BRSM Form 009 Qms SL

BRSM
Systems:QMS ISO 9001 (2008)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): DR SOROURI LABORATORY
PHYSICAL LOCATION(s): 22 Bahman St., Azadi Cross Road, Darab , Fars,
Iran
stage II Audit Date(s): 12 May 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 Marjan Azadmanesh
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.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
Reference Clause ATTENTION WILL BE REQUIRE please Tick
mark √

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 more
Requirements – than 3 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,
Customer Satisfaction, Training, Health and safety, Internal audit,
CAR/PAR, Management review, Improvement.
Sequence and interaction between processes identified in Process Map
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.
The Quality Manual was observed. All required standards clauses have
been mentioned. The excluded clause (7.3) is explained in the quality
4.2.2 Quality Manual √
manual. Quality manual has been Approved By Dr. Bita Sorouri technical
supervisor.
Control of documents & records procedure is specified Master list with

code of 77 by determining the documents distribution was observed. The
Control of
4.2.3 method of documents coding, approving and obsolescing the documents √
Documents was checked.
The records retention table with code of 80 was observed. The method
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 2 of 12
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

taking backup from electronic records is determined as daily, monthly

Control of and 6-months. For example the Records of internal quality control tests is
a year.
4.2.4 Records – Are √
So according to reference lab of Iran requirements, patient sample will
records…
keep in lab for 7 days. Except pathology result which kept in software for
20 years.
Quality policy approved By Dr. Sorori which includes commitment
MD herself, objective and continual improvement and in some cases he,
Management
5
Commitment
followed complaints and closed them by herself √
Refer to 8.2.1
Refer to 5.4.1
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 Customer Satisfaction
improvement staff knowledge by training
5.3 Quality Policy √
Improvement of equipment.
The policy was seen on the laboratory's wall.
QC manager was aware of policy
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 Reduce the response the interval in accordance Test
system planning Increasing training Courses 3 course
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
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.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

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 Management review frequency is every Six. Last meeting date is √
March 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,
5.6.2 Review Inputs Out put √
Such as:
Determine the new test SOPs
Renovating and painting waiting room.
5.6.3 Review Output √
6 Resource Management
6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

6.2 Human Resources
Mr. Akbari knew about infection control in lab.

6.2.1 General
Training Plan for new year and last year were observed. √
In last year plan ,There was a training courses for internal audit for
Mrs. Saghar Asghari, training course was Held by IOC company
and effectiveness of course measured on internal audit session in
Competence, Feb 2016,Total grade was 92% which is acceptable.
6.2.2 Awareness and In new year plan there is 5 courses, such as CRM, and √
Training Pathobiology Test.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

Records of PM for Hood laminar have been observed.

Last visit date: 95/1/20 for maintenance from main company.
Next visit planned in 95/6/28
For Sampler
There is a calibration certificate from manufacturer. It’s ID
6.3 Infrastructure 94/CSB/208 √

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.
The environment situation is according to MOH requires.

They used safety box per 3 days and they disinfection those box
Waste Management & Disposal Work Instruction (Code 34)

every day.
They use steam indicators per each cycle and used biological vial
class 5 per each weeks.
Record of 95/02/16 of autoclaves work observed, and
We checked Exp. Date of vial and indicators.
We can check autoclave calibration certificate that use for infection
control and waste disinfection.
Work environment id neat and clean, Record of resource
Work
6.4 management checklist (all resources except human resource) AR
Environment
checked monthly by Mrs. Asghari
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 oven (dry sterilizer) was observed for 31/6/1394 August
2016 has been observed as validation records Brown vial and TST
has been observed.
In sampling sections, Infectious waste was in a yellow nylon bags,
as Iran health reference regulations.
7 Product Realization
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

There are SOPs in laboratory which are based work instruction,

refer to 6.2.2 samples and performance of staff, equipment 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. R203 in May 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.
Reception ID’ No. 979 in 10 May for this tests:
CBC, CRP and C.C.P
Determination of
Date, patient, Dr. name and order, insurance company name and
Requirements
other info which needs record in the software.
7.2.1
Related to the Reception gives 72 hours for answering except there is a exception √
Product such as "tissue pathology" test which takes 10 working days.
Also Reception ID NO 205 11 May 2016.for hematology test : ESR
Were checked.
7.2 Customer‐Related Processes
Reviewing the tests required for patient is the duty of the

Review of
Requirements
Supervisor and reception section staff. They have to reconfirm the
7.2.2
Related to the name of test with patient verbally. The tests specifies by the √
Product prescription of the physician. For request Reception ID’ No. 979 in
10 May.
Communication with customers (patient and Dr.) is executed
Digital board
Appointing system
Emails
Customer
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
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

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
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 “SAMIN company”
Grade is 85 and date of evaluation is 94/9/20
tests:
Urine Protein √
Purchasing CK-MB is done
7.4.2
Information Samples are from Masood 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 3 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 Ms Asghari
7.5 Production and Service Provision
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

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 Reception ID’s No. 203 in 10 May for this tests:
Processes for CBC, CRP and C.C.P
7.5.2
Production and Date, patient, Dr. name and order, insurance company name and
Service Provision other info which needs record in the software.
Record of informing HBSAg patients to Fars Central lab
Laboratory with admission number of 550, female, 36 years old in
20-Nov-15 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.590 in √
Hematology CBC WBS- whole Blood test notebook in Hematology
section was observed.
Identification and
7.5.3
Traceability The records of cooperating with reference laboratories in tests
(such as):
The record of transferring sample to the reference laboratory “Fars
central lab” of the ESR test for the patient with admission No. 979
in August, 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
Customer Reports are in software program, back up period is every hour on
7.5.4
Property HDD and daily on server. Server uses raid technology.
√
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 (300) order point 50 and papers (3 boxes of
500 sheets) order point 1 boxes.
Hemochromatosis kit one box, order point one kit.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

Calibration For Following Devices were Checked

PH METER: PHD-396
Control of SAMPLER: SAD-946
Monitoring and SCALE: DPG-55641
7.6
Measuring PIPPET: DPG-23981 √
Devices “FarsCal services” 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 feedbacks are collect through Questioner form
Doctors, Telephone
Laboratories which sent samples to Fars Central Lab semi-annually
surveys
Surveys include:
Customer Variety of test
8.2.1
Satisfaction Consistent results with the patient's clinical status √
Manner of staff.
If any complaints arise, they issued corrective action.
For customer complaint about delay in responding of test,
The rout cause was
Corrective action: recruiting more personnel
Average of customer satisfaction is “83” which is acceptable
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. Akbari, Mrs. salehi and on
Feb 2016.
11 non conformities discovered.
8.2.2 Internal Audits For example training effectiveness had not been checked for last √
course, Corrective action was observed.
Inventory of kit was not in accordance the order point, corrective
action was considered. The root cause was lack of knowledge of
related staff,
The Staff had been trained.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

Reception process:
Criteria: Duration when patients wait
Measurement period six month
Acceptance level: 25 minutes and in first six month of 1395 result
became 18 minutes.
Monitoring and Post-test process:
8.2.3 Measurement Criteria: Number of Non Conformities √
Process Measurement period annually
Acceptance level: maximum 8 Non Conformities
Result shows 3 Non Conformities, Customer Satisfaction index
80,the result show 75.
Corrective action: mending WC services fan.
Efficiency effectiveness shall be measured on July 2016
Monitoring and measurement of final product is done for every

case by supervisors
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.
sorouri which validated by Fars Central laboratory.
Control of Non‐
8.3 Conforming NCR was related to internal Audit √
Product
This data evidence is according to:

8.4 Analysis of Data √

8.2.1, 8.2.3, 8.5.3, 7.4.1
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
mark √

Customer satisfaction measurement and actions taken

Continual regarding measurements and actions taken regarding external
8.5.1
Improvement QC lab results show management commitment and continual
√
Improvements
Record of corrective action is about internal audit was
observed .refer to 8.2.2
CA # 95011 is about customer satisfaction is below the index
RC: fan of wc need repair, because WC smells very bad.
8.5.2 Corrective Action √

Correction: mending Fan
Corrective action: changing interval of PRP control from
annually to seasonally
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
Management Commitment Training

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: In sampling sections , Infectious waste was in a black nylon, but in accordance Iran health reference
regulations Infectious waste must be kept in yellow nylon.
Observation Form-018 – with uniquely specific identification: N/A
ATL: Marjan Azadmanesh DATE: 12 May 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

BRSM Form 009 Qms SL

Transféré par

Informations du document

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

BRSM Form 009 Qms SL

Transféré par

Droits d'auteur :

Formats disponibles

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

Process monitoring customer satisfaction (CRM). Indicator: Percentage

The identification process of continuous improvement, evaluation

Control of documents & records procedure is specified Master list with

taking backup from electronic records is determined as daily, monthly

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:

5.6.3 Review Output √

6.1 Refer to 6.2 ,6.3, 7.4 ,8.2.1

Mr. Akbari knew about infection control in lab.

Records of PM for Hood laminar have been observed.

The environment situation is according to MOH requires.

Waste Management & Disposal Work Instruction (Code 34)

There are SOPs in laboratory which are based work instruction,

Reviewing the tests required for patient is the duty of 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

List of items controlled warehouse. Warehouses lay outing been

Calibration For Following Devices were Checked

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

Customer satisfaction measurement and actions taken

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

ATL: Marjan Azadmanesh DATE: 12 May 2016

Vous aimerez peut-être aussi