Doc No: TFV-QM-001, REV:00, Date effective: 1/9/2022
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1.0 INTRODUCTION
The purpose of this manual is to
describe the policies and company-wide control structure of the quality
management system (QMS) used to achieve the corporate mission at TRI FORTUNE SDN BHD.
The quality management
system described in this manual addresses the requirements of the following
standards
ISO
9001:2015 QUALITY MANAGEMENT SYSTEM
and
ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT
SYSTEM – REQUIREMENTS
FOR REGULATORY PURPOSES
The structure of this
manual has been designed to follow the structure of the ISO 9001:2015 / ISO 13485:2016 standard. and all requirements
of the Regulatory Authorities to be adopted by ABC is incorporated in the relevant sections of this manual.
a) PREFACE
TRI FORTUNE VENTURE is located and operated at:
(to be update)
STANDARD FOR CERTIFICATION
a. ISO
9001:2015 QUALITY MANAGEMENT SYSTEM
b. ISO
13485:2016 MEDICAL DEVICES
SCOPE OF REGISTRATION
TRI FORTUNE SDN BHD (TFV)
(address)
b)
EXCLUSION
TFV has identified the permissible exclusions based on the requirement
of ISO 13485: 2016 under
clause 7, which is not relevant to our company
core processes. The exclusions are as
below:
ISO 13485 and ISO 9001
·
7.3 Designs and
Development - The company activities do not involve in design and
development whereas company main activities is providing the service.
ISO 13485
·
7.5.3.2.2 Particular requirements for active implantable medical devices and
implantable medical devices
ISO 13485
· 7.5.3.2.2 Particular requirements for sterilization of medical devices
ISO 13485
· 7.5.3.2.2 Particular requirements for sterilization of medical devices
ISO 13485
·
8.2.4.2
Particular requirements for
active implantable medical devices and implantable medical devices
c)
COMPANY PROFILE
TFV is
an established name in medical industry, particularly on medical ventilator and
respiratory care segment. Besides
carrying its own brand for domestic and international market, TFV also carries
some exclusive distributorship for various brands, some are of internationally
renowned and top rated brands.
d) QUALITY POLICY
Please refer document
QM-003 attached.
e)
QUALITY OBJECTIVES
Please
refer document QM-004 attached.
.
2.0 Quality MANAGEMENT system
2.1 GENERAL REQUIREMENTS
TFV shall establish, document, implement and
maintain a quality management system and continually improves its effectiveness
in accordance with the requirements of ISO 13485: 2016 and of Regulatory
Authorities.
ABC shall:
a)
Identify
the processes needed for the quality management system and their application
throughout the organization.
b)
Determine
the sequence and interaction of these processes. (QM-002)
c)
Determine
the criteria and methods needed to ensure that both the operation and control
of these processes are effective.
d)
Ensure
the availability of resources and information necessary to support the
operation and monitoring of these processes.
e)
Monitor,
measure and analyze these processes.
f)
Implement
actions necessary to achieve planned results and maintain the effectiveness of
these processes.
In the case where processes within the
quality management system have to be outsourced, the Management Team is
responsible to identify and control these processes to ensure conformity of services.
ABC‘s Quality Management System Process Flow
Chart is refer to the Process Mapping
and Interaction (QM-002 ).
2.2 DOCUMENTATION REQUIREMENTS
2.2.1 GENERAL
2.2.1.1 ABC maintains
documented quality system as a mean to ensure that all services conform to
specified requirements and to effectively manage and control the quality
system.
2.2.1.2
The
Quality Management System documentation shall include:
a)
Documented
statements of a quality policy and quality objectives.
b)
A
quality manual.
c)
Documented
procedures required by ISO 13485:2012 Quality Management Systems -
Requirements.
d)
Documents
needed by ABC to ensure the effective
planning, operation and control of its processes (such as work instructions).
e)
Records
and Forms required by ISO 13485:2012 and Quality Management System -
Requirements.
f)
Any
other documentation specified by national or regional regulations.
2.2.1.3
The
QMS of ABC shall be assessed by notified
body/ certification body to comply the requirement of ISO 13485:2012.
2.2.1.4
The
steps followed in establishing, implementing, maintaining and controlling
documented procedures are defined in the procedure for Control of Document (SM-D-002)
2.2.2 QUALITY MANUAL
2.2.2.1
The
quality manual of ABC includes:
a.
The
scope of the quality management system, including details of and justification
for any exclusion and/or non-application in service realization. It also
describes the quality policy and general company-wide structure and methods for
maintaining the quality management system.
b.
The
manual references that the related system procedures followed to meet the
specified policies and approaches.
c.
The
linkages and interactions between the processes of the Quality Management
System.
d.
The
implementation of ABC quality management
system is based on the P-D-C-A cycle, as follow to the Process Mapping and Interaction:
(refer QM-002)
2.2.2.2 Documentation
Structure
The structure of the documentation used in
the quality management system is as follows:
Level 1
Quality Manual
Level 2
System Procedures
Level 3
Supporting Documents
(work instructions, Records
etc)
2.2.2.3 System
Procedures
-
Documented
procedures are used to specify who do
what, when it is done, and what documentation is used to verify that the
quality activities are executed as required.
·
Refer List of
Documents (L-001)
2.2.2.3 Protocol
-
Protocols
are used by ABC to detail out how
particular tasks are performed, where if the absence of the instructions would
and could adversely affect the required or desired qualities.
2.2.2.4 The steps followed in
establishing, implementing, maintaining, and controlling quality manual,
quality system procedures and work instructions are defined in the Control of Documents Procedure (SM-D-002).
2.2.2.5 The steps followed in maintaining and controlling records are defined in
the Control of Records Procedure (SM-D-001).
2.2.3 CONTROL OF DOCUMENTS
2.2.3.2
Documents
required by the quality management system shall be controlled. Records are special
type of document and shall be controlled according to the requirements given in
the Control of Records Procedure.
2.2.3.3
The
control needed can be defined in the Control of Document Procedure.
2.2.4 CONTROL OF RECORDS
2.2.4.1
Documents
required by the quality management system shall be controlled. Records are a
special type of document and shall be controlled according to the requirements
given in the Control of Records Procedure.
2.2.4.2
The
control needed can be defined in the Control of Records Procedure.
3.0
MANAGEMENT RESPONSIBILITIES
3.1 RESPONSIBILITIES, AUTHORITIES AND
COMMUNICATIONS
The specific roles for the various functions in the QMS Committee are
described in the following document.
Detail explanation to be described in the Job Description. SM-D-007.
As for additional, the
organizational chart as documented to define the responsibility of individual
within the organization. Illustrates the interrelations and authority of
personnel who manage, perform and verify work affecting the quality of services
and services provided by tfv .
3.2 CUSTOMER FOCUS
3.2.1 Top management and staff of tfv are committed to ensure that customer requirements are fulfilled and met with the aim of enhancing customer satisfactions.
3.2.2 Customer communication
All related personnel are responsible to communicate with customers (as per Job Descriptions, SM-D-007) in relation to:
a. Service information
b. Enquiries or order handling
3.2.3 Determination of customer requirement
1. Storage and Store Protocol, SM-D-018
2. Service and Commissioning Protocol, SM-D-019.
3. 3. Product Specification/ Catalogue, SM-D-016
3.2. 4 Customer Satisfaction
As one of the measurements in performance of quality management system, the organization shall monitor information based on customer perception whether the organization has met customer requirements.
TFV determines the perception of customer after service has been delivered through numbers and types of complaint received.
Data should be analyzed through customer complaint process and customer feedback form. Analyzed data then will be presented and discussed during management review.
Any complaint received, the Quality Assurance Manager (QAM) shall validate the information and record it in the Corrective And Preventive Action Request, SM-F-004 (CPAR). If QAM accepted and agreed that due to the non-conformity, necessary action need to be taken, then the Corrective and Preventive Action will be used.
3.3
PLANNING
3.3.1 Quality objectives
a.
Top
management of ABC is committed to ensure that quality objectives, including
those as described in the Service Flowchart, are established at relevant
functions and levels within the organization.
b.
The
quality objectives shall be measurable and consistent with the quality policy
as per reference: Quality Objectives QM-004
3.3.2 Quality management system planning
a. The top management shall ensure that quality management system plans are carried out as defined. The specific quality practices, procedures and work instructions are followed, resources observe the prescribed rules and regulations, sequences of activities to be adhered to, in order to achieve the quality objectives.
b. Plan-Do-Check-Action (PDCA) system is used comprehensibly in ensuring the quality management system is observed effectively in the organization. The PDCA are:
c. Plan – Any input raises during Management Review, will be translated into determination of activities through What, Where, When, Who, Why and How.
d. Do – Implementation of process to satisfy the demanded services
e. Check – The measurement approach to evaluate the effectiveness of the implementation.
f. Action – Countermeasure taken in result of check
g. Determination of QMS Planning should not be lesser than monitoring the performance of Quality Objectives, necessary awareness/training, internal quality audit and management review.
h. Management Representative shall ensure the activity should be carry out as planned.
3.3.3 Internal communication
a.Top
management shall ensure that appropriate communication processes are
established within the organization and that communication regarding the
effectiveness of the quality management system is carried out.
b.This is
achieved through periodic management communication meeting, staff meeting,
operational meeting, and performance review and through various notices and
memos issued at appropriate interval.
3.4 MANAGEMENT
REVIEW
3.4.1 General
a. ABC top management shall review the company
quality management system at least once
a year to ensure continuing suitability, adequacy and effectiveness. The
review shall include assessing avenues for improvements; and needs for changes
to the quality management system, including the quality policies and quality
objectives.
b.
All elements of the quality management system
at ABC are reviewed by executive management personnel who are directly
responsible to the system.
c.
QMR shall coordinate quality management
system review with ABC top management.
d.
Records of the management reviews are filed
and maintained by the Management
Representative in accordance to Control of Records Procedure. The records
shall depict evidences on how reviews are conducted, who involves, what factors
are taken into considerations, what conclusions are adopted and what actions are
taken.
3.4.2 Review
input
The review
input addresses the following agenda items:
a)
Results of audits (Prepared by QMR/QAM)
b)
Customer feedbacks, including activities as
well as feedbacks from Competent/Accredited authorities, Notified Bodies,
Authorised Representatives, distributors, customers and others. (Prepared by QAM)
c)
Process performance and service conformity
(Prepared by QAM)
d)
Status of preventive and corrective actions
(Prepared by QAM)
e)
Follow-up actions from previous management
reviews (Prepared by QAM)
f)
Changes that could affect the quality
management system,
g)
Recommendations for improvement
h)
New or revised regulatory requirements
3.4.3 Review
output
The review
output addresses decisions and actions related to:
a)
Improvements needed to maintain the
effectiveness of the quality management system and its processes,
b)
Improvement of service related to customer
requirements.
4.0 RESOURCES MANAGEMENT
4.1 PROVISION OF RESOURCES
4.1.1 ABC is committed to determine and provide
the resources needed for the following:
a.
Implement and maintain the quality management
system and continuously improve and maintain its effectiveness.
b.
Adhere to regulatory and customer
requirements.
4.1.2 The resources needed are explicitly
defined in the quality manual, procedures and supporting documents.
4.2 HUMAN
RESOURCES
4.2.1 General
All employees of all
level, training, background and qualifications are involve in quality
improvement in ABC.
4.2.2 Competence, awareness and training
a.
At ABC, people are the company’s most
valuable asset. Investing in people through effective training is key to
achieving the company’s mission and quality policy.
b.
Training shall be given to new employees and
shall be repeated as appropriate, especially so for personnel engaged in work affecting
quality.
c.
Training will be reviewed annually to
consider changes in regulatory and technology.
d.
Training provided to these personnel shall be
comprehensive to ensure suitable adeptness is achieved and maintained.
Experience or background requirements are detailed in job descriptions and are
on file at the Human Resources Admin. (SM-D-007).
e.
It is our policy at ABC to:
a.
Determine the necessary competency for
personnel performing work affecting service quality.
b.
Provide training or necessary coaching to ensure
quality consistencies are not compromise.
c.
Do periodic evaluations to review the actions
effectiveness.
d.
Ensure that all staff are aware of the
importance of keeping quality standard in their work and how they could contribute
to achieve the quality objectives.
e.
Evaluate any training after being conducted.
f.
Maintain appropriate records of education,
training, skills and experience (see 2.2.4 of Quality Manual).
5.1
Customer Related Process
a. TFV
shall determine customer requirements of
its products including:
i.
Requirement specified by the customer, including the
requirements for service delivery and post-service delivery activities;
ii.
Requirements not specified by the customer but
necessary for intended, known or specified use;
iii.
Obligations related to products and/or services,
including regulatory and legal requirements.
iv.
Any additional requirements to ensure customer
satisfaction such as providing expertise information or assistance.
b. The
review shall be conducted prior to the commitment to acceptance of order to the
customer by ensuring: -
i.
Clear definition of the service requirements
ii.
Ability to meet defined requirements.
iii.
Review and subsequent follow-up actions after record
c.
Details of customer related
process can be explained in the Operation
Flow Chart. (Appendix D – QM-002)
5.2 Control of Service Provision
a. ABC
shall plan and carry out the appropriate control to ensure that the customer
requirements are understood, accepted and executed to ABC quality standard.
b. In
ensuring service provision under controlled conditions, the requirement should
be fulfilled including:
i.
the availability of work instructions, as necessary
ii.
the use of suitable equipment, vehicles and other
machineries.
iii.
the implementation of monitoring and measurement
iv.
the implementation of product release, delivery and
post-delivery activities
5.3 Purchasing
5.3.1 Purchasing process (Refer SMD-015)
·
Any staff intend to purchase any item in the company has
to ensure that the item conform to the preset purchase requirements. The following
are the authorized person/persons to make decision for purchasing process
a)
Group Managing Director will make the final decision
for purchasing of medical unit item.
b)
Operation Director will be responsible for decision to
purchase the item related with repair and maintenance of equipment.
c)
Head of Departments will decide the medical unit to be
purchased, the quantity and supplier preferred.
·
Type of material / service that apply the purchasing
control requirements are;
1. Spare
part
2. Equipment
or instrument
3. Medical
Disposable
·
Issuance of Purchase
Order is under responsible of ALL
RELEVANT PERSONNEL. (for customer order with LPO only). Order without
LPO must obtain proper authorization from the Director.
·
Records keeping and purchasing activity is carried out
by relevant personnel once instructions are given by the director.
·
The Company has established the method of supplier
evaluation based from their ability to provide product or service in accordance
with the company's requirements. All approved supplier are registered in the Approved Supplier List , L-004 (ASL)
·
New supplier shall be evaluated before listed in the
ASL. (However, no evaluation of existing
supplier who has business network with the company before the establishment of this
QMS. )
·
Re-evaluation of supplier shall be conducted by annual
basis apply for active supplier only;
·
Active supplier can be defined as follows;
1. Purchase
of material or service significant with company service conformity.
2. Volume
of purchase not less than RM 500 per invoice.
3. Not
less than 3 Purchase Order issued per year.
·
Records of the purchase activity including the results
of evaluations and any necessary actions arising from the evaluation shall be
maintain as per Control of Records Procedure (SM-D-001).
6.0 MONITORING
AND MEASUREMENT
a)
The company has implemented the
monitoring, measurement, analysis and improvement processes needed to
demonstrate conformity to the product requirements and QMS effectiveness.
b)
Method is determined as refer as
follows;
1)
Customer satisfaction
See
customer Focus
2)
Internal audit
The
internal audit is an activity to determine whether the quality management
system conformed to the planned arrangements
(as described in QMS Planning and effectively implemented and
maintained.
Internal Audit Procedure
is established to ensure the responsibilities and requirements for planning and
conducting audits, establishing records and reporting results are defined and
effectively implemented.
In ABC, the
internal audit shall be conducted at
least once a year or by any impromptu decision made by the top management.
3) Monitoring of processes
To
achieve the effectiveness of service provide by company, QMR/QAM has to ensure that readiness of available resources
is maintained. Monitoring can be made through;
1. Training
Records.
2. Manpower
competency record.
3. Customer
Feedback Form
4. CPAR
These methods shall demonstrate the ability of the
processes to achieve planned results. When the above planned does not met the
requirement, corrective and preventive action, SM-F-004 (CPAR) shall be taken.
Where appropriate, the action should follow Control of Non-Conformance Procedure (SM-D-003) and Corrective and Preventive Action Procedure (SM-D-004).
c)
The data are then collected to demonstrate the
suitability and effectiveness of the quality management system. Result from the
analysis will be reviewed during Management Meeting.
7.0 CONTROL
OF NONCONFORMING SERVICE
7.1 ABC shall ensure that product which does not conform
to service and product requirements is identified, controlled and isolated to
prevent accidental use.
7.2
The control, responsibility and authorities for
dealing with non-conformity issues can be referred with Control of Non-Conformance
Procedure (SM-D-003).
8.0 IMPROVEMENT
The
following measures of activities and procedures will be applied to ensure continuous
improvement and guarantee effectiveness of the quality management system:
1. Audit
Result
2. Management
Review
3.
Corrective
and Preventive Action procedure (SM-D-004).
