BRSM Form 009 Qms PPL

BRSM
Systems:QMS ISO 9001 (2008)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): PASTEUR PATHOBIOLOGY LAB.
PHYSICAL LOCATION(s): Alley No. 42, Inghelab Sq., Shahre kord, IRAN.
stage II Audit Date(s): 30 April 2016
stage I Audit Date(s): 23 April 2016
NAICS (or NACE) CODE 86.90
ISO 9001 EXCLUSIONS: 7‐3

Assessment objectives: to audit requirements of iso9001:2008
Iran Reference lab regulations in ms of the
company

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Gita Zarsazi
Assessor 2
Assessor 3
Assessor 4
Assessor 5
Assessor 6

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
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REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
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We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
Providing of medical diagnostic tests including Biochemistry, Hematology, Hormone,
2 Scope of activities
Immunology, Microbiology, Serology, Parasitology, Spermogram, Pathology and Cytology.
BRSM requires that the organization’s legal obligations and regulatory
3 Legal status are met as part of granting certification.
Certificate of lab 23472C-1394 valid until end of one Shamsi Year
4 Quality Management System
General the organization has implemented integrated management systems for 3
Requirements – years. The general requirements are obliged by MOH and Iranian
4.1 What is the Reference Laboratory. All diagnostic laboratories have to abide these √
implementation / regulations. Also the mandatory requirements of ISO 9001:2008 have
transition date? been covered in implemented in organization management systems.
Quality Management System has identification of process, these
processes are:
Reception, sampling, testing, answering, QC, Calibration, Purchasing,
CRM, Training, Health and safety, Internal audit, CAR/PAR,
Management review, Improvement.
Sequence and interaction between processes identified only as arrows
The name of the process: sampling. Indicator: the number of cases of

non-conforming in reporting. Acceptance criteria: 1% of non-conforming
Documentation in relation to the number of patients.
4.2 Requirements √
(includes records) The name of the process: testing. Indicator: the number of cases of non-
conforming in testing. Acceptance criteria: 1%.
Process monitoring customer satisfaction(CRM). Indicator: Percentage of

satisfaction. Acceptance criteria: for laboratories contracted by 80%.
The identification process of continuous improvement, evaluation

criteria: effectiveness of corrective and preventive actions, the acceptance
of at least 80%. And many minor NCs in the integrated management
system third-party audits. Acceptance criteria: maximum 5.
Quality manual has been checked in stage one, scope, exclusions (7.3)
and relation between QMS clauses and documents are clear such as
4.2.2 Quality Manual √
reference to (management review) for clause 5.6
Quality manual has been signed By Dr. Moghni technical supervisor.
Control documents procedure dose exist. Approval documentation or

supervisor's responsibility is responsible for the process or management
Control of
4.2.3 representative. Technical director's approval documentation. √
Documents Accessibility to documents are in job description of QA manager/MR
whom is Mrs. Hadi she give access to all staff via the internal network is
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 2 of 13
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provided. The records document the change is in form " Development

and Change Document"
Record control procedure: Distribution, maintenance, location and
Control of method of elimination are in records list is specified. Such as insurance
4.2.4 Records – Are documents and genetics records duration is 5 years. Purchased items to √
records… one year. Records of internal quality control tests a year.
So according to reference lab of Iran requirements, patient sample will
keep in lab for 7 days. Except pathology result which kept in software for
20 years.
Quality policy approved By Dr. moghni which includes commitment
MD herself, objective and continual improvement and in some cases he,
Management followed complaints and closed them by herself
5
Commitment Refer to 8.2.1 √
Refer to 5.4.1
The percentage of accomplished MOH output to all output is 100%
Customer Focus –
Actions taken regarding Customer feedback shows customer focus and
5.2 (may relate to
refer to 7.2.1 and 8.2.1 we did find evidences of customer focus √
7.2.1 and 8.2.1)
Policies(Rev3 in 1395) headline are:

Increasing the variety of tests and processes with the launch of new
sections and new equipment.
Implementing satisfaction of clients (patients and Doctors)
according to ISO10002
5.3 Quality Policy √
improvement staff knowledge by training and
Improvement of equipment.
According to the representative of management, policy will be
trained to new employees.
The policy was seen on the laboratory's wall.
Objective table of past year and new year has been observed are the
Planning;5.4.1 form which objectives break down in it, such as:
Quality According to policy, they have 3 action plans to make a road map
Objectives/5.4.2
5.4 for objectives. √
quality
management For “improvement of equipment”, action plan observed. They
system planning bought a Xll device for some biological tests, and it’s to be
continue.
5.5
Organization chart contains all necessary departments and based on

chart, job description have been provided, we checked Molecule
Responsibility,
5.5.1 department operator job descriptions such as: √
Authority
Technical supervisor and infection control person.
Job requirement: Master of science in molecular branch
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Management representative is Mrs. Hadi from 5 years with a letter

Management
5.5.2 from Dr. rezaei √
Representative
She is Quality assurance manager too.
Organization chart, contains all necessary departments such as:

Molecular. The reception and response, and sampling and write.
Internal Department of Microbiology .biochemical, Fertility and Infertility.
5.5.3 √
Communication Molecular section. Department of Pathology and Cytology
Communication is done by internal telephone system, email and
formal letter or forms.
5.6
5.6.1 General The frequency is annual management review. Last meeting date is √
Feb 2016.
All registered inputs to the meeting procedure. Output of meeting
the specified procedures, corresponds to the standard requirements.
the period specified in the procedure, the next meeting has not been
5.6.2 Review Inputs held. √
Such as:
Recommendation for improvement:
Determine the new test SOPs
Determine the new equipment profiles
5.6.3 Review Output Impediment Green lab software. √
6 Resource Management
6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

6.2 Human Resources
Mrs. alirezaei knew about infection control in lab.

6.2.1 General
Training Plan for new year and last year were observed. √
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In last year plan ,There was a training courses for internal audit for
Mrs. hesamipour, training course was internal by consultant and
effectiveness of course measured on internal audit session which
Competence, Mr. boostan as lead auditor has her on his side. Total grade is good.
6.2.2 Awareness and There was an exam on (September 2015) which for ensuring level √
Training of awareness of each department.
Ms. Hoseini and Mr. semnani grade eas less than 90%,
Effectiveness of course of Mr. boostan measured 100% on
19/6/1394 (course had been held one day earlier)
Records of PM for Capilarnys-SEBIA-Flex piercing have been
observed.
Last visit date: 95/1/28 for maintenance from main company.
Next visit planned in 95/7/29
There is a calibration certificate from manufacturer. It’s ID
94/F/208
6.3 Infrastructure √

Cleaning syringe, needle and output water and needle junction.
Changing needle board, pipe, fan, air filter
In records for printers and money paying machine, reception
section they choose to verify performance of machine.
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The environment situation is according to MOH requires.

We can check autoclave calibration certificate that use for infection
control and waste disinfection.
They used safety box per 2 days and they disinfection those box
every day. They use steam indicators per each cycle and used
biological vial class 5 per each weeks.
Record of 95/01/22 of autoclaves work observed, and
We checked Exp. Date of vial and indicators.
Work environment id neat and clean, Record of resource
management checklist (all resources except human resource)
checked monthly by Mr. boostan.
There are some issues it may be considered by top manager such
as:
Floor of Biochemical department
Work Air condition system
6.4 √
Environment Exhaust of Microbiological section
Exhaust Of PCR
Waste management
HBS antigen
Hepatitis B
Anti HCV
HIV is done for Mrs. nahid
SOP of Elimination of Disposition infectious and noninfectious and
records of SOP (cleaning and sanitizing) were observed for 6th
month of 1395 (April 2015) and for elimination contract with
municipal from 1/1/1394 to 29/12/1394 has been observed
Record of autoclave and oven was observed for 31/6/1394 has been
observed as validation records Brown vial and TST has been
observed.
7 Product Realization
There are SOPs in laboratory which are based work instruction,
refer to 6.2.2 samples and performance of staff, equipments are
validate annually (refer to 6.3) and based on 6.4 of this report,
company controls infrastructure monthly.
Planning of Reception unite asks information of patient due to Drs. Prescription
7.1 Product of patients or in some cases such as FBS verbal inquires will be √
Realization accepted For records:
Reception ID’s No. 979 in today for this tests:
CBC, CRP and C.C.P
Date, patient, Dr. name and order, insurance company name and
other info which needs record in the software.
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Determination of
CBC, CRP and C.C.P
Requirements Date, patient, Dr. name and order, insurance company name and
7.2.1
Related to the other info which needs record in the software. √
Product Reception gives 2 days for answering except there is a exception
such as "normal molecule" test which takes 7 working days.
7.2 Customer‐Related Processes
There are rare situation for change in contract, this lab has no
record of change yet. As procedure, change should be considered as
Review of new inquiry.
Requirements
7.2.2
Related to the Reviewing the tests required for patient is the duty of the √
Product Supervisor and reception section staff. They have to reconfirm the
name of test with patient verbally. The tests specifies by the
prescription of the physician.
Communication with customers (patient and Dr.) is executed
through the ERP system such as:
Digital board
Appointing system
Customer Emails
7.2.3
Communication Supervisor telephone for emergency cases and informing result
√
readiness and through face to face communication, for example
when one is taking sample talks to patient to introduce the process
and actions needed to be done by patient in order to take sample.
Such as putting urine cup place, where to put it after coming out of
WC in refrigerator.
7.3 Design and Development
Design and
D&D is excluded because of nature of organization, labs shall
7.3.1 Development
use national-international approved methods √
Planning
7.3.2 D & D Inputs NA
7.3.3 D & D Outputs NA
D & D
7.3.4 NA
Reviewing
7.3.5 Verification NA
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7.3.6 Validation NA
Control of (D & D)
7.3.7 NA
Changes
7.4 Purchasing
Purchasing In assessment of subcontractors form, inventory control, name of
7.4.1
Process suppliers of using items are recorded such as
all kits which provided by “akbariyeh company”
Grade is 9.5/10 and date of evaluation is 94/9/20
tests:
Urine Protein
Purchasing CK-MB is done
7.4.2 √

Information Samples are from Parse lab, Noor lab and central lab
Because of wide diversions QC team deseeded to choose
reference labs based on two recent EQAP result of each lab. And
they concluded to repeat CK-MB test in more 4 laboratories to
find out root cause of diversions.
Verification of purchase is done in two steps:
- Visionary control include date, quantity and packaging
- Verifying with control and standards before first use (refer to
7.5.1 and 8.2.4)
Verification of Record of verification of D3 Kit has been observed,
7.4.3
Purchases Date of arrival: 2/2/1395, lot numbers: √
563265289 expiration date June 2017
542569321 expiration date June 2017
532526587 Expiration date march 2017
Responsible is Mrs. Joodaki
7.5 Production and Service Provision
Control of
According to the developed SOP’s, all tests which are executed are
7.5.1 Production and
based on SOPs. The record of executed tests till result preparing
Service Provision
were observed such as admission numbers:
Validation of
√
Processes for
7.5.2
Production and
CBC, CRP and C.C.P
Service Provision
Date, patient, Dr. name and order, insurance company name and
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other info which needs record in the software.

Record of informing HBSAg patients to Nobel Reference
Laboratory with admission number of 3656, female, 42 years old in
19-Oct-74 was observed.
All results will be delivered just to the patient or the individual who
has the admission receipt.
The record of patient with admission number of No.6536 in urine
test notebook in microbiology section was observed .
Protein: Neg.
Glucose: Neg.
Bilirubin: Neg.
Identification and
7.5.3 Culture: No growth
Traceability
The records of cooperating with reference laboratories in tests
(such as):
The record of transferring sample to the reference laboratory
“NOBEL Lab” of the ZINC test for the patient with admission No.
2532 in Jan-16, Vitamin E, Vitamin A test for the patient with
admission number of 562 were observed.
Also they have developed a work instruction for traceability and
identification which is comprehensive. As explained in
requirements of service the tracking number is allocated from
admission.
Samples and reports are considering as customer property
Reports are in ERP program, back up period is every hour on HDD
and daily on server. Server uses raid technology.
Customer
7.5.4
Property
There are Non Conformity for customer property such as: √
Patient with admission Number 452, sample became slippery, Mr.
Hamed called patient and asked him to come to re-test, he did claim
anything regarding Non Conformity notebook of reception.
List of items controlled warehouse. Warehouses lay outing been
sent internally within the unit. The condition of the items was in
stock. For example, maintenance kits, buckets Health Laboratory in
refrigerator- maintenance needles used in blood samples kept at
Preservation of
7.5.5
Product
refrigerator temperature was investigated. Illegible items were in √
stock. Blood samples were illegible. Inventory corresponds
illegible for syringes (730) order point 200 and papers (16 boxes of
500 sheets) order point 5 boxes.
Hemochromatosis kit one box, order point one kit.
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Below is sample of six sample which I taken during audit, calibration si

effective:
TDS METER: DPG-54321
Control of SAMPLER: DPG-67643
Monitoring and SCALE: DPG-55641
7.6
Measuring PH METER: DPG-70114 √
Devices PIPPET: DPG-23981
“RASA Co.” is involved to calibration and that have NACI
certificate to insure they responsible.
8 Measurement, Analysis and Improvement
8.1 General As 8.2&8.3&8.4
8.2 Monitoring and Measuring
There are three kinds of customers:
Patients feedback is via verbal, surveys, Telephone, Email and
website
Doctors verbal, surveys, Telephone
Laboratories which sent samples to Parse lab annually surveys
Surveys include:
Variety of test
Consistent results with the patient's clinical status
Customer
8.2.1
Satisfaction
Manner of staff. √
laboratory will take action regarding to weak or unpleasant
situation via telephone, such as case 31/1/1395, there were a
compliant recorded on ERP system " Long waiting time", Mrs.
Hatami called the patient and asked him more details, root cause
shortage of staff in some hours.
Corrective action: recruiting more personnel
Average of customer satisfaction is “Very Good” in too parameter:
lab staff and accessibility ways.
Internal audit shall be hold at least once a year, audit checklist are
based on reference lab requirements, ISO 9001.
Internal audit is done by a team, Mrs. boostan, Mrs. Joodaki and
Mrs. Hadi on Feb 2016.
8.2.2 Internal Audits "sending sample to reference laboratories checklist" has observed √
Non Conformity was as below:
8 corrective action teak in this audit and we can check corrective
action to solve that.
E.g. refrigerator temp log.
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Reception process:
Criteria: Duration when patients wait
Measurement period six month
Acceptance level: 20 minutes and in first six month of 1395 result
became 18 minutes.
Post-test process:
Monitoring and Criteria: Number of Non Conformities
8.2.3 Measurement Measurement period annually √
Process Acceptance level: maximum 10 Non Conformities
Result is 6 in first 7 months of 1394 so as preventive action serial
01 company analysis shows in "last three month of year 1394" it
was 4 and in next 3 months there was just 2 complaints.
Data analysis mom on 1394 shows the most Non Conformity in
organization is for section "reception" that company have plan to
extend space and human resource.
In some cases organization did not do trend analysis
Monitoring and measurement of final product is done for every

case by supervisors (ID: 979)
For Processes as SOPs, setup is kit and equipment test, for out of
range results there should be a repeated test which confirms results
For the record:
Biochemy:
Monitoring and Linear control of LDL for 17 patients tested for setup:
8.2.4 Measurement of Result CV=1.7 as kit's Brochure √
Product There is last ECAP report from reference lab.
According to ECAP report all test result is in average rang.
Company uses "kits" which have low and high control and
standard such as "Hemochromatosis kits"
Pathology verification is done such as lung cancer case 6352
which detection is no cancer by his Dr. and confirmed by Dr.
moghni which validated by Nobel laboratory.
Control of Non‐
8.3 Conforming There is no any NCR report in all department of Lab in 1395 √

Product
This data evidence is according to:

8.4 Analysis of Data √

8.2.1, 8.2.3, 8.5.3, 7.4.1
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8.5 Improvement
Refer to 8.2.1
Continual Refer to 5.4.1
8.5.1
The percentage of accomplished MOM output to all output is
Improvement √
100%
Record of corrective action is about internal audit and some
report about disinfection system.
procedure code 24
Non-conformities,
Corrective action
Preventive and
CAR No. 22 is about result of steam indicator of autoclaves.
8.5.2 Corrective Action As solving meeting report they making a decision about
A
buying a new autoclave and it are done. R
The effectiveness date Jan 2016 and it’s Ok.
For non-conformities ,root causes have not been determined
There is no recodes.
8.5.3 Preventive Action √
By exception, we indicate the specific Strengths and weakness of the organization in light of the management system, as we perceive and seen through
processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and planning of the assessment.
This aspect relates to Accreditation Body as it does to the protection of consumers in the client-organization’s role within their respective supply – chain.
Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.
Strength Weakness
Technical staff
Work place
equipment

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:N/A
action Request Type II Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:
For non-conformities ,root causes have not been determined
Observation Form-018 – with uniquely specific identification: N/A
ATL: Gita Zarsazi DATE: 30 April 2016
END of REPORT
FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,
FORM-017 – Closing Meeting Checklist FORM-008 – RA / AR, as requires
FORM-005 – Participants of opening & closing meetings FORM-018 – OBS, as requires
FORM-004 – Assessment Plan FORM-010 – As requires, recommendation for CoR
FORM-007 – Planning onto -004, as process determined FORM-026 – Assessment documents check-sheet, optional

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The name of the process: sampling. Indicator: the number of cases of

Process monitoring customer satisfaction(CRM). Indicator: Percentage of

The identification process of continuous improvement, evaluation

Control documents procedure dose exist. Approval documentation or

provided. The records document the change is in form " Development

Policies(Rev3 in 1395) headline are:

Organization chart contains all necessary departments and based on

Management representative is Mrs. Hadi from 5 years with a letter

Organization chart, contains all necessary departments such as:

6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

Mrs. alirezaei knew about infection control in lab.

The environment situation is according to MOH requires.

Reception ID’s No. 979 in today for this tests:

7.3.2 D & D Inputs NA

7.3.3 D & D Outputs NA

7.3.5 Verification NA

7.3.6 Validation NA

other info which needs record in the software.

Below is sample of six sample which I taken during audit, calibration si

Monitoring and measurement of final product is done for every

This data evidence is according to:

8.2.1, 8.2.3, 8.5.3, 7.4.1

Observation Form-018 – with uniquely specific identification: N/A

ATL: Gita Zarsazi DATE: 30 April 2016

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