ISO 13485 Audit Report for Haiyan Kangyuan Medical

ISO 13485:2016 / 21 CFR 820 / MO 169 Audit
FOR CLIENT:
VIMAP / VIMAP Technologies
AT:
Haiyan Kangyuan Medical Instrument Co.,Ltd.
REPORT NUMBER:
VIMAP00107754QMS3
AUDIT DATE:
2021.10.13 to 14
ISO 13485:2016 / 21 CFR 820 / MO 169 Audit Rev.
GENERAL INFORMATION 5
Supplier Name Audit Date Report Number
Haiyan Kangyuan Medical Instrument Co.,Ltd. 2021.10.13 to 14 VIMAP00107754QMS3
A. Factory/Supplier Information
Supplier Information Factory Picture (Main Gate)

Supplier Name (EN) Haiyan Kangyuan Medical Instrument Co.,Ltd.
Supplier Name (Local) 海盐康源医疗器械有限公司
Supplier Address (EN) Songpodong Road Shendang Town,314311, Haiyan, Zhejiang China.
Supplier Address (Local) 沈荡镇宋坡东路
Supplier Contact Person Cathy Xu
Contact Number 18268411075.00
Contact E-mail 36491773@qq.com
Company Website
Year Established 2005年
Business License No. 91330424779353407P
Type of Ownership Individual/Sole Proprietor
Type of Service Provided OEM Service and Other Services
Size of Production Area (sqm) 2580
Size of Warehouse Area (sqm) 2000
Business Hours Hour/Shift 8 Shift/Day
Business Days 5 Days/Week Monday to Friday
Annual Sales Turnover Not provided
The information presented in this section is for reference purposes only. Company registration documents and financial data are not verifiable by Pro QC within the scope of this audit (beyond the documentation provided hereto as
evidence). To verify the truth and correctness of this information, Pro QC recommends requesting notarised company registry certificates and or audited financial records, as applicable, from the supplier.
Pro QC Personnel
Mr./Mrs. NTYAME Jean Champlain Title: Auditor (On-site)
Mr./Mrs. Eugene Title: Technical Supervisor / Auditor (Job Reviewer) Email:

Mr./Mrs. Nina Wang Title: Project Coordinator Email:
Supplier Personnel Participating During Audit

Mr./Mrs. 张福勇 Title: Production Manager Email: 542013571@qq.com
Mr./Mrs. 周伟 Title: R&D Manager Email: 719979826@qq.com
Mr./Mrs. 骆琴 Title: Quality Manager Email: 695245115@qq.com
Mr./Mrs. 陈新明 Title: Sales Manager Email: itd@kymedical.cn
Mr./Mrs. Title: Email:

B. Certificates
Standard Yes/No Certificate Number Issue Date Valid To

ISO 13485 Yes SX 601514440001 2020.9.9 2023.8.25
C. Employee Information
Key Personnel
Position Name Email Position #
General M. 钱江 Total # of Employees 265
Production M. 张福勇 542013571@qq.com Total # of Inspectors 16
R&D Manager 周伟 719979826@qq.com Total # of Auditors 5
QA & QC
Quality M. 骆琴 695245115@qq.com Total # of Machine Maintenance 2
Team
Sales M. 陈新明 itd@kymedical.cn Total # of Lab Technicians 8
Equipment M. Total # of Production Employees 177
H&S M. Total # of Assembly Employees 152
Other Total # of Packaging Employees 25
ISO 13485:2016 Quality System By: Antonio P. Reviewed by: Eugene T. 2/30
SCORING GUIDELINES 5
AUDIT SCOPE
The purpose of this audit is to assess the factory's Quality Management System according to ISO 13485:2016, 21 CFR 820 and Japanese standard (MHLW #169,
Revision by MHLW Ministerial Ordinance No. 87 Dated July 30, 2014) for Medical Device. The result of the report shall highlight any strength and weakness of the
supplier, and provide the necessary information for the client to make informed decisions on business viability and subsequent follow up actions with the supplier.
SCORING GUIDELINES
Pro QC's scoring method is based on C = Complies with the Requirements (3 points), I = Improvement Needed (1 point) , NC = Does Not Comply with the Requirements
(0 Point), N/A = Not Applicable (N/A are not counted and will not affect the final score)
Each compliance chapter is scored separately in order to display the strength/weakness in the factory's ability to comply, and it helps to identify area of improvement. The
average score of all the chapters will then conclude the overall risk level of the factory, as follows:
- Low Risk = 90% to 100%
- Medium Risk = 60% to 89%
- High Risk = 59% and below
AUDIT SCORE / RISK LEVEL
SECTION SCORE QUALITY MANAGEMENT
SYSTEM
4 QUALITY MANAGEMENT SYSTEM 66% 100%
80%
60%
5 MANAGEMENT RESPONSIBILITY 86% MANAGEMENT 40% MEASURING, ANALYSIS AND
RESPONSIBILITY 20% IMPROVEMENT
6 RESOURCE MANAGEMENT 89% 0%
7 PRODUCT REALIZATION 100%
MEASURING, ANALYSIS AND IMPROVEMENT RESOURCE MANAGEMENT PRODUCT REALIZATION

8 95%
OVERALL SCORING 87%

System compliance is partially acceptable with some major issues. Request
MEDIUM
OVERALL RISK immediate corrective actions and arrange follow up in case a long-term partnership is
RISK sought.
AUDIT SUMMARY
The company Haiyan Kangyuan Medical Instrument Co., Ltd is a medical device manufacturer established in 2005 with a land covering 14169 ㎡, with workshops,
cleanroom Class 100,000 clean room. The factory mainly OEM for most of their client. For some other clients they take over responsibility of Design and Development.
Currently, the total employee is around 264 people.
The company produce mainly Silicone Foley Catheter, Laryngeal Mask Airway, Silicone Stomach tube, Endotracheal Tube, etc in the respect of ISO 3485 as well as CE's
requirement. For VIMAP, they produce AS-Series and IS-Series of single use administration sets / disposable which will be connected to VIMAP's machine INX-1000A
XCO2 injector and VMX-1020A CO2 insufflator.
The company QMS is fully established as per ISO 13485:2016, as well as CE's requirement and part of 21 CRF 820. On the base of those standards, the company
demonstrated enough evidences of compliance. Each product of AS-SERIE such as AS-3W-H-R35A, AS-3W-R35A and AS-3W-Y-R35A has DMR file well maintained,
each received production order has DHR with identification of material lot number with good traceability. As shown in the photo page, the production area is well
maintained and controlled as per requirement of cleanroom to avoid contamination on product. It was inform that there is no DMR file for IS-Series because it still under
development between VIMAP and the company.
Furthermore, since the client VIMAP is also concern about their knowledge on the compliance to Japanese standard (MHLW #169, Revision by MHLW Ministerial
Ordinance No. 87 Dated July 30, 2014), it was found that the members at the company are not aware of this requirement, and it is not yet part of the scope of their
existing Quality Management system. They are not registrated as PMDA manufacturer, and has never been assessed versus this Japanese requirements. The company
did not appoint a designated Marketing Authorization Holder (D-MAH) to represent them in Japan.
Below few recommendation action were raised up and shared to the company members during closing meeting with the encouragement to implement necessary
corrective action to share to VIMAP.
RECOMMENDED CORRECTIVE ACTIONS

1 MO 169, Article 79: In the procedure QP/KY4.2.5-2017, Rev C/3, retention period of records is at least 10 years, but sheets mention 5 years.
MO 169: The company is not aware that Japan is also a destination market for the administration sets AS-Series and IS-Series. designated Marketing
2
Authorization Holder (D-MAH) to represent them in Japan?
3 ISO 13485, Clause 4.2.3: No DMR file for IS-Series because it still under development between VIMAP and the company.
4 ISO 13485, Clause 5.6.3: Out put of management review should be putted in the way to follow up implementation of improvement plan
MO 169: The company did not appointed a designated Marketing Authorization Holder (D-MAH) to represent them in Japan.
5 ISO 13485, Clause 6.2: no visibility the current competence that enable to see the gap, and use as input for development of training program.
6 ISO 13485. 6.4.1: The Auditor was not asked to sign on the visitor check before entering the cleanroom
7 ISO 13485, Clause 8.2.1: Dealing with customer feedback with more indolent
8 Customer Satisfaction to improve data collection and display
9 Should plan to do a mob for the recall process at least 1 time per year
FACTORY COOPERATION FACTORY ORGANIZATION FACTORY CONDITION
GOOD GOOD GOOD
THE RESULTS DETAILED AND DETERMINATION JUDGED IN THIS DOCUMENT REFLECTS THE FINDINGS OF PRO QC INTERNATIONAL AT THE TIME AND PLACE OF AUDIT ONLY. EVIDENCE OF ACTUAL PRODUCT QUALITY IS NEITHER
OFFERED NOR IMPLIED. THIS REPORT DOES NOT RELEASE THE VENDOR OR MANUFACTURER FROM ANY OBLIGATIONS, CONTRACTUAL OR OTHERWISE, IN EFFECT WITH THE CLIENT TO REPAIR, REPLACE, OR COMPENSATE FOR
ANY PRODUCT OR PART THEREOF IN WHICH DEFECTIVE CONDITIONS MIGHT HEREAFTER BE FOUND OR SUBSEQUENTLY DEVELOP. PRO QC INTERNATIONAL ASSUMES NO RESPONSIBILITY, AND SHALL IN NO WAY BE HELD LIABLE,
FOR ANY DEFECTIVE CONDITIONS BEYOND THOSE CLEARLY DETECTABLE WITHIN THE LIMITS OF THE SPECIFIC INSPECTION SERVICES ORDERED BY THE CLIENT.
AUDIT CHECKLIST 5
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRE FINDINGS PHOTO SCORE
4.0 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
Are the role(s) undertaken by the organization defined

[4.1.1] and documented?
The role undertaken by the organization is defined in the Business
21 CFR 820.5 License #9133 042477 9353407P as Development, Production and 14, 15, 16 C
(Article 4.1 specifies that Class 1 medical devices are
Sales. It also defined in the Quality Manual #QM/KY01, Rev C/4
MO 169, Article 5-1 exempted from the requirements of design and
development)
There is procedure #QP/KY9.0-04, Rev C/5 for Risk Assessment on

(4.1.2) production of medical device, according to MDR (EU) 2017/745, ISO
Does the organization identify and document 14971:2019 (Chinese standard YY/T0316).
21 CFR 820.5 C
processes and related risks?
MO 169, Article 5-2 Reviewed the risk report for Urinary Catheters for Single Use in file #
CE/KY-01-0501, Rev D/0 done in 2021.03.15
Yes, the general process map is documented in file QM/KY01, Rev

(4.1.3) Is each process documented with all process
C/4, with interaction between processes. But it not described in the I
21 CFR 820.5 elements?
way to see its elements which are described at various procedures
Yes, there is a procedure QP/KY4.1.4, Rev C/2 for the control of

changes. Applicable for all type of change that could happen on QMS
files, Development of Medical Device, Production and control,
Production equipment, Production environment. Etc.
(4.1.4)
Is there an individual process to manage changes that
21 CFR 820.5 affect medical device, QMS, manufacturing There is a list of change in the file QR-4.1.4-02 in which 10 changes 17, 18 C
process, facilities …etc? are recorded. For example of Change #200801-01 which happened
MO 169, Article 5-4
from 2020.08.01 to 2020.12.01, and recorded in the sheet QR-4.1.4-
01. The change is about the production process of material. This
change was validated as per report #Q/KY-TC7.5.6-03-01-16-2020
on date 2020.09.05
They do not have outsource process. They buy raw material and
(4.1.5) If applicable, is there an individual process to manage
component and process according to the procedure
the Outsourcing of processes that affect product N/A
MO 169, Article 5-5 QP/KY7.4-01-2019, Rev C/1 for Supplier Management.
conformity?
QP/KY7.4-04-2017, Rev C/4 for Purchasing Control
There is a procedure QP/KY4.1.6, Rev C/0 for Validation of

Computer Software. Which is applicable for Software used in QMS,
Production and Service, Measurement and control of equip.
(4.1.6)
If applicable, is there a procedure for validation of
19 C
MO 169, Article 5-6 computer software prior to initial use? Apart from Office Software, they also have Sterilizer software #
GCA1122-C10 that works in the Operation System Windows XP, and
in the Sterilization Equipment #HMQ-20m 3 . The last validation of this
software were done in 2017.12.15
The company is not aware that Japan is also a destination market for
Does the company comply to Japanese PMDA
the administration sets AS-Series and IS-Series. Therefore, the
X (Pharmaceuticals and Medical Devices Act), do you NC
Japanese Ordinance # 169 is not included in the current QMS, and
have PMDA manufacturer's registration?
they do not have PMDA manufacturer's registration
Has the company conducted a gap analysis between

X ISO 13485 and Ordinance #169 to see how far does No gap analysis conducted between ISO 13485 vs Ordinance #169 NC
the company can comply to Ordinance #169?
Have you ever been audited according to Japanese The company has never been audited or assessed to PMDA
X NC
PMDA (Pharmaceuticals and Medical Devices Act)? (Pharmaceuticals and Medical Devices Act)
AUDIT CHECKLIST 5
4.2 Documented requirements
The Quality Policy is posted in the Meeting room and also in the
Quality Manual QM/KY01-Rev C/4, Chapter 5.3.
Quality Objectives in the Quality Manual QM/KY01-Rev C/4, Annex

(4.2.1) #2, with 6 Quality Objectives, including its distribution to different
Is the quality management system include the following functions.
21 CFR 820.5 C
documents?
Article 6 33 Applicable procedures in the file QP/KY00-2017, applicable for
ISO 9001:2015, EN ISO 13485:2016 and MDD 93/42/EEC.
There is a list of External National / regional regulation in the file QR-

4.2.4-03, Rev C/1
Quality Manual QM/KY01-Rev C/4, last published in 2021.03.10
The scope cover EN ISO 13485:2016, YY/T0287:2017, MDR

EU2017/745, MDD93/42/EEC and 21 QRS 820.
(4.2.2)
Excluded clauses, including reason (s) as defined in the Chapter 1.2
21 CFR 820.20 (e) Does the Quality Manual documented with followed
are : 7.4.3 Installation, 7.5.9.2 and 7.5.4 Service. 20, 21 C
elements?
MO 169, Article 7-1 33 Applicable procedures in the file QP/KY00-2017, applicable for
ISO 9001:2015, EN ISO 13485:2016 and MDD 93/42/EEC.
Process map and their interactions visible in Quality Manual

QM/KY01, Rev C/4, Chapter 4.2.1
Yes, the requirement to establish and maintain Medical Device File

for each medical device type or family is writing in the Work
Instruction #Q/KY-MG4.2.5-01-2019.
(4.2.3)
Has the organization established and maintains a
The DMR-002 file for VIMAP's product AS-3W-H-R35A, AS-3W-R35A
21 CFR 820.5 Medical Device File for each medical device type or 22 I
and AS-3W-Y-R35A recorded in the sheet QR-4.2.3-01, Rev C/0 was
medical device family?
MO 169, Article 7-1 found effective. Those files are complete.
No DMR file for IS-Series because it still under development between

VIMAP and the company.
Yes, there is procedure QP/KY4.2.4-2017, Rev C/8 for the control of

documents.
(4.2.4) List documents to control in the sheet QR-4.2.4-13
Is there a documented procedure for the controls of Record of distribution in the sheet QR-4.2.4-06. 23, 24, 25,
21 CFR 820.40 C
documents? 26
MO 169, Article 78 Reviewed file QP/KY4.2.4-2017, Rev C/5 which was updated in
2020.2.18 to rev. C/6, and distributed to relevant department as per
record QSR-4.2.4-06, Rev C/1
(4.2.5)
There is procedure QP/KY4.2.5-2017, Rev C/3 for the control of
Is there a documented procedure for the control of
21 CFR 820.186 quality records. Record are properly stored at a central office. C
records for their security and integrity?
MO 169, Article 78
Yes, there is sheet QR-4.2.4-14 mentioned as been the list of

records to control. This list were not available. The retention period
was defined in the procedure QP/KY4.2.5-2017, Rev C/3 to be at
Does the company has a list of all Quality record to least 10-years, plus the shelf-life of the device.
MO 169, Article 79 27 I
retain, including retention period, place
However, it was noted that almost all record sheet did mention 5
years as retention period, instead of 10 as required by MO 169,
Article 79
AUDIT CHECKLIST 5
5.0 MANAGEMENT RESPONSIBILITY
The Quality Policy posted in the Meeting room and also in the Quality
Manual QM/KY01-Rev C/4, Chapter 5.3.
(5.1) Quality Objectives in Annex #2, with 6 Quality Objectives, including

Does top management have evidence demonstrating its distribution to different functions.
21 CFR 820.20 (b) 28, 29, 30 C
the implementation of their commitment?
MO 169, Article 10 Organizational Chart in the Quality Manual QM/KY01, Rev C/5.
Procedure QP/KY5.6-2017, Rev C/2 with record QR-8.2.4, Rev C/0 of

attendance of last Management review of 2021.02.05
Yes, there is a procedure QP/KY7.2-2007, Rev C/3 to ensure the

(5.2)
Does top management ensure that customer identification of customer requirement and their understanding. Each
C
MO 169, Article 11 requirement are understood? new inquiry will be assess before it move to Design Development or
to Production.
(5.3)
21 CFR 820.20 (a) Is the Quality policy well documented as required in The Quality Policy posted in the Meeting room and also in the Quality
28 C
ISO 13485, clause 5.3? Manual QM/KY01-Rev C/4, Chapter 5.3, and it well conform
MO 169, Article 12
(5.4.1)
Quality Objectives in the Quality Manual QM/KY01-Rev C/4, Annex
Are Quality Objectives well documented and distributed
21 CFR 820.20 (b) #2, with 6 Quality Objectives, including its distribution to different 29 C
to relevant level processes or departments?
functions.
MO 169, Article 13
(5.4.2)
Is the Quality management system planning Yes, there is a procedure QP/KY7.2-2007, Rev C/3 to ensure the
C
MO 169, Article 14 established in such a way to meet quality objectives? identification of customer requirement and their understanding
(5.5.1)
21 CFR 820.20 (b) Is there an Organization chart defining responsibilities

Organizational Chart in the Quality Manual QM/KY01, Rev C/5. 30 C
and authorities?
MO 169, Article 15
(5.5.2)
Is there someone nominated as Management
Yes, Ms. Cathy is Management Rep. signed in 2021.03.19 by
21 CFR 820.20 (b) Representatives (MR) with responsibilities to ensure 31 C
Managing Director. She certified to ISO 13485:2016 auditor
the effectiveness of QMS?
MO 169, Article 16
Does the company appointed a designated Marketing

No, The company did not appointed a designated Marketing
X Authorization Holder (D-MAH) to represent them in NC
Authorization Holder (D-MAH) to represent them in Japan.
Japan?
(5.5.3) Are appropriate internal communication processes

There is a procedure QP/KY5.4.2-2017, Rev C/0 for internal
established within the organization to monitor the 28, 29, 32 C
MO 169, Article 17 communication. Regular posting, and meeting
effectiveness of the QMS?
(5.6.1)
Does the organization have documented procedure for Yes, there is a procedure QP/KY5.6-2017, Rev C/2 for Management
21 CFR 820.20 (c ) C
Management Review? Review.
MO 169, Article 18
The last Management Review were conducted in 2021.02.05 to

review result and performance of year 2020. The planning was done
(5.6.2) by Ms. Cathy in 2021.01.18 and input defined in the sheet QR-5.6-01,
Rev C/0, No. 2021-01.
21 CFR 820.20 (c ) Do records of Management Review input defined? 33, 34 C
MO 169, Article 19 Attendee peoples in the QR-8.2.4-05, Rev C/0, Record # 2021-02.
The report of Management review in the sheet QR-5.6-03, Rev C/0,
including Process Performance, Non-conforming rate.
(5.6.3)
There is a improvement plan, including responsibility and completion
21 CFR 820.20 (c ) Does top management maintain records of output from
date. But it not presented in the way to facilitate the follow up of I
Management Reviews?
MO 169, Article 20 implementation and the progress.
AUDIT CHECKLIST 5
6.0 RESOURCE MANAGEMENT
6.2 Human Resources
Yes, there is Job Description in sheet QR-6.2-12, Rev C/0, including

(6.2.a) Skill the employee should have for each specific process.
Is there a documented skill set that determines the
21 CFR 820.25 necessary competencies that personnel performing I
However, there is no visibility over current skill level / matrix that
work affecting product quality should have?
MO 169, Article 22/23 enable to see the gap versus the requirement of a specific position,
and which can be use as input to develop training program.
There is a procedure QP/KY6.2-2017, Rev C/3 for establishing and

maintaining competence, providing needed training.
(6.2.b)
Does the organization have documented procedure for
21 CFR 820.25 establishing and maintaining competence, providing There is a training program documented in the sheet QR-6.2-01, Rev 36, 37 C
needed training? C/1, with 23 training topics for the year 2021. It define training
MO 169, Article 22/23
method such as Internal, External and Online, including name of the
trainer.
Yes, type of evaluation is defined in the training record QR-6.2-06,

(6.2.c) Rev C/1. For example of training on Critical Processes of 2021.04.26
Are types of evaluation planned and implemented to in which 29 employees attended.
21 CFR 820.25 37 C
evaluate training efficiency?
MO 169, Article 22/23 New comers are training as per plan, with training record maintained
in the sheet QR-6.2.2-09, Rev C/0
(6.2.d)
Any evidence that personnel are aware of quality
After interviewed few Management level people, it was noted the 2
21 CFR 820.50 (a) objectives and how they can contribute to achieving I
out 3 not aware quality objective related to its job
them?
6.3 Infrastructure
The company cover a land area of 14169㎡, workshops cover around

11200㎡, 4000㎡ in cleanroom Class 100,000, laboratory 300㎡ and R
(6.3.a)
Are buildings, workspace, and associated utilities & D Centre 500㎡. The layout is in the file QR6.3-02-05T. 1, 2, 3, 4, 5,
21 CFR 820.70 (b) needed to achieve conformity of medical device in 6, 7, 8, 9, 10, C
place, including their maintenance plan? There is a Procedure Q/KY-MG6.3-01-2017 for control of those 11, 12
MO 169, Article 24
facilities, and associated utilities. But it seems that only the
cleanroom are properly maintained regularly as per plan.
There is maintenance plan for production equipment's in sheet QR-

(6.3.b) 6.3-02-03, Rev C/1.
Does the organization has a maintenance plan for the
21 CFR 820.70 (g) process equipment (both hardware and software); used C
Record of maintenance in sheet QR-6.3-02-04, Rev C/1. For example
in production?
MO 169, Article 24 of Equipment #SS-01-37, SS-01-36, SS-01-30, SS-01-31, SS-01-42
which is done each month
There is the Sterilizer software # GCA1122-C10 that works in the

If software's are used to achieve conformity of the Operation System Windows XP, and in the Sterilization Equipment
(6.3.c) product, prevent mix-up, and ensure orderly handling, #HMQ-20m3. The last validation of this software were done in
C
21 CFR 820.70 (I) are cables that supply energy well protected to avoid 2017.12.15. The Sterilization process itself is done each year and
unwanted interruption? this include the review of the cables that supply energy and also
those for data collection from Machine to the server in computer.
(6.3.d)
Yes, the company Haiyan Kangyuan Medical Instrument Co., Ltd has
If applicable, are cleanrooms used and maintained 38, 39, 40,
21 CFR a workshop of over 4000㎡ under cleanroom Class 100,000,
according to the requirement of cleanroom standard 41, 42, 43, C
820.70 (c) laboratory of 300㎡ under class 100,000. The establishment of the
ISO 14644-1 or FED STD 209E? 44, 45, 46
MO 169, Article 24
cleanroom follow requirement of ISO 14644-1.
AUDIT CHECKLIST 5
6.4 Work Environment and Contamination Control (For class II and III)
Yes, there is procedure QP/KY6.4-2017, Rev C/1 for the control of

work environment. It include identification of source of contamination
and respective methods / SOP to control the source to avoid to
(6.4.1)
If applicable, does the organization has documented contaminate Medical Device.
21 CFR 820.70 (c ) requirements for the work environment needed to 48 C
avoid contamination on medical device? Record of hand / work table contamination check in the sheet QR-6.4-
MO 169, Article 25-1
08-02, Rev C/4. For example of Record #211009 on date 2021.10.09
on 10 employees, Qty of bacteria found is between 37 to 70 which
lower than 300 cfu / hand.
Yes, documented Health certificate for employees in direct contact

(6.4.1.a) with Medical device in sheet QR-6.4-01.
If applicable, does the organization has documented
21 CFR 820.70 (d) requirements for the health of personnel in contact with 49 C
Annually, all employee have health check, with record available. Also
medical devices?
MO 169, Article 25-1 any new employee will have health check as input for the
onboarding.
Yes, requirements for the cleanliness of personnel in contact with

medical devices as per Q/KY-MG6.4-02-2017, Rev C/3.
(6.4.1.b)
21 CFR 820.70 (c ) requirements for the cleanliness of personnel in Record of hand / work table contamination check in the sheet QR-6.4- 48 C
contact with medical devices? 08-02, Rev C/4. For example of Record #211009 on date 2021.10.09
Yes, requirements for clothing of personnel in contact with medical

(6.4.1.c) devices as per Q/KY-MG6.4-05-2017, Rev C/0.
21 CFR 820.70 (c ) requirements for clothing of personnel in contact with 44, 50 C
Record of clothes washing and sterilization in sheet QR-6.4-02-1,
medical devices?
MO 169, Article 25-1 Rev C/0. For example of 67 clothes been sterilized between
2021.09.01 to20 as per Record #210901.
Yes, requirements for temporarily worker is defined in the Work

If applicable, are personnel who works temporarily Instruction Q/KY-MG6.4-02-2017, Rev C/3.
(6.4.1.d)
21 CFR 820.70 (b)
under special environmental conditions trained or 47 C
supervised by a competent person? The record of visitors or temporary worker is posted at the entrance
of the cleanroom
Yes, the plan for the control of contamination is defined in procedure

Q/KY6.4-2017, Rev C/1
(6.4.2.a) Employee hand / work table contamination check in the sheet QR-6.4-
If applicable, does the organization defined a plan for
21 CFR 820.70 (d) the control of the level of contamination in order to 48, 51 C
prevent contamination?
MO 169, Article 25-2 lower than 300 cfu / hand.
Cleanness and disinfection of work place/table in sheet QR-6.4-11,

Rev C/0
Yes, the plan for the control of contamination is defined in procedure

If applicable, does the organization have documented Q/KY6.4-2017, Rev C/1
(6.4.2. b)
requirements for control of contamination with micro-
52 C
MO 169, Article 25-2 organisms or particulate matter on sterile medical Particle check in the sheet QR-6.4-06, Rev C/2. For example of
devices? Record #210822 on date 2021.08.22 according to standard
GB/T16292-2010
AUDIT CHECKLIST 5
7.0 PRODUCT REALIZATION
7.1 Planning of Product Realization
(7.1.a)
Is there a plan of processes needed for the audited Yes, there is process for product realization, which is defined in the
C
MO 169, Article 26 product realization? procedure QP/KY7.3, Rev C/5
There is procedure #QP/KY9.0-04, Rev C/5 for Risk Assessment on

production of medical device, according to MDR (EU) 2017/745, ISO
(7.1.b)
Are records of risk management activities for the 14971:2019 (Chinese standard YY/T0316).
53 C
MO 169, Article 26 audited product maintained?
Reviewed the risk report for Urinary Catheters for Single Use in file #
CE/KY-01-0501, Rev D/0 done in 2021.03.15
(7.1.c)
Is the output of product planning defined and
Yes, the output of product planning defined and documented. C
MO 169, Article 26 documented with the following as appropriate?
7.2 Customer-related processes
(7.2.1) There is procedure QP/KY7.2, Rev C/4 as guideline for the

Does the organization determine requirements related
determination of customer related requirement, including Delivery & C
MO 169, Article 27 to the audited product?
post-delivery activities, statutory and regulatory.
For the audited VIMAP's product AS-3W-H-R35A, AS-3W-R35A and

AS-3W-Y-R35A, The order review in recorded in the sheet QR-7.2-
02, Rev C/2. For example of Report # 2210705W that were received
(7.2.2)
Are results of customer requirements review in 2021/07/12 to deliver in 2021/10/20, for Product :
55 C
MO 169, Article 28 maintained?
AS-3W-H-R35A, Lot # KG21J01R, quantity 3005 pcs
AS-3W-Y-R35A, Lot # KG21J02, quality 4805 pcs
AS-3W-R35A, Lot # KG21J03, quality 1205 pcs.
Yes, Procedure QP/KY7.3, Rev C/5.
(7.2.3)
Does the organization have procedures in place during The order were reviewed in 2021.07.14, but in standby after VIMAP
C
MO 169, Article 29 the planning stage of communication with customers? has notified the company to wait to free VIMAP's stock before they
can make this order, see RECORD # 210928 in the sheet QR-8.2.1-
01, Rev C/0 of date 2021.09.28
AUDIT CHECKLIST 5
7.3 Design & Development

(7.3.1)
Does the organization have a documented procedure
21 CFR 820.30 (a) Procedure QP/KY7.3, Rev C/5 for the Design and Development 54 C
(s) as a guideline for Design and Development?
MO 169, Article 30
(7.3.2)
Is the planning for the Design and Development of the
21 CFR 820.30 (b) Yes, there is project plan use for VIMAP' s Silicone Folay catheter 56 C
audited product (s) documented?
MO 169, Article 30
(7.3.3) Procedure QP/KY7.3, Rev C/5 for the Design and Development.
Do Design & Development inputs of the audited
21 CFR 820.30 (c ) product clearly identified, documented, reviewed, and C
Inputs for the design and Development were defined in the sheet YF-
approved by authorities?
MO 169, Article 31 SJ-XTG-06-01-02
Procedure QP/KY7.3, Rev C/5 for the Design and Development.
Outputs for the design and Development were defined in the sheet
QR-7.3-04, Rev C/0, record #YF-SJ-VIP-06-05-01. DMR file for AS-
3W-H-R35A, AS-3W-R35A and AS-3W-Y-R35A include following
elements:
(7.3.4)
Are Design & Development outputs of the audited 1. BOM list in sheet QR-7.4-02, Rev C/1
22, 38, 57,
21 CFR 820.30 (d) product in a form suitable for verification against the 2. Material specification in sheet QR-7.4-14, Rev C/0 C
58, 59
Design & Development Inputs? 3. Drawing
MO 169, Article 32
2. Production methods in sheet YF-GY-01-02-05-01, Rev C/0
3. QA/QC with acceptance criteria.
4. Product identification, traceability.
5. Packaging work instruction.
6. Inspection procedures.
9. Proof of review and approval by authorities
Are the Design & Development reviews conducted and
21 CFR 820.30 (e) C
approved? Design review are conducted and recorded ON 2019.03.03 in the
MO 169, Article 33 sheet QR-7.3-05, Rev C/0, record # YF-SJ-VIM-06-01-03
Is Design & Development verification activities
21 CFR 820.30 (f) performed for the audited product, with records confirm C
Verification were conducted and recorded on 2019.04.16 in the sheet
that input specifications were satisfied?
MO 169, Article 34 QR-7.3-06, Rev C/0, record # YF-SJ-VIM-06-01-03
(7.3.7) (a) Procedure QP/KY7.3, Rev C/5 for the Design and Development.
Are Design & Development validation activities
21 CFR 820.30 (g) performed for the audited product, with records confirm C
Validation were conducted and recorded on 2019.04.20 in the sheet
that intended use was satisfied?
MO 169, Article 35-1 QR-7.3-08, Rev C/0, record # YF-SJ-VIM-06-01-03
(7.3.7) (b) If applicable, are sufficient clinical evaluations

The product is class IIa, according to audited people, the clinical
conducted to prove that the medical device fulfills the
21 CFR 820.30 (g) evaluation is conducted together with VIMAP's machine VMX-1020A N/A
performance, design characteristics, and intended
CO2 insufflator
MO 169, Article 35-1 purpose.
If applicable for the audited product, is there a plan to

(7.3.7) ( c) According to audited people, the medical device should work
ensure conformance of any interface or other medical
together with VIMAP's machine VMX-1020A CO2 insufflator which is N/A
MO 169, Article 35-1 device(s) that should be connected to the audited
the interface. This part is completed by VIMAP
product for the purpose of its validation?

(7.3.8)
Is there a procedure for Design & Development
21 CFR 820.30 (h) The transfer is conducted by give the file set DMR-02 to production 60 C
transfer to manufacturing?
team, including necessary training, recorded in sheet QR-7.3-10, Rev
C/0, Record # YF-SJ-XTG-06-07-01, on date 2021.02.01
(7.3.9)
Is there a procedure for the control of changes during
21 CFR 820.30 (I) The transfer is conducted by give the file set DMR-02 to production C
Design & Development?
team, including necessary training, recorded in sheet QR-7.3-13, Rev
C/0.
Yes, DHF file for AS-3W-H-R35A, AS-3W-R35A and AS-3W-Y-R35A

include following elements:
1. Planning (clause 7.3.2).
(7.3.10)
Does the organization maintain a Design and 2. Inputs (clause 7.3.3).
21 CFR 820.30 (j) Development File (DHF) for each medical device type 3. outputs (clause 7.3.4) C
medical device? 4. all reviews conducted (clause 7.3.5)
5. Verification (clause 7.3.6)
6. Validation (clause 7.3.7)
7. Design changes that happened (7.3.9)
AUDIT CHECKLIST 5
7.4 Purchasing process
(7.4.1) (a)
Is there a documented procedure to ensure that the
21 CFR 820.50 purchased product conforms to specified purchasing Yes, there is procedure QP/KY7.4-2017, Rev C/4 C
information?
MO 169, Article 37
(7.4.1) (b)
Are criteria and records for evaluation and selection of Yes, there is a procedure QP/KY7.4-01-2019, Rev C/1 for selection
21 CFR 820.50 (a) C
suppliers defined and documented? and evaluation of supplier
MO 169, Article 37
There is list of approve suppliers in the sheet QR-7.4-04 with around

147 SUPPLIERS.
(7.4.2)
Reviewed of supplier for Material MCH-3032-70…etc. And for Filters
Is there a list of approved suppliers of material,
21 CFR 820.50 (a) component. 61 C
services, consultants, subcontract, etc.?
MO 169, Article 38
All have Business License, Supplier Evaluation in sheet QR-7.4-05,
Rev C/1 and Quality Agreement in file
There is Work Instruction Q/KY-TC8.2.6-01-05, Rev C/3 for Incoming

(7.4.3) (a) Inspection of all Component and packaging material, such as
Are Work Instruction for incoming inspection of Hydrophobic and bacterial filters, supplier Code #ZF-009
21 CFR 820.50 (b) 62 C
purchased product documented?
MO 169, Article 39 There is Work Instruction Q/KY-TC8.2.6-01-01-2007, Rev C/4 for raw
material MCH-3032-80 for the production of Silicone Folay catheter
The result of Incoming Inspection is recorded in the sheet QR-8.2.6-

01-01, Rev C/2.
For example IQC# J-202105-28-04 conducted on Hydrophobic and

bacterial filters, Code #ZF-009, Supplier Lot # 21052502, Company
(7.4.3) (b) Lot # 210528, Qty 7800 pcs, IQC conducted in 2021.05.31,
Do records of incoming inspection provide traceability inspected 5 pcs from Sample plan S-2, AQL (0,1). The supplier
21 CFR 820.65 63 C
information for each purchasing order? provided their certificate report in sheet ZF/FL-ZGB-22, Rev C,
MO 169, Article 39 Record # 210515-04-03, inspected in 2021.05.19.
IQC# J-202010-07-03 conducted on raw material MCH-3032-80 for

the production of Silicone Folay catheter, Supplier Lot# 200809203,
200928201, Company Lot# 201007, 201007-1, respectively with qty
240kg and 160kg
An incoming inspection were conducted in 2021.08.09 on Material

Lot # 20210622/20210728, company lot # 210809/210809-1, it was
(7.4.3) (c )
found Nonconforming, see record # J-202108-09-07.
Does the result of incoming inspection used as input to
21 CFR 820.50 (b) C
the supplier re-evaluation process?
A nonconforming notice in sheet QR-8.3-01, Rec C/4 were submitted
MO 169, Article 39
in record# NC-210818 for review, a decision were made to reject
1440 pcs.
(7.4.3) (d) Is there a written agreement that the supplier SHALL

Yes, each supplier has signed Quality Agreement in which it
notify the organization of any changes in the purchased C
MO 169, Article 39 stipulated to notify for any changes
product prior to its implementation?
When the organization becomes aware of any changes

(7.4.3) € Yes, risk of changes on supplier delivery material is assessment
to the purchased product, does the organization
before a decision is transferred to supplier for implementation of C
MO 169, Article 39 determine whether these changes affect the product
change.
realization process or the medical device?
AUDIT CHECKLIST 5
7.5 Production and Service Provision
Yes, records are maintained for each manufactured medical device,

per each Production order submitted by VIMAP. Each production
order is identified by VIMAP Lot# as described in the file #F-00119,
Rev 3.0 Labels and IFU AS-series.
(7.5.1) For example of Item AS-3W-R35A, qty 963 pcs, Production order
Are records maintained for each medical device or
#210406W recorded in the sheet #QR-7.5.9-06, Record # 210524-
21 CFR 820.65 batch of medical devices with traceability to the lot 65, 66 C
03, Lot # KG21F03.
number and respective quantity?
MO 169, Article 40
For others customers, lot / batch # is assigned as per Work
Instruction Q/KY-MG7.5.9-03-2020, Rev C/0, Chapter 4. For example
of Item customer ITALY SECURMED, qty 44800 pcs, Production
order #210901 recorded in the sheet #QR-7.5.9-06, Record # 211008-
05, Lot # 20211015.

work environment to ensure the cleanliness of the medical device.
(7.5.2)
Does the organization have documented requirements
21 CFR 820.70 Record of hand / work table contamination check in the sheet QR-6.4- C
for the cleanliness of the product?
MO 169, Article 41
(7.5.3) If applicable, does the organization has records for

medical device installation and verification of Not applicable, this clause is excluded from the QMS N/A
MO 169, Article 42 installation?
(7.5.4)
If applicable, Is the procedure for servicing of the
Not applicable, this clause is excluded from the QMS N/A
MO 169, Article 43 medical device defined
(7.5.5)
If applicable, are records of the sterilization process The have sterilization process, but VIMAP product does not need
21 CFR 820.75 N/A
maintained? sterilization, it was not audited
MO 169, Article 44
(7.5.6) Are there processes that have a finished product that

cannot be monitored, measured, and verified? If so, All processes can be monitored during manufacturing process with
21 CFR 820.75 N/A
what processes are there? Does the organization regular IPQC
MO 169, Article 45 define the procedure for validation of such processes?
(7.5.7)
Are procedures and records for validation of The have sterilization process, but VIMAP product does not need
21 CFR 820.75 N/A
sterilization and sterile barrier systems available? sterilization, it was not audited
MO 169, Article 46
(7.5.8)
Is there a procedure for assigning unique device Yes, there is procedure for uniquely assign identification number to
21 CFR 820.65 67, 68 C
identification to the medical device? each unit
MO 169, Article 47
(7.5.9.1)
21 CFR 820.65 Is there a procedure to keep traceability of records? Yes, there is procedure for traceability C
MO 169, Article 48
Yes, production record clearly indicate Lot # KG21F03, for example

(7.5.9.2) Are production records clearly indicate lot number or
of Unit AS-3W-R35A, Production Lot # 20210526.
21 CFR 820.65 batch number, date, part name, quantity, name, and C
MO 169, Article 49 Production Order Notice in sheet #QR-7.5.9-06, Rev C/0, Record#
signature of responsible person.
210524-03. DHR file QR-7.5.9-05, Rev C/0 for Qty 963 pcs
(7.5.10) If applicable, does the organization maintain records

Yes, records are maintained for customer property C
MO 169, Article 51 that identify, verify, protect customer property?
(7.5.11) (a) If applicable, does the organization identified and

documented the work environment to avoid
21 CFR 820.70 (c ) work environment parameters such as Temp. Humidity, Air pressure, C
contamination or damage to the medical device
air flow, airborne particulate. Records are maintained as per plan
MO 169, Article 52 produced?
Yes, requirements for clothing of personnel in contact with medical
(7.5.11) (b)
If applicable, is there a procedure that defines certain devices as per Q/KY-MG6.4-05-2017, Rev C/0. Record of clothes
21 CFR 820.70 (c ) working conditions to avoid contamination or damage washing and sterilization in sheet QR-6.4-02-1, Rev C/0. For example C
on medical device produced? of 67 clothes been sterilized between 2021.09.01 to20 as per Record
MO 169, Article 52
#210901.
(7.5.11) (c )
Record of hand / work table contamination check in the sheet QR-6.4-
If applicable, is contamination controlled and record
21 CFR 820.70 (e ) 08-02, Rev C/4. For example of Record #211009 on date 2021.10.09
maintained with information that indicates product C
MO 169, Article 52 date?
AUDIT CHECKLIST 5
7.6 Control and monitoring of measuring equipment
Yes, there is a procedure QP/KY7.6-2017, Rev C/4 for the control of

(7.6) (a)
monitoring and measuring equipment.
21 CFR 820.72 Chapter 4.3 : Calibration method.
Is there a documented procedure for the control of
Chapter 4.4.: Maintenance of equipment's. C
MO 169, Article 53 monitoring and measuring equipment?
Chapter 4.5: Equipment repair
Chapter 4.6 Equipment obsolete.
Chapter 4.7 Reaction in case find an expired equipment.
(7.6) (b)
Is there a master list of inspection, measurement, and Yes, there is a list of calibration plan with 225 equipment's in the
21 CFR 820.72 test equipment in which the calibration and expiration sheet QR-7.6-01, Rev C/1, with name of Calibrator, Responsible 69 C
date are clearly stated? person, next calibration date.
MO 169, Article 53
Yes, calibration are performed with certificate available, see number.

Calibration certificate are available, for equip. J-07-01, j-57-01.
(7.6) (c )
for In-house calibration J-25-16 in sheet QR-7.6-03. It conducted as
21 CFR 820.72 Are calibrations performed and with records kept? 70, 71, 72 C
per Work Instruction Q/KY-TC7.6-02-XX-2017. For example of equip.
MO 169, Article 53 J-25-16 been calibrated, record # 210202-1 by Thermometer J-62-
01 which calibrated at external. In-house calibration were conducted
in 2021.02.02
(7.6) (d)
Is the status of calibration visible with a tag on each
21 CFR 820.72 Yes, it posted in the equipment 70, 71, 72 C
calibrated equipment?
MO 169, Article 53
There is the Sterilizer software # GCA1122-C10 that works in the

Operation System Windows XP, and in the Sterilization Equipment
(7.6) (e ) #HMQ-20m3.
If applicable, is there a procedure and records for
21 CFR 820.72 validation of the application of computer software used C
The last validation of this software were done in 2017.12.15. The
for monitoring and measuring?
MO 169, Article 53 Sterilization process itself is done each year and this include the
review of the cables that supply energy and also those for data
collection from Machine to the server in computer.
AUDIT CHECKLIST 5
8.0 MEASURING, ANALYSIS AND IMPROVEMENT
8.2 Monitor and Measure processes and products
Yes, there is a procedure QP/KY8.2.1, Rev C/2 for Customer

satisfaction and feedback.
(8.2.1)
Is there documented procedure and record for There is sheet to record feedback QR-8.2.2-01, but it has not been
21 CFR 820.198 I
customer feedback? used properly to collect feedback from client, they said no feedback.
However., the do annual customer satisfaction survey in the sheet
QR-8.2.1-03, Rev C/0. But record are not sued to present the graphic
There is a procedure QP/KY8.2.2-2017, Rev C/7 for handling

complaints.
There is a list of complaint in the sheet QR-8.2.2-03, Rev C/0, with 19

complaints in year 2021. The Goal for the year 2021 is < 48 cases.
(8.2.2)
Is there documented procedure and record for handling
21 CFR 820.198 From those 19 complaints, 5 from local authorities of medical device C
complaints?
control, 3 from TUV, 2 from customers, and 8 from external audit. 18
of them in the list QR-8.5.2.-02, Rev C/0 has have CAPAs prepared.
Reviewed CAPA-210219-01 and CAPA-210410-01.
The report of CAPA in the sheet QR-8.2.2-01, Rev C/0 for Lot#
191101, qty 2000 pcs, complaint receive din 2021.02.03
(8.2.3) The procedure QP/KY8.2.2A-2017, Rev C/2, which planned the

process of reporting to regulatory authorities about issues related to
21 CFR 820.198 Are there records of reporting to regulatory authorities? C
their medical devices, including sheet to use. But there is not record
MO 169, Article 55-3 of reporting because it has never happen since.
Have you do a mob of Adverse event management and

Not implemented NC
reporting
There is procedure for Internal Audit QP/KY8.2.4-2017, Rev C/2, they

(8.2.4) (a) do it at least 1 time per year.
Is there a documented procedure for planning and
21 CFR 820.22 74 C
conducting of internal audit? The last internal audit were conducted in 2021.01.04 as indicated in
MO 169, Article 56 the audit plan QR-8.2.4-02, No. 2021-01, with scope ISO
13485:2016, MDD93/42/EEC, MDR EU2017/745 and QSR 820
The last internal audit were conducted in 2021.01.04 as indicated in

(8.2.4) (b) the audit plan QR-8.2.4-02, No. 2021-01, with scope ISO
Is the audit planned in such a way that the auditor does 13485:2016, MDD93/42/EEC, MDR EU2017/745 and QSR 820.
21 CFR 820.22 74, 75 C
not audit their own department or process?
MO 169, Article 56 Auditors are certified to ISO 13485:2016
(8.2.4) (c )
Are audit finding recorded? Do follow-up activities 4 ncf were found on clause 1.7.1, 11.1.1, 2.8.2 and 3.3.1 of national
21 CFR 820.22 76 C
include it verify of actions taken? standard for medical devices, see In the sheet QR-8.2.4-04, Rev C/0
MO 169, Article 56
(8.2.5) Yes, there is Work Instruction Q/KY-TC8.2.6-01-05, Rev C/3 for

Are there procedures or Work Instruction for
Incoming Inspection of all Component and packaging material.
21 CFR 820.80 monitoring, measuring, and acceptance of processes C
and products?
MO 169, Article 57 There are also Work Instruction for IPQP and Final Inspection
(8.2.6)
Are there documented procedures identifying the
Yes, there is procedure for the release of product, with
21 CFR 820.80 person(s) authorizing the release of products during C
responsibilities defined
the manufacturing process?
AUDIT CHECKLIST 5
8.3 Control of nonconforming product
(8.3.1)
There is a procedure QP/KY8.2-2017, Rev C/6 for handling
Is there documented procedures and record for the
21 CFR 820.90 (a) nonconforming material and product during the manufacturing C
handling of nonconforming material?
process to avoid mix-up with good material.
Yes, disposition for the treatment of Nonconforming material or

(8.3.2) product are defined, such as Scrap, Rework, Return for received
Is the procedure defined disposition options and material or accepted by concession.
21 CFR 820.90 (b) C
conditions of nonconforming material?
MO 169, Article 60-2 A failure defect picture is posted on site in the workshop it use as
guideline
(8.3.3)
Is there physical segregation of nonconforming Yes, there is physically separation area to keep nonconforming
21 CFR 820.90 (b) 78, 79 C
material during subsequent storage & processing? material.
(8.3.4)
If applicable, is there a procedure that describes how Yes, there is a special work step for the reworking to remove burrs
21 CFR 820.90 (b) rework will be accomplished and re-inspected, and are after molding. Work Instruction are posted on site. All reworked C
records maintained? product re 100% inspected by another team
8.4 Analysis of data
(8.4) (a) Does the organization have documented procedure to

There is a procedure QP/KY8.4-2017, Rev C/3 for the collection and
determine, collect and analyse appropriate data to
21 CFR 820.250 use of QMS and process performance data, as those in Photo 29 - 29 C
demonstrate the suitability, adequacy, and
Quality Objectives posted
MO 169, Article 61 effectiveness of the QMS?
Customer Feedback / satisfaction survey are conducted, but data are

(8.4) (b)
not summarised to see the area of improvement.
Does the analysis of data include data generated as a
21 CFR 820.250 80 C
result of monitoring and measurement?
Conformity rate of product is followed annually and displayed in the
MO 169, Article 61
public board
(8.4) (c )
If the result of the analysis shows the QMS is not
21 CFR 820.20 (c ) suitable, adequate, or effective, does the organization Yes, result of performance, as well as for QMS internal audit and
C
use this analysis as input to Management Review for used as input to the management review meeting
MO 169, Article 61
improvement?
8.5 Improvement
There is a procedure QP/KY8.5, Rev C/2 for identification of

opportunities of improvement. It basically use input from :
(8.5.1)
Does the organization has a procedure to identify the
1. analysis of KPI data as posted in photo 80 C
opportunity for improvement of the QMS?
MO 169, Article 62 2. audit results, such a internal and external
3. post-market surveillance, event reporting
4. Client complaints and corrective actions,
There is a procedure QP/KY8.5.2, Rev C/4 for initiating root cause

(8.5.2)
investigation and CAPA from a complaint.
Is there a procedure for initiate actions to eliminate the
21 CFR 820.198
causes of nonconformities in order to prevent C
There is a list of complaint in the sheet QR-8.2.2-03, Rev C/0, with 19
recurrences?
MO 169, Article 63
complaint in the year 2021. Including the list of CAPA in the sheet QR-
8.2.2-02, Rev C/0 with 18 cases.
There is a procedure QP/KY8.5.2, Rev C/4 for identification of

(8.5.3) potential issue from the existing
Is there a documented procedure to identify potential
C
nonconformities and their causes?
MO 169, Article 64 Those will be discussed during management review and effective
action plan will be defined.
FACTORY PHOTOS 5
Photo 1 - Factory Gate Photo 2 - External view of Workshops buildings
Photo 3 - External view of Workshops buildings / Dormitories Photo 4 - Warehouse for Components
Photo 5 - Warehouse for Raw materials Photo 6 - Extrusion line
FACTORY PHOTOS 5
Photo 7 - Assembly Workshop Photo 8 - Assembly workshop
Photo 9 - Assembly Workshop Photo 10 - Packaging Workshop
Photo 11 - Testing room Photo 12 - Sterilization room
FACTORY PHOTOS 5
Photo 13 - Warehouse for finished product Photo 14 - Business License #9133 042477 9353407P
Photo 15 - ISO 13485:2016 Certificate Photo 16 - Quality Manual #QM/KY01, Rev C/4
Photo 17 - list of change in the file QR-4.1.4-02 Photo 18 - Record of change recorded in the sheet QR-4.1.4-01
FACTORY PHOTOS 5
Photo 19 - Validation of software Sterilizer # GCA1122-C10 Photo 20 - Procedures for CE and ISO 13485:2016
Photo 21 - List of 33 Applicable procedures in the file QP/KY00-2017 Photo 22 - DMR file for AS-3W-H-R35A, AS-3W-R35A and AS-3W-Y-R35A
Photo 23 - List documents to control in the sheet QR-4.2.4-13 Photo 24 - Record of distribution in the sheet QR-4.2.4-06.
FACTORY PHOTOS 5
Photo 25 - Record of change in file QP/KY4.2.4-2017, Rev C/5 Photo 26 - Record of obsolete of file QP/KY4.2.4-2017, Rev C/4
Photo 27 - Record retention plan for 5 years, instead of 10 at least Photo 27 - Record retention plan for 5 years, instead of 10 at least
Photo 28 - Quality Policy posted Photo 29 - Quality Objectives posted
FACTORY PHOTOS 5
Photo 30 - Organizational Chart Photo 31 - Management Rep. signed in 2021.03.19
Photo 33 - Posting in public board Photo 34 - Plan for Management Review
Photo 35 - Record of participants to the last Management review Photo 36 - Training program in the sheet QR-6.2-01, Rev C/1
FACTORY PHOTOS 5
Photo 37 - Record of training in sheet QR-6.2-06, Rev C/1 Photo 38 - Production flow Diagram vs Cleanroom area
Photo 39 - Cleanroom Map, class 100,000 Photo 40 - Work Instruction of Material IN/OUT to Cleanroom
Photo 41 - Entrance to cleanroom Photo 42 - Facilities for hand wash
FACTORY PHOTOS 5
Photo 43 - Drying facility Photo 44 - Req. for clothing as per Q/KY-MG6.4-05-2017, Rev C/0.
Photo 45 - Hand disinfection Photo 46 - Cleaning record
Photo 47 - Record of visitor Photo 48 - Hand Contamination in sheet QR-6.4-08-02, Rev C/4
FACTORY PHOTOS 5
Photo 49 - Record of health check Photo 50 - Clothes washing and sterilization in sheet QR-6.4-02-1, Rev C/0
Photo 51 - Cleaning and disinfection of work place in sheet QR-6.4-11, Rev C/0 Photo 52 - Particle check in the sheet QR-6.4-06, Rev C/2.
Photo 53 - Risk Assessment for Urinary Catheters for Single Use. Photo 54 - Design and Development QP/KY7.3, Rev C/5
FACTORY PHOTOS 5
Photo 55 - Record of order review sheet QR-7.2-02, Rev C/2 Photo 56 - project plan use for VIMAP' s Silicone Folay catheter
Photo 57 - Outputs for design and Development sheet QR-7.3-04, Rev C/0 Photo 58 - Production Process for AS-3W-H-R35A
Photo 59 - Drawing Photo 60 - Record # YF-SJ-XTG-06-07-01 for Design transfer
FACTORY PHOTOS 5
Photo 61 - List of approved suppliers Photo 62 - Work Instruction Q/KY-TC8.2.6-01-05, Rev C/3 for IQC of Component
Photo 63 - Record of IQC in the sheet QR-8.2.6-01-01, Rev C/2. Photo 64 - Raw material identification in warehouse
Photo 64 - Raw material identification in warehouse Photo 65 - F-00119, Rev 3.0 Labels and IFU AS-series.
FACTORY PHOTOS 5
Photo 66 - Production order Photo 67 - Identification of medical device in assembly line Lot # 20211010
Photo 68 - Identification of medical device in packaging Lot # 20210933 Photo 69 - Calibration plan
Photo 70 - PH / Vm Meter with calibration tag to expire in 2022.07.21 Photo 71 - Hardness Equip # J-07-01 to expired in 2022.07.21
FACTORY PHOTOS 5
Photo 72 - Tensile machine Photo 73 - Certificate for the metrologist for in-house calibration
Photo 74 - Attendees to Internal Audit Photo 75 - Internals Auditor Certificate to ISO 13485:2016
Photo 76 - Nonconformity report and evidences of corrective action Photo 77 - Failure picture posted
FACTORY PHOTOS 5
Photo 78 - Nonconforming area in the Warehouse Photo 79 - Nonconforming product in the assembly line
Photo 80 - Product conforming rate posted Photo 81 - List of complaints for year 2021
END OF REPORT
Visit us at www.proqc.com

ISO 13485 Audit Report for Haiyan Kangyuan Medical

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

ISO 13485 Audit Report for Haiyan Kangyuan Medical

Uploaded by

Copyright:

Available Formats

ISO 13485:2016 / 21 CFR 820 / MO 169 Audit

Supplier Information Factory Picture (Main Gate)

Mr./Mrs. Eugene Title: Technical Supervisor / Auditor (Job Reviewer) Email:

Supplier Personnel Participating During Audit

Mr./Mrs. 周伟 Title: R&D Manager Email: 719979826@qq.com

Mr./Mrs. 骆琴 Title: Quality Manager Email: 695245115@qq.com

Mr./Mrs. 陈新明 Title: Sales Manager Email: itd@kymedical.cn

Mr./Mrs. Title: Email:

Standard Yes/No Certificate Number Issue Date Valid To

7 PRODUCT REALIZATION 100%

MEASURING, ANALYSIS AND IMPROVEMENT RESOURCE MANAGEMENT PRODUCT REALIZATION

OVERALL SCORING 87%

RECOMMENDED CORRECTIVE ACTIONS

4.0 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

Are the role(s) undertaken by the organization defined

There is procedure #QP/KY9.0-04, Rev C/5 for Risk Assessment on

Yes, the general process map is documented in file QM/KY01, Rev

Yes, there is a procedure QP/KY4.1.4, Rev C/2 for the control of

There is a procedure QP/KY4.1.6, Rev C/0 for Validation of

Has the company conducted a gap analysis between

4.2 Documented requirements

Quality Objectives in the Quality Manual QM/KY01-Rev C/4, Annex

There is a list of External National / regional regulation in the file QR-

Quality Manual QM/KY01-Rev C/4, last published in 2021.03.10

The scope cover EN ISO 13485:2016, YY/T0287:2017, MDR

Process map and their interactions visible in Quality Manual

Yes, the requirement to establish and maintain Medical Device File

No DMR file for IS-Series because it still under development between

Yes, there is procedure QP/KY4.2.4-2017, Rev C/8 for the control of

Yes, there is sheet QR-4.2.4-14 mentioned as been the list of

5.0 MANAGEMENT RESPONSIBILITY

(5.1) Quality Objectives in Annex #2, with 6 Quality Objectives, including

Procedure QP/KY5.6-2017, Rev C/2 with record QR-8.2.4, Rev C/0 of

Yes, there is a procedure QP/KY7.2-2007, Rev C/3 to ensure the

21 CFR 820.20 (b) Is there an Organization chart defining responsibilities

Does the company appointed a designated Marketing

(5.5.3) Are appropriate internal communication processes

The last Management Review were conducted in 2021.02.05 to

6.0 RESOURCE MANAGEMENT

6.2 Human Resources

Yes, there is Job Description in sheet QR-6.2-12, Rev C/0, including

There is a procedure QP/KY6.2-2017, Rev C/3 for establishing and

Yes, type of evaluation is defined in the training record QR-6.2-06,

The company cover a land area of 14169㎡, workshops cover around

There is maintenance plan for production equipment's in sheet QR-

There is the Sterilizer software # GCA1122-C10 that works in the

Yes, there is procedure QP/KY6.4-2017, Rev C/1 for the control of

Yes, documented Health certificate for employees in direct contact

Yes, requirements for the cleanliness of personnel in contact with

Yes, requirements for clothing of personnel in contact with medical

Yes, requirements for temporarily worker is defined in the Work

Yes, the plan for the control of contamination is defined in procedure

Cleanness and disinfection of work place/table in sheet QR-6.4-11,

Yes, the plan for the control of contamination is defined in procedure

7.0 PRODUCT REALIZATION

7.1 Planning of Product Realization

There is procedure #QP/KY9.0-04, Rev C/5 for Risk Assessment on

7.2 Customer-related processes

(7.2.1) There is procedure QP/KY7.2, Rev C/4 as guideline for the

For the audited VIMAP's product AS-3W-H-R35A, AS-3W-R35A and

Yes, Procedure QP/KY7.3, Rev C/5.

7.3 Design & Development