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THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS
A group of interacting, interrelated, or interdependent elements forming a complex whole Set of detailed methods ,procedures and routines established or formulated to carry out a specific activity , perform a duty , or solve a problem
International Organization for Standardization Founded in 1946 in Geneva , Switzerland ISO is a non-governmental organization that forms a bridge between the public and private sectors.
World's largest developer and publisher of International Standards.
"ISO", derived from the Greek. ISO, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO. "ISO", is a system audit not for product audit
ISO 9001:2008 - Quality Management Systems Requirements ISO 9000:2000 - Quality Management Systems fundamentals and vocabulary ISO 9004:2000 - Quality Management System guidelines for performance improvements ISO 19011:2000- Guide for Auditing Management System
Principle 1
Leaders must create and maintain internal environment that encourages people to achieve the organizations objectives
Principle 2
Principle 3
Control
Input
Activities + Resources
Output
A desired result is more efficiently achieved when resources and activities are managed as a process
Principle 4
Process A
Process C
Process D
Process
Any activity that takes inputs and converts them to outputs
Process Approach
The systematic identification and management of these activities and the interaction between activities.
Purchasing Procedure
Interactions to
Storage Inspection and Testing Manufacturing Finance
Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time
Identifying , understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency
Principle 5
Customer Focus
PLAN
Demings wheel (P.D.C.A.)
DO
ACT
ISO 9000
CHECK
Continual Improvement
Principle 6
Continual improvement of the organization's overall performance should be a permanent objective of the organization.
Principle 7
An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
Principle 8
Satisfaction
CUSTOMERS
CUSTOMERS
Input Data
Output Data
Product Service
The Structure
0 1 2 3 4 5 6 7 8 Introduction Scope Normative reference Terms and definitions Quality management system requirements Management responsibility Resource management Product realization Measurement, analysis and improvement
5 Management Responsibility
6 Resource Management
7 Product Realization
Management Commitment(5.1)
Provision of resources(6.1)
Planning(7.1)
General (8.1)
Customer related processes(7.2)
Human resources(6.2)
Planning(5.4)
Control of NCP(8.3)
Purchasing(7.4)
Analysis of data(8.4)
Production & service provision(7.5)
Improvements(8.5)
5.1 Management Commitment 5.2 Customer Focus 5.3 Quality policy 5.4 Planning 5.4.1Quality objectives 5.4.2 Quality Planning
5.5 Responsibility, authority and communication 5.5.1 Responsibility & authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management Review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
5.5
5.5.1 Responsibility and authority Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management
Note: Responsibilities may include liaison with external parties in relation to QMS
5.5.3 Internal Communication Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness
6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environment
6.1 Provision of Resources The organization shall determine and determine the resources needed for : implement and maintain the QMS and continually improve its effectiveness. Enhance customer satisfaction by meeting customer requirements.
Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience
6.3 Infrastructure
Identify, provide and maintain the infrastructure needed to achieve product conformity This shall include : Workspace & associated utilities Equipment, hardware and software Supporting services (transport or communication)
7 Product Realization
7.1 7.2 7.3 7.4 7.5 7.6 Planning of product realization Customer related processes Design & development Purchasing Production & service operation Control of measuring & monitoring devices
7.1
Sequence of process to achieve product Consistent with QMS and documented to suit method of operations Quality objectives and requirements for the product The need for processes, documentation, resources and facilities specific to the product Verification and validation activities and acceptance criteria Records
7.2
7.2.1
Determination of requirements related to the product 7.2.2 Review of product requirements 7.2.3 Customer communication
Review identified requirements and ensure before commitment to supply product that; Product requirements are defined For verbal orders requirements are confirmed Difference between tender and contract are resolved Organization has ability to meet the requirements Records of the results arising from the review shall be recorded.
7.4 Purchasing
7.4.1 7.4.2 7.4.3 Purchasing process Purchasing information Verification of purchased product
Availability of information specifying product characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring devices Implementation of monitoring
8.1 General 8.2 Monitoring & Measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product
8.1 General
Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement
This include determination of the need and use of applicable methodologies and statistical techniques
8.2
The methodologies for obtaining and utilizing such information must be determined
Define audit scope, frequency and methodologies performed by personnel not performing audited work
Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customers requirements.
Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product Release or delivery must not
Documented procedures for control of non conforming product to prevent unintended use or delivery Non conforming product shall be corrected Re-verify after correction If non-conformance
Management Review
EXPECTED BENEFITS
Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability Planning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced
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