WITH WHAT?

WITH
(Training, WHO? Skills,
Knowledge,
(Equipment, Installation) Competence)
5.4 Quality Objectives 5.1 Management Commitment
6.3 Infrastructure 5.5 Responsibility, Authority, Communication
7.1 Planning of Product Realization 6.1 Provsion of Resources
7.2 Customer Related Processes 6.2 Human Resources - training
7.3 Design & development 7.3 Design/Development
7.4 Purchasing 7.3.1.1 Multidisciplinary
7.5 Production & Service

REQUIREMENTS
REQUIREMENTS

PROCESS
INPUT Where & How is it defined? OUTPUT
Who defined it?
Is there any objective evidence?
What are the inputs? If it needs to be documented, What are the outputs?
Where do they come where & how is it documented. Where do they go?
from? How many are there?
How many are there? Who is the customer?
Who is the supplier? What other processes
What other processes are linked?
are linked?

HOW MANY? HOW?

HOW MUCH? (Instructions, Procedures,
(Key Measurables) Methods)
5.2 Customer Focus 4.1 General Management Reqts 4.2.2 Quality Manual
5.6 Management Review 4.2 Documentation Reqts 6.3 Infrastructure
7.6 Control & Monitoring of Measurement 5.3 Quality Policy 7.1 Planning of Product Realization
Devices 7.3 Design & Development
8.1.1 Identification of Statistical Tools 7.5 Production & Service Provision
8.2 Monitoring & Measurement 7.6 Control & Monitoring of Measuring
8.3 Control of Non-confroming Product Devices
8.4 Analysis of Data 8.2 Monitoring & Measuring
8.5 Improvemnt

Devices
8.1.1 Identification of Statistical Tools
8.2 Monitoring & Measurement
8.3 Control of Non-confroming Product
8.4 Analysis of Data
8.5 Improvemnt
7.1 Planning of Product Realization
7.3 Design & Development
7.5 Production & Service Provision
7.6 Control & Monitoring of Measuring
Devices
8.2 Monitoring & Measuring