Professional Documents
Culture Documents
Biological Electro-Technical
Chemical Mechanical
Electrical Radiological
Electronics
Thermal & Optical
Fluid-Flow
Fluid-Flow etc
Mechanical
Non-Destructive
Testing etc.
Clinical
Forensic
Accreditation
Procedure by which an authoritative body (NABL)
gives formal recognition that a body (laboratory) or
person (signatory) is competent to carry out specific
tasks (scope)
Criteria - ISO/IEC 17025 (includes all those
requirements of ISO 9001 relevant to the scope of
laboratories)
Assures the client that the procedures and test results
are technically valid
Recognizes the technical competence of laboratory
staff
Endorses the the laboratory operates the the
management system effectively
BENEFITS OF ACCREDITATION
National and international recognition
Public and industry acceptance
Assurance to clients of good laboratory practice
Provides global equivalence
Provides comparability in measurements
Decision makers can rely on test results
Improves staff motivation
Ensures better support in the event of legal
challenge
Saves money by getting it right at first time.
Information About Laboratory
Required by NABL
Testing /Calibration
In-house/Open to others /Partially open
Fixed/Mobile
Legal status
Name of the Lab
1. Lab is responsible for all legal
requirements.
1. Customer needs
2. Regulatory authorities.
- Proprietary rights
- Electronic Email.
Policies and Procedures for
Protection of customers confidential
reports
Property rights
Protecting the electronic storage and
transmission results
Having confidence in its competence,
impartiality, judgment or operational
integrity.
Organization Chart A
Organization Chart B
Organization Structure
Who is Q.M. /T.M./Dy QM/Dy TM ?
Can all be one person?
What is NABL requirement for QM?
What should be responsibilities of QM and
TM?
Quality Manager (QM)
Responsibilities
Day to day administration lab.
To maintain discipline, safety within the lab.
initiating needs for training of lab personnel.
Checking for effectiveness for testing & management systems.
Attending customer complaints and customer feedback and conducting
customer satisfaction survey.
To conduct management review meetings& internal audits
Establishing, implementing & maintaining the laboratory management
system as per IS/ISO 17025: 2005.
Liasioning with NABL for Laboratory accreditation and managing
associated activities
Preparation of Test Report
Reports to Director on QMS as well as Branch manager.
managerial personnel
Ensure that personnel are
aware of their activities and
contribution to Management
System.
4.2 Management System
4.2.1 Laboratory shall
Establish
Implement
Maintain
• Policies
• System procedures
• Operational procedures
• Work instructions
• Blank forms
• Manuals
• Plans and programs
• Drawings and schematics
• Standards and specifications
• Videos
• Photographs, Snapshots
• Sample boards
Good Document Control
Identification & Traceability
Authorities for Preparation, Review
,Approve & Issue of document
Document Issue, Distribution & Control
(To ensure Current document is
available at point of Use)
Document Change & Obsolete Control
Control of External Origin Documents
Master List
Identification & Traceability of Document
Authority
Sr.no Doc.Name Doc.No. Prepared & Reviewed &
Issued By Approved By
1 Policy XYZ/POLICY MR MD
2 Objectives XYZ/OBJECTIVE MR MD
3 Apex Manual XYZ/AML MR MD
Jr.
Procedure/Work XYZ/SOP/ Section/Departm
4 Engineer/Activity
Instructions Abbreviation of SOP ent Head
Incharge
Document Issue, Distribution & Control
Master Copy: Original Copy generally kept with
originator (Soft/Hard)
Controlled Copy: Distributed at point of
uses/locations with controlled number to the concern(
Here to give current version, responsibility lies with
Originator)
In soft: Write protected and controlled sharing through
server
Uncontrolled/Reference Copy: For reference
Reading ( Here there is no responsibility of originator
Document Change & Obsolete Control Process
Change: any modification to product, document, process, equipment, instrument,
system, facility etc.
Change control: procedure reviews, verifies, regulates, manages, approves and
controls changes made to the existing operating system or facility or process or
procedure or document or product of any combination
The key principles of change control are understanding and documenting:
What was done, why, when, where, by whom, how and Results, including the
impact of changes to other processes.
Sr. No. Steps to Change the Document
1 Changes are proposed (In the Format: Encl)
2 Change Reviewed by Preparing authority
3 Change approved by Approving Authority
4 Changes made in the document
5 Master list of document modified
6 Entry made in Document change record
7 New document issued to concerned person as per distribution list
8 Old document retrieved from the place of use , Marked as obsolete & filed
separately
Format of Document Change Request
Date: 15.05.2015 DCN No:
Sr. Document Document Original Changes required Reason for change
No Name
01 ID No Issue/Rev. no
1. More Columns
Data Document
XYZ/DC 01/00 Required in data
Collection adequacy
collection Table
Change Impact details( by Preparing authority/TL)
Reviewed by (Preparing Authority):________________________(Sign,, Name, Date, Time)
Approved By(Approving Authority):________________________(Sign,, Name, Date, Time)
YZPECS Level
XYZ/MR/AM 01/05/ General XYZ
1 Apex Manual 01/00 MR
L 15 Manager Members
MR Documents
Annual Internal Audit XYZ 01.05.1 General XYZ
1 Calender /MR/AIAC 01/00 5 MR Manager Members
XYZ 01.05.1 General XYZ
Internal Audit Schedule
2 /MR/IAS 01/00 5 MR Manager Members
Internal Audit observation XYZ 01.05.1 General XYZ
3 Sheet /MR/IAO 01/00 5 MR Manager Members
Internal Audit Summary XYZ 01.02.1 General XYZ
4 Report /MR/IASR 01/00 5 MR Manager Members
Protection, Retrieval
4.3. DOCUMENT CONTROL
Establish procedure for control of all documents
(Internally generated or from external sources).
Documents include:-
– Regulations
– Standards or other normative documents.
– Test and Calibration methods
– Drawings
– Software
– Specifications
– Instructions.
Manuals
Policy statements.
Photograph
Procedures
Specifications
Calibrations tables
Charts
Text Books
Posters
Notices
Memorandum
Hard or Soft Copy
4.3.2 Document Approval and
Issue
4.3.2.1 Authorized person for preparation,
review, Approval and issue of documents.
Master list to identify current revision
status.
List for distribution of documents.
Avoid use of invalid/ obsolete documents.
4.3.2.2 Procedure shall ensure:-
Availability of authorized editions of
documents at user location
Periodic review and revision of
documents.
Removal of invalid/ obsolete documents
from all points of issue / use to avoid
unintended use.
Marking of obsolete documents, suitably,
retained for legal or knowledge purpose.
Identify documents uniquely.
Materials Procedures
Quality
Problem
People Equipment
Fishbone Diagram
Measurement Human Machines
Quality
Inaccurate
Poor process
Problem
temperature
Defective from vendor design
control
Ineffective quality
Not to specifications management
Dust and
Dirt Material- Deficiencies
handling problems in Testing
design
Environment Materials Process
4.11.3 Selection and Implementation of C.A.
Identify Potential Corrective Actions.
Select and Implement the action(s).
Document required changes resulting from
Corrective Actions.
IDENTIFICATION
STORAGE & RETRIEVAL
RETENTION TIME
DISPOSAL
MASTER LIST
Record Indexing & Storage
Master List Of Record
ISSU ISSU RETE
RECOR PREPAR APPRO
E/RE E/RE ISSUE LOC NTIO
D ED VED
S.N NAME OF RECORDS V. V. ATIO N
N PERIO
NO. NO. DATE BY BY TO
D
MR Records
Annual Internal Audit PTPS/MR 01.05. General PTPS MR
1 Calender /AIAC 01/00 15 MR Manager Members Cabin 3 Yrs.
PTPS/MR 01.05. General PTPS MR
Internal Audit Schedule
2 /IAS 01/00 15 MR Manager Members Cabin 3 Yrs.
Internal Audit PTPS/MR 01.05. General PTPS MR
3 observation Sheet /IAO 01/00 15 MR Manager Members Cabin 3 Yrs.
Internal Audit Summary PTPS/MR 01.05. General PTPS MR
4 Report /IASR 01/00 15 MR Manager Members Cabin 3 Yrs.
PTPS/MR 01.05. General PTPS MR
Non conformity Report
5 /NCR 01/00 15 MR Manager Members Cabin 3 Yrs.
PTPS/MR 01.05. General PTPS MR
Document Change Note
6 /DCN 01/00 15 MR Manager Members Cabin 3 Yrs.
4.13 Control of Records
4.13.1 General
4.13.1.1 Establish and maintain procedure for :-
Identification
Collection
Indexing
Access
Filing
Storage
Maintenance
Disposal of Quality & Technical records.
Quality records include:-
– Reports form Internal Audits.
– Reports of Management Review.
– Records of Corrective & Preventive Actions.
Records should be
– Legible
– Retrievable
– Protected from damage, loss
Retention time
Records may be in Hard Copy or
Electronic Media.
Security and confidentiality of Records
Electrically stored records:-
– Protection
– Back up of records
– Prevent unauthorized access
– Prevent amendment of records
4.13.2 Technical Records
4.13.2.1 Retain the records for defined Period-
Records of Original observations.
Derived data.
Information to establish an audit trait.
Calibration records
Staff records
Copy of each test report
Copy of Calibration Certificate issued.
Record of each Test/ Calibration should include
sufficient information to-
– Identify factors affecting uncertainty
– Repetition of test under conditions as close as
original
Include-
– Identity of person responsible for
– Sampling
– Performance of each test
– Checking of results.
Technical records are accumulation of data and
information which result from carrying out tests/
calibrations and which indicate whether specified
quality or process parameters are achieved.
These may include:-
Forms
Contracts
Work checks
Work Books
Check Sheets
Work Notes
Contract Graphs
External and Internal test Reports
Calibration Certificates
Customers Notes papers and Feedback.
4.13.2.2 Observations, data and calculations
should be recorded at the time they are made and
shall be identifiable to the specific task.
4.13.2.3 If mistake occurs in records-
Cross out each mistake. Do no Erase.
Make it illegible or delete it.
Enter corrected value alongside.
Person making alterations/ correction should sign
and initial.
Resource Provision
Audit Results
Qualified staff
Education
Training
Experience
Demonstrated Skills.