Introduction to Quality
Management Systems for
Medical Devices
1
Introduction to Quality
Management Systems of
for Medical Devices
Sponsored by: Community College of
Allegheny County
Presented by: Calvin W. Eggers, Quality
and Regulatory Consultant
2
Purpose of the course
This course is intended to review the
quality management system (QMS)
requirements for medical device
manufacturers and specifically the
implementation of the QMS at Renal
Solutions, Inc.
3
Expected Learning






Review the regulatory requirements for the
Quality Management System (QMS)
Understand the concept and structure of a
quality system
Identify the common elements and processes of
a QMS and key requirements that apply to them
Differentiate between the medical device QMS
and that of other industries
Locate information in the RSI quality manual
Learn personal quality system responsibilities
4
Triage of Knowledge
All employees
Aware of system
requirements, able to use
the quality manual and
follow procedures
All Leaders
Able to understand policy,
write procedures, and
apply regulations
Regulatory
Leaders and
Professionals
Detailed knowledge and
application of regulations
5
Course Agenda

Medical Regulatory Requirements

Compliance with ISO 13485 and FDA QSR


RSI Quality System Documents
System Clauses and Elements





Management Responsibility
Resources
Realization Processes
Measurement and Improvement
Additional Learning
7
Medical Regulatory
Requirements for QMS



US/FDA: Quality Management System per
21 CFR820, Quality System Regulation
Europe, Canada, and Other International:
QMS per EN/ISO 13485:2003, Medical
devices – Quality management systems –
Requirements for regulatory purposes
Additional directives, regulations, and
standards as they pertain to the QMS
8
Is 13485 = 9000?

More emphasis on:






Specific records related to medical device
requirements
Risk management
Work environment and cleanliness
Complaint handling and corrective action
Others
Less on customer satisfaction and
continual improvement
9
What is a System?
A regularly interacting or
interdependent group of items
forming a unified whole
10
What is a Quality System?


The quality management system consists
of the organizational structure,
responsibilities, procedures,
specifications, processes, and resources
that work together to comply with the
company’s quality policy and meet the
requirements of our customers and
applicable regulatory requirements
Quality is the degree to which a set of
inherent characteristics fulfils
requirements
11
ISO 13485 Model
5.0
Mgmt
8.O
Measure
4.0 QMS
6.0
Resources
7.0
Processes
12
Documented System?
We don’t use
no stinking
documents
We don’t keep
no stinking
records
13
Requirements for a
Documented Quality System

QSR



820.40 Document Controls
820.180 to 198: Records
ISO 13485




Clause 4, Quality Management System
4.2.2 Quality manual
4.2.3 Control of Documents
4.2.4 Control of Records
14
RSI Quality System
Document Pyramid
Quality Manual
Procedures
Work Instructions
Forms
Work
Work
Instructions
Instructions
Quality
Records
15
RSI QMS Implementation

Quality Manual



QSM-001, Controlled document
Describes the QMS
Set policy for the organization based on
 External regulations
 Company business practices and plans
 Company culture

Remainder of class will be based on
QSM-001
16
Quality System Procedures

Implement policy through
 Definition of processes
 Assignment of responsibility and authority
 Establishment of review and approval
mechanisms
 Maintenance of records


QSP-0xx; non-significant numbering
Referred to in quality manual section
for respective process
17
Who is Responsible to Establish
and Maintain Procedures?



Process Owner as Identified in Quality
Manual
Establish = design process, write,
validate
Maintain = respond to audits, revise for
corrective action, changing conditions
Owner:
……………….
18
Third and Lower Tier
Documents
Work Instruction (build, test,
inspect, purchase)
 Form or template for developing
documents or keeping records



Can be established by procedures
within the process
Records
19
Quality Manual Road Map


1 to 3 -- Policy and introduction
4–




QMS description
Requirements for documents and
records
5 to 8 -- Requirements for processes
9 --Trace of compliance
20
Typical Section Outline


General Policy
Detailed policy in outline form



Sub-processes
Specific requirements
Reference to owner and procedures
21
1.0 Introduction and Scope

This section is intended to describe
the scope of the quality
management system (QMS)




Organization
Products
Compliance (Regulations and
Standards)
Manual is intended for both external
and internal purposes
22
2.0 Quality Policy


Mission
Quality Policy
23
3.0 Organization


High level
Responsibility for elements
24
4.0 Quality Management
System
This section describes the quality
management system (QMS) in
general terms.
The requirements of this section
establish a basic structure for the
QMS in the form of documents and
records
25
Document Control

Changes only with approval by same
persons or functions as original



Communicate changes and documents
Use only latest revision


Record of changes
On line version is only controlled copy
Control over standards and other
documents of external origin
26
Document Control
Procedures

QSP-002 Document Management



Document Control Group
All originators and users
QSP-030 Change Control


Document Control Group
All originators and users
Owner:
Document
Management
27
Record Control
Record is a document that furnishes
objective evidence of activities
performed or results achieved
 Quality record is one that relates to
the quality management system

28
Procedures Required
Identifying, collecting, indexing,
accessing, filing, storing,
maintaining, and disposition
 Storage location and archiving
 Storage media (may be electronic)
 Retention times
 Methods of disposition

29
Why Quality records?

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Provide objective evidence of the
achievement of customer and internal
quality requirements
Verify effective operation of the QMS
Comply with regulatory requirements
Provide for traceability of devices and
components
Provide information for corrective and
preventative action and continuous
improvement
30
Record Control Procedures

QSP-004 Record Management

All employees
Specific instructions in procedures
for your process
 Specific directions from your leaders

Owner:
Compliance
and Regulatory
Affairs
31
9.0 Demonstration of compliance



9.1 21 CFR 820 Quality System
Regulation (FDA)
9.2 ISO/EN 13485:2003
9.3 Other Regulations and Standard


Medical Devices Directive
Other 21 CFR (e.g., Clinicals, 510(k), etc.)
32
9.0 Demonstration of compliance
4.2
Documentation requirements
4.1.3 Structure of the Quality Management System
4.2.1
General
4.1.3 Structure of the Quality Management System
4.2.2
Quality manual
4.1.3 Structure of the Quality Management System
4.2.3
Control of documents
4.2 Document Management
4.2.4
Control of records
4.3 Control of Quality Records
5
Management responsibility
5.0 Management Responsibility
5.1
Management commitment
5.1 General Policy
5.2
Customer focus
5.1 General Policy
5.3
Quality policy
2.3 Quality Policy
5.2 Establishment of Quality Policy
33
9.0 Demonstration of compliance
820.150(a)
Control of storage
7.6.2 Storage of Finished Goods
7.5.8 Preservation of Product
820.150(b)
Authorizing receipt and dispatch
7.5.3 Inspection and Testing
820.160
Distribution
7.6 Distribution
820.160(a)
Procedures for control
7.6.3 Distribution Activities
820.160(b)
Distribution records
7.6.4 Distribution Records
820.170
Installation
7.7.4 Installation
820.180
Records -- General requirements
4.3 Control of Quality Records
34
Course Agenda


Medical Regulatory Requirements
RSI Quality System Documents


System Clauses and Elements





Compliance with ISO 13485 and FDA QSR
Management Responsibility
Resources
Realization Processes
Measurement and Improvement
Additional Learning
35
ISO 13485:2003 Model
4.0 Quality
System
5.0 Management
Controls
Document Control
6.0 Resources
Record Control
7.0 Realization
Processes
8.0 Measure
and Improve
36
5.0 Management
Responsibility



Executive Responsibility
Direction to establish Quality Policy
Management Representative




Alternate
Authorized Representative
Management Review
Quality Planning
37
Management Review

Hold regularly with inputs including



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
Status of QMS
Audits, Complaints, Corrective and
Preventive Action
Metrics of processes
Actions for improvement
Records of meeting, including
conclusion on suitability of QMS
38
Management Review Procedure

QSP-005 Management Review
(Management and QA)
Owner:
CEO and
Management
Representative
39
Resources

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
6.1
6.2
6.3
6.4
6.5
6.6
General
Human Resources
Infrastructure
Working Environment
Measurement Equipment
Information Systems
40
6.2 Human Resources



Sufficient personnel with appropriate
background, education, and experience
Determine required competence
Provide training to ensure competence


Ensure that the assigned tasks are performed
in accordance with the quality system and
associated policies, procedures, and work
instructions
Include instruction on the importance of the
associate’s activities and their contribution to
the quality objectives
41
Training

Identify the training needs and plan the training


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


Identify of device defects or nonconforming conditions
that may occur as a result of improper performance
Identify types of defects that may be encountered on
validation, verification, inspection, or test activities,
Include training on any special processes, and any need
to work under special environmental conditions
Conduct the training
Evaluate effectiveness of training
Records of all training
42
Training Procedure
QSP-006 Training
(All Leaders)
 Everyone: Get trained; do quality
system jobs only if trained

Owner:
Chief Financial
Officer
43
6.3 Infrastructure



Controlled conditions to ensure that
devices meet their requirements and are
shipped free of contamination
Buildings adequate, orderly, to prevent
contamination and mix-up
Processing Equipment


Selected and designed to meet requirements
Cleaned, maintained, and adjusted
44
Infrastructure Procedures

None at this time
Owner:
Senior VP,
Operations and
Engineering
45
6.4 Working Environment

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Processes in compliance with all applicable Environmental, Health, and
Safety requirements
Where necessary, control environmental conditions
Cleaning where necessary to meet specifications and prevent device or
equipment contamination
Handle items sensitive to electrostatic discharge (ESD) per procedures.
Smoking prohibited
Eating and drinking limited to designated areas
Each associate help maintain a clean and safe work environment
Inform all associates who contact devices or components of requirements
for health, cleanliness, personal practices, and attire as well as any
adverse effects that the health of the associates could have on product
quality
Train any employee who may be exposed to Blood Born Pathogens (BBP)
in personal protective measures and the handling of BBP contaminates
46
Working Environment Procedures

None at this time
Owner:
Senior VP,
Operations and
Engineering
47
6.5 Measurement
Equipment





Measuring equipment used to provide evidence
of conformity to requirements
Ensure that it is suitable for its intended use and
to assure confidence in the measurements
Include selection, qualification, identification,
preservation, calibration, and corrective action
Calibration based on primary standards that are
traceable to National Institute of Standards and
Technology (NIST) standards
Suppliers of calibration services shall be qualified
48
Measurement Equipment Procedure
QSP-007 Control of Measuring
Equipment (QA and all who use
equipment)
 Procedure is based on outsourcing
calibration
Owner:
 Everyone: use only if
Compliance
and Regulatory
in current calibration
Affairs

49
6.6 Information Systems

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Systems that support the quality
management system shall be developed,
operated, and maintained under
controlled conditions
Adequate equipment, environment,
software, procedures, and personnel
Validate all systems and software
Electronic record requirements
Electronic signature requirements
50
Information System Procedures

None at this time
Owner:
Chief Financial
Officer
51
ISO 13485 Model
5.0
Mgmt
4.0 QMS
7.0
Processes
6.0
Resources
52
7.0 Realization Processes

Plan, define, implement, and maintain processes
to meet customer requirements




Consider quality objectives
Comply with the requirements of the quality
management system, and any unique requirements of
the products.
Use risk management methods
Changes to manufacturing or service processes
shall include appropriate quality planning, with
provision for any required quality controls,
verification, or validation
53
7.0 Realization Processes
7.3 Design
Control
7.4 Supply
Management
7.2 Customer
Service
7.8
Regulatory
7.5
Manufacturing
7.9 Clinical
7.6
Distribution
7.7 Service
54
7.2 Customer Processes

Ensure effective communication with
customers

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
Receipt and entry of orders and order status
Product information, pricing, inquiries,
contracts, service-level agreements
Changes affecting the products and services
Recording customer complaints
Collection of customer feedback
Provide clinical training necessary for
effective use of the product
55
Order Entry



Offers and orders only for products that
have been released for sale and which
RSI is capable of providing within a
reasonable time
Review any customer requirements for
delivery and post-delivery activity
Each standard product shall be assigned a
material number for ordering
identification
56
Customer Process Procedures
QSP-008 New Customer Contact and
Initial Order Entry
 QSP-023 Existing Customer Contact
and Order Entry
(Customer Service and Warehouse)

Owner:
Senior VP,
Operations and
Engineering
57
7.3 Design Control

Plan and control the design and
development of all products and
their labeling in order to assure the
safety, clinical utility, effectiveness,
and reliability of the device design
and to ensure that specified design
requirements are met
58
Design Control Sub-processes
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
Design and Development Planning
Design Input
Design Output
Design Review
Verification
Validation
Control of Changes
Design Transfer
59
Device Master Record


A compilation of records that completely describe the
device and the processes by which the device is produced,
inspected, tested, labeled, stored, and distributed
Contain -- or refer to the location of -- all applicable:








Device specifications and software specifications
Process and production environment, including appropriate
equipment specifications, work instructions, and drawings
Component specifications
Identification of any special processes
Packaging and labeling specifications and copies of all labeling
Quality control procedures and specifications, including
acceptance criteria and equipment
Installation, maintenance, and servicing procedures
Record of all changes
60
Design History File/Technical File
DMR = the recipe for the device
 DHF = How we got there
 Technical File = MDD version of DHF,
showing conformance to Essential
Requirements

61
DHF/TF Contents





Design reviews including the design, the date, and
individuals performing the review
Design verification including the design, date, methods,
identification of how design outputs meet design inputs,
and individuals performing the verification
Design validation including the design, date, methods, and
individuals performing the validation
Evidence of clinical utility and acceptance, including the
records of any clinical studies performed as part of the
development of the device
Records of all risk management activities
62
Labeling Design






Designed to help the user achieve safe and
effective operation of the device, prevent mixup, and prevent any compromise to the safety
and effectiveness
Meet the provisions of 21 CFR Part 801
Include only approved claims
For EU, meet the requirements of the Medical
Devices Directive Article 17 and Annex 1,
paragraph 13
For Canada meet the requirements of Canadian
Medical Devices Directive, Sections 21 to 23
Translate if necessary for user countries
63
Design Control Procedures
Owner:
QSP-009 Design Controls
Director of
Engineering
 QSP-010 Design Reviews
 QSP-011 Risk Management
 QSP-012 Design Verification and
Validation
 QSP-013 Creation of Design History
File, Technical File, and Declaration
of Conformity

64
Labeling Procedure

QSP-015 Labeling Design
Owner:
Senior VP
Commercial
Operations
65
7.4 Supply Management
Manage the supply of material and
outsourced products and services
 Ensure that all purchased or
otherwise received products,
components, and services
conform to specified
requirements

66
Supply Management
Sub-processes
Evaluation of Suppliers
 Control of Contract Manufacturers
 Purchasing Information
 Verification of Purchased Product



Inspection Records
Monitoring of Suppliers
67
Supplier Evaluation





Evaluate and select based on ability to supply products or
services in accordance with the specified requirements
Maintain record of approved suppliers and their evaluation
Type and extent of control applied to the supplier and the
purchased product shall depend on the effect on the final product
Suppliers of goods or services that do not directly affect the QMS
may be selected based on their ability to meet purchase order
requirements.
Contract manufacturers of outsourced finished good items




Establish contracts that include a supplier agreement
Ensure compliance with all process control requirements
Ensure development of a quality plan by the supplier
Sterile product suppliers


Provide evidence of process validation
Maintain records of the parameters for the sterilization of each batch.
68
Supply Management Procedures
QSP-014 Supplier Qualification
 QSP-016 Purchasing Controls
 QSP-018 Receiving, Inspection and
Acceptance
 QSP-037 Return of Purchased
Material

Owner:
Senior VP,
Operations and
Engineering
69
7.5 Manufacturing


Processes performed under controlled
conditions in accordance with written
instructions or drawings by qualified and
trained personnel to assure that the
devices conform to the approved original
or modified design
Policies of this section concerning product
identification, traceability, preservation of
product, and labeling apply to all areas of
the quality management system
70
Manufacturing Requirements
Process Control
 Process Validation
 Inspection and Testing
 Rework and Reprocessing
 Preservation of Product

71
Identification and Traceability



Identify all materials by material number and, as
necessary, by status, or by other appropriate method at all
stages
Distinguish devices returned for service or reprocessing
Control and trace by means of a unique control number:





All electromechanical therapy equipment
All serviceable accessories
Any other therapy accessories that might present a risk
requiring recall or other corrective action
Control number on the device or on its label, if possible
For all traced devices any components or subassemblies
that can reasonably be expected to require corrective
action shall be traced
72
Control of Labeling

Labeling accompanying the device (i.e., product
labels, package labeling, or user instructions)




Have a revision designation specified
Identify and store to prevent mix-up
Control, distribute, and maintain marketing
literature to prevent mix-up.
Labels or labeling that contain significant
warnings, cautions, or warning instructions

Traceable through part number, revision, or other
appropriate means
73
Device History Record

DHR is a compilation of records containing the production history
of a device or a batch of devices to:




Document the production history in the “as built” configuration
Demonstrate the device has been built in accordance with the DMR
Provide traceability information
A DHR shall be maintained for each device or batch of devices
produced including directly or by the reference to the location
thereof:







Date of manufacture
Quantity manufactured and quantity released for distribution
The acceptance record that demonstrates the device is manufactured
in accordance with the DMR
The primary identification label and labeling
Any identification and control number
Record of rework or revaluation activities
Record of any special processes
74
Manufacturing Procedures
QSP-017 Product Identification and
Traceability
 QSP-019 Manufacturing, Storage,
and Distribution

Owner:
Senior VP,
Operations and
Engineering
75
7.6 Distribution Process









Includes handling, storage, preservation, and distribution
Prevent damage, mix-up, and contamination
Identify finished goods with a part number
Account for the inventory and verify accuracy
Remove time-sensitive finished goods before expiration
Label and handle hazardous Material per regulatory
requirements
Distribute finished goods only from RSI manufacturing
facilities or designated RSI distribution centers
Ensure that distribution occurs only after devices have
been authorized for release
Ship in first-in/first-out order to the extent possible
76
Distribution Records

For all finished good and rental items,
except for promotional literature, include:






Name and address of consignee
Material number
Description of the item
Quantity shipped
Date shipped
Control number, if applicable
• Provide for product traceability
77
Distribution Procedures
QSP-019 Manufacturing, Storage,
and Distribution
 QSP-026 Handling of Biohazardous
Material

Owner:
Senior VP,
Operations and
Engineering
78
7.7 Servicing










Ensure that customer expectations for service are met and
serviced devices meet specified requirements
Develop, update, and control service documentation
Identify and validate tools, test equipment, work environment,
and safety
Qualify and train service personnel
Timely distribution of replacement parts (only replacement parts
distributed or authorized by RSI)
Material identification and traceability throughout the process
Care and identification of customer owned devices
Cleaning and decontamination of returned equipment, and
protective equipment for service associates
Packaging, storage, and handling
Communicate and implement mandatory product changes.
79
Servicing Procedure

QSP-021 Servicing
Owner:
Senior VP,
Operations and
Engineering
80
7.8 Regulatory Processes
QSP-024 Regulatory Submittals
 Specialty knowledge by leaders and
professionals

Owner:
Compliance and
Regulatory
Affairs
81
7.9 Clinical Studies
QSP-022 Clinical Site Selection,
Initiation, and Assessment
 QSP-025 Clinical Site Monitoring
 Specialty knowledge by leaders and
professionals

Owner:
Compliance
and Regulatory
Affairs
82
ISO 13485 Model
5.0
Mgmt
4.0 QMS
7.0
Processes
6.0
Resources
83
Measurement and
Improvement
Goals
Processes
Results
Feedback
84
8.0 Measurement and
Improvement Processes
8.1 Feedback
and
Complaints
5.0
Management
Controls
8.2 Internal
Audits
8.3 Control of
Nonconforming
Material
8.4 Corrective
and Preventive
Action
7.0
Realization
Processes
85
8.1 Feedback and
Complaints


Collect feedback and complaints from all
sources, including customers
A quality complaint is any written,
electronic, or oral communication from
any source that alleges deficiencies
related to the identity, quality, durability,
reliability, safety, effectiveness, labeling,
packaging, or performance of a device
after its release for distribution
86
Complaint Process






Receive and record complaints from any
source
Review and evaluate complaints
Determine if an investigation is required
and the level of investigation
Implement corrective action where
required
Respond to complaints
Maintain complaint records and trends
87
Adverse Events/Incidents


Reporting requirements of FDA, the European
Union (Vigilance), and the Canadian Medical
Device Regulations
Review complaints for any information that
reasonably suggest that




a device manufactured or distributed by RSI
may have caused or contributed to a death or serious
injury,
or may have malfunctioned and that the device would
be likely to cause or contribute to a death or serious
injury if the malfunction were to recur
Review internal failures for adverse events
88
Complaint Procedures





QSP-028 Complaint Handling Process
QSP-038 Customer Returned Product
QSP-033 Medical Device Incident
Reporting
QSP-035 Post Market Surveillance
Everyone: Report complaints to Customer
Service
Owner:
Compliance
and Regulatory
Affairs
89
8.2 Internal Quality Audits

Conduct at planned intervals to
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Schedule at planned intervals based on the status and
importance of the activity and results of previous audits
Each element of the QMS audited at least annually.
By qualified auditors without direct responsibility in audit
area
Verify implementation of corrective and preventive actions
Reports to the management of the area being audited

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ensure that all aspects of the QMS are effectively
implemented and maintained
ensure continuous compliance with applicable regulatory
standards
identify areas for improvement
Take timely action to eliminate detected nonconformities and their causes
Report results to Management Review
90
Audit Procedure
QSP-027 Internal Quality Audits
(Quality Assurance, Management)

Owner:
Compliance
and Regulatory
Affairs
91
8.3 Control of
Nonconforming Material
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Identify nonconforming material (NCM) and
prevent its inadvertent use or delivery
Clearly identified and appropriately segregated
from acceptable material
Prevent inadvertent use or shipment
Identify responsible internal function or supplier
Process for review and disposition of
nonconforming material, including initiating
corrective and preventive action, where
appropriate
Maintain records
92
Control of Nonconforming
Material


If released under concession the release
shall be recorded and the concession shall
be reviewed to ensure that it does not
increase the safety risk above that
allowed by regulatory or internal quality
requirements
If reworked or sorted to meet quality
requirements, any rework or sort process
that is part of the disposition shall be in
accordance with approved written
instructions
93
Delivery Holds


If investigation of a indicates
nonconforming products have been
manufactured and are available for
distribution, a delivery hold shall be
placed on the item in question
Release upon correction of the
nonconforming condition, or
determination that there is no further
likelihood of nonconforming finished
goods being available for distribution
94
Post Market

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Take appropriate corrective action (recall) to address
potentially nonconforming product that has already been
distributed
Use field corrections or safety advisory notifications if
more appropriate than a product recall
Monitor progress of product recalls and reconcile the
amount of product returned
Evaluate for reporting under 21 CFR Part 806, Article 10 of
the Medical Devices Directive, the Canadian Medical Device
Regulation, and any requirements of other governments
If a safety issue with a CE-marked device, inform the
Notified Body and the Authorized Representative
95
NCM Procedures


QSP-031 Control of Nonconforming
Material (QA, Operations, Everyone)
QSP-034 Corrections and Removals
(QA, Customer Service,
Management)
Owner:
Compliance
and Regulatory
Affairs
96
8.4 Corrective and
Preventive Action (CAPA)

Ensure that the causes or potential causes of
nonconforming product, material or processes are
identified, evaluated, documented, and corrected,

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to prevent recurrence of the problem (CA)
to prevent the problem from initially occurring (PA)
Provide a systematic, problem-solving approach to
continuous quality improvement with the objective of
detecting and eliminating all causes of nonconforming
product, material, and processes
Implementation commensurate with the significance of the
problem or potential problem
Verify actions so they don’t adversely affect the device
Report as part of Management Review
97
Sources of information
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Complaints service records, and returned product
External regulatory agencies
Receiving inspection records and data on supplier quality or
audits
Nonconforming material reports
Production quality data and process capability
Nonconformities in production processes, tools, equipment, or
facilities
Delivery holds and production shut-downs
Internal quality audits
Reports of noncompliance with procedures or of inadequate
procedures
Customer relationship performance (e.g., delivery, billing, etc.)
Management Review, or other management meetings
Associate surveys
98
Preventive Action Process


Help prevent the occurrence of nonconforming
conditions by identifying, analyzing, and
eliminating potential quality problems, and
analyzing and trending information on quality
Same sources of information as for CA, plus:
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Information from processes that affect product quality;
audit results; quality records; service reports; customer
complaints and Adverse Event Reports
Product and process risk management and reliability
analyses
Design reviews
Product and process verification and validation
Changes in the product, the process, or suppliers
99
Corrective and Preventive
Action Procedure
•QSP-029 Corrective and
Preventive Action (QA and Everyone)
Owner:
Compliance
and Regulatory
Affairs
100
Expected Learning
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Review the regulatory requirements for the
Quality Management System (QMS)
Understand the concept and structure of a
quality system
Identify the common elements and processes of
a QMS and key requirements that apply to them
Differentiate between the medical device QMS
and that of other industries
Locate information in the RSI quality manual
Learn personal quality system responsibilities
101
Course Agenda
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
Medical Regulatory Requirements
RSI Quality System Documents


System Clauses and Elements

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


Compliance with ISO 13485 and FDA QSR
Management Responsibility
Resources
Realization Processes
Measurement and Improvement
Additional Learning
102
Additional Learning Path
Regulatory
Requirements
Class
Quality System
Class
Seminars and
Self-study
Classes on
Procedures
(Include review of
policy from quality
manual)
Trained
Worker
On-the-job
Training
103
Any Questions?
104