This document provides details on implementing a Quality Management System (QMS) including percentages completed for various requirements. It lists areas like management responsibility, training, audits, and documentation control. For each area, it specifies requirements from the ISO standard and provides a percentage for how much of the implementation is complete in that area. An overall percentage is also calculated to indicate the total progress of the QMS implementation.

1. QMS
Implementation
DENNIS J MORGAN
QMS Implementation is a set of rules that are followed that requires being checked and assessed
during implementation to achieve compliance.

2. * T rain all personnel
* Introduction to QMS 5%
* Management Responsibility 89%
* Competency and Awareness 44%
* 25%
* Control of Documents-Records 2%
* Control of Non-Conforming Product 14%
* Customer Data and Property Controls 10%
* Purchasing and Verification of Product 5%
* Corrective and Preventative Action 45%
* Control of Monitoring and Measuring Equipment 32%
* Customer Audits 45%
* Quality Audits 50%
* Accredited Requirements 31%
* Posted in facility
* Policy Statement 22%
* Core Values 23%
* Goals & Objectives 45%
ISO Standard - 5.3 Quality Policy / 5.4.1 Quality Objectives
Enter working data
here
5.3 Policy Statement (Reliability, Quality and Product
Product-Service Provision-Identification-T raceability-
Each ISO element has it’s set of checks to review to ensure compliance within those areas. Gap
Analysis are the first point to give the implementer a foothold where to begin by simply reviewing
everything the way things are prior to implementation.
Bullet points to check based on association with standard.
(A)
Type here how
much time in
percentage has
been completed
each time
particular areas
are worked on.

3. % Complete
30%
30.44% 30.27%
30.54%
5.00%
89.00%
44.00%
25.00%
2.00%
14.00%
10.00%
5.00%
45.00%
32.00%
45.00%
50.00%
31.00%
30.00%
22.00%
23.00%
45.00%
(DoNot enter anything in these columns, just in the "Enter Data Column only, as calculations for these
columns have been calculated as part of the equation)
%
Implemented
%
A cco mplished
Based on A on
previous slide,
once data is
entered the
system calculates
for you, all
remaining data
columns.
These 2 columns indicate %
accomplished and % implemented
This box will total all data
entered and give the
correct percentage where
you are in implementation
stage/
(B)

4. This diagram gives analyzer the percentage
of the total amount of implementation has
been accomplished.
This graph shows the percentage of each bullet
point at what stage specific implementation has
been accomplished.

5. ISO Standard - 4.2.3 Control of documents
4.2.3 Document Control
* Approved prior to issue
* 5%
* 40%
* Effective date displayed 25%
* Revision identifier displayed 40%
* Document Change Request (DCR) process
* All team member's can request 32%
* All Team Members can request 50%
* Personnel notified / trained 100%
* 40%
Managers and Supervisors on release
* Location 30%
* Changes and current revision status identified
* Review / update and reaapprove 40%
* Same function as original issue 50%
* Personnel notified / trained 50%
50%
* Available at points of use
* 45%
* Legible 20%
* Readily identifiable (unique numbering) 15%
* Easy retrieval 30%
* Master list of External Documents
* Origin identified / distribution controlled 45%
* Obsolete documents
* 45%
* Identification number not reused 30%
* 20%
* Obsolete - for reference only 20%
* Electronic systems used
* Security 55%
* System currently used 40%
* Business specific being used 33%
* Any New System 22%
* Uncontrolled when printed is displayed 10%
15%
* Revisions
* Bold and italic font 40%
* Applicable to Manual and document contents 30%
Enter working data
here
Email notice (of document(s) release) distributed to
If retained by team member clearly marked -
* Changes - any team member can do so using Document
Top Management or Respresentative generally
Reviewers and approvers are used appropriate to
* Master List of Records (4.2.3.1 Control of documents - ISO
* Email notice distributed to managers and
Team Members responsible to ensure
Remain in system - identified / prevented from
Each element has it’s
own set of bullet points to
score percentages of
accomplishments during
implementation.

6. % Accomplish % Implement % Complete
36.46% 30% 30%
45%
32.00%
40.00%
25.00%
40.00%
32.00%
32.00%
50.00%
100.00%
40.00%
30.00%
30.00%
46.67%
40.00%
50.00%
50.00%
100.00%
45.00%
45.00%
20.00% 20.00%
15.00% 15.00%
30.00% 30.00%
45.00%
45.00%
28.75%
45.00%
30.00%
20.00%
20.00%
37.50%
55.00%
40.00%
33.00%
22.00%
10.00% 10.00%
15.00% 15.00%
35.00%
40.00%
30.00%

8. ISO Standard - 4.2.4 Control of records
4.2.4 Record Control
* Explicitly required by specifications / procedures -
essential evidence of conformity
* To customers 235%
* To regulatory authorities 55%
* To certification bodies 55%
* Other needed records - essential evidence of conformity
* To customers 5%
* To regulatory authorities 14%
* To certification bodies 20%
* All records
* Maintained and controlled (forms) 30%
* Stored on drives or other storage devices 50%
* Management Representative ensures:
* Designated locations of records identified
* Systems / facilities used 44%
* Suitable protection 15%
* Procedures or indexes of locations
* 30%
Available document types
* Readily retrievable 22%
* Aware of importance of proper handling 55%
* Timely collection 60%
* Indexed correctly 30%
* Maintenance 45%
* Storage
30%
* Hard copy (Meets 4.2.4 requirements) 20%
* Changes
* Strikethrough single line 55%
* Initial or sign 30%
* Date of change 20%
* No “white out” 55%
* Retained
* Retention policy identified 22%
* Verified
* Legible 60%
* Complete 40%
* Properly identified 30%
20%* Well file creation in system (depending on size)
* Electronically on server - considered
Records Search -
* Functions responsible for generating identified
Enter working data
here

9. % A c c o m plis h % % Complete
54.85% 36.24% 41%
115.00%
235.00%
55.00%
55.00%
13.00%
5.00%
14.00%
20.00%
36.56%
30.00%
50.00%
29.67%
29.67%
44.00%
15.00%
30.00%
22.00%
43.00%
55.00%
60.00%
30.00%
45.00%
25.00%
40.00%
55.00%
30.00%
20.00%
55.00%
22.00%
22.00%
43.33%
60.00%
40.00%
30.00%
20.00%