Principles, concepts behind ISO standards (Week 2)

Question 1

Quality management principles?

Answer 1

Iso 9001 built on the 7 quality management principles
Set of rules to be used as the basis for good quality management

1) Customer focus - meet customer requirements and exceed expectations
2) Leadership - They establish unity of purpose and direction
3) Engagement of people - need to engage people of organisation to acheive goals, need competence, skills
4) Process approach - allows for consistent, predictable results
5) Improvement - ongoing focus - better service for customers
6) Evident based decision making - based on data and info
7) Relationship management - good relationship with customers, suppliers

Question 2

QMP - Customers?

Answer 2

External Customer - They buy the products, services
University example - Students

Internal Customers - Within the same organisation
University example - staff

Question 3

QMP - Customer requirements?

Answer 3

Understanding and documenting customer requirements important for QA

Customer requirements different for external and internal

Question 4

ISO Core concepts?

Answer 4

3 Concepts

1) Process approach
2) Plan do check act cycle
3) Risk based thinking

Question 5

ISO core concepts 1 - process approach

Answer 5

How we manage different processes and interaction of processes to enable organisation to achieve intended results
Fits into QMS

Example - input - Empty milk bottle, Action - fill bottle, Output - filled bottle
This requires processes - buy lids,bottles, sterilise, fill, seal, label

Question 6

ISO core concept 2 - Plan do check act cycle

Answer 6

Applies to individual process and system as a whole
How processes fit together, and if successfull in achieving organisations goal
Applies to QMS

Example - Need to plan - fill bottle milk, do - fill the bottle, check - process carried out correctly - milk filled and sealed, Act - Act on any issues - bottle may not be sealed

Question 7

ISO core concepts 3 - Risk based thinking

Answer 7

Identify risks, reduce them
Used to prevent undesirable outcomes
Understand risks 
How can you avoid?
Implement plan - take action 
Check effectiveness - did action work?
Learn from experience - improve