your laboratory must provide a statement that all responsibilities ultimately
revert to the laboratory manager who may delegate them again if necessary.
The laboratory should always try to ensure that the laboratory manager and his
or her deputy are never unavailable at the same time.
Provide Flexibility When Writing a Quality Manual
It contains:
The person accepting the work is under an obligation to make sure your
laboratory has the expertise and equipment to execute the work.
The person accepting the work must not enter into a commitment unless they
can be certain on this point.
Quality documentation
This area determines the structure of the quality documentation. This will traditionally
be a hierarchy, headed by the quality manual, which refers to the methods manual or
equivalent technical and other procedural documentation.
Mandatory documents for ISO/IEC 17025 2017 version
Additionally, your laboratory should refer to mandatory records and documentation
such as :
Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
Quality Policy (Clauses 8.2.1 & 8.2.2)
Competence, Training and Awareness Procedure (Clause 6.2.5)
Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
Externally Provided Products and Services Procedure (Clause 6.6.2)
Facilities and Environment Procedure (Clause 6.3)
Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
Customer Service Procedure (Clauses 7.1.1 & 8.6)
Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that
do sampling)
Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10
& 8.7)
Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories
that write test reports)
Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and
7.8.4, applicable to calibration laboratories that write calibration certificates)
Internal Audit Procedure (Clause 8.8.2)
Management Review Procedure (Clause 8.9)
List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
List of Types of Records (Clause 8.4)
Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
Quality Objectives (Clauses 8.2.1 & 8.2.2)
Training Program (Clause 6.2.3)
Training Record and Performance Monitoring (Clause 6.2.2)
Record of Attendance (Clause 6.2.2)
Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
Supplier Evaluation and Approval Record (Clause 6.6.2a)
List of Approved Suppliers of Products and Services (Clause 6.6.2a)
Record of Laboratory Environmental Controls (Clause 6.3.3)
List of Laboratory Equipment (Clause 6.4.13a)
Calibrated Equipment Record (Clause 6.4.13a)
Calibration Record (Clause 6.4.13e)
Equipment Maintenance Record (Clause 6.4.13g)
Customer Order Review (Clause 7.1.1a)
Report of Customer Satisfaction (Clause 8.6.2)
Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
Sampling Plan (Clause 7.3.1) (as applicable)
Sampling Report (Clause 7.3.3) (as applicable)
Corrective Action Report (Clause 8.7.3)
Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
Measurement Uncertainty Record (Clause 7.6.3)
Audit Nonconformity Report (Clause 8.8.2d)
Internal Audit Report (Clause 8.8.2e)
Management Review Record (Clause 8.9.2)
Quality documentation should identify:
Recording of results
This section must explain the use of notebooks and/or worksheets. Likewise, your
laboratory must indicate instructions on the use of ink and the way of making
corrections.
Disposal of samples and other waste
In writing this area of the quality manual following ISO/IEC 17025, your laboratory
must identify:
This should establish who may authorize disposal and require that an inventory be kept
of the records disposed of.
Your laboratory must state the policy on the security of records, including computer
data and the person responsible for archiving and computer back-up.
Reporting of results
Your laboratory must provide the minimum requirement for the contents of a report
(see section 13.2) and include an example of the preferred layout.
This means staff must be instructed to take all reasonable precautions to keep the
client’s data and other information confidential. Similarly, no such information is left
out in the laboratory overnight or in an unattended room.
Staff appointment, training and review
In this area of the quality manual, your laboratory must write the operation of the staff
records, including their use for recording new staff and changes in the training or status
of existing staff.
It must describe the following:
The mechanism for selecting staff for training, carrying out the training.
The mechanism for assessing competence.
The mechanism for issuing authorizations to carry out calibrations, tests, and other
procedures.
The mechanism for an annual review of staff capabilities and the means of recording the
results.
Hence, staff should be instructed of their responsibility to carry out only operations for
which they are authorized. It should also clearly instruct that staff is entitled to refuse to
do work for which they are not authorized.
Procedures for audit and review of the quality system
To write a comprehensive quality manual, this segment must describe the procedures
for the audit and review of the quality system. Besides, your laboratory must include
the records to be kept and the policy on the frequency of audits and reviews.
Corrective action
According to ISO 17025, a quality manual should describe:
Any parts of the premises to which access is restricted and who is authorized to
grant access.
Any areas subject to special environmental controls as well as the mechanism for
monitoring, recording, and maintaining such control.
Likewise, you must describe the facilities provided to ensure necessary segregation if
there are activities conducted by your laboratory that are incompatible.
Security of premises
Writing a quality manual in line with ISO/IEC 17025 requires this section to describe
the arrangements for the security of the premises during and outside working hours.
This must also identify the persons authorized to hold keys, establish the procedure for
granting authorization, and determine the person with overall responsibility for
security.
Appendices
Finally, for your quality manual to comply with ISO/IEC 17025 standards, there should
be appendices covering a list of the scope of accreditation held or applied for, as well as
a list of holders of the quality manual.
This area must also identify a list of all controlled documents and subsidiary
documentation together with their scope of issue or storage locations.
It must incorporate examples of recording quality issues like client complaints, audits,
and corrective and preventive actions. An example of your laboratory’s proposed report
format should be accounted for.