Quality Management Systems (QMS) Flashcards
What is ISO9000?
- It is a series of standards, developed by the International Organisation for Standardisation, that define, establish, and maintain an effective quality assurance system for manufacturing and service industries.
- It’s Quality Management
-Aims to
>improve quality awareness
>reduce requirement for supplier audit
>facilitate international trade
-real reasons to implement
>existing + potential customers insist
>”badge” is good for business
>good way of enforcing discipline on the workforce
What would ISO9000 help to?
- Understand existing system
- replace “fire-fighting” with “fire-prevention”
- provide regular health check
- identify opportunities for improvements
- lay foundations for TQM, world class manufacturing, etc
Concerns with ISO9000
- result is often a costly, inflexible, paperwork nightmare yielding no quality improvements
- in the UK, whilst only 70% are satisfied with experiences of ISO900, only 25% report significant gains in quality
- poorly designed system will be a millstone you may find impossible to get rid of
- if suppliers have badly designed systems you will end up paying
ISO9000 8 Principles essential to achieve a quality focus
-Customer focus
Understanding their current and future needs. Meeting their requirements and striving to exceed their expectations
-Leadership
For unity of purpose and direction, and creating the organisations internal environment
- Involvement of people
- Developing their abilities and fully utilising them
-Process design
Managing resources as a process and improving the efficiency of those processes
-Systems approach to management
Identifying, understanding, and managing the interelated processes of a system to achieve objectives
-Continual improvement
Becomes a permanent objective
-Factual approach to decision making
Logical analysis of data and information
-Mutually beneficial supplier relationships
For the creation of value
Documentation Requirements
-Quality policy manual
>This is a policy document, a statement of intent about what you intend to do
-Quality procedures manual
>More detailed series of documents detailing how you will carry out the “whats” of the quality policy manual
-Quality records
>These are proofs that the “hows” have been carried out
-Work instructions
>These are the small details that explain how specific tasks which might impact on quality or the customer are carried out. Each procedure may have several work instructions for different products of services.
Integration of systems
- An Integrated Management System (IMS) integrates all of an organisation’s systems and processes in to one complete framework, enabling an organisation to work as a single unit with unified objectives.
- Organisations often focus on management systems individually, often in silos and sometimes even in conflict. A quality team is concerned with the QMS, often an EHS manager handles both Environmental and Health and Safety issues, etc.