BRSM Form 009 Qms PL - Ppagl

BRSM
Systems:QMS ISO 9001 (2008)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): Parseh Pathobiology And Genetics Laboratory
PHYSICAL LOCATION(s): Parseh Medical Building, Jenah St., Sadeghieh
Sq., Tehran, Iran
Phase II Audit Date(s): 24‐NOV‐2016
Phase I Audit Date(s):
NAICS (or NACE) CODE 86.90
ISO 9001 EXCLUSIONS: 7‐3

Assessment objectives: to audit requirements of iso9001:2008
Iran Refrence 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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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).
2 Scope of activities Performing Clinical, Pathological and Genetic Tests
BRSM requires that the organization’s legal obligations and regulatory
3 Legal status are met as part of granting certification.
Certificate of lab 1391-12354-‫ ب‬valid until end of Shamsi Year
4 Quality Management System
There was no change in products, locations and scope. Company uses BRS logo
on packages and head letters as work instruction.
Initial Audit:
PL‐01‐15:
There was no record of "Bioscientia laboratory" in Germany, in the case, records of
supplier evaluation have been observed.
PL‐02‐15:
General Corrective action is not done regarding non conformity No. 03 in
Requirements – microbiology section about exhaust of hood, but there is no corrective
4.1 What is the action regarding to this. √
implementation / The action plan is effective, correction has been observed and in audit
transition date? no case founded regarding this NC
PL‐03‐15:
In some cases organization did not do trend analysis such as post test process
The action plan is effective, correction has been observed and in audit
no case founded regarding this NC
Such as trend of customer satsifaction or trend of reception
Documentation
4.2 Requirements No change happened in scope, methods and places √
(includes records)
4.2.2 Quality Manual No change happened in scope, methods and places √
Control documents procedure PL-PR-14. Approval documentation or

supervisor's responsibility is responsible for the process or management
Control of
4.2.3 representative. Technical director's approval documentation or √
Documents documentation
Accesibility to documents are in job description of QA manager/MR
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 2 of 14
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whom is Mrs. Soleimani she give access to all staff via the internal
network is provided. The records document the change is in form "
Development and Change Document"
Control of Record control procedure PL-PR-05. Distribution, maintenance, location
4.2.4 Records – Are and method of elimination are in records list PL-RF-107 is specified. √
records… Such as insurance documents and genetics records duration is 5 years.
purchased items to one year. Records of internal quality control tests a
year.
All NC and observation has been enhanced

Management
5
Commitment
Software of reference lab has been enhanced √
Customer satisfaction and customer reception rate increased
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)
Quality policy review has been observed in management review on

5.3 Quality Policy √
20/6/1395 (September 2016)
Planning;5.4.1 Objective table of past year and new year has been observed
Quality
PL‐RE‐12 are the form which objectives break down in it, such as:
Objectives/5.4.2
5.4
quality Promotion of customer satisfaction criteria is the number of complaints
management that is 6 and the objective is to decrease it to 4 in this year
system planning
5.5
Organization chart, PL‐RE‐24 contains all necessary departments and
based on chart, job description PL‐JD‐29 have been provided, I checked
Pathology department operator job descriptions such as:
1‐Tasks related to the availability and operating the devices, and other
Responsibility,
5.5.1 technical factors for laboratory tests √
Authority
2‐ Survey and control different parts of laboratory devices and devices
with violations to the appropriate authorities
Management representative is Mrs. Soleimani from two years with a
letter from Mir Majid Mosallaiee
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Management representative is Mrs. Soleimani from three years with a

Management
5.5.2 letter from Mir Majid Mosallaiee √
Representative
She is Quality assurance manager too.
Organization chart, PL‐RE‐24 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
Management review procedure PL‐PR‐02. The frequency is annual
5.6.1 General management review. All registered inputs to the meeting procedure. √
Output of meeting the specified procedures, corresponds to the
standard requirements.
The last minutes of management review dated management review on
20/6/1395 (September 2016) and the period specified 12 month in the
5.6.2 Review Inputs procedure. √
Outputs of management review observed Such as:
Customer satisfaction
Improving the staffs health
5.6.3 Review Output Increasing the due date of tests answers √
Increase level of awareness of each department
6 Resource Management
6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

6.2 Human Resources
There is PL‐PR‐01 "training procedure" for this clause of standard, which
6.2.1 General
contains Training needs assessment, training calendar, evaluate the √
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effectiveness of training
Ms. Mohamadipor knew about transferring the sample of patient
There was a training courses for Mahanz Babai to improve the ISO
9001:2008 to 2015, training course was internal and done by Mrs.
Soleimani, effectiveness of course is weighted by written exam and her
grade id 18 ,the acceptance grade is consider 12
Mrs Gholami is working in reception for almost 2 year, course of
“Dealing with clients” is hold for hir, effectiveness of the course was
reducing the complaints of clients, complaints of the September was 8
but the complaint in October was 2
PL-PR-01
Competence, There was a training about “Infection and Disinfection” for Mr. Akbari
6.2.2 Awareness and on august 2016 effectiveness of course is weighted by written exam and AR
Training his grade is 15 ,the acceptance grade is consider 10
Proper sampling techniques course is hold for all technical experts on
July 2016. Documents of Mr. Semnani observed and effectiveness of
course is weighted by written exam and his grade is 19 ,the acceptance
grade is consider 10.
In case of job Improvement, there was no need assessment for job
holder, such as Ms. Fahime Mohammadpour which was QC Department
but now is in QA department

Records of PM for Conventional thermal cycler Corbett has been
observed such as:
Daily: cleaning after and before work
Annually: overhaul by supplier which is done on 5/5/95 (august 2016)
with an accredited company by reference lab.
Verification and validation of overhaul done on same date on MOM no
95‐102.
record of log of photometer A33 observed
PL‐R‐2‐00
Record of overhaul and calibration of photometer on June 2016
6.3 Infrastructure OBS
Lamp adjusting
Cleaning sucking box.
Compressed air passages cleaning.
Calibration and validation is done by "ASA calibration company" includes
accuracy and repeat test
Average 96.2
SD 1.58
Result approve

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Work environment clean, Record of resource management checklist (all
resources except human resource) checked monthly by Mr. Semnani.
For records checklist on end of May 2016 has been observed. There are
two corrective action serial 01 15/3/1395 and 02 18/5/1395 regarding
this checklist to change test tubes tray and air‐condition, the root cause
Work was test tubes tray and air‐condition are rusted during time.
6.4 √
Environment Correction: buying test tubes tray and air‐condition
Surface testing is done monthly due to reference lab regulation, plan of
random test has been observed in PL‐CL‐25. Surface test of reception
desk and laminar hood has been observed for August 2016.

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 accepted
√
Realization
For records:
Ms. Bakshhaee, with admission No. 41229
Company has a list on reception desk as a guide for subcontracted
laboratories.
Ms. Bakshhaee, with admission No. 41229
Company uses an ERP so after appointing system patient waits
Determination of until his/her turn. so reception gives 2 days for answering except
Requirements there is a exception (which are described in WI-RP-05) such as
7.2.1
Related to the "normal molecule" test which takes 7 working days √
Product For above three cases I saw records of sampling information in
sampling unit on the touch computer. Company uses automatic
labeling system on samples.
7.2 Customer‐Related Processes
There are rare situation for change in contract, parse lab has no
Review of
record of change in recent years
Requirements
7.2.2
Related to the Reviewing the tests required for patient is the duty of the Supervisor and √
Product reception section staff. They have to reconfirm the name of test with
patient verbally. The tests specifies by the prescription of the physician.
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Communication with customers (patient and Dr) is executed through the

ERP system such as:
Digital board
Customer Appointing system
7.2.3
Communication SMS panel √
Emails
telephone for emergency cases
face to face communication.
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
7.3.6 Validation NA
Control of (D & D)
7.3.7 NA
Changes
7.4 Purchasing
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Procedure PL‐Pr‐21 is for purchasing, verifying and supplier evaluation,
Form of assessment of subcontractors is PL‐RF‐91
Purchasing
7.4.1 For case Ms. Bakshhaee, with admission No. 41229, test tube lot is
Process
160410 that has been bought in May 2016, provider is “AVA Pezeshk”
Grade and score is 92, acceptable score is more than 85
another subcontractor is Biosceintia in Germany, as procedure PL‐RF‐91
records of evaluation has are available in laboratory, grade is 83 and
certificate of this lab "Biosceintia" from American pathologist has been
observed which was valid to June‐10‐2018
Purchasing
7.4.2 √

Information
Verification of purchase is done in two steps:
1‐ Visionary control include date, quantity and packaging
2‐ Verifying with control and standards before first use (refer to
7.5.1 and 8.2.4)
Verification of
7.4.3
Purchases
Record of verification of Vitamin D3 Kit has been observed, √
Date of arrival: 28/5/1395, lot numbers:
5415413 expiration date march 2018
7541541 expiration date June 2019
6094854 Expiration date march 2016
Responsible is Dr. Mr Mohseni
7.5 Production and Service Provision
Control of
7.5.1 Production and According to the developed SOP’s, all tests which are executed are based √
Service Provision on SOPs. The record of executed tests till result preparing were observed
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Validation of such as admission numbers:

Processes for For case Ms. Bakshhaee, with admission No. 41229
7.5.2
Production and All results will be delivered just to the patient or the individual who has
Service Provision the admission receipt.
Identification and Its traceable to test tube lot 41229

7.5.3 Vitamin D3 Kit lot 187364732
Traceability
Mindray SOP has been observed in Farsi
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 There are Non Conformity for customer property such as:
7.5.4
Property Patient with admission Number WR 58, sample became slippery,
√
Mr Hosseini called patient and asked him to come to re-test, he
didn’t claim anything regarding Non Conformity notebook of
reception.
Preservation of
7.5.5 -
Product
Control of
Monitoring and
7.6
Measuring -
Devices
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, SMS, Telephone, Email and
website
Doctors verbal, surveys, Telephone, SMS
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: √
Reception
Sampling
Answering
Technical supervisor
Company will take action regarding to weak or unpleasant situation via
telephone, such as case 19/4/1395, there were no compliant recorded
from Initial audit to now.
It show effectiveness of company objectives.
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Internal audit shall be hold at least once a year, audit checklist are base
on reference lab requirements, ISO 9001, ISO15189, EMS and OHSMS.
Internal audit is done by a team, Mrs. Soleimani, Mr. Semnani and Mr.
Maleki as Consultant and lead auditor on 9&8‐ 6‐95(August 2016)
8.2.2 Internal Audits "sending sample to reference laboratories checklist" has observed √
Non Conformity was as below:
4 corrective action for serology, 12 for training effectiveness,
effectiveness of corrective action was 14/07/95, correction were
followed effectivley.
Reception process:
Criteria: Duration when patients wait
Measurement period 3 month
Acceptance level: 14 minutes and in first 3 month of 1395 result became
12 minutes. Corrective action of last year was changing lining program
and now it is effective. Ro reach 12 minutes they recruited a new
sampler.
Monitoring and

8.2.3 Measurement
Post‐test process: √
Process
Criteria: Number of Non Conformities
Acceptance level: maximum 10 Non Conformities
Result is 3 in first 6 months of 1395.

Data analysis output is a plan to enhance phisycal area of test lab and
buy new equipments.
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Monitoring and measurement of final product is done for

every case by supervisors (Dr. Mohseni and or Dr. Mir Majid
Mosallaiee)
For Processes as SOPs, setup is kit and equipment test, for out
of range results there should be a repeated test which confirms
results
Monitoring and For the record:
8.2.4 Measurement of Mc fareland QC test has been observed in Microbiology √
Product department
Cr CV is 1.3 for august 2016 in form pl-rf-55 for lot 95003
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Every department has Non Conformity notebook, I wrote Non

Conformity of reception above, for record:
Control of Non‐ Sampling
8.3 Conforming Sampling test was not enough √

Product Corrective action:
Calling to client for re-test
Reception process:
Criteria: Duration when patients wait
Acceptance level: 14 minutes and in first 3 month of 1395 result became
12 minutes. Corrective action of last year was changing lining program
and now it is effective. Ro reach 12 minutes they recruited a new
sampler.
PL-RE-15

8.4 Analysis of Data
Post‐test process: AR
Criteria: Number of Non Conformities
Acceptance level: maximum 10 Non Conformities
Result is 3 in first 6 months of 1395.

Data analysis output is a plan to enhance phisycal area of test lab and
buy new equipments.
8.5 Improvement
Refer to 8.2.1
Continual
8.5.1
Improvement
Refer to 5.4.1 √
The percentage of accomplished MOM output to all output is 100%
There are 46 CA and 8 PA forms in period of surveillance, such as CA#36
NC: Mr. chegini transferred urine cup in hand and not in special baskets
Root Cause: there is just one basket in organization, negligence of Mr.
chengini
8.5.2 Corrective Action Company bought one more basket with another color to distinguish the √
place basket shall be placed
Re‐training of Mr. chegini by me semnani

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PA#8 to preventing customers from cold, adding
8.5.3 Preventive Action √
automatic door to reception

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

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:
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:
PL-01-16: In case of job Improvement, there was no need assessment for job holder, such as Ms. Fahime
Mohammadpour which was QC Department but now is in QA department
Observation Form-018 – with uniquely specific identification:
ATL: Gita Zarsazi DATE: 24‐NOV‐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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4.2.2 Quality Manual No change happened in scope, methods and places √

Control documents procedure PL-PR-14. Approval documentation or

All NC and observation has been enhanced

Quality policy review has been observed in management review on

Management representative is Mrs. Soleimani from three years with a

6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

Communication with customers (patient and Dr) is executed through the

7.3.2 D & D Inputs NA

7.3.3 D & D Outputs NA

7.3.5 Verification NA

7.3.6 Validation NA

Validation of such as admission numbers:

Identification and Its traceable to test tube lot 41229

Monitoring and measurement of final product is done for

Every department has Non Conformity notebook, I wrote Non

Observation Form-018 – with uniquely specific identification:

ATL: Gita Zarsazi DATE: 24‐NOV‐2016

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