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QUALITY MANUAL
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TABLE CONTENTS
LOGO LAB NAME
Document No XXXX/QM/001 Document Quality manual
Name
Issue No.: 01 Issue Date: Copy No.: Page 3 of69
ANNEXURE
1 1 List of Quality System Procedures 56
2 2 List of Standard Operating Procedures 57
3 3 List of External Origin Documents 59
4 4 List of Documents 62
5 5 List of Records 63
6 6 Organisation Chart 65
7 7 Duties and Responsibilities and Authority 66
8 8 Risk Assessment 71
a. Calibration 72
b. Impartiality 75
DISTRIBUTION LIST
* Uncontrolled: Any other copy other than the above list is uncontrolled copy.
ABBREVIATIONS
XXXX Lab Name
QUALITY POLICY
Quality Objectives
Enhance Customer satisfaction
Enhance accuracy of test results by way of quality assurance efforts
like. ILC, PT etc.
Focus on continual improvements
Reduction of errors in sample collection
Improving of results
Knowledge Upgradation
Timely Calibration of Instruments / Validation of measuring devices
Reducing Downtime
Reducing Complaints
Introduction
LOGO LAB NAME
Document No XXXX/QM/001 Document Quality manual
Name
Issue No.: 01 Issue Date: Copy No.: Page 8 of69
3.2 Complaint
Expression of dissatisfaction by any person or organization to laboratory,
relating to the activities or results of that laboratory, where a response is
expected.
3.6 Laboratory
Body that performs one or more of the following activities:
Testing
Calibration
Sampling, associated with subsequent testing
3.8 Verification
Provision of objective evidence that a given item fulfils specified requirements.
4 GENERAL REQUIREMENTS
4.1.3 XXXX responsible for the impartiality of its laboratory activities does not
allow commercial, financial or other pressures to compromise impartiality.
XXXX established procedure for risk assessment to identify various risks wrt
impartiality and the mitigation plan. For being impartial, XXXX conduct its
activities without any bias. Results of the laboratory is not compromised due to
being influenced by any relationships of the laboratory’s personnel involved in
the activities of the XXXX, with its customer. Risks to impartiality may also
arise within XXXX itself by means of creating undue pressure on the analysts/
technicians to skip the test procedural steps for faster results delivery or to
overlook the adverse results which will distress a customer. Further undue
pressure may also include offering monetary incentives to the employees for
the number of tests conducted or the results of test. (Ref: XXXX/QSP/001 –
Quality Procedure for Risk Assessment). Annexure 10 – Risk
Assessment.
For example:
4.2 Confidentiality
4.2.1 XXXX established Quality System procedure for handling
confidentiality. (Ref: XXXX/QSP/002- Handling Customer’s Confidential
Information). XXXX responsible, through legally enforceable commitments,
for the management of all information obtained or created during the
performance of laboratory activities. XXXX inform the customer in advance, of
the information it intends to place in the public domain. Except for information
that the customer makes publicly available, or when agreed between XXXX
and the customer (e.g. for the purpose of responding to complaints), all other
information is considered proprietary information and regarded as confidential.
Technical Manager ensure that customer related data accessible to his/her
only & do not share to other customer. All data in hard-copy should be locked
& safe. The soft copies are password protected.
4.2.3 Information about the customer obtained from sources other than the
customer (e.g. complainant, regulators) confidential between the customer and
the laboratory. The provider (source) of this information is confidential to
XXXX and do not share with the customer, unless agreed by the source.
5 STRUCTURAL REQUIREMENTS
LOGO LAB NAME
Document No XXXX/QM/001 Document Quality manual
Name
Issue No.: 01 Issue Date: Copy No.: Page 16 of69
XXXX is a legal entity. XXXX comply with the legal status requirement of
clause 5. Quality Manager periodically review these documents for updation,
annual filing and renewal as applicable.
5.3 XXXX defines and document the range of laboratory activities for which it
conforms with this document. Refer:-1.0 Scope of Accreditation. XXXX
claim conformity with this document for this range of laboratory activities,
which excludes externally, provided laboratory activities on an ongoing basis.
Communication Plan
PHOTO
6.1 General
LOGO LAB NAME
Document No XXXX/QM/001 Document Quality manual
Name
Issue No.: 01 Issue Date: Copy No.: Page 21 of69
6.2 Personnel
6.2.1 All personnel of the laboratory, both internal and external, act
impartially, are competent and work in accordance with the laboratory’s
management system.
6.2.3 XXXX ensures that the personnel have the competence to perform
laboratory activities for which they are responsible and to evaluate the
significance of deviations.
b. Electromagnetic disturbances
c. Radiation
d. Humidity
e. Electrical supply
f. Temperature
a) Only the lab staffs and Authorized person area allowed to enter in the
lab. On particular circumstances, like witnessing by the customer,
or
XXXX do not perform any activities at sites or facilities outside our permanent
control.
6.4 Equipment
6.4.1 XXXX has established Quality System Procedure
(Ref: XXXX/QSP/005- Equipment Maintenance). XXXX have access to
equipment including, but not limited to, measuring instruments, software,
measurement standards, reference data, reagents, consumables or auxiliary
apparatus which is required for the correct performance of laboratory activities
and which can influence the result. XXXX have access to the equipment for
its dedicated use only either by ownership or by long term contract / lease.
Such contract shall be of minimum of 02 years. The control of such equipment
shall lie with the laboratory under the contractual agreement.
6.4.2 When XXXX uses equipment outside its permanent control, it ensures
that the requirements for equipment of this document are met or XXXX uses
equipment only in its permanent facility.
Or
XXXX do not perform any activities at sites or facilities outside our permanent
control.
PHOTO PHOTO
PHOTO PHOTO
7.1.2 XXXX informs the customer when the method requested by the
customer is considered to be inappropriate or out of date.
7.1.4 Any differences between the requests or tender and the contract are
resolved before laboratory activities commence. Each contract is acceptable
both to XXXX and the customer: Deviations requested by the customer impact
the integrity of XXXX or the validity of the results.
7.1.5 The customer has to be informed of any deviation from the contract.
7.2.1.1 XXXX appropriate methods and procedures for all laboratory activities
and, where appropriate, for evaluation of the measurement uncertainty as well
as statistical techniques for analysis of data.
7.2.1.3 XXXX ensure that is uses the latest valid version of a method unless it
is not appropriate or possible to do so. Application of the method
supplemented with additional details to ensure consistent application.
7.2.1.4 When the customer does not specify the method to be used, XXXX
selects an appropriate method and informs the customer for the method
chosen. Methods published either in international, regional or national
standards, or by reputable technical organizations, or in relevant scientific
texts or journals, or as specified by the manufacturer of the equipment, are
recommended. Laboratory-developed or modified methods can also used.
These can be retained only if the lab adopts all these methods and in the
scope of accreditation also.
7.2.1.5 XXXX verifies that it can properly perform methods before introducing
them by ensuring that it can achieve the required performance. Records of the
verification are retained. If the method is revised by the issuing body,
verification is repeated to the extent necessary.
7.2.1.7 Deviations from methods for all laboratory activities occur only if the
deviation has been documented, technically justified, authorized, and accepted
by the customer:
7.2.2.1 XXXX conducts its tests as per nationally and internationally approved
test methods. For example IS AAAA, IS BBBB, etc. In case, such test methods
are not available, XXXX develop non-standard methods. XXXX established
Quality System procedure for (Ref: XXXX /QSP/012-Test Methods and
Methods Validation). XXXX validates non-standard methods, laboratory-
developed methods and standard methods used outside their intended scope
or otherwise modified. The validation as extensive as in necessary to meet
the needs of the given application or field of application.
7.2.2.2 When changes are made to a validated method, the influence of such
changes determined and where they are found to affect the original validation,
a new method validation performed.
7.2.2.4 XXXX retains the following records of validation (Form No: XXXX
/LQMS/0220 - Statement of Method Validation).
Or
XXXX do not perform sampling activities. The sampling is in the scope of the
customer.
7.4.3 Upon receipt of the test or calibration item, deviations from specified
conditions recorded. When there is doubt about the suitability of an item for
calibration, or when an item does not conform to the description provided,
XXXX consult the customer for further instructions before proceeding and
record the results of this consultation. When the customer requires the item to
be tested or calibrated acknowledging a deviation from specified conditions,
XXXX includes a disclaimer in the report indicating which results may is
affected by the deviation.
7.8.1.2 When agreed with the customer, the results may report in a simplified
way. Any information listed in 7.8.2 to 7.8.7 that is not reported to the
customer readily available.
7.8.2.1 Each report includes at least the following information, unless XXXX
has valid reasons for not doing so, thereby minimizing any possibility of
misunderstanding or misuse: (Annexure 11 – Sample Test Report)
7.8.2.2 XXXX responsible for all the information provided in the report, except
when information is provided by the customer. Data provided by a customer
clearly identified. In addition, a disclaimer put on the report when the
information is supplied by the customer and can affect the validity of results.
Where XXXX has not been responsible for the sampling stage (e.g. the
sample has been provided by the customer), it state in the report that the
results apply to the sample as received.
Or
Or
All accredited XXXX measurement facilities perform calibrations and
issue calibration certificates. Thus section 7.8.5 of ISO/IEC 17025
dealing with Sampling Report is not applicable.
7.8.6.2 XXXX report on the statement of conformity, such that the statement
clearly identifies:
7.8.8.2 Amendments to a report after issue are made only in the form of a
further document, or data transfer, which includes the statement “Amendment
to Report, serial number… [Or an otherwise identified]”, or an equivalent form
of wording.
7.8.8.3 When it is necessary to issue a complete new report, this will contain
an new report number and contain number of old report to the original that it
replaces.
7.9 Complaints
7.9.1 XXXX has a documented process (XXXX/QSP/018-Complaint
Handling) to receive, evaluate and make decisions on complaints.
7.9.7 Whenever possible, XXXX gives formal notice of the end of the
complaint handling to the complainant. (Form No: XXXX/LQMS/0270 –
Customer Complaint Register).
7.11.1 XXXX has access to the data and information needed to perform
laboratory activities.
All files (hard or soft) kept in proper manner that it can be protected with
password or locked, backup is taken periodically, easy retrieval.
Or
7.11.5 XXXX ensures that instructions, manuals and reference data relevant
to XXXX information management system is made readily available to
personnel.
8.1.2 Option A
As a minimum, the management system of XXXX addresses the following:
8.2.2 The policies and objectives address the competence, impartiality and
consistent operation of the laboratory.
8.2.5 All personnel involved in laboratory activities have access to the parts
of the management system documentation and related information that are
applicable to their responsibilities.
8.4.2 XXXX implements the controls needed for the identification, storage,
protection, back-up, archive, retrieval, retention time, and disposal of its
records. XXXX retains records for a period consistent with its contractual
obligations. Access to these records consistent with the confidentiality
commitments and records readily available.
8.6 Improvement
8.6.2 XXXX seeks feedback, both positive and negative, from its customers.
The feedback are analyzed and used to improve the management system,
laboratory activities and customer service. (Ref: Form No:
XXXX/LQMS/0280).
XXXX consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that are
addressed as part of continual improvement.
a) Conforms to:
The laboratory’s own requirements for its management system,
including XXXX activities;
The requirements of this document;
b) Is effectively implemented and maintained.
8.8.2 XXXX:
a) Plan, establish, implement and maintain an audit programme including
the frequency, methods, responsibilities, planning requirements and
reporting, which take into consideration the importance of XXXX
activities concerned, changes affecting the laboratory, and the results of
previous audits;
b) Define the audit criteria and scope for each audit;
c) Ensure that the results of the audits are reported to relevant
management;
d) Implement appropriate correction and corrective actions without undue
delay;
e) Retain records as evidence of the implementation of the audit
programme and the audit results.
8.9.3 The outputs from the management review record all decisions and
actions related to at least:
S. No Title Doc. No
ANNEXURE - 2
S. No Title Doc. No
1
Current Date of
Name of Document Document Origin Revision Issue
No. Status
Quality management International Organization 2015 15/09/2015
systems -- Requirements ISO 9001 for Standardization
General requirements for
the competence of testing International Organization 2017 10/09/2017
and calibration ISO/IEC for Standardization
laboratories 17025
Guidelines for auditing ISO 19011 International Organization 2018 07/2018
management systems for Standardization
3. Technical Manager:
6. Administration
7. Analyst
Maintains records of all quality activities as documented in SOPs
and test methods
Handles samples and performing analyses according to SOPs
and test methods
Writes SOPs and test methods
Signs reports when designated with signing authority
Maintains and calibrates equipment
Reports deficiencies or malfunction to the supervisor
Identifies and records nonconformities on Corrective Action *
Requests
Identifies and recording potential nonconformities on Preventive
Action Requests
Corrects nonconformities and potential nonconformities
Improves laboratory and/or quality activities on a continuous
basis
8. Sample Collector
ANNEXURE – 8
RISK ASSESSMENT
Risk Index
Risk Matrix
Highly Likely
MED HIGH HIGH
Unlikely
LOW LOW MED
Severity
Risk Index
Frequency
(Mitigation (Doc,
Severity
Plan) Record,
Training
etc.,)
1. Receipt of Mix of samples The report of are H L M Sample SOP for
samples sample may go to Identification Sample
another Collection
2. Sample Quality of Calibration Cannot be H L M Quality to be SOP for
Collection sample completed standardized Sample
insufficient Collection
3. Sample Breakage/ Calibration Cannot be H M H Closure, Box, SOP for
Transportatio Damage completed Fixture to be Sample
n provided Collection
4. Sample Inadequate Calibration cannot be H M H Contract SOP for
receipt information completed review, Training Test
about for test request. review
calibration
such as test
method, No of
calibration etc
5. Calibration In Accuracy/ Test result will be in H L M Regular SOP for
Imprecision accurate and calibration Calibratio
impression n
6. Calibration Customer may Inadequate test result H L M Disciplinary Impartialit
ask to change action y
the result declaratio
value. n
7. Calibration Delay in M L L Inform the Communi
testing due to Customer, Shift cation to
Risk Index
Frequency
o Conformity) (Doc,
Severity
Record,
Training
etc.,)
1. Governance Disclosure Possible conflicts H L M Executing agency to Internal
of interest among ensure all staff sign the audit
implementation disclosures report
staff
2. Finance Finance Minimize Cash H L M Where petty cash Evidence
Management Management Transactions procedures seen
stated in lab shall not be on
allowed, Laboratory to financial
make all progress files
payments to and
contractors, suppliers disbursem
and consultants – firms, ent
individuals, national and vouchers
international – by check
or transfer to bank
accounts, and retain
evidence for audit and
donor supervision
missions
3. Relationship Some times Misuse the Test H L M Client name shall not be Display
between may result value known to calibration staff “No
client & staff inference the only with unique number Admission
calibration to should be conducted. ” Board
change test Entry restricted for the
result value external persons inside
the laboratory
4. Sales Sales Inadequate Test H L M Cash transactions not Lab Policy
Commission Commission result value. allowed.
No proper Policies should include