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Laboratory Quality Manual: Haren Textiles Pvt. LTD
Laboratory Quality Manual: Haren Textiles Pvt. LTD
M-QA-01-00
PAGE : 1 OF 43
HAREN TEXTILES LAB
VERSION : 1.0
REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
LABORATORY
QUALITY
MANUAL
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
PAGE : 2 OF 43
HAREN TEXTILES LAB
VERSION : 1.0
REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
HEAD OFFICE;
HAREN TEXTILES PVT. LTD.
WESTERN EXPRESS HIGHWAY
BEFORE TOLL NAKA
DAHISAR (EAST)
MUMBAI - 400068
MAHARASHTRA - INDIA
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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HAREN TEXTILES LAB
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REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
DISTRUBUTION LIST
The following are the authorised holders of the controlled copy of HAREN TEXTILES PVT. LTD. LABORATORY QUALITY MANUAL;
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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HAREN TEXTILES LAB
VERSION : 1.0
REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
ABBREVIATIONS
VERSION 1.0, 2.0 A version is an iteration, something that is different than before.
REVISION 1.0, 2.0 A Revision is to make a new, amended, improved, or up-to-date version.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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HAREN TEXTILES LAB
VERSION : 1.0
REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
This Haren Textiles Pvt. Ltd. Laboratory Quality Manual (LQM) forms part of the overall Laboratory Management System
(LMS) of Haren Textiles Pvt. Ltd. and is, issued by the LAB MANAGER and approved by the DIRECTOR.
Changes may only be approved by LAB MANAGER and DIRECTOR.
This is a Controlled Document subject to updating and hence should not be copied and only signed.
Approved copies are used as working documents.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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HAREN TEXTILES LAB
VERSION : 1.0
REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
To ensure that every copy of this Haren Textiles Pvt. Ltd. Laboratory Quality Manual has a complete record of
amendaments in the appendix no.2. The below is an example of format.
EXAMPLE:
SECTION / CLAUSE /
DATE OF REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
To establish zero
Organisation Chart Ronak shah
1.6 influence of
1 12 12.04.2017 updated for better Quality
(Management Req.) production dept on
clarity on structure In-Charge
Lab operations
Added;
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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TABLE OF CONTENTS
SUB SECTION NO. CONTENTS ISO 17025 : 2005 CLAUSE NO. PAGE NO.
1.0 Organisation 4.1 10
2.0 Management System 4.2 13
3.0 Document Control 4.3 15
4.0 Review of Requests, Tenders & Contracts 4.4 16
5.0 Subcontracting of Tests 4.5 17
6.0 Purchasing, Services & Supplies 4.6 17
7.0 Service to Customer 4.7 18
8.0 Complaints 4.8 19
9.0 Control of NC Testing 4.9 19
10.0 Improvement 4.10 20
11.0 Corrective Action 4.11 21
12.0 Preventive Action 4.12 22
13.0 Records 4.13 22
14.0 Internal Audits 4.14 24
15.0 Management Reviews 4.15 25
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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TABLE OF CONTENTS
SUB SECTION NO. CONTENTS ISO 17025 : 2005 CLAUSE NO. PAGE NO.
1.0 General 5.1 26
2.0 Personnel 5.2 26
3.0 Accommodation & Environmental Conditions 5.3 27
4.0 Test Methods & Method Validation 5.4 28
5.0 Equipment 5.5 29
6.0 Measurement Traceability 5.6 31
7.0 Sampling 5.7 32
8.0 Handling of Test Items 5.8 32
9.0 Assuring Quality of Test Results 5.9 33
10.0 Reporting the Results 5.10 34
APPENDIX 1 to Section 8.4 for the
8.4 5.8 37
SAMPLE PROCESS FLOW IN LABORATORY
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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REVISION : 6.0
QUALITY MANUAL
EFF. DATE : 16.11.2022
We, at HAREN TEXTILES PVT. LTD. LABORATORY are committed to ensure continual improvement in achieving cusomters'
total satisfaction by consistently pursuing the agreed Quality Plan based on established Quality Standard.
The above policy is achieved through effective implementation of the ISO 17025 : 2005 Quality Management System
standard requirements following below listed objectives;
=> establishing a good management system to comply with the requirements as specified in ISO 17025 : 2005 and
continually improving the effectiveness of the management system
=> employing qualified personnel, providing them continuous training in testing and documentation and ensuring that they
understand and implement the policies and procedures in their work.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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MANAGEMENT REQUIREMENTS
1.3 LMS to cover testing operations in its permanent and mobile facilities
1.3.1 The laboratory has permanent infrastructural facilities to carry out the tests for which it is to be accredited and the
LMS covers all testing operations carried out in its permanent facility
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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1.5.2 It is ensured that the Management and Staff are free from commercial and financial pressures and influences that may
adversely affect the quality of testing or its results during the time of employment. Yearly Budget well forecasted planned
and shared with managaments to plan accordingly. (B-QA-01-00)
1.5.3 Protecting customers' confidential information and propietory rights;
Policy - To protect customers' confidential info and propietory rights, all visitors, who are not employee of Haren Textiles
Pvt. Ltd., must sign a 'Visitor Confidentiality Form' before visiting lab. All the electronic data is securely stored which is
only accessible by Lab personnel.
1.5.4.2 The personnel involved in testing / lab are not allowed to undertake any other work during their tenure, unless they
are officially transferred from one department to another, after which they would not be involved in the functioning of lab.
1.5.5 The Organisation Structure along with the relationships between quality management, technical operations and
support services is provided in the organisation chart. The Job Descriptions along with their responsibility, authority and
interrelationship of all staff personnel are available in their respective personal files in Human Resource Department.
Each lab staffs and individual and lab performance are monitoring by their activities and end results towards to KPI
individual KPI's are such as TAT, testing Errors, Marks, Kaizen, test Delays, 6S, Other operational parameters, etc...
Those individual indicators feed into centralized PMS sheets every month and will be review yearly quarter with OPEX Team
1.5.6 LAB SUPERVISOR is involved in supervising all testing activities carried out by lab staff, including trainees
1.5.7 LAB SUPERVISOR - LAB SUPERVISOR has the overall responsibility & authority over the technical operations &
provisionoperations of laboratory activities. The Senior Lab Technician can perform the role of LAB SUPERVISOR in his/her
absence.
1.5.8 LAB MANAGER - The LAB MANAGER has responsibility and authority of over all quality matters concerning the
implementation of the Quality & Technical Management System at all times. He/She is responsible for communicating the
objectives of organisation and ensures that the staff are aware of the relevance and importance of their activities in
contributing to theachievement of the overall objectives. He/She is also responsible to take care to close any
non-conformity and subsequent action plan. He/She has direct access to highest level of Management at which decisions
are made on laboratory policies.The Lab supervisor can perform the role of LAB MANAGER in his/her absence.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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1.6 Organisation Chart for Haren Textiles Pvt. Ltd. AND Haren Textiles Pvt. Ltd. Laboratory
LAB SUPERVISOR
2. AYAN PATEL
HEAD HUMAN RESOURCES HEAD KNITTING
SENIOR TEST
OFFICER
DIRECTOR
QUALITY, NEW LAB MANAGER
DEVELOPMENTS LAB SUPERVISOR JUNIOR TEST
AND (QA & TECH) OFFICER
COMPLIANCES
TRAINEES
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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2.1.2 The policies related to quality including Policy Statement of LAB are provided in the Haren Textiles Pvt. Ltd. Lab Quality
Manual (LQM). The overall objectives as documented in the manual are reviewed during Management Review Meeting.
2.3.2 Appropriate Plan is prepared and verified that all regulation are met in applicable areas.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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2.4.2 The DIRECTOR and LAB MANAGER are committed to the development and implementation of the LMS and to
continually improve its effectiveness. This is evaluated at Management Review Meetings.
2.4.3 Haren Textiles Pvt. Ltd. Laboratory Quality Manual is prepared by LAB MANAGER and approved by the DIRECTOR of
Haren Textiles Pvt. Ltd. The LAB MANAGER is responsible for compliance to ISO 17025:2005 and implementation of LMS.
2.4.4 The LAB MANAGER ensures that the integrity of the Management System is maintained wherever changes to the
Management System are planned and implemented.
2.4.5 Each distributed copy of the Quality Manual is assigned a copy number which is displayed on the 1st page. The
LAB MANAGER retains the signed Original Copy.
2.6 Roles and Responsibilities of Quality and Technical Management Staff / Personnel
The Roles and Responsibilities of various Technical and Quality Personnel are defined in Section 1.5.7 and 1.5.8
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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3.2.2 A Master List of controlled documents is maintained indicating the current revision / distribution status / reviewing /
approval authority for each level of documents is available with the Quality Department to prevent the use of invalid /
obselete documents.
3.2.3 The Procedure adopted is according to the Internal / External Document and Data Control Procedure and ensures that;
==> authorised editions / versions of the appropriate documents are available at the required locations.
==> Documents are periodically reviewed before Management Reviews and changes made, whatever necessary to ensure
continual suitability and compliance with applicable requirements. All documents are reviewed at least once in 2 years.
==> Invalid or Obselete documents are promptly marked as OBSELETE and not allowed to use and ensure unintended use.
LAB MANAGER maintains the details for all the updates / changes for a clear record of document use / revision history.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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3.2.4 All Management System documents generated are uniquely identifiable (for example - M-QA-01-00) and carry Version
details, Revision details, Effective Date & also Page No. along with total no. of pages.
3.3.2 Documents are reissued by updating the Version and Revision for the document. The details about Version & Revision
are explained in P-QA-02-00 (Internal / External Document and Data Control Procedure)
3.3.3 The laboratory’s document control system allows for the revision and re-issue of documents only by the Quality
In-Charge with the Version, Revision and Effective Date clearly marked, signed and dated.
3.3.4 The Documents, including those in the computer system are maintained according to P-QA-02-00 (Internal / External
Document and Data Control Procedure)
4.1.2 The Test Request is reviewed by LAB SUPERVISOR or LAB TEST OFFICERS ensures that;
a. The scope of the work including the test methods to be used is adequately defined, documented and understood.
b. The Laboratory has the necessary physical infrastructure, information resources and trained staff to carry out the tests
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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and the test methods are suitable to meet the submitters’ requirements.
c. In the case of new testing requirement the LAB SUPERVISOR ensures the availability of instrument / reference material /
required chemicals.
4.3 Deviation
There is no deviation allowed in the procedure for testing (sampling, testing, test methods). Testing is done according to ISO
Standard or Customer Prescribed method / standard.
4.4 Amendament
4.4.1 For any amendment / change in the test request after the commencement of work, the Review of Request is done
once again as per the original procedure and the details of amendments is communicated to all affected parties.
6.0 PURCHASING, SERVICES AND SUPPLIES ISO / IEC 17025 CLAUSE 4.6
6. 1 Policy
6.1.1 This policy defines the procedure for purchase goods, supplies or outside services according to P-QA-03-00;
Purchasing (Equipments and Consumables) and Servicing
6.1.2 Whenever the above items are procured for testing activities, it is ensured that all such items as well as services
are checked for adequate quality to sustain confidence in the testing activities before use.
6.1.3 Wherever possible goods, supplies and services are purchased from those suppliers from approved supplier list or
any new supplier with prior approval from LAB MANAGER.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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6.1.4 Where independent assurance of quality is not available, it is ensured by inspection and through checking of goods
that specifications defined in the purchase order are met before use.
6.1.5 It is ensured that the purchase document contains quality, quantity and suppliers name. All purchase documents are
reviewed for technical content by LAB SUPERVISOR (if required), except capital equipment and glassware
6.1.6 It is responsibility of Lab & LAB MANAGER to evaluate the organization for seeking support for outside calibration
and Maintenance services maintaining the traceability as required by the Management System and International Standards
6.2 Records
6.2.1 A record is maintained under the purchasing procedure as given in P-QA-03-00 of all the suppliers which are
identified vendors and all are evaluated for quality and other parameters as mentioned in P-QA-03-00
6.2.2 Records of checks on critical items (if any items are classified as critical), received & approved are also maintained.
6.3 Storage
The LAB SUPERVISOR is responsible for storage of the reagents & consumable materials in suitable environmental
conditions as explained in P-QA-03-00
REFERENCE - P-QA-03-00 Purchasing (Equipments and Consumables) and Servicing
7.1.2 With the objective of providing complete satisfaction, opportunities are provided to customers to enable them if they
wish to monitor the laboratory's performance in relation to their testing activity.
7.1.3 Good communication is maintained with customers, providing clarification / guidance wherever required.
Communication with the person who submitted the sample is ensured if there is any delay in testing their sample due to
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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unforeseen reasons.
7.1.4 Witnessing of tests is allowed without affecting the confidentiality of customer and / or specified testing method.
7.1.5 Test Officers performing the test are not disclosed about the Customer where the fabric shall be going. Only relevant
DS related info is provided to ensure correct DS & its Version are followed for testing. This is to ensure integirty in testing.
8.2 Responsibility
On receipt of customer (submitter) complaint, forward to LAB for registering complaint and acknowledge the customer or
submitter about the complaint providing assurance to check and revert in accordance to P-QA-07-00. LAB MANAGER
investigates the problem involving the appropriate laboratory staff and takes necessary corrective actions. Complaints of
a technical nature or where there is an NC in testing, corrective action is suggested by the LAB SUPERVISOR along with the
concerned functional after investigation. LAB MANAGER ensures the implementation of the corrective action (long term
or short term) and subsequent preventive actions.
8.3 Records
8.3.1 All records pertaining to customer complaints, investigations undertaken, corrective action and closure details are
maintained and reviewed at the Management Review Meeting.
9.2 Responsibility
LAB MANAGER
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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9.3.2 Comprehensive details of the investigation & any resultant corrective / preventive action required is recorded in the
In-house Nonconformity Log Book and the department HOD’s approval obtained when any report is revised.
Corrective actions are taken immediately along with the decision about the acceptability of the NC which includes halting
of further work and withholding of relevant test reports if necessary after evaluating the significance of the non conforming
work.
9.3.3 Records of relevant NC's is maintained in the LAB by LAB MANAGER & these are made available at Mgt Reviews.
10.2 Responsibility
10.2.1 LAB MANAGER
10.3 Steps taken to continually improve the effectiveness of the management system
10.3.1 Communication and interaction with staff at all times and at all levels by means of notice board displays & review
meetings.
10.3.3 Interaction with submitters, obtaining and reviewing feedback from them.
10.3.4 Allowing customers to witness tests being performed on their samples and getting their comments on performance.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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11.2 Responsibility
11.2.1 LAB MANAGER / LAB SUPERVISOR
11.5.2 The root cause as well as all potential corrective actions are recorded in the In-house Nonconformity Register Form
and maintained.
11.5.3 It is the ultimate responsibility of the LAB MANAGER to ensure that the corrective actions taken are implemented
properly and are effective.
11.5.4 AUDITS - Where a complaint / investigation or any other issue raises a doubt concerning compliance with stated
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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policies or procedures with the requirements of ISO 17025:2005 standard or otherwise concerning the quality testing
activities, the LAB MANAGER ensures that those areas of activity and responsibility involved are promptly audited in
accordance with Section 4.14 (Internal Audit) of ISO 17025:2005 Standard.
REFERENCE - P-QA-11-00
12.2 Responsibility
12.2.1 LAB MANAGER
12.3 The identification of preventive action could be based on the findings from;
==> Reviewing of Repeatability and correlation results(Same reports testing in other validated labs)
==> Review of standard operational procedures
==> Trend Analysis of Quality Control data(Blocking Rate, Limits)
==> Internal or external Audits
12.4 Once preventive actions are identified, action plans are developed, implemented and monitored so that occurrence of
non-conformances can be stopped and the quality of work can be improved.
12.5 Preventive action includes application of controls to study the effectiveness of the preventive action.
REFERENCE - P-QA-07-00
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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13.1.2 All records are ensured to be legible and are placed in suitable environment & are maintained as hard/soft copies
(as applicable) to protect them from damage or loss. Retention times for records have been established.
13.1.4 Procedure P-QA-12-00 describes how records stored electronically are protected & to prevent unauthorized access
or amendment to these records.
13.2.2 The records include for each test performed, all information required to compile test reports as per ISO 17025:2005.
13.2.3 The record identification and numbering system follows a logical sequence and retained in specific areas in
accordance with P-QA-12-00
13.2.4 All original observations, calculations and notes are clearly, legibly and permanently recorded by the testing staff
at the time they are made. Entries in the Chain of Custody Form, Observation Records and Instrument Log Records, include
the name of persons carrying out the tests and the dates.
13.2.5 When mistakes occur in manual recording, any mistake will not be erased, made illegible or deleted, but crossed out
and correction entered alongside. All such corrections made to records are endorsed and dated by the person making the
original entry and apprroved by the LAB SUPERVISOR
13.3.2 Records pertaining to LMS and quality like audit and Management Reviews, customer complaints, proficiency and
inter laboratory testing are maintained by the LAB MANAGER.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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13.3.3 P-QA-12-00 provides a complete list of quality records, person responsible for their maintenance, retention time &
location.
REFERENCE - P-QA-12-00
14.2 Responsibility
14.2.1 An audit plan is prepared & administered by the LAB MANAGER ensuring that each area is audited at least once
every twelve months.
14.2.2 The LAB MANAGER is also responsible for the operation of all auditing activities and the verification of the
completion of any corrective action. The LAB MANAGER ensures that the DIRECTOR is immediately informed of failures
and delays in the implementation of corrective action.
14.2.3 The LAB MANAGER ensures that the staff is not allowed to audit their own activities. Auditor should be
independent of area of activity being audited.
14.2.4 The LAB MANAGER may also draw upon an external body or individual to carry out internal audits to meet the
requirements of the Laboratory
14.2.5 The LAB MANAGER is responsible for follow-up of audit activities to verify and record the implementation and
effectiveness of corrective actions taken to present in management review.
14.3 Documentation
14.3.1 The audit documentation used, e.g. audit schedule reports, summaries, checklists are all maintained by the Quality
In-Charge and are placed at the Management Review.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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15.1.2 Management Reviews are planned meetings chaired by the DIRECTOR, LAB MANAGER and LAB SUPERVISOR to ensure
the continuing effectiveness of the LMS.
15.2 Responsibility
15.2.1 The LAB MANAGER is responsible for ensuring that relevant Management Review topics including ISO 17025:2005
standard requirement are included in the Management Review agenda and that the reviews are scheduled to cover all these
topics at-least once in a year and that complete records of the reviews are maintained.
15.2.2 The topics to be considered during the review includes suitability of the Quality Policy and procedures, reports from
supervisory and managerial staff, the outcome of external assessments and internal quality audits, corrective & preventive
actions, complaints/feedback from customers, changes in volume and type of work, personnel requirement, training, scope
for improvement, review, approval and re-approval of all documents and other relevant issues.
During MRM, shall discuss about Previous year and current year Lab Budgets, Departmental KPI's and Individual KPI's such
as their Individual TAT, NC, Performances and structural changes.
15.2.3 The LAB MANAGER also has the overall responsibility to ensure that Management Reviews are conducted in
accordance with the requirements and actions that arise from them are carried out within an appropriate and agreed time
frame.
15.3 Documentation
15.3.1 Documentation concerning Management Reviews is generated, maintained and retained by the LAB MANAGER.
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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TECHNICAL REQUIREMENTS
1.2 As the extent to which the above factors contribute to total uncertainty of measurement varies depending on the type
of tests carried out, these factors are taken into account in selection of equipment and training the personnel.
2.1.2 Responsibilities are assigned based on technical qualification, training, experience and or demonstrable skills.
2.1.3 Wherever it is mandatory that personnel performing specific tests hold personal certification it is ensured that such
requirements are fulfilled.
2.1.4 The policy is to draw up systematic plans for upgrading technical skills and providing training in required areas.
Training is provided based on procedure P-QA-14-00 – Procedure for Identifying Training Needs, Providing Training and
Evaluation. The training program is drawn based on the position of personnel appointed. The effectiveness of the training
programme is systematically evaluated.
2.2 Work
2.2.1 Personnel are employed full time for carrying out testing and administrative work.
2.2.2 Job descriptions for all managerial, technical and support personnel including their responsibilities with respect to
performing specific tests, issuing test reports and operating specific instruments are provided in their individual files with
LAB MANAGER
ACTION PREPARED AND ISSUED BY; CHECKED AND AGREED UPON BY; APPROVED BY;
NAME AHAMED MANSOOR AYAN PATEL NISHANT MEHTA
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3.0 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS ISO / IEC 17025 CLAUSE 5.3
3.1 Policy
3.1.1 The Laboratory environment is maintained such that the quality of tests being carried out is not jeopardized. Special
attention is paid to environmental requirements of relevant standards / specifications and adequate lighting facilities to
ensure correct performace of test.
3.1.2 It is ensured that environmental conditions do not invalidate results or adversely affect the required quality of any
measurement
3.2 Responsibilty
3.2.1 LAB SUPERVISOR
3.3.2 Where environmental conditions drift out of specification, all testing activities are suspended until the environment
has returned to specification. Where activities have been suspended the causes are investigated and the details recorded
including any corrective and preventive action.
3.3.3 Adequate space to carry out various activities related to the scope of work & the areas with incompatible activities
are well separated to prevent cross contamination. Laboratory sections are provided with sufficient lighting & ventilation.
3.4 Access
3.4.1 Access to the testing sections and equipment are restricted to authorized personnel designated by the LAB SUPERVISOR.
3.5 Safety
3.5.1 Safety equipment like fire extinguishers, gloves, first aid kits are available in the testing areas and in appropriate
places. Training is given on first aid for some of the staff.
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4.0 TEST METHODS AND METHOD VALIDATION ISO / IEC 17025 CLAUSE 5.4
4.1 Policy
4.1.1 To use only appropriate test methods to meet customer’s requirements for all tests included in its scope of activities.
The procedures of standards used are only International Standard Procedures and validated test methods.
4.1.2 Testing procedures, methods and specification are updated systematically and are made readily available to the
personnel as defined in P-QA-02-00. It is the responsibility of the LAB MANAGER to ensure that only current standards
and specifications are used. In case a necessity is felt, the deviation is validated as described in P-QA-17-00
4.1.3 Whenever there is change in the Version of the Test Method or when applying for validation of new Test, capability to
perform updated version or test ar met as detailed in P-QA-18-00
4.2 Responsibility
4.2.1 LAB MANAGER / LAB SUPERVISOR
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acceptance of results.
4.6.2 Measurement Uncertainty is calculated taking into account all the parameters that contribute to the measurement
of analysis.
4.7.2 All calculations and data transfers are subject to appropriate checks.
5.2 It is ensured that all instruments and its software used for testing and sampling are capable of achieving the accuracy
required and comply with specification relevant to the tests. Calibrations programs are established for key equipment
which affect the test result and all instruments where required are calibrated before being placed in service.
5.3 All equipment including software received into the Laboratory for use in test activities are subject to appropriate
receiving, checking, testing and calibration procedures prior to use.
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5.6 A comprehensive list of all testing instruments and equipment available is maintained by the LAB SUPERVISOR.
5.7 A history card is maintained for each instrument & includes the following as required by ISO 17025:2005 Clause 5.5;
a. Name of the Equipment
b. Name of manufacturer and model or type identification
c. Any Serial Number allocated by the manufacturer or internally assgined by LAB
d. Details of any checks made for compliance with relevant standards
e. Date when equipment was placed in service
f. Copy of Manufacturers Instruction Manual where available
g. Details of maintenance schedule and its implementation.
h. History of Repair
5.9 Maintenance department ensures that all testing equipment is serviced and maintained on a regular basis as
appropriate. It is also ensured that all such instruments are protected from misuse.
5.10 Any equipment that has suffered damage during use is identified as such, segregated and subject to review, repair,
test & recalibration as appropriate before further use. It is the responsibility of all technicians to ensure that any damage
to an instrument is reported immediately to concerned Technician through LAB SUPERVISOR as applicable.
5.11 Where the equipment requires calibration, the record also includes calibration status, calibration reports with
adjustment, acceptance criteria and due date for next calibration and other relevant calibration documents.
5.12 Calibrated equipment wherever practical is labeled or marked in associated List, to indicate the status of Calibration
and the date when recalibration is due.
5.13 Based on the actual use of all related equipment, intermediate checks are required on some instruments. The check
points and its frequency are determined based on its use. The procedure P-QA-15-00 is followed for the same.
5.14 Safe handling, transport and storage of instruments are ensured by Maintenance department.
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5.15 Correction factors due to calibration are updated in the system where applicable.
5.16 Care is taken to ensure that equipments and its software are safeguarded from adjustments that would invalidate
results by having only authorised personnel to operate.
5.17 Any item or equipment that suffers damage, overloading or mishandling or that gives suspect results or that is shown
by calibration or otherwise to be unfit for use is immediately withdrawn from use. These items are clearly labelled as
"UNDER MAINTENANCE" and are returned to service only after they are repaired and / or recalibrated as appropriate.
6.1.2 To ensure timely calibration of inspection, measuring and test equipment so as to ensure the accuracy and validity
of test result to the specified requirement.
6.3 Testing
6.3.1 Identification of test samples, test reports, measuring and test equipment are implemented & maintained to avoid
the mixing and to ensure that they are traceable back when needed. To ensure proper identification & traceability of test
samples, reports and equipment P-QA-04-00 is followed.
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6.4.2 Storage
Reference Standards are stored separately, wherever needed transported safely & in appropriate environmental conditions
to prevent contamination or deterioration.
REFERENCE - P-QA-06-00
P-QA-10-00
P-QA-04-00
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the laboratory. All samples received are allocated and identified by an unique code number. All laboratory work records,
intermediate sample containers, data sheets and reports of analysis originating from the Laboratory testing sections are
identified by this unique code no. This is also to ensure that samples do not get lost or mixed up within or between jobs.
8.3.2 If they are uncertain as to whether a sample can be accepted for a test or not and requires technical assistance, they
check with the concerned team before accepting the sample.
8.4.2 Samples after analysis are retained and disposed off after a stipulated period of time.
REFERENCE - APPENDIX 1 for the SAMPLE PROCESS FLOW IN LABORATORY (Pg. 37 in Quality Manual) and P-QA-05-00
9.0 ASSURING THE QUALITY OF TEST RESULTS ISO / IEC 17025 CLAUSE 5.9
9.1 Quality Control (QC) Practices
9.1.1 The QC programme comprises;
* Use of Standard Reference Material (SRM). Tests are systematically carried out with a SRM.
* Dynamical Frequency Control Testing (DFC) & Inter Laboratory Comparisons (Every 1/16th reports) : A DFC and inter
laboratory testing plan /is prepared the samples analyzed by the LAB SUPERVISOR & SENIOR TEST OFFICER and
samples sent out as per schedule and results documented.
* Perform the repeatability / re-test on the retained sample, retained at stores, by pulling randomly to maintain the
confidence in testing
9.2 Besides the above, other QC measures like correlation of results for different characteristics of an item where possible
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are also carried out and data recorded. LAB MANAGER initiates corrective action wherever required.
9.3 Review of quality control data is regularly carried out and it is ensured that corrective actions are taken immediately
whenever NC's occur and to prevent incorrect test results being reported.
9.4 Responsibility
9.4.1 LAB MANAGER
REFERENCE - P-QA-09-00
10.1.2 LAB SUPERVISOR puts the initials at designated place & Mailing the report to concerned functional heads after
approved by Lab Manager. Send the approved report to the concerned department who has submitted the sample for testing.
For external customers, Mail the report to Customers as per BSR file which provided by Folding dept along with Marketing /
PPC team who are in communication with the customer.
10.1.3 The requirements of ISO 17025:2005 apply to all forms of presentation of test results. The report includes all info
that is relevant to the validity and application of the test and information on the test method used.
10.2 This information is provided such that it is easy to understand. It is ensured that information provided in the test
report reduces the possibility of misuse or misunderstanding.
10.3 The pages of the Test Report are so numbered & the end of report indicated as to minimize the possibility of addition
or removal of pages or tampering with information presented. The Test Report clearly states that the results are only for the
item tested. No partial report is allowed to release.
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10.4 Authorisation
10.4.1 Only authorized signatories recognized are allowed to sign Test Reports. A list of authorized signatories is available
in L-QA-11-00
10.4.2 It is ensured that all test reports issued are factually correct and checked and endorsed by an authorized person
before issue
10.4.3 Each test report issued provides at least the following information;
==> A title "LAB TEST REPORT NO."
==> The name, Haren Textiles Pvt. Ltd. and address
==> Internal lot no, sort no & Shade
number by adding Clause "REV 1". If further revision is required the modify the clause to “REV 2”, “REV 3”…
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10.8.2 Send the approved report to the concern department who has submitted the sample for testing. Store the tested
specimen along with raw data sheets in defined storage area for specified time period.
REFERENCE - P-QA-08-00
- THE END -
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DATE OF
SECTION / CLAUSE /
REVISION/ REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
Added;
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DATE OF
SECTION / CLAUSE /
REVISION/ REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
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DATE OF
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REVISION/ REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
Organisation Chart
updated with LAB
Organisation Chart AHAMED
27-09-2020 MANAGER
10 12 - updated for better MANSOOR
Rev: 2 (Quality&Technical), Lab
clarity on structure (LAB MANAGER)
supervisor replacing Lab
Incharge
Detailed abbreviation of
Made for clarity and to AHAMED
27-09-2020 quality document
13 4 avoid misconception MANSOOR
Rev: 2 numbers, Version and
further. (LAB MANAGER)
revision.
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DATE OF
SECTION / CLAUSE /
REVISION/ REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
AHAMED
05-08-2021 Few More Abbreviations For Better
15 4 - MANSOOR
Rev: 3 are added (s.no 7,8,9) understanding
(LAB MANAGER)
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DATE OF
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SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
Lab Should run free
from financial pressure
AHAMED
27-09-2021 which can affect to
21 11 1.5.2 Quote about lab budegt MANSOOR
Rev: 4 quality of results also
(LAB MANAGER)
helpt to control the
financial.
AHAMED
27-09-2021 Sampling Procedure not Currently, There is no
23 32 7.0 MANSOOR
Rev: 4 applicable to haren lab scope to do
(LAB MANAGER)
AHAMED
06-07-2022 Organisation Chart Added new joiners and
24 12 1.6 MANSOOR
Rev: 5 updated Erased resigned staff's
(LAB MANAGER)
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DATE OF
SECTION / CLAUSE /
REVISION/ REASON FOR AUTHORISED
SR. NO. PAGE NO. PARA WHERE REVISION MADE
REVISION REVISION SIGNATORY
REVISION DONE
NO.
AHAMED
16-11-2022 KPI details updated as per Updated as per Haren
27 11 - MANSOOR
Rev: 6 Plant OPEX team new Rule
(LAB MANAGER)
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