ISO 9001 Quality Management System Awareness

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ISO 9001 Quality Management System Awareness


Presentation Transcript

ISO 9000:

ISO 9000 Quality Management System


Contents Customer satisfaction Purpose and benefits of a quality management system Process approach used in quality management. Plan , Do, Check, Act (PDCA) cycle Eight Quality Principles Structure and content of ISO 9001 Quality policy and objectives Conformity of product Resource management Product realisation processes Measurement, analysis and improvement of quality performance Internal audit Continual improvement of quality



Customer satisfaction:

Customer satisfaction Customers prefer goods that do not break, and really like goods that do what they want them to do . It simply means that the product or service meets the customer’s needs .



The Quality Gurus:

The Quality Gurus Kaoru Ishikawa Edwards Deming Joseph Juran

Evolution of Quality:

Evolution of Quality 1800s Industrial Revolution – focus on product inspection 1900s Use of quality processes in manufacturing 1920s – 1940s Use of SPC in World War I and II 1947 Japan devastated by World War II 1950-1970 Japan builds Quality 1960s – 1970s Japan’s imports into the USA and Europe increased significantly 24 June 1980 NBC TV program "If Japan Can, Why Can't We? 1980s onwards America takes interest in Quality

Milestones of Quality:

Milestones of Quality 1924 Walter A. Shewhart [Bell Labs] Statistical Process Control 1943 Kaoru Ishikawa developed the cause and effect diagram 1946 The International Organization for Standardization (ISO) founded 1947 Dr Edwards Deming was sent to Japan 1954 Joseph Juran was invited to Japan 1979 BS 5750 was issued 1986 Six Sigma formulated by Bill Smith in Motorola 15 March 1987 ISO issued the first version of the ISO 9000 series 2008 ISO issued the fourth version of the ISO 9000 series

What is Quality:

What is Quality Reliability Faultless Performance Serviceability Durability Courtesy Communication Responsiveness Empathy Quality is 90% attitude and 10% knowledge (Barry, T ) Quality is fitness for use (Joseph Juran & Frank Gryna ) Quality means fitness for purpose . Quality does not necessarily mean ‘excellence’ or ‘best product ’ Dimensions of Quality Definitions

QMS Benefits:

QMS Benefits The company is losing business because customers are not satisfied A key staff has left the company and no one knows how to proceed with a project left midway Someone in the production line made a mistake and everyone has to redo their work Consistent , repeatable processes and a common system Fewer failures in service/ product quality People know exactly what to do Many problems disappear because you know how to prevent them Better management control and reporting Problems Solutions

Why Quality:

Why Quality If you make or do something right the first time, chances are it will not go wrong later 85% of the reasons for failure are related to deficiencies in systems and processes (Deming, E )

Quality Management Principles:

Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach to Management Factual Approach to Decision Making Continual Improvement Mutually Beneficial Supplier Relationships

Deming’s Quality Principles:

Deming’s Quality Principles Next presentation…



PowerPoint Presentation:

What is a system

Integrated Management System:

Integrated Management System

The Process Approach:

The Process Approach CONTROLS & RESOURCES Any activity that accepts inputs, adds value to these inputs for customers, and produces outputs for these customers (BS 7850) Customers may be internal or external to the organization

How is a process measured:

How is a process measured

More on processes:

More on processes Process Owner - The person responsible for performing and/or controlling the activity

Identifying a process:

Identifying a process All activities represent processes, but these could have harmful or beneficial effects. Not all processes add value to the product – eg . Cross-checking someone else’s work or rectifying an error. Non-value adding processes should be avoided or eliminated where ever possible .

ISO 9001 QMS:

Structure and content ISO 9001 QMS

The ISO 9000 family:

The ISO 9000 family ISO 9001:2008 sets out the requirements of a quality management system ISO 9000:2005 covers the basic concepts and language ISO 9004:2009 focuses on how to make a quality management system more efficient and effective ISO 19011:2011 sets out guidance on internal and external audits of quality management systems

PowerPoint Presentation:

Establish the objectives and processes necessary to deliver results Implement the processes Monitor and measure processes against objectives, targets Take actions to continually improve performance management system

Management System Hierarchy:

Management System Hierarchy Document key processes, work procedures and supporting documentation including records

Document, document, document:

Document, document, document

Structure of ISO 9001:2008:


Clause 4: Documentation Requirements:

Clause 4: Documentation Requirements Control of Documents Control of Records Quality Management System Manual External Documents Register Document Control Register Document Creation, Revision And Deletion Form Work Procedures Register PROCEDURES RECORDS

4.2.3 Control of documents:

4.2.3 Control of documents Documents are approved prior to issue Changes & current revision status of documents are identified Relevant versions of documents are available at points of use Documents remain legible and readily identifiable If it is not documented, you are not doing it !

4.2.4 Control of Records:

4.2.4 Control of Records Records should be legible, readily identifiable and retrievable Procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records

Clause 5: Management Responsibility:

Clause 5: Management Responsibility Management Review Customer Complaint & Feedback Organization Chart Individual Responsibilities and Authorities Customer Complaints Quality Policy & Objectives Management Review PROCEDURES RECORDS

It’s not my job:

It’s not my job This is a story about four people named Everybody , Somebody , Anybody , and Nobody . There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody's job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn't do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done!

Quality is everyone’s responsibility:

Quality is everyone’s responsibility 5.1 Management Commitment Establish Quality Policy and Objectives Communicate the importance of meeting customer as well as regulatory requirements Conduct management reviews Ensure the availability of resources

5.6 Management Review:

5.6 Management Review Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement Improvement of the effectiveness of the QMS Improvement of product Resource needs INPUT OUTPUT

Clause 6: Resource Management:

Clause 6: Resource Management Competence, Training and Awareness New Employee Induction Training Enrolment Training Attendee List Training Evaluation PROCEDURES RECORDS

6.2 Human Resources:

6.2 Human Resources Personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience Provide training or take other actions to satisfy these needs

6.3 Infrastructure:

6.3 Infrastructure Determine , provide and maintain building , workspace , equipment and supporting services needed to achieve conformity to product requirements

Clause 7: Product realization:

Clause 7: Product realization Vendor Selection and Assessment Procurement Sales and Contract Review Plant and Equipment Vendor Assessment Approved Vendors Contract Review Authorisation Key Equipment/ Assets Test Equipment/ Calibration PROCEDURES RECORDS

Product realization:

Product realization

PowerPoint Presentation:

7.3 Design and development

7.4 Purchasing:

7.4 Purchasing

7.5.1 Control of production:

7.5.1 Control of production Plan and carry out production under controlled conditions Information work instruction suitable equipment monitoring and measuring equipment validation of processes for production

7.5.2 Validation of processes:

7.5.2 Validation of processes Validate where the resulting output cannot be verified by monitoring or measurement

7.5.3 Identification and traceability:

7.5.3 Identification and traceability Identify the product throughout production Control the unique identification of the product and maintain record

7.5.4 Customer property:

7.5.4 Customer property Identify , verify, protect and safeguard customer property If any customer property is lost, damaged or otherwise found to be unsuitable for use, report this to the customer and maintain records Customer property can include intellectual property and personal data .

7.5.5 Preservation of product:

7.5.5 Preservation of product

PowerPoint Presentation:

7.6 Control of monitoring and measuring equipment

Clause 8: Measurement, Analysis & Improvement:

Clause 8 : Measurement, Analysis & Improvement Internal Audit Control of Non- Conformance Corrective and Preventive Action Customer Satisfaction Survey Audit Schedule Audit Attendee List Non Conformance Report Internal Audit Report Opportunity for Improvement PROCEDURES RECORDS

8.2.1 Customer Satisfaction:

8.2.1 Customer Satisfaction Monitor information relating to customer perception as to whether the organisation has met customer requirements

8.2.2 Internal Audits:

8.2.2 Internal Audits Conduct internal audits at planned intervals Actions are taken without undue delay to eliminate detected non-conformities and their causes Audit criteria, scope, frequency and methods are determined Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit

8.3 Control of Non Conforming Products:

8.3 Control of Non Conforming Products Ensure that products which do not conform to product requirements are identified and controlled to prevent unintended use or delivery

8.4 Continual Improvement:

8.4 Continual Improvement Continually improve the effectiveness of the QMS


CAPA Action to eliminate the causes of nonconformities in order to prevent recurrence Action to eliminate the causes of potential nonconformities in order to prevent their occurrence 8.5.2 CORRECTIVE ACTION 8.5.3 PREVENTIVE ACTION

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