QMS Implementation Presentation

QMS ImplementationDENNIS J MORGAN

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

* Train 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 here5.3 Policy Statement (Reliability, Quality and Product

Product-Service Provision-Identification-Traceability-

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.

% Complete30%

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

% Accomplished

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)

This diagram gives analyzer the percentageof 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.

ISO Standard - 4.2.3 Control of documents4.2.3 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 duringimplementation.

% Accomplish % Implement % Complete36.46% 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%

ISO Standard - 4.2.4 Control of records4.2.4 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

% Accomplish % % Complete54.85% 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%