Documents and

Records
Labs for Life
Quality Management System

A quality management system (QMS) is a set of policies,

processes and procedures required for planning and execution
(production/development/service) of an organization. 
ISO 9001: the guide to developing a
QMS: Tells you what to do
ISO: 9001 2008
ISO 9001: 2015

A tool to streamline an organization’s activities

To make them more efficient at what they do
Offer services of consistently good quality
ISO 15189

08/21/2021
Parent Standards ISO 15189: Quality
and Competence

Labs for Life Project

1. ISO 9001 (QMS)
The international
2. ISO/IEC 17025 standard of
(Competence of Testing) ) excellence for
medical labs

4
A Lab QMS
Documentation + QMS = Documented QMS

• To Establish a QMS
• To Implement a QMS
• To Maintain a QMS
Write What to Do!
Do What you Write!
Prove it!
Improve it!
How to set up a QMS?

Depends on the standard you want to follow:

Available Standards
ISO
CLSI
What is QMS documentation?

Systematic handling of
organizational knowledge
in conformity with
the standard
Documentation requirement ISO
Comparison between ISO 9001 and 15189
Documentationrequirement
: CLSI GP 26 A-4
CLSI and ISO Comparisons
Can you say where all documents and records
are warranted in the PDCA cycle of a well
documented QMS?
Document Hierarchy
Policies - The “WHAT TO
DO”
“A written statement of overall intentions and
directions defined by those in the organization and
endorsed by management.” (CLSI HS1-A3)

Policies:

Documents and Records -

Module 16
 tell “what to do” in a broad and general way
 include the organizational mission, goals, and purpose
 serve as the framework for the quality system
 should always be specified in the quality manual

17
Processes - The “HOW IT HAPPENS”
A “set of interrelated or interacting activities that transform
inputs into outputs.” (ISO 9000 4.3.1)
Processes:
• describe the steps involved to carry out quality policies
• easily represented in flow charts

Documents and Records -

Module 16
• involve a series of steps, usually occurring over a period of time

18
Procedures - The “HOW TO DO IT”
Testing:
Standard operating procedures (SOP)
 step-by-step instructions for performing a single activity

Job aid

Documents and Records -

Module 16
 a shortened version of the SOP
 does not replace the SOP

Non testing
 Quality System Procedures (Mandatory Procedures)

19
Hierarchy of Documents

“How to do it”

Documents and Records -

Module 16
“How it happens”

“What to do”
Records!
Documents and Records

Documents: Information for

activities
Do what you wrote!
Records: Information from
activities
Write what you did!
Difference between Documents
and Records
Document Record

Live Dead

How to carry out an activity How the activity was carried out
and the results

Subject to change Not subject to change.

Approved and issued (or Approved after the activity is over

released) by designated by designated authorities
authorities before issue.
Retention period generally are Retention period has to be clearly
not defined as these are live. defined as per local regulations
LIFE CYCLE OF DOCUMENTS AND
RECOREDS! 4.13
• IDENTIFICATION
• COLLECTION
• INDEXING
• ACCESS
• STORAGE
• MAINTENANCE
• AMENDMENT
• SAFE DISPOSAL
POLICY DOCUMENTS
LEVEL 1
ESTABLISHING A
DOCUMENTED QMS
Policies: Establishing a QMS
4 Questions to answer
• What are QMS Policies?
• How to create policy documents?
• How to maintain policy documents?
(will discuss under document control)
• How to retain policy documents?
(will discuss under storage and retention)
What are QMS Policies?

• The framework for the institution’s quality

system
• Broad, general directions or guidance on “what
to do”
• States the organizational mission, goals and
purpose
• Each lab develops its own policies in compliance
to the standard it is following, e.g. ISO
Policy Documents

Monitoring
Quality and Continual
Improvement
Policy Mechanisms

Quality Objectives and

Quality Indicators

Quality Manual
QUALITY POLICY
What is a Quality Policy?

An agreement, a promise, a
commitment of the
TOP MANAGEMENT
to establish, implement and
maintain
the QMS
Quality Policy ISO 15189:2012 Clause 4.1.2.3
Sample Quality Policy
Should be read, understood,
followed…….by all….
 QUALITY
OBJECTIVES
Quality Objectives ISO 15189:
4.1.2.4
Quality Objectives
• Set by top management in discussion with
the staff involved in daily activities
• Should engage all functions of the lab
• Should engage all levels of the lab
• Consistent with the Quality Policy
• Measureable, measured, monitored
• Continual improvement should be based
on this
• Directed at areas of highest priority based
on risk assessments
Quality Objectives
 Measure it!
Quality Objectives, Quality Indicators
 Measure it!
Quality Objectives, Quality Indicators
Sample Quality Objectives..
Linking different clauses of
ISO 15189 4.1.2.4, 4.14.7, 4.12
Linking…..cont…Risk assessment,
Quality Indicators….ISO 15189 Cl 4.7
 Quality Objectives: Quality Manager is
the link
• Both Management and Technical sides
should be actively involved
• Means that can be used to set Quality
Objectives: Evaluations and Audits
(4.14)
• Customer feedback (4.14.3)
• Staff Suggestions( 4.14.4)
• Internal Audits (4.14.5)
• Risk assessments (4.14.6)
• Quality (Key Performance) Indicators
(4.14.7)
• External audits (4.14.8)
• NCE/Incident reports
 Quality Objectives: Measure it!!
• Make it measurable: Define ways to
measure the performance
• Set the frequency at which the objectives
will be measured
• The results should be communicated to all
staff involved
• Should be reviewed and revised as
required
Quality Indicators…..your
choice
• Z scores in EQAS
• CV% in IQCs
• Sample collection NCEs
• Needle sticks
• Adverse Incidents
• Equipment Downtime
• Stock-outs
• TAT violations
• …………..choose your bottlenecks plus what you
would track anyway regardless of it being a bottleneck
or not….
Quality/Key Performance Indicator …
Sample…Equipment Downtime
Risk Prioritization…Identify
risks
 Identify Non-Conforming Events
 
S. No/ Date/Reported by
 
 
Type of NCE/Incident**
 
 
Immediate Action  
 

Corrective Action  
 
 
Preventive Action  
 
 
Root Cause Analysis
 
 
Time taken for resolution
 
 Quality Objectives: Review it!!
• The results should be communicated to all
staff involved
• Should be reviewed and revised as
required
 IDENTIFY
RISKS/ BOTTLENECKS

DEFINE QUALITY OBJECTIVES

SET AND MEASURE INDICATORS

MEASURE PROGRESS

INFORM, DISCUSS

REVIEW AND RESET

Quality Policy, Objectives and
Indicators…..Inter-relationship
Q. Objectives, conclusion
• Most objectives need indicators.
• Not every Indicator need to become an
objective
• Defining the objectives and indicators are
the Lab’s sole prerogative
• The process should be aimed at continual
improvement
QUALITY
MANUAL
Quality Manual
• The Apex manual of the lab
• The roadmap for meeting the QMS requirements
• All documents in level 2 and 3 should be consistent with the
QM
• A must for ISO accreditation
• ISO gives considerable flexibility in the creation of the manual
• All stakeholders should be involved in the preparation
• NABL 160 (Free download) gives guidelines on writing
Quality manuals
Quality Manual as per ISO
15189
NABL 160
• There is no required structure or format for a Quality
Manual.
• However, any Quality Manual should convey accurately,
completely and concisely
• Quality Policy
• Objectives
• Address or reference to the next level of documentation
• Management responsibilities of the laboratory.
• One of the methods of assuring that the subject matter is
adequately addressed and located would be to align the
sections of the Quality Manual to the elements of the ISO
15189
NABL 160..Structure and Format of
Quality Manual
• Recommendations for the few pages of the Quality Manual for
general information like
• Title
• Authority under which it is issued
• Scope of the quality manual
• Amendment record of the manual
• Contents of the manual
• References to other documents
• Definitions and abbreviations used
• Distribution record
• Brief description of the laboratory and the management system.
Content Page…… Sample
Distribution List.. sample…
Scope of activities under the
QMS……Sample
References to other documents…sample
Definitions…..sample
Abbreviations…..sample
Other info as appropriate….
NABL 160….
The remaining sections of the
Quality Manual should
describe all elements of ISO
15189.
The description of these
sections of the Quality
Manual should be in a
sequence similar to that of
ISO 15189
Other sequencing or cross-
referencing, as appropriate to
the laboratory, is acceptable.
Addressing the clauses….sample
• 4.1.1 Organization
• 4.1.1.1 General
XXX Lab meets the requirements of this standard when carrying
out work at its facilities including its main lab and collection
centers

• 4.1.1.2 Legal Identity

The XXX, Address..., a unit of ABC, and EFG , under MOU
came into existence on 27th December 2007. XXX is registered
with Registrar of Companies, PQRST. Its corporate identity
number is CIN:U25193KL1966GOI002621
As extensions to the set up at ….., XXX has also opened 10
collection centers in these locations……..
Cross references at the end of
each clause….sample Clause 4.1
Addressing clauses, technical
5.2..sample
Addressing clauses, technical 5.3
Annexures in Quality Manual

Why? For supportive

information on any QMS
process: …
How? Tables, flow charts….
How Many? As many processes
you identify in your lab
Processes: Steps involved in carrying
out policies: How is it done here….
• Activities
• What are the basic activities carried out in your department?
• Can you explain to me your operations here?
• Inputs/Resources:
• What information and resources do you need to start your work?
• Where does it come from?
• Outputs
• Who receives the result of your work?
• How do you know if you've done your job correctly? (meet
objectives)
PROCESS INPUT / OUTPUT MATRIX: Lab Safety (5.2)
Inputs Process /Responsibility Output Records / Documents Quality
Maintained Objectives

Risks Reading and Safe Risk Audit records Zero

Bio Medical Wastes understanding safety laboratory NCE / incidents/
Bio Hazards in collection and protocols practices Incident/Accident accidents
processing Segregation at source Elimination (Accidents, spills,
Electrical hazards as per guidelines. of lab acquired Zero non-
Equipment hazards Pre-treatment before occupational infections) conforman
Chemical hazards outsourcing BMW hazards CAPA records ce
Glassware hazards Observing standard BMW records
Fire Hazards precautions Training Records
Safety Abiding with the
Lab safety Manual spillage and all safety
Equipment handling polices
guidelines Safe storage of
Training chemicals
Assurance of safe premises Safe handling of
Hepatitis B vaccination equipment
MSDS sheets Participating in fire
Fire Extinguishers, Fire safety trainings and
blankets drills
Fire Training
PPE (Personal Protective
Equipment)
Eye wash
Signage
Communication…
4.1.2.6..Flowchart
Annexures cont.. Organograms
4.1.2.5 Responsibility, authority, inter-
relationships: Organogram
Dy QM
Quality Manager
Safety Officer

Technicians
HOD

Residents
Technical Managers
PG students
Accounts

………….
Housekeeping
Level 2
WDIs
Level 2: Procedures
Implementing the QMS You’ve Established……
A Specific Activity/ Part of a Process
Says “how to do it”

Quality System Procedures

Standard Operating Procedures
Job Aids (Work Desk Instructions)
Quality System Procedures
• Earlier called Mandatory Procedures
• Does not directly involve testing
• Involves part of a process
• It is mandated that these are clearly documented so that each
one understands his/her role
• Defined clearly in ISO 15189
• Even if not required by ISO, ideal to document steps of
complex activities
QSPs required as per ISO
Sl No Process ISO
clause
1 Responsibilities, authority, and interrelations 4.1.2.5
2 Document Control 4.3
3 Establishment of service agreements 4.4.1
4 Selection and evaluation of referral labs 4.5.1
5 External Services and Supplies 4.6
6 Resolution of complaints 4.8
7 Identification and control of nonconformities 4.9
8 Control of Records 4.13
9 Personnel Management 5.1
10 Selection, purchase and management of equipment 5.3.1.1
11 Calibration of Equipment 5.3.1.4
12 Preventive maintenance of Equipment 5.3.1.5
13 Reagents and consumables: Reception, storage, acceptance testing, inventory management 5.3.2.1
14 Pre-examination activities 5.4.1
15 Collection and Handling of samples 5.4.4.1
16 Inter Laboratory Comparisons (PT/ EQAS) 5.6.3.1
17 Storage, retention and disposal of clinical samples 5.7.2
18 Release of results 5.9.1
ISO Guidelines….
Combined QSPs
• A single document may address the requirements for one or
more procedures.
• Responsibilities, authority and interrelations (4.1) + Personnel,
JD (5.1) + organogram
• Document Control (4.3) + Control of Records (4.13)
• Equipment management including Selection, purchase and
management of equipment (4.6) +Calibration of Equipment,
Preventive Maintenance of Equipment (5.3)
• Pre-examination Establishment of service agreements (4.4),
Collection, and Handling of samples (5.4), Storage, Retention and
disposal of clinical samples (5.7): In the Sample Collection
Manual
QSP: Major elements
• Purpose
• Scope
• Responsibility
• Method.
SOPs!!!!!
• Required for ALL Tests Done in the Lab,
including the calculated and derived
parameters
• Step by step instructions with accuracy and
quality
• To be followed verbatim
• Detailed, clear, concise
• Easily Understood; local language..
Getting Started…… Decide on
whether to
write
single test
Assess SOPs, Gather all
scientific Equipment- documents
validity wise SOP Include
each step
Understan as per
d 5.5.3
procedures Establish
used Procedure
for Use

List out
tests done
Establish
When means for
preparin updating
g SOP
Gathering documents
• Kit Inserts and manufacturer's instructions
• Text Books
• SOPs for same methods Gather all
•
•
Lab policies on QC, reporting documents
Clinician's inputs on Critical Alerts
• Others….

Determine
• Location
Procedure for
• Holder use
• Verifications of use
• Others…
ISO 15189 5.5.3
• Detailed
• Concise
• Sub clauses a-t
Example: SOP of GLUCOSE TESTING

a. PURPOSE
Enzymatic UV test (hexokinase method) for the quantitative determination of glucose in human
serum, plasma, urine, haemolysate and cerebrospinal fluid on Beckman Coulter AU analysers.
For in vitro diagnostic use only.

b. PRINCIPLE OF TEST
Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP)
and magnesium ions to produce glucose-6- phosphate and adenosine diphosphate (ADP).
Glucose-6-phosphate dehydrogenase (G6P-DH) specifically oxidises glucose-6-phosphate to
gluconate-6-phosphate with the concurrent reduction of NAD+ to NADH. The increase in
absorbance at 340nm is proportional to the glucose concentration in the sample.

CHEMICAL REACTION SCHEME

HK+ Mg2+
Glucose + ATP → Glucose-6-phosphate + ADP
 
G6P-DH
Glucose-6-Phosphate + NAD+ → Gluconate-6-P + NADH + H+
 
c. PERFORMANCE CHARECTERISTICS
 
Linearity:
Stated Linearity
The test is linear within a concentration range of 10 – 800 mg/dL for serum, plasma,
haemolysate and CSF.

The lab as verified the linearity between 10-750 mg/dL

Precision:
Stated Precision :The following data was obtained on 3 serum pools analysed over 10 days.
n = 60 within Run, Serum, CV% 1.25, 0.97, 1.11
 
This has been verified by the lab
 
Method Comparison:
Stated Accuracy
Patient serum samples were used to compare this Glucose assay OSR6121 on the AU600
against another commercially available glucose assay. Results of linear regression analysis
were as follows:
r = 0.998 n = 117
 
This has been verified by the lab
d .SAMPLES
Plasma
Sample Stability: Sample stability has been validated in the lab
for a period of 24 hours at 2-8°C. The sample storage period of
1 day has been decided as the routine protocol and NABL 112
Sample requirement: Minimum sample volume required is 2 .0
ml in grey tubes containing sodium fluoride.
Sample rejection: Haemolysed or lipeamic serum, inadequate
sample volume, unlabelled sample
e. PATIENT PREPARATION
 
Fasting glucose: 8-10 hours of fasting
Post prandial: 2 hours post meal
Random: any time
Loading tests: As given below
 
f. TYPE OF CONTAINER
 
Blood samples should be collected into grey tubes containing
fluoride. Other samples are accepted in sterile containers
 
g. EQUIPMENT and REAGENT REQUIREMENT:
EQUIPMENT: Beckman Coulter AU analyser, Fluoride tubes
REAGENT: AU 480 Enzymatic UV test (hexokinase method) kit
 Final concentration of reactive ingredients:
PIPES buffer (pH 7.6) 24.0 mmol/L
 
ATP ≥ 2.0 mmol/L
NAD+ ≥ 1.32 mmol/L
Mg2+ 2.37 mmol/L
 
Hexokinase ≥ 0.59 kU/L
G6P-DH ≥ 1.58 kU/L
Preservative  

Reagent Preparation
The reagents are ready for use and can be placed directly on
board the instrument.
Storage and Stability
The reagents are stable, unopened, up to the stated expiry date
when stored at 2-8°C. Once open, reagents stored on board the
instrument are stable for 30 days.
h. SAFETY:
 
Exercise the normal precautions required for handling all
laboratory reagents.
To avoid the possible build-up of azide compounds, flush
waste-pipes with water after the disposal of undiluted reagent.
Dispose of all waste material in accordance with BMW
guidelines.
The material used as a calibrator or quality control should be
handled as infectious and universal precautions to be followed.
• 
i. CALIBRATION
 
Calibrator required
Plasma: Use System Calibrator Cat. No. 66300.
 
Calibration frequency
As per manufacturer’s instructions recalibration is lot/lot or every 30 days, or when the following occur:
Change in reagent lot or significant shift in control values;
Major preventative maintenance was performed on the analyzer or a critical part was replaced.
However, daily or bottle to bottle calibration may be done as per the discretion of the lab manager
 
Calibrator Preparation
1. Allow the vial to equilibrate to room temperature before opening to prevent condensation in the vial.
2. Tap the top of the vial before opening to dislodge any lyophilsate caught in the stopper. Always open the vial gently to
prevent any loss of lyophilisate.
3. Add to the vial of fresh deionized water equilibrated to room temperature, (approx. 20°C). Use a calibrated pipette that
can accurately dispense 5.0 mL - weigh if unsure.
4. Invert the vial 3 times and then leave to stand for 10 minutes. Dissolve the contents completely by gently mixing on a
roller for 30 minutes. Do not shake the vial as this will cause foaming.
5. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted.
6. Record the date the vial was reconstituted on the bottle label. Store at 2-8°C.
Calibrator Stability
Store in aliquots at -20°C for 30 days
Traceability
The glucose values of both calibrators are traceable to the National Institute of Standards and Technology (NIST)
Standard Reference Material (SRM) 965.
 
 
j. TESTING PROCEDURE
 
Follow the AU 480 user guide. Refer to the appropriate Setting Sheet for
analyzer-specific assay instructions
 
k. QUALITY CONTROL:
 
INTERNAL CONTROL:
2 levels of controls, Level 1 and Level 2 are to be run for every 75 patients. In
addition, controls should be run with each new calibration, with each new
reagent cartridge, and after specific maintenance or troubleshooting procedure
as detailed in the AU 480 operating instructions manual.
Interpretation of QC is to be done as per protocol. All outliers; warning and
rejection, corrective actions should be documented. CV % should be analyzed
monthly for trends. Comparison with peer group to be maintained for biases
EXTERNAL CONTROLS: registered with EQAS- worldwide program
Interpretation of EQAS results to be done after every cycle. Root cause analysis
and Corrective actions should be documented.
l. INTERFERENCE AND LIMITATIONS OF PROCEDURE
 
Results of serum studies conducted to evaluate the susceptibility
of the method to interference were as follows

SUBSTANCE Limit

Ascorbate Interference less than 3% up to 20 mg/dL ascorbate

Icterus Interference less than 10% up to 40 mg/dL bilirubin

Haemolysis Interference less than 3% up to 5 g/L haemoglobin

Lipemia Interference less than 10% up to 700 mg/dL Intralipid

m. CALCULATING RESULTS TO INCLUDE
MEASUREMENT UNCERTAINTY
 
The expanded measurement uncertainty of glucose is 6 months
CVs multipled by a coverage factor of 2. The details of this will
be given to the clinicians on request. This is reviewed every 6
months and is available in the lab
n. BIOLOGICAL TEST INTERVALS:
 
Serum/Plasma (fasting)
Adults: 74 – 99 mg/dL
Children: 60 – 99 mg/dL
Urine
1 – 15 mg/dL
CSF
Adult: 40 – 70 mg/dL ≈ 60% of plasma value
Post prandial Glucose: ≤140 mg/dL
 
Oral Glucose Tolerance Test (OGTT) fasting and a sample drawn 2 hours after a 75-gram
glucose load
Fasting Glucose value Interpretation
From 70-99 *mg/Dl Normal fasting glucose
From 100* to 125 mg/Dl Impaired fasting glucose (pre-diabetes)
126 mg/dL and above on more than one Diabetes
testing occasion

2 hour value Interpretation (Levels applicable except

during pregnancy.)
Less than 140 mg/dL Normal glucose tolerance
From 140 to 199 mg/dL Impaired glucose tolerance (pre-diabetes)
Over 200 mg/dL on more than one Diabetes
testing occasion
*Upper limit of FBS as per AU 480 reference ranges, other values as per ADA norms
Criteria for the diagnosis of Diabetes Mellitus (ADA)
Any of the following
Diabetes mellitus
 Fasting plasma venous glucose ≥ 126 mg/dl
 2-hour oral glucose tolerance test (OGTT) (with 75g
glucose) plasma venous glucose ≥ 200 mg/dl
 Random glucose ≥ 200 mg/dl

Impaired fasting  Fasting plasma venous glucose measurement 100*-

glucose (IFG) 125 mg/dl

Impaired glucose Both of the following

tolerance (IGT)
 Fasting plasma venous glucose < 126 mg/dl
 2-hour OGTT plasma venous glucose ≥ 140 mg/dl
and < 200 mg/dl

Gestational Diabetes Screening: Glucose Challenge Test (Sample drawn 1 hour after a 50-
gram glucose load)
1 hour value Interpretation
Less than 140* mg/dL Normal screen
140* mg/dL and over Abnormal, needs GTT (see below)
* A cutoff of 130 mg/dL if used identifies 90% of women with gestational diabetes, compared to
80% identified using the threshold of 140 mg/dL
Gestational Diabetes Diagnostic: OGTT (Fasting + 2 samples drawn after 75-gram* glucose
load).

Sample Type Target

Fasting (prior to glucose load) 92 mg/Dl
1 hour after glucose load 180 mg/dL
2 hours after glucose load 153 mg/dL
Interpretation: If any value exceeds the target level, gestational diabetes is diagnosed.
o. REPORTABLE RANGE: 10 to 1500 mg/dL
 
p. DETERMINING RESULTS WHEN THE RESULT IS NOT
WITHIN MEASURABLE RANGE
 
LINEARITY: The test is linear within a concentration range of 10 –
750 mg/dL for plasma 
Limits of detection (LOD) verified in the lab: 10 – 750 mg/dL
 
For samples with concentration less than 10 mg/dL; the result should
be reported as < 10 mg/dl. For samples with concentration more than
750 mg/dL, the plasma should be diluted 1:1 and multiplied. The
system performs all calculations internally to produce the final
reported result. AU 480 does not calculate the final result for sample
dilutions made by the operator. In these cases, the result produced by
the instrument must be multiplied by the dilution factor before
reporting the final result.
 
 
s. POTENTIAL SOURCES OF VARIATION
 
The quickness of separation of the red blood cells from the plasma by centrifugation is a
critical element, because it is estimated that plasma glucose levels are reduced ∼ 10 mg/dl
per hour by consumption of glucose in the red blood cell's glycolytic pathway. Thus, a
plasma sample that was immediately centrifuged would be expected to have a significantly
different glucose than one centrifuged many hours later.
Intra individual variation of plasma glucose have been reported to ∼ 14%
If fasting can include both morning and afternoon, this biological variation is even larger,
because morning fasting blood glucose is higher than afternoon fasting blood glucose
 
t. REFERENCES.
 
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics by Carl A. Burtis, Edward
R. Ashwood, David E. Bruns, Fourth Edition, 2006, Table - 56.3 Page No 2317, 868-875
AU 480 chemistry information Manual
ADA Guidelines 2013
 
• 
• 
Job-aids/ Bench-aids/WDI/ WI
• Shortened version od an SOP/ QSP that can be posted at the
worksite as a reminder of the steps to be completed
• Supplements and NOT REPLACE the SOP
• To be placed in a visible location
• Should include the SAME information as an SOP but not ALL
the information
• All job-aids are required to be under document control unless
otherwise indicated.
• They may be flowcharts, pictorial forms
Hand Hygiene
Lab XYX…..(Document Control elements)
Sample Collection: Order of Draw
Lab XYX…..(Document Control elements)
Accessioning
Lab XYX…..(Document Control elements)
Sample Transport
Lab XYX…..(Document Control elements)
Clinical Path
Lab XYX…..(Document Control elements)
 Lab XYX…..(Document Control elements)

Method for inserting a calibrated loop into urine to ensure that the
proper amount of specimen adheres to the loop
 Lab XYX…..(Document Control elements)

Method for streaking with calibrated urine loop to produce isolated

colonies and countable colony-forming units
Biochemistry, Hematology….
Lab XYX…..(Document Control elements)
Level 3
 Level 3
1. Documents (Formats: A place
to record data)
2. Records (A form with recorded
data)
Where are level 3 documents required?
• Any activity that needs evidence of the
correctness of implementation.
When are level 3 documents prepared?
• These are formatted upfront for data capture
How are level 3 documents designed?
• As per the aspects of the activity that need
evidence
List of Minimum Records 4.13
List of Minimum Records 4.13
Understanding the format
requirements……
List of activities needing formats
• Go by 4.13…..
• Go clause-wise starting from 4.1as (you write your
quality manual)and see where you need records and
make formats
• Don’t over-do!!!
Designing the format…How to capture the required data
• Understand the purpose of the activity
• Understand the complexity of activities
• Don’t over complicate
Some additional points:
Controlling
1. All formats should be indexed (Numbered)
2. All formats should be traceable to the second level of
documents where the activity is described
3. All formats come under document control
• If a format requires reformatting to capture additional
information, note down reason for revision, date, revision
number…
• All in-use formats should be control stamped
• All obsolete formats should be removed from the site of use
• One copy should be retained with obsolete stamp
 A format for 4.4
Document
Control

F 05 REVIEW OF CONTRACT Ref: XYZ/QSP/2

Issue Date 12/3/15 Amend Date 02/12/15
Issue Number 07 Approved By
Scope of
the proof
needed
Date Patient name Registration Tests Reason for Cancelled/ Consent Signature
Number Under Review Outsourced Taken of QM
Review of
Contract
A format for 5.5

F 15 ESR TEST RECORD Ref: XYX/Hem/SOP/1

Issue Date 12/3/15 Amend Date 00/00/00
Issue Number 05 Approved By

Date Sl No Patient name Registration Reading Comments Signature

Number
Record Retention
• Retention of records is mandatory to track specific activities.
• The laboratory shall decide the retention time of records as per
the national, regional and local regulations
• Duration of retention depends on the scope of the activity
• Some examples
• HR Files: As long as the person is in service
• Equipment Files: As long as the equipment is in use
• QC Files: At least 1 year (Audit to audit)
• Complaints…..
• MRM…..
• Adverse incidents…….
Retention of Records: NABL
112
Reports are also Records….5.8.3
 The Flow……

Policy Process Procedure Records

Statement of Define activities that Performing the activity Evidence retained
intent transform intent into
action
DOCUMENT CONTROL
Why?
• Helps in maintaining an Inventory of Documents
• Helps in uniform formatting
• Helps in Indexing
• Helps in review and update
• Helps in keeping the current versions on the work desk
• Helps in removing the obsolete versions to prevent
unintentional use
Which Documents?
Any document that can change
• Policy statements, flowcharts….
• QSPs, SOP: Procedures may change
• Text Books which are referenced in the lab: Editions may
change
• Documents of external origin: service manuals,
regulations….new guidelines will be issued
• Documents of external origin: Kit inserts.. New formulations
in new lots, new instructions for use
 Elements of Document
Control System: ISO 15189
Cl 4.3
ISO: Regarding Soft Copy
Documents
ISO: Regarding Document
Identity
Complete Standardized Header, 4.3 On
The First Page Of All Level 2 Documents

Lab Document Identity Pages 1 of…..

Document Name
Issue Number Issue Date Revision Due No of Copies
Prepared By Issued By
Reduced Standardized Header
On Every Page

Name of Hospital/Department Document Identity Page 1 of…..

Name of Manual

Andhra Med College: Dept Of Biochemistry AMC/BIOC/SOP/12 Page 15 of 230

Name of Manual SOP for AU 480

Header level 3 Documents
FF0505 REVIEW
REVIEWOFOFCONTRACT
CONTRACT Ref:
Ref: XYZ/QSP/2
XYZ/QSP/2
Issue
IssueDate
Date 12/3/15
12/3/15 Amend
AmendDate
Date 02/12/15
02/12/15
Issue
IssueNumber
Number 0707 Approved
ApprovedByBy

Date
Date Patient
Patientname
name Registration
Registration Tests
Tests Reason
Reasonforfor Cancelled/
Cancelled/ Consent
Consent Signature
Signature
Number
Number Under Under Review
Review Outsourced
Outsourced Taken
Taken ofofQM
QM
Review
Reviewofof
Contract
Contract
Level 3 Document, Header
F 15 ESR TEST RECORD Ref: XYX/Hem/SOP/1
Issue Date 12/3/15 Amend Date 00/00/00
Issue Number 05 Approved By

Date Sl No Patient name Registration Reading Comments Signature

Number
Make a uniform format
• Use a letter for the type of document,
• Use an incremental number for each of the documents of this
kind.
Some Suggestions
• R1, R2, R3 for non-formatted records: MoUs, EQAS reports
• F1, F2…. for formats;
• T1, T2, for official texts,
• RG1 1, RG 2 registers, etc.
• Time consuming process, so if you already have a system,
don’t change…Try to make the necessary changes
ISO: Regarding
Some Terms
AMENDMENT: Small changes made that does not warrant
reissue

EDITION/ ISSUE/VERSION/ REVISION: Significant number

of change made that warrants reissue

APPROVED BY/ ISSUED BY: Authority of issue

Amendments
• Every amendment should be documented in the amendment
page.
• The lab can decide on how many amendments it will
incorporate before the issue is changed
• The lab can decide how it will convey the amendments to the
readers before and after the issue change.
• The lab may also decide if the amendments will be made by
hand, pending reissue.
Amendment Page: an example
ISO: Regarding
Master List/ Document Log

Document Document Issue/Ve Issue/ Revision Revisi Copy Locati Approval

Number Name rsion version /Amend on/A Holder on Authority
Number Date ment mend
Num ment
Date
D 01 Quality 01 1/11/1 00 00 Quality QM Medical
Manual 5 Manager office Supt
D 02 QSP 01 1/12/1 00 00 Quality QM HOD
5 Manager office
Master List: An example…..
ISO…contd
Prevent Use of Obsolete
Documents
• Remove from the point of use
• Stamp as obsolete
Approvals/ Reviews/Approvals
• Performed by laboratory management, and
approval is indicated by signatures with
appropriate dates.
• Policies for the approval, distribution and
revision of documents should be clearly
established as a part of the Documents and
Records policy.
• An in-use document should be “controlled”
stamped.
Assuring Accessibility
• Make a Distribution plan or list e.g.
• Sample Collection Manuals in wards
• Formats in all places of use
• Make sure the documents reach the
areas of use
• Make sure that the locations are
documented
• Assure that correct versions are used
Distribution List, an example

Format 5 : Distribution List Format: With example

Name and Identity Controlled copy No. Name/ Designation Signature of authority
of Document of the holder of
controlled copy
Sample Collection 03 Ward 10 Sister in
Manual charge
Archival of Documents and
Records
Why?
• Important to research a problem
• Reviewing Quality Practices
How?
• Collect all copies from all locations using
the distribution list and master list
Points to remember: Manual and
Electronic Archival
• Permanence
• Accessibility
• Security
• Traceability
Audit Trails
It is a record showing who has accessed
a computer system and what operations
s/he has performed during a particular
period.
• For maintaining integrity of data
• System security and encouragement
• Personal accountability
Common Problems
• Out-dated documents in circulation.
• Distribution problems
• Failure to account for documents of external origin:
• Not Logging kit inserts..
• Forms that are inadequately designed to meet laboratory and
client needs
• Standardized forms prepared by others may not be suitable for
all laboratories
• Inability to retrieve data due to poor archiving processes or
insufficient back-up of computerized information
• Thank
You!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
!!!!!!!!!!