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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
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APPLICABLE1
Has been
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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 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
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 2 of 12
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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)
5.5
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 3 of 12
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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.
6 Resource Management
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 4 of 12
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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.
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 5 of 12
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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
7.3 Design and Development
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 6 of 12
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Design and
D&D is excluded because of nature of organization, labs shall
7.3.1 Development
use national-international approved methods
√
Planning
D & D
7.3.4 NA
Reviewing
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
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 7 of 12
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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.
√
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 8 of 12
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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.
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 9 of 12
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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
Control of Non‐
8.3 Conforming NCR was related to internal Audit √
Product
8.5 Improvement
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 10 of 12
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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 √
FORM‐009_V4_QMS Issued: July 9, 2003 Revised: March 2013 Page 11 of 12
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.
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