QISS—Management System
Automation
WOULD YOU LIKE TO:
QUICKLY SET UP AND RUN A NEW
MANAGEMENT SYSTEM (ISO 9001 etc.) ?
MAKE AN EXISTING SYSTEM MUCH EASIER TO
OPERATE WITH LESS EFFORT?
MAKE COMPLIANCE AND AUDITS MUCH
EASIER?



MAKE MORE $$ MONEY $$ WITH
LESS COSTS?

IF
4/8/2020
YES TO ANY, THEN PROCEED!!
Copyright  Quality Institute of America
QISS—Management System
Automation
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4/8/2020
Copyright  Quality Institute of America
Quality Institute of America, Inc
PROFESSIONAL SERVICES IN ISO 9000, AS 9100, TS
16940, ISO 14000 QUALITY, AND ENVIRONMENTAL
MANAGEMENT
•Training
•Consulting
•Auditing
•Software
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Quality Institute
Software Solution
Central Quality Nervous System©
INTRODUCTION
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QIA and QISS
MISSION
To provide clients with an engine to automate
their Quality Management System.
This tool will seamlessly integrate all required
functions, eliminate drudgery, assist in decision
making, and do so in an easy-to-use, intuitive
and cost-effective manner.
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Copyright  Quality Institute of America
Components of a Quality
Management System
Goal: to comply with the requirements
Requirements:

These are defined typically by ISO 9001
or one or more of its related standards: TS16949,
AS9100, API QI, ISO 14001, 17025, 13485, 22000,
…etc., AND organizational requirements
Processes:

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These are sets of interrelated steps (procedures)
designed to ensure that the requirements will be
complied with.
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ISO 9001 Requirements and QISS
processes/ modules
QISS provides integrated processes to
ensure that ISO 9001 requirements are
met:

Clause 4: Quality Management System
Document Control and Records Control Modules

Clause 5: Management Responsibility
Management Review, Administrative and
Communication Modules.

Clause 6: Resources Management
Training and Maintenance Modules
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Copyright  Quality Institute of America
ISO 9001 Requirements and QISS
processes/ modules
ISO Standard Clauses and Modules,
continued.

Clause 7: Product Realization
Organization specific procedures stored in in the
controlled document library; and Calibration
Modules

Clause 8: Measurement, Analysis and
Improvement
Nonconformance Control, Corrective & Preventive
Action, and Internal Audit Modules
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Copyright  Quality Institute of America
How Does QISS Work?
QISS is a workflow software:
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Takes the work and flows it from person to person
until the job is complete.
In other words….provides the procedure that people
need to follow, and ensures that they follow it.
QISS has been written with ISO 9001 requirements in
mind…..So in all the sections of ISO 9001 that QISS
covers, using QISS gets you into compliance.
AND… QISS covers all the sections of ISO 9001
excepting those that are organization specific, and
usually covered by ERP.
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The POWER of QISS
You don’t have to remember the
procedure…QISS will ensure that all
people involved in required tasks follow
the right steps, and on time!
QISS will assign people to tasks and then
monitor progress:
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Send reminders via e-mail
Escalate to supervisor for intervention
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The POWER of QISS
Important requirements are on a calendar,
and QISS ensures that people involved
are alerted at right time to take action.
Dashboards and To-Do lists help people
manage their time and priorities.
Top management can monitor entire
Quality System from their desk or PDA.
Charts, Reports, help make your system
effective and efficient.
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Copyright  Quality Institute of America
The POWER of QISS
QISS ELIMINATES THE DRUDGERY
AND THE TIME INVOLVED IN
ENSURING THAT THE RIGHT
PROCEDURES ARE USED, AND USED
CORRECTLY.
QISS RELEASES PEOPLE TO DO ONLY
WHAT PEOPLE CAN DO…MAKE
DECISIONS AND ADD VALUE
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Copyright  Quality Institute of America
QISS—if you don’t yet have a
formal System
Installing and using QISS gets you to
instantly meet ISO 9001 requirements for:

Document control, Record Control,
Nonconformance Control, Corrective &
Preventive Actions, Calibration, Equipment
Maintenance, Training, Internal Audits,
Management Review.
You can, (and we can help you), fill in the
rest with simple procedures to meet the
rest of the requirements.
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Copyright  Quality Institute of America
QISS—if you don’t yet have a
formal System
SIMPLE THREE STEP PROCESS:
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INSTALL AND IMPLEMENT QISS…START
USING CORE QUALITY PROCESSES IN A
ISO COMPLIANT MANNER
FORMALIZE (USUALLY) COMPLIANT
PROCESSES FOR OTHER FUNCTIONS
GET AUDITED, GET CERTIFICATE
Copyright  Quality Institute of America
QISS—if you already have a formal
System
Install and implement QISS, and you can:

Stop keeping tabs on:
what needs to be done
what is late and who has to do what
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Start working on the important things… the
ones that make the organization money, and
take it further along its goals.
Know that you are in compliance…24/7…and
if you are not…you know precisely where, and
the moment that it happens.
Copyright  Quality Institute of America
Drastically reduce paperwork.
ISO related documents (and others, if you
like) are all uploaded into the QISS
system.
Each document from The Quality Manual,
Work Instructions, Records, to Nonconformances, Corrective Actions and
Internal Audits are all generated, changed,
archived and easily accessible paperlessly
through QISS.
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Copyright  Quality Institute of America
Automate the flow of tasks from function
to function and employee to employee.
Tracking and documenting each step of
the ISO required workflow is automated
through QISS.
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Simply initiate whichever action you choose.
(ie: Document Change or Training)
Designate the other employees involved.
QISS manages the communication via email
and timely reminders.
It even alerts you and the tardy assignee
when a task is overdue.
Copyright  Quality Institute of America
Remotely access your QMS
Any computer with access to your server
can access QISS to perform necessary
tasks.
If hosted by QIA, any internet connection
can access QISS with the proper security
permissions.
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Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
Simple process of integrating QISS with your
current QMS.
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Input Organization Chart into Administrative Module.
Initiate all documents into QISS for formal review,
approval, and training of affected people.
Input Equipment for Calibration and Maintenance.
Create Employee Competency Checklists in Training
Module.
Input your Non-Conformance Report design into
QISS.
You are ready to start using QISS!
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Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
Comprehensive training is provided.
QIA provides a fully functional Demo copy
of QISS for Training and Practice.
QISS is intuitive and logical in its workflow
management.
A helpful user manual is provided.
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Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
QIA can host QISS securely on our own servers.
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Allows secure access from any internet connection.
Only designated employees can access the password
protected, and encrypted system.
Speed determined by your internet connection.
Extremely low maintenance, we take care of the
server maintenance and backing up of files.
Get your Software updates much more quickly and
easily.
Simply login, set up, and start using QISS!
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Copyright  Quality Institute of America
COMPLETE &
COMPREHENSIVE!!
QISS consists of the following modules:
Administrative—(Setup, Organization,
and Security) 5.5.1
Correspondence (Messaging) 5.5.3
Document Management 4.2.3
Records Control 4.2.4
Nonconformance Management 8.3
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COMPLETE &
COMPREHENSIVE!!
Corrective and Preventive Actions 8.5.2-3
Calibration 7.6
Maintenance 6.4
Training (Employee Competence
Management) 6.2.2
Internal Audits 8.2.2
Management Review 5.6
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CONTINUAL IMPROVEMENTOF THE
QUALITY MANAGEMENT SYSTEM
Customers
(and other
Interested
Parties)
Customers
(and other
Interested
Parties)
Orgn, Security,
In Aud, Mgm Rev
Training,
Equipment
Requirements
INPUT
NCR, CAPA
Doc Mgm, Proced
Cal, Maint
OUTPUT
Product
Value-adding
activities
Information flow
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Model of the process approach in
QISS
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Satisfaction
Summary Page upon Login
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Example of Data Analysis
NCR Status
14
13
12
2
2
0
0
NCR Closed
5
Still Open
Au
gu
Se
st
pt
em
be
r
O
ct
ob
er
N
ov
em
b
D
ec er
em
be
r
Copyright  Quality Institute of America
NCR Issued
7
0
Month
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10
9
2
2
Ju
ly
0
0
Ju
ne
1
Ja
nu
a
Fe ry
br
ua
ry
M
ar
ch
0
1
8
5
4
ay
2
5
4
7
6
6
M
4
9
9
Ap
ri l
Number
8
7
8
6
11
11
10
1
WITH OR WITHOUT QISS
WITHOUT:
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WITH
LONG IMPLEMENTATION
TOO MUCH PAPERWORK
TOUGH TO MAINTAIN
DISCIPLINE & OVERSIGHT
COSTS TOO MUCH IN
LABOR TO START, AND
TO MAINTAIN
CUMBERSOMEBUSINESS BENEFITS
HARD TO GET

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RAPID IMPLEMENTATION
NO PAPERWORK
QISS PROVIDES
OVERSIGHT ..SIMPLIFIES
DISCIPLINE
MINIMIZES LABOR,
FREES UP PEOPLE FOR
VALUE ADDED JOBS
EFFICIENT SYSTEM,
HELPS IN BUSINESS
BENEFITS.
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Detailed Description of QISS
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The Modules
Administrative (Setup)
This is a critical module where the decisions
are made that determine the scope and
direction of the Culture Change that is QISS.
Your company’s organization and its
personnel, documents, equipment,
customers, and suppliers are input here.
Also, new employees will be input through
setup, with their security assignments and
administrative duties.
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Administrative Module Menu Options
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The Modules
Correspondence (Communication)
Primary purpose is to inform the
appropriate people of actions that have
been assigned to them, and to inform
them of others’ actions that require their
response.
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Copyright  Quality Institute of America
The Modules
Document Management
Create new documents
Initiate Document Change Requests
QISS assigns an intelligent number to a
document based on type, department,
standard element, and sequence
Manage the review and approval process
involving all relevant personnel.
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Copyright  Quality Institute of America
The Modules
Document Management (cont.):
Automatic messaging of people who need to
collaborate, including those who need to be
trained.
Automatic revision control, informing relevant
personnel regarding changes; then tracking,
and recording the revision cycle review and
approval process for any individual
document.
Easy revival of obsolete documents if
needed.
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Copyright  Quality Institute of America
Document Control
Module WorkFlow
Approval Only
(ISO 9001:2000:4.2.3-4)
Author:
Initiates Document
Routed through QISS
Approvers: Approve or
Disapprove
(5.5)
Approved and Released
Disapproved
Archived as Disapproved
Document.
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Copyright  Quality Institute of America
Employees:
If assigned, employees must
self-verify training.
(5.5.3, 6.2.2)
Document Control Module WorkFlow
For Review and Approval
(ISO 9001:2000:4.2.3-4)
Author:
1. Initiates Document
2. Edits and Resends Document
3. Sends Document for Final
Approval
Routed through QISS
Reviewers/Approvers:
Approve, Disapprove, or
Resubmit
(5.5)
Approved and Released
Resubmitted to Author
Disapproved
Archived as Disapproved
Document.
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Employees:
If assigned, employees must
self-verify training.
(5.5.3, 6.2.2)
Document Management Menu Options
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Initiating a Document in Document Control
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The Modules
Management of Nonconformance
Create Nonconformance Report (NCR) for
a process or a product
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
Automatically route NCR to Authorized
personnel.
They can View and Act on NCRs in process.
Record Disposition Decisions
Record actions, including cost
Generate/View Reports
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Copyright  Quality Institute of America
Control of Nonconforming Products
Process Flow
Authority to Bypass
NCR Manager
Initiate NCR
Yes
Authority to Assign
Himself?
No
No
NCR Manager
B
Yes
A
B
Approve and
Assign Himself as
the Responsible
person?*
No
Assign Someone else
as responsible person
MRB required?
Yes
Send to MRB for input
NO
Yes
MRB provide Input
Not Approved
A
Notify initiator and
discard NCR
Decide on
disposition or send
someone else for
disposition
decision
Job Title Explained:
Initiator: Person initiates the NCR
Initial Approver: Person Initially checks the validity of the
NCR and approves/ disapproves it for further processing
Take disposition
action
Responsible person: Person responsible for the NCR
once the initial NCR gets approved.
Disposition Decision Maker: Person who makes the
Disposition decision by selecting which types of disposition
Disposition Action Doer: A person who carries out the
disposition decision.
Close NCR by
initial Approver or
Responsible
person based on
option selected
earlier
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Initiating a Nonconformance Report
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The Modules
Corrective & Preventive Actions (CAPA)
Create Corrective/ Preventive Action Report
(CPAR) Request
(Internal/Customer/Supplier)
CAPA Mgr. ensures proper conduct of a
CPAR by
 Assign and track assigned tasks,
 Monitor progress for each CPAR
 Assess effectiveness of actions taken
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Copyright  Quality Institute of America
CPAR Module WorkFlow
(ISO 9001:2000:8.5.2-3)
Author:
Initiates CPAR and describes reason for
Corrective/Preventive Action.
CPAR Manager
Approves or
Disapproves.
1.
Root Cause
Analysis
assigned.
Root Cause Analysis Submitted
Disapproved
2.
Implementation
Assigned.
CPAR
Manager
Implementation Performed
Aborted
Archived by QISS as a
Disapproved CPAR, notice sent to
Initiator of reason for disapproval.
(4.2.4)
Aborted
CPAR
Manager
Aborted
4.
Updated
Documentation
Assigned
(4.2.3)
=Emp Submission
5.
CPAR Closed
(4.2.4)
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Verification Submitted
CPAR
Manager
= Approved Step
=Disapproved/Aborted Step
3.
Verification of
Implementation
Assigned.
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CPAR Module Menu Options
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Viewing a Corrective/Preventive Action Report (Top)
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Viewing a Corrective/Preventive Action Report (Bottom)
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The Modules
Calibration System
Maintain Calibration equipment
list/information by identification number or
location
Notify authorized personnel regarding
upcoming calibration tasks
View Equipment Input calibration information
/ Review calibration history
Create Reports (cost, man-hours required,
past calibration due date info, etc.)
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The Modules
Maintenance Module
Maintain equipment list/Information
Notify upcoming maintenance tasks, remind,
escalate, etc.
Input Preventive maintenance or Breakdown
maintenance information
Review maintenance history (by date/equipment
etc.)
Create Reports (cost, man-hours required, etc.)
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Copyright  Quality Institute of America
Maintenance/Calibration Module
WorkFlow
(ISO 9001:2000:6.3, 7.5, 7.6)
Module Manager inputs equipment in
Administrative module.
(6.3, 7.5, 7.6)
Reminder appears
on Summary screen
of individual
responsible for
calibration/
maintenance.
(5.5, 6.3, 7.5, 7.6)
1. Assigns Maintenance/Calibration
intervals. (daily, weekly, quarterly, annually)
2. Assigns individual responsible for
maintenance/calibration.
(6.3, 7.5, 7.6)
If task is not completed by the next
day:
1. Email sent to remind the
individual responsible.
2. Email sent to Module Manager
to inform them of the lapse.
(5.5)
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Copyright  Quality Institute of America
Maintenance/Calibration
performed.
A. Details recorded in QISS
B. Any documents associated
with maintenance are uploaded
in QISS.
(4.2.4, 6.3, 7.5, 7.6)
The Modules
Training Module:
Planning of courses & other training
events
Planning of trainee groups
Periodic Individual Training Needs
Assessment (at performance appraisal)
Evaluation of Effectiveness of Training
after completion
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Copyright  Quality Institute of America
The Modules
Training Module:
New employee training
 Automatically triggered by QISS when an
employee is entered into the data-base.
Training procedures
 Automatically triggered by QISS when a new
procedure is approved and issued.
Ad-hoc training
 Training identified outside of formal (scheduled)
needs assessment.
Numerous helpful reports
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Copyright  Quality Institute of America
Training Module WorkFlow
Scheduled Training
(ISO 9001:2000:6.2.2)
Training Manager Schedules Training
Attendance request
sent to employees
scheduled to
attend.
(5.5.3)
Training takes place and
is confirmed complete in
QISS by the Training
Module Manager.
The supervisors of all
employees who
attended are notified
upon completion of
training.
(5.5.3)
Supervisor is requested to:
1. Evaluate effectiveness of employee training.
2. Upload any exams, certificates, etc. into training
record.
(4.2.4)
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Copyright  Quality Institute of America
Training Module WorkFlow
Employee Requested
(ISO 9001:2000:6.2.2)
Employee clicks “Request a Training” and fills out
form.
Employee Supervisor receives
notice of requested training on
Summary Page of QISS.
(5.5.3)
Training Module Manager
receives an email requesting
action for a requested training.
(5.5.3)
Disapproved:
Explanation
returned to
Employee.
(5.5.3)
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Copyright  Quality Institute of America
Approved:
1. Training scheduled.
2. Employee notified of
scheduled training via email.
3. Employee Supervisor
notified of scheduled training
via email.
(5.5.3)
Training Module WorkFlow
Self-Verification Training on Documented Procedures
(ISO 9001:2000:6.2.2)
1. Document is approved and employee is selected to be
notified.
2. Document Control Mgr. assigns self-verification training.
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Employee receives email notice to
acknowledge a specific document
(5.5.3)
Employee self-verifies in QISS
and a training record is created.
(4.2.4)
Employee feels that further training is
needed. A training request is sent to their
Supervisor.
(5.5.3)
Leads to
“Employee
Requested
Training”
Workflow.
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Scheduling a Training (Top)
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Scheduling a Training (Bottom)
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The Modules
Internal Audit Module:
Schedule full company audit
Schedule departmental audits
Assign auditors to different tasks
Assign and provide different checklists
Perform audits, prepare reports
Keep reports and records
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Setting up a Departmental Audit in Internal Audit Module
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The Modules
Management Review
Set up Management Team
Schedule Reviews
Prepare agendas, assign tasks
Conduct management review, create and
store records.
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Scheduling a Management Review Meeting
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Analyzing Data
More powerful QISS version 8 & above
now provides you capabilities of exporting
your data to Microsoft Excel software for
data analysis and trending.
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Exporting Data to Excel
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Copyright  Quality Institute of America
Example of Data Analysis
Paint peeling
Manufacturing
Engineering
Human Resource
Shop
Corporate
Administration
Purchasing
Management
Quality Assurance
Sales
Total
O.D.
5
Misaligned
Cust. Comp. Late
Misalignment seams
Finishes Late delivery delivery Injury
7
7
1
2
1
2
8
1
1
1
1
10
4
5
11
8
20
Percentile per Department
100%
90%
80%
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1
70%
2
1
2
1
1
1
1
Copyright  Quality Institute of America
3
3
1
9
3
1
1
4
1
Example of Data Analysis
Total
20
20
Finishes
Misaligned
seams
Misalignment
Paint peeling
3
4
Failure Classification
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Copyright  Quality Institute of America
1
Injury
5
5
0
Total
9
8
Late
delivery
10
11
Cust. Comp.
Late
delivery
15
O.D.
Number of Failure
25
Example of Data Analysis
Percentile per Departm ent
100%
90%
80%
2
1
2
1
1
1
1
70%
60%
P e r c e nt
7
3
8
50%
1
1
1
10
3
1
40%
Injur y
7
30%
Lat e deliver y
1
4
20%
10%
Cust . Comp. Lat e deliver y
Finishes
5
Misaligned seams
0%
Man Engi Hum
uf ac neer
t ur i
ing
p
Cor Adm Pur Man Qual
por a inist chas age
te
r at i
it y
ing men Assu
Misalignment
Sale
s
Lat e deliver y
2
Cust . Comp. Lat e deliver y
1
Finishes
2
Misaligned seams
1
Misalignment
7
1
1
8
1
1
1
1
3
O.D.
Paint peeling
1
Injur y
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an
Res
Sho
3
10
1
D e pa r t me nt
Copyright  Quality Institute of America
Example of Data Analysis
Month
NCR Issued NCR Closed Still Open
January
5
4
1
February
8
7
1
March
6
6
0
April
11
9
2
May
4
4
0
June
6
6
0
July
7
5
2
August
13
11
2
September
9
9
0
October
8
8
0
November
7
5
2
December
10
9
1
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Copyright  Quality Institute of America
Example of Data Analysis
NCR Status
14
13
12
2
2
0
0
NCR Closed
5
Still Open
Au
gu
Se
st
pt
em
be
r
O
ct
ob
er
N
ov
em
b
D
ec er
em
be
r
Copyright  Quality Institute of America
NCR Issued
7
0
Month
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10
9
2
2
Ju
ly
0
0
Ju
ne
1
Ja
nu
a
Fe ry
br
ua
ry
M
ar
ch
0
1
8
5
4
ay
2
5
4
7
6
6
M
4
9
9
Ap
ri l
Number
8
7
8
6
11
11
10
1
Example of Data Analysis
NCR Status
Disposition Action
Responsibility Assigned
Approved & Closed
MRB Review
Approved and Pending Vrfn
Aborted & Closed
Number f NCR
4
5
13
9
1
1
NCR Status
1
1
4
9
5
Disposition Action
Responsibility Assigned
Approved & Closed
MRB Review
Approved and Pending Vrfn
Aborted & Closed
13
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Copyright  Quality Institute of America
Example of Data Analysis
Department
Manufacturing
Shop
Purchasing
Engineering
Corporate
Management
Administrative
Human Resource
Quality Assurance
Sales
Number of NCR
25
2
10
8
1
3
1
1
9
1
Number of NCR
Sales
1
Quality Assurance
9
Human Resource
1
Administrative
1
3
Management
Corporate
Number of NCR
1
Engineering
8
Purchasing
10
Shop
2
Manufacturing
25
0
4/8/2020
5
10
15
20
25
Copyright  Quality Institute of America
30
WITH OR WITHOUT QISS
WITHOUT:





4/8/2020
WITH
LONG IMPLEMENTATION
TOO MUCH PAPERWORK
TOUGH TO MAINTAIN
DISCIPLINE & OVERSIGHT
COSTS TOO MUCH IN
LABOR TO START, AND
TO MAINTAIN
CUMBERSOMEBUSINESS BENEFITS
HARD TO GET





RAPID IMPLEMENTATION
NO PAPERWORK
QISS PROVIDES
OVERSIGHT ..SIMPLIFIES
DISCIPLINE
MINIMIZES LABOR,
FREES UP PEOPLE FOR
VALUE ADDED JOBS
EFFICIENT SYSTEM,
HELPS IN BUSINESS
BENEFITS.
Copyright  Quality Institute of America
System Requirements
For Server:
Processor: 600 MHz Pentium III Compatible (1GHz
or Faster Recommended
Operating System: Windows 2000 or Above
Memory: 512 MB RAM (1 GB or More
Recommended)
Disk Space: Minimum 400 MB for MS-SQL Server
Database or 100 MB for MS-Access Version
Database: MS-SQL Server 2000 or Higher or MSAccess 2000 or Higher. For MS-SQL Server Version,
the SQL Server Instance Need to Be Installed on the
Web Server or Any Other Machine Where Web
Server has Connectivity
4/8/2020
Copyright  Quality Institute of America
System Requirements
Windows Component: IIS 6.0 or Higher
Email: SMTP Account for QISS so that QISS
can Relay Messages from Web Server to Your
Email Server
For Client Workstations:
Browser: Internet Explorer 6 or Above,
Javascript Enabled, Popup Enabled for QISS,
and Session Handling Enabled
Display: Resolution of 1024 x 768 or Higher
4/8/2020
Copyright  Quality Institute of America
Thank you
8951 Ruthby St, Suite 12
Houston, Texas 77061
281-335-7979
www.qisssoftware.com
4/8/2020
Copyright  Quality Institute of America
Quality Institute of America, Inc
PROFESSIONAL SERVICES IN ISO 9000, AS 9100, TS
16940, ISO 14000 QUALITY, AND ENVIRONMENTAL
MANAGEMENT
•Training
•Consulting
•Auditing
•Software
Copyright  Quality Institute of America
Quality Institute
Software Solution
Central Quality Nervous System©
BRIEF PRESENTATION
Copyright  Quality Institute of America
QIA and QISS
MISSION
To provide clients with an engine to automate
their Quality Management System.
This tool will seamlessly integrate all required
functions, eliminate drudgery, assist in decision
making, and do so in an easy-to-use, intuitive
and cost-effective manner.
4/8/2020
Copyright  Quality Institute of America
Components of a Quality
Management System
Goal: to comply with the requirements
Requirements:

These are defined typically by ISO 9001
or one or more of its related standards: TS16949,
AS9100, API QI, ISO 14001, 17025, 13485, 22000,
…etc., AND organizational requirements
Processes:

4/8/2020
These are sets of interrelated steps (procedures)
designed to ensure that the requirements will be
complied with.
Copyright  Quality Institute of America
ISO 9001 Requirements and QISS
processes/ modules
QISS provides integrated processes to
ensure that ISO 9001 requirements are
met:

Clause 4: Quality Management System
Document Control and Records Control Modules

Clause 5: Management Responsibility
Management Review, Administrative and
Communication Modules.

Clause 6: Resources Management
Training and Maintenance Modules
4/8/2020
Copyright  Quality Institute of America
ISO 9001 Requirements and QISS
processes/ modules
ISO Standard Clauses and Modules, continued.
 Clause 7: Product Realization
Organization specific procedures stored in
in the controlled document library; and
Calibration Modules
 Clause 8: Measurement, Analysis and
Improvement
Nonconformance Control, Corrective &
Preventive Action, and Internal Audit Modules
4/8/2020
Copyright  Quality Institute of America
How Does QISS Work?
QISS is a workflow software:
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4/8/2020
Takes the work and flows it from person to person
until the job is complete.
In other words….provides the procedure that people
need to follow, and ensures that they follow it.
QISS has been written with ISO 9001 requirements in
mind…..So in all the sections of ISO 9001 that QISS
covers, using QISS gets you into compliance.
AND… QISS covers all the sections of ISO 9001
excepting those that are organization specific, and
usually covered by ERP.
Copyright  Quality Institute of America
The POWER of QISS
You don’t have to remember the
procedure…QISS will ensure that all
people involved in required tasks follow
the right steps, and on time!
QISS will assign people to tasks and then
monitor progress:
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4/8/2020
Send reminders via e-mail
Escalate to supervisor for intervention
Copyright  Quality Institute of America
The POWER of QISS
Important requirements are on a calendar,
and QISS ensures that people involved
are alerted at right time to take action.
Dashboards and To-Do lists help people
manage their time and priorities.
Top management can monitor entire
Quality System from their desk or PDA.
Charts, Reports, help make your system
effective and efficient.
4/8/2020
Copyright  Quality Institute of America
The POWER of QISS
QISS ELIMINATES THE DRUDGERY
AND THE TIME INVOLVED IN
ENSURING THAT THE RIGHT
PROCEDURES ARE USED, AND USED
CORRECTLY.
QISS RELEASES PEOPLE TO DO ONLY
WHAT PEOPLE CAN DO…MAKE
DECISIONS AND ADD VALUE
4/8/2020
Copyright  Quality Institute of America
QISS—if you don’t yet have a
formal System
Installing and using QISS gets you to
instantly meet ISO 9001 requirements for:

Document control, Record Control,
Nonconformance Control, Corrective &
Preventive Actions, Calibration, Equipment
Maintenance, Training, Internal Audits,
Management Review.
You can, (and we can help you), fill in the
rest with simple procedures to meet the
rest of the requirements.
4/8/2020
Copyright  Quality Institute of America
QISS—if you don’t yet have a
formal System
SIMPLE THREE STEP PROCESS:
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
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4/8/2020
INSTALL AND IMPLEMENT QISS…START
USING CORE QUALITY PROCESSES IN A
ISO COMPLIANT MANNER
FORMALIZE (USUALLY) COMPLIANT
PROCESSES FOR OTHER FUNCTIONS
GET AUDITED, GET CERTIFICATE
Copyright  Quality Institute of America
QISS—if you already have a formal
System
Install and implement QISS, and you can:

Stop keeping tabs on:
what needs to be done
what is late and who has to do what
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Start working on the important things… the
ones that make the organization money, and
take it further along its goals.
Know that you are in compliance…24/7…and
if you are not…you know precisely where, and
the moment that it happens.
Copyright  Quality Institute of America
Drastically reduce paperwork.
ISO related documents (and others, if you
like) are all uploaded into the QISS
system.
Each document from The Quality Manual,
Work Instructions, Records, to Nonconformances, Corrective Actions and
Internal Audits are all generated, changed,
archived and easily accessible paperlessly
through QISS.
4/8/2020
Copyright  Quality Institute of America
Automate the flow of tasks from function to
function and employee to employee.
Tracking and documenting each step of
the ISO required workflow is automated
through QISS.
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Simply initiate whichever action you choose.
(ie: Document Change or Training)
Designate the other employees involved.
QISS manages the communication via email
and timely reminders.
It even alerts you and the tardy assignee
when a task is overdue.
Copyright  Quality Institute of America
Remotely access your QMS
Any computer with access to your server
can access QISS to perform necessary
tasks.
If hosted by QIA, any internet connection
can access QISS with the proper security
permissions.
4/8/2020
Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
Simple process of integrating QISS with your
current QMS.

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Input Organization Chart into Administrative Module.
Initiate all documents into QISS for formal review,
approval, and training of affected people.
Input Equipment for Calibration and Maintenance.
Create Employee Competency Checklists in Training
Module.
Input your Non-Conformance Report design into
QISS.
You are ready to start using QISS!
4/8/2020
Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
Comprehensive training is provided.
QIA provides a fully functional Demo copy
of QISS for Training and Practice.
QISS is intuitive and logical in its workflow
management.
A helpful user manual is provided.
4/8/2020
Copyright  Quality Institute of America
Easily realize these benefits in a
short time.
QIA can host QISS securely on our own servers.

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Allows secure access from any internet connection.
Only designated employees can access the password
protected, and encrypted system.
Speed determined by your internet connection.
Extremely low maintenance, we take care of the
server maintenance and backing up of files.
Get your Software updates much more quickly and
easily.
Simply login, set up, and start using QISS!
4/8/2020
Copyright  Quality Institute of America
COMPLETE &
COMPREHENSIVE!!
QISS consists of the following modules:
Administrative—(Setup, Organization,
and Security) 5.5.1
Correspondence (Messaging) 5.5.3
Document Management 4.2.3
Records Control 4.2.4
Nonconformance Management 8.3
4/8/2020
Copyright  Quality Institute of America
COMPLETE &
COMPREHENSIVE!!
Corrective and Preventive Actions 8.5.2-3
Calibration 7.6
Maintenance 6.4
Training (Employee Competence
Management) 6.2.2
Internal Audits 8.2.2
Management Review 5.6
4/8/2020
Copyright  Quality Institute of America
CONTINUAL IMPROVEMENTOF THE
QUALITY MANAGEMENT SYSTEM
Customers
(and other
Interested
Parties)
Customers
(and other
Interested
Parties)
Orgn, Security,
In Aud, Mgm Rev
Training,
Equipment
Requirements
INPUT
NCR, CAPA
Doc Mgm, Proced
Cal, Maint
OUTPUT
Product
Value-adding
activities
Information flow
4/8/2020
Model of the process approach in
QISS
Copyright  Quality Institute of America
Satisfaction
Summary Page upon Login
4/8/2020
Copyright  Quality Institute of America
The Modules
Administrative (Setup)
This is a critical module where the decisions
are made that determine the scope and
direction of the Culture Change that is QISS.
Your company’s organization and its
personnel, documents, equipment,
customers, and suppliers are input here.
Also, new employees will be input through
setup, with their security assignments and
administrative duties.
4/8/2020
Copyright  Quality Institute of America
The Modules
Correspondence (Communication)
Primary purpose is to inform the
appropriate people of actions that have
been assigned to them, and to inform
them of others’ actions that require their
response.
4/8/2020
Copyright  Quality Institute of America
The Modules
Document Management
Create new documents
Initiate Document Change Requests
QISS assigns an intelligent number to a
document based on type, department,
standard element, and sequence
Manage the review and approval process
involving all relevant personnel.
4/8/2020
Copyright  Quality Institute of America
The Modules
Document Management (cont.):
Automatic messaging of people who need to
collaborate, including those who need to be
trained.
Automatic revision control, informing relevant
personnel regarding changes; then tracking,
and recording the revision cycle review and
approval process for any individual
document.
Easy revival of obsolete documents if
needed.
4/8/2020
Copyright  Quality Institute of America
The Modules
Calibration System
Maintain Calibration equipment
list/information by identification number or
location
Notify authorized personnel regarding
upcoming calibration tasks
View Equipment Input calibration information
/ Review calibration history
Create Reports (cost, man-hours required,
past calibration due date info, etc.)
4/8/2020
Copyright  Quality Institute of America
The Modules
Maintenance Module
Maintain equipment list/Information
Notify upcoming maintenance tasks, remind,
escalate, etc.
Input Preventive maintenance or Breakdown
maintenance information
Review maintenance history (by date/equipment
etc.)
Create Reports (cost, man-hours required, etc.)
4/8/2020
Copyright  Quality Institute of America
The Modules
Management of Nonconformance
Create Nonconformance Report (NCR) for
a process or a product


Automatically route NCR to Authorized
personnel.
They can View and Act on NCRs in process.
Record Disposition Decisions
Record actions, including cost
Generate/View Reports
4/8/2020
Copyright  Quality Institute of America
Control of Nonconforming Products
Process Flow
Authority to Bypass
NCR Manager
Initiate NCR
Yes
Authority to Assign
Himself?
No
No
NCR Manager
B
Yes
A
B
Approve and
Assign Himself as
the Responsible
person?*
No
Assign Someone else
as responsible person
MRB required?
Yes
Send to MRB for input
NO
Yes
MRB provide Input
Not Approved
A
Notify initiator and
discard NCR
Decide on
disposition or send
someone else for
disposition
decision
Job Title Explained:
Initiator: Person initiates the NCR
Initial Approver: Person Initially checks the validity of the
NCR and approves/ disapproves it for further processing
Take disposition
action
Responsible person: Person responsible for the NCR
once the initial NCR gets approved.
Disposition Decision Maker: Person who makes the
Disposition decision by selecting which types of disposition
Disposition Action Doer: A person who carries out the
disposition decision.
Close NCR by
initial Approver or
Responsible
person based on
option selected
earlier
4/8/2020
Copyright  Quality Institute of America
The Modules
Corrective & Preventive Actions (CAPA)
Create Corrective/ Preventive Action Report
(CPAR) Request
(Internal/Customer/Supplier)
CAPA Mgr. ensures proper conduct of a
CPAR by
 Assign and track assigned tasks,
 Monitor progress for each CPAR
 Assess effectiveness of actions taken
4/8/2020
Copyright  Quality Institute of America
The Modules
Training Module:
Planning of courses & other training
events—tied to nature of job and
individual.
Planning of trainee groups
Periodic Individual Training Needs
Assessment (at performance appraisal)
Evaluation of Effectiveness of Training
after completion
4/8/2020
Copyright  Quality Institute of America
The Modules
Internal Audit Module:




Comprehensive planning, execution of audits.
Checklists
Auditor qualification
Nonconformances and Corrective Actions
Management Review Module:

4/8/2020
Comprehensive planning and execution of
periodic management reviews, with reports.
Copyright  Quality Institute of America
Exporting Data to Excel
4/8/2020
Copyright  Quality Institute of America
Example of Data Analysis
NCR Status
14
13
12
2
2
0
0
NCR Closed
5
Still Open
Au
gu
Se
st
pt
em
be
r
O
ct
ob
er
N
ov
em
b
D
ec er
em
be
r
Copyright  Quality Institute of America
NCR Issued
7
0
Month
4/8/2020
10
9
2
2
Ju
ly
0
0
Ju
ne
1
Ja
nu
a
Fe ry
br
ua
ry
M
ar
ch
0
1
8
5
4
ay
2
5
4
7
6
6
M
4
9
9
Ap
ri l
Number
8
7
8
6
11
11
10
1
Example of Data Analysis
NCR Status
Disposition Action
Responsibility Assigned
Approved & Closed
MRB Review
Approved and Pending Vrfn
Aborted & Closed
Number f NCR
4
5
13
9
1
1
NCR Status
1
1
4
9
5
Disposition Action
Responsibility Assigned
Approved & Closed
MRB Review
Approved and Pending Vrfn
Aborted & Closed
13
4/8/2020
Copyright  Quality Institute of America
WITH OR WITHOUT QISS
WITHOUT:





4/8/2020
WITH
LONG IMPLEMENTATION
TOO MUCH PAPERWORK
TOUGH TO MAINTAIN
DISCIPLINE & OVERSIGHT
COSTS TOO MUCH IN
LABOR TO START, AND
TO MAINTAIN
CUMBERSOMEBUSINESS BENEFITS
HARD TO GET





RAPID IMPLEMENTATION
NO PAPERWORK
QISS PROVIDES
OVERSIGHT ..SIMPLIFIES
DISCIPLINE
MINIMIZES LABOR,
FREES UP PEOPLE FOR
VALUE ADDED JOBS
EFFICIENT SYSTEM,
HELPS IN BUSINESS
BENEFITS.
Copyright  Quality Institute of America
Thank you
8951 Ruthby St, Suite 12
Houston, Texas 77061
281-335-7979
www.qisssoftware.com
4/8/2020
Copyright  Quality Institute of America