Professional Documents
Culture Documents
THE 5 THINGS
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AN
January 2016
ISO9001:2015 STANDARD
QUALITY MANAGEMENT
Disclaimer:
In Order To Comply To
ISO9001:2015
FILL-IN-THE-BLANKS
In Terms Of The Rest Of The
Standard’s Requirements
The 5 THINGS
Define Your Processes
Since The Major Changes That
Were Introduced In 2008
The
PROCESS-BASED-APPROACH
★ Management Processes
★ Operational Processes
★ Support Processes
THING #2
PROCESS MEASURES
A Relevant Saying
Let’s Illustrate
As Follows
PROCESS MEASURES
★ Marketing 15% Of Turnover
★ Sales 100 Million $
★ Manufacturing <5 NCRs Per Week
★ Warehousing98% Stock Level
★ Purchasing 98% On Time
★ HR 1% Absenteeism
★ Finance 10 M $ Net Profit
PROCESS MEASURES
Your Company
Should Have
Similar Measures
In Place
PROCESS MEASURES
Each Process
Should Have Clear Measure
Requirements
Each Process
May Have Numerous
Measures
PROCESS MEASURES
Now Let’s Move On
To The
Next section
THING #3
PROCESS MEASURES
Determine
SEQUENCE & INTERACTION
SEQUENCE & INTERACTION
Requirements
There Were No
Traffic Lights Or Lanes
In Our Road System
Everybody
Drives In Whatever Way
They Want
Some Drive
On The Left Hand Side
And Some Drive
On The Right Hand Side?
Ensures That
Is Beyond
The Scope Of This
Tutorial : )
THING #4
DOCUMENT TREE
Designing An Effective
Quality Management System
Is NOT About
DOCUMENT TREE
So Breath A Sigh Of Relief
For
This Section!
DOCUMENT TREE
Nevertheless
We Need To Consider
Documents
As Per The Following
Scenarios
DOCUMENT TREE
★ Legal Requirements
★ Contractual Requirements
★ Operational SOP’s
★ Design Specifications
DOCUMENT TREE
★ Drawings
★ Financial Procedures
★ Training Records
DOCUMENT TREE
Your Organization’s
Document Requirements
Includes Your
INTELLECTUAL CAPITAL
And Should Not Be
Under-Estimated
DOCUMENT TREE
Document Requirements
Include ALL Requirements
For The Preservation Of Your
INTELLECTUAL CAPITAL
And
ANY-RISKS-ASSOCIATED
With This Requirement
DOCUMENT TREE
To Go Further Would Beyond
The Scope Of This Tutorial
But Again
DOCUMENT TREE
WORLD-CLASS ORGANIZATIONS
Use IT SYSTEMS
for …
DOCUMENT TREE
For
Complete And Robust Addressing
Of This Often
Under-Estimated And
Mis-Understood Requirement
DOCUMENT TREE
Let Us Just Close Off This Section
By Saying That
DOCUMENT TREE
The Expected Controls Would
Include Back-ups, Disaster
Recovery
And So On
DOCUMENT TREE
Now Let’s Move On
To The
Next section
THING #5
DOCUMENT TREE
Finalize The BOUNDARIES
of Your SYSTEM
Just When
Some Quality Practitioners
Were Starting To Get Bored
SYSTEM BOUNDARIES
The Newly Ratified Standard
ISO9001:2015
Has Come Along
AND
SYSTEM BOUNDARIES
There Are A Few
NEW REQUIREMENTS
SYSTEM BOUNDARIES
Let Us Mention
Just A Few That Pertain To
THING NO #5
SYSTEM BOUNDARIES
1) Context of Your Organization
2) Interested Parties
3) Scope of Your QMS
SYSTEM BOUNDARIES
It Is Not The Objective Of This
Tutorial
To Do A
Full Technical Analysis
BUT
SYSTEM BOUNDARIES
Keeping The Above Elements
In Mind
SYSTEM BOUNDARIES
It Is Important That We
Define
The Boundaries
Of Our Organization
SYSTEM BOUNDARIES
Moving Away From The
Purely
Technical Requirements
Of The ISO9001:2015
Standard
SYSTEM BOUNDARIES
★Knowing Who We Are
★ Knowing Our Customer Base
★ Understanding Our Market
SYSTEM BOUNDARIES
★ Understanding Impacts of
Organizations Outside Our
Own
SYSTEM BOUNDARIES
Or That
SYSTEM BOUNDARIES
Finalizing The Boundaries of
Our
QUALITY MANAGEMENT
SYSTEM
Includes:
SYSTEM BOUNDARIES
Interlinking Our Processes
With Outside Parties
SYSTEM BOUNDARIES
Examples Include
SUPPLY CHAIN MANAGEMENT
Organizations That INTERFACE
DIRECTLY With Customs Databases
SYSTEM BOUNDARIES
DEFINING THE BOUNDARIES
Of Our Quality Management
System
SYSTEM BOUNDARIES
DEFINING OUR SYSTEM
BOUNDARIES
SYSTEM BOUNDARIES
★ Who We Are
★ Our Values And Mission
★ Our Brand Identity
★ Who Benefits From Our Existence
★ Our Sustainability
SYSTEM BOUNDARIES
Defining Our Boundaries
Also Ensures That:
SYSTEM BOUNDARIES
Every Part/Every Activity/
Every Improvement We Make
Dove Tails
Perfectly Into Our
QUALITY MANAGEMENT
SYSTEM
SYSTEM BOUNDARIES
That’s About The End
Except For
THING #6
SYSTEM BOUNDARIES
Thing Six?
Yes!
Thing Six
Is The BONUS THING
You Must Do
SYSTEM BOUNDARIES
Join
JoinThe
TheDots!
Dots
I Know There Might Be A Few
Quality Practitioners Out
There Saying
QUALITY MANAGEMENT
SYSTEM
OUTPUT
CONTACT US
As Per The Following:
CONTACT US
Our LinkedIn:
HOW TO COMPILE AN
HOW TO INTERNAL AUDIT A WORLD-CLASS
CONDUCT AN PROGRAM YOUR CORRECTIVE
INTERNAL STAKEHOLDERS WILL
ACTION SYSTEM
AUDIT LOVE
WITHIN YOUR
ORGANIZATION
Contact Us: For-your-ISO-requirements:
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