02 - Quality Management System

Quality Management System
Contents
 System Requirements
 Control of Documents
 Control of Records
 Management Responsibility
 Resource management
 Product realization
 Measurement, analysis and improvement
www.BrooklynAcademy.net 1
International Organization for Standardization (ISO)
3
 Non-governmental organization,
 Established in 1947.
 Derived from the Greek “ISOS”, meaning "equal".
 Network of the national standards institutes of 164
countries,
In-house Training Program
International Organization for Standardization (ISO)

4
 World's largest developer and publisher of
international standards.
 Central secretariat in Geneva, Switzerland.
 www.ISO.org
ISO 9000 Series
5
 ISO 9000:2005 - covers the basic concepts and
terminology.
 ISO 9001:2008 - sets out the requirements of a quality
management system.
 ISO 9004:2009 - focuses on how to make a quality
management system more efficient and effective
Quality Management System (ISO 9001:2008)

6
 Guidelines may be applied on any organization.
 Not intended to be applied as standard format
 Implementation depends on:
 Organization size
 Product and service?
Product Characteristics
 Tangible (materialized)
 Ability to be stored
 Relatively easy to measure quality
Service Characteristics
 Inability to be stored
 Required more interaction between customer and
service provider
 Relatively difficult to measure quality
Quality Management System Objectives
9
 Main objectives of ISO 9001:2008:
 Customer Satisfaction
 Continual Improvement
Quality Management System (ISO 9001:2008)
 Main Clauses:
 Quality Management System Documentation
 Management Responsibility
 Resource management
 Product realization
 Measurement, analysis and improvement
Quality Management System
Continual Improvement of the

C Quality Management System S C
a
U Management t U
i
S R responsibility
s
S
e
T q
f T
a
O u
i
c O
M r Resource Measurement, analysis, t
M
management improvement i
e
E m
o
n
E
e
R n R
S t Product Product S
s realisation
Input
Output
Document Structure
Policy
May be available in any
form or medium.
Manual
Procedures
Work Instructions
Records
Job Descriptions
Reference Documents
Quality Policy
Few simple sentences (documented and approved)
 Scope and purpose of the organization.
 Commitment to comply with requirements
 Continually improve the effectiveness of system.
 Communicated and understood within the organization.
 Reviewed for continuing suitability.
Quality Policy
 Provide framework for establishing and reviewing

Quality objectives.
 Quality objectives - SMART Rule
 S: Specific
 M: Measurable
 A: Agreed
 R: Realistic
 T: Time Framed
Quality Manual
Quality Manual should at least include:
 Quality policy and objectives
 Organizational overview
 List of procedure
 Scope of the quality management system
 Justification for any exclusion (clause 7 only).
 Sequence and interaction between processes.
Procedure
- Describe WHO is responsible for doing WHAT, WHEN &

WHERE?
- Usually, HOW is described in work instructions.
- Procedure Contents:
 Purpose of procedure
 Scope of procedure implementation
 Explanations for operation definition.
Procedure
 Responsibilities of participants in procedure execution.
 Flowchart (steps required to execute procedure).
 Measurements required to evaluate the effectiveness
 Records required to provide evidence that procedure
results are achieved
 List of reference documents
Work Instructions
- Detailed requirements for a specific activity
- At least should include:
 Tasks involved
 HOW these should be performed.
 Standard to be used
Job Descriptions
Determined for each employee to define:
 Responsibility
 Authority
 Reporting and interfacing relationship
Quality Records
 Special type of document
 Result of applying the procedure
 Provide evidence of activities performance
 May be available in any form or medium.
Reference Documentation
Documentation that needs to be consulted
 Technical Codes,
 Standards
 Law,
 Regulation
 Equipment's Manual,
Documentation Advantages
Benefits of documentation include:

1. Define requirements
2. Define authority and responsibilities
3. Fulfill requirements of regulation and certificates
4. Used as a base for future improvement
5. Reference for audit
6. Used in new staff orientation
* May be available in any form or medium.
Documentation Disadvantages
Drawback of documentation include:
1. Requires resources
2. Consumes time
3. Needs continuous update
4. Limiting creativity
Workshop
 Write procedure steps to describe one of the following processes:
A. Human Resources
B. Marketing
C. Finance
D. Quality Control / Quality Assurance
E. Information Technology
F. Procurement
G. Warehouse
H. Health & Safety
I. Maintenance
J. Environmental Protection
K. Continual Improvement
Workshop Tips
 Purpose of procedure
 Define procedure boundaries (start & finish)
 One sentences to describe scope of procedure
 Few sentences to describe main tasks
 Measures of effectiveness
 Include titles only of:
 Work instructions
 Records
 Reference Documents
 Time allowed: 20 min.
 Discussion duration: 10 min.
Mandatory Documented Procedures
1. Control of documents
2. Control of records
3. Control of non-conforming product
4. Corrective action
5. Preventive action
6. Internal Audit
Control of Documents
Documented procedure to define the controls

needed to:
a) Approve documents for adequacy prior to issue,
b) Review and update as necessary and re-

approve documents,
c) Ensure that changes and the current revision

status of documents are identified,
Control of Documents
d) Ensure that relevant versions of applicable documents

are available at points of use,
e) Ensure that documents remain legible and readily

identifiable,
f) Ensure that documents of external origin determined by

the organization are identified and their distribution
controlled,
g) Prevent the unintended use of obsolete documents.
Control of Records
Documented procedure to define the controls needed for

records management:
 Identification,
 Storage,
 Protection,
 Retrieval,
 Retention
 Disposition
Management Representative
 Member of the organization's management
 Have responsibility and authority that includes:
a) Ensuring that processes needed for the quality

management system are established, implemented and
maintained,
b) Reporting to top management on the performance of the
quality management system and any need for
improvement,
Management Representative
c) Ensuring the promotion of awareness of customer

requirements throughout the organization.
 Liaison with external parties on matters relating to
the quality management system.
Management Review
 Review of the organization's quality management
system, at planned intervals.
 Ensure continuing suitability, adequacy and
effectiveness.
 Assessing opportunities for improvement and the
need for changes to the quality management system
Management Review Input
Input to management review includes:
a) Results of audits,
b) Customer feedback,
c) Process performance and product conformity,
d) Status of preventive and corrective actions,
e) Follow-up actions from previous management reviews,
Management Review Input
f) Changes that could affect the quality management

system, and
g) Recommendations for improvement.
Management Review Output
Decisions and actions related to:
a) Improvement of the effectiveness of the quality

management system and its processes,
b) Improvement of product related to customer

requirements, and
c) Resource needs.
Resource management
 Provision of resources
 Human resources
 Awareness
 Training
 Competence
 Infrastructure
 Work environment
Product realization
1. Planning of product realization

1. Quality objectives
2. Processes, documents, and resources
3. Verification, validation, monitoring, measurement,
inspection
4. Criteria for product acceptance
5. Records evidencing that product meets
requirements
Product realization
2. Customer-related processes
1. Determination of requirements related to the

product
 Delivery and post-delivery Requirements
 Requirements necessary for specified or

intended use,
 Statutory and regulatory requirements,
Product realization
2. Review of requirements related to the product

1. Product requirements are defined
2. Differences are resolved
3. Organizational ability to meet requirements

* Where no documented statement of requirements,
customer requirements must be confirmed.
Product realization
3. Customer communication
1. Product information,
2. Enquiries, contracts or order handling, including

amendments, and
3. Customer feedback, including customer

complaints.
Product realization
3. Design and Development

1. Design and Development Planning
2. Design and Development Inputs
3. Design and Development Outputs
4. Design and Development Review
5. Design and Development Verification
6. Design and Development Validation
7. Control of Design and Development Changes
Product realization
1. Design and Development Planning
1. Design and development stages,
2. Responsibilities & authorities for design
Product realization
2. Design and Development Inputs

1. Functional and performance requirements,
2. Statutory and regulatory requirements,
3. Information derived from previous similar

designs
Product realization

3. Design and Development Outputs
1. Meet the input requirements for design,
2. Provide appropriate information for purchasing,
production and service provision,
3. Contain or reference product acceptance criteria,
4. Specify the characteristics of the product that are
essential for its safe and proper use.
Product realization
4. Design and Development Review

1. Evaluate the ability of design results to
meet requirements,
2. Identify any problems and propose

necessary actions.
Product realization
5. Design and Development Verification
‫التحقق من التصميم والتطوير‬
Ensure that the design outputs have met the

design input requirements
Product realization
6. Design and Development Validation

‫إقرار صالحية التصميم والتطوير‬
Ensure that the resulting product is capable of
meeting the requirements for the specified
application or intended use,
Design and Development
Pre-Design Phase
Design
Requirement Design Review Results
Design Phase
Inputs Design Verification Outputs
Post-Design Phase
Requirement Design Validation Product
Product realization
7. Control of Design and

Development Changes
1. Review, verify, validate & approve
change prior to implementation
2. Evaluate effect of changes on parts
and product already delivered.
Purchasing
 Purchasing process
 Purchasing information
 Verification of purchased product
Production and Service Provision
 Identification and traceability
 Customer property
 Material
 Document
 Method
 Ideas
 Preservation of product
Production and Service Provision
 Control of monitoring and measuring equipment

 Calibrated or verified
 Adjusted or re-adjusted
 Identification
 Safeguarded
 Protected from damage
Measurement, analysis and improvement
 Objectives:
 Demonstrate conformity to product
requirements,
 Ensure conformity of the quality management
system
 Continually improve the effectiveness of the
quality management system
 Monitoring and measurement
 Customer satisfaction
• Questionnaire / Survey
• Interview
 Internal audit
 Monitoring and measurement of processes
 Monitoring and measurement of product
 Control of nonconforming product
 Root Cause
 Way out
 Analysis of data
 Customer satisfaction
 Conformity to product requirements
 Characteristics and trends of processes and products
 Suppliers
 Improvement
 Continual improvement
 Corrective action
 Correction
 Root Cause
 Prevent Re-occurrence
 Recorded
 Evaluate Effectiveness
 Improvement
 Continual improvement
 Preventive action
 Avoid potential defect
 Recorded
 Evaluate Effectiveness
Malcolm Baldrige National Quality Award
Provided by the US Government since 1987

Category Point Values
1 Leadership 120
2 Strategic Planning 85
3 Customer Focus 85
4 Measurement, Analysis, and
Knowledge Management 90
5 Workforce Focus 85
6 Operations focus 85
7 Business Results 450
Total Points 1000

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Quality Management System

 Measurement, analysis and improvement

 Derived from the Greek “ISOS”, meaning "equal".

 Network of the national standards institutes of 164

In-house Training Program

International Organization for Standardization (ISO)

 World's largest developer and publisher of

 Central secretariat in Geneva, Switzerland.

In-house Training Program

 ISO 9000:2005 - covers the basic concepts and

 ISO 9001:2008 - sets out the requirements of a quality

 ISO 9004:2009 - focuses on how to make a quality

management system more efficient and effective

In-house Training Program

Quality Management System (ISO 9001:2008)

 Guidelines may be applied on any organization.

 Not intended to be applied as standard format

 Implementation depends on:

 Product and service?

In-house Training Program

 Relatively easy to measure quality

 Required more interaction between customer and

 Relatively difficult to measure quality

 Main objectives of ISO 9001:2008:

In-house Training Program

Quality Management System (ISO 9001:2008)

 Quality Management System Documentation

 Measurement, analysis and improvement

Continual Improvement of the

Few simple sentences (documented and approved)

 Scope and purpose of the organization.

 Commitment to comply with requirements

 Continually improve the effectiveness of system.

 Communicated and understood within the organization.

 Reviewed for continuing suitability.

 Provide framework for establishing and reviewing

 Quality objectives - SMART Rule

Quality Manual should at least include:

 Quality policy and objectives

 Scope of the quality management system

 Justification for any exclusion (clause 7 only).

 Sequence and interaction between processes.

- Describe WHO is responsible for doing WHAT, WHEN &

- Usually, HOW is described in work instructions.

 Scope of procedure implementation

 Explanations for operation definition.

 Responsibilities of participants in procedure execution.

 Flowchart (steps required to execute procedure).

 Measurements required to evaluate the effectiveness

 Records required to provide evidence that procedure

results are achieved

 List of reference documents

- Detailed requirements for a specific activity

- At least should include:

 HOW these should be performed.

Determined for each employee to define:

 Reporting and interfacing relationship

 Special type of document

 Result of applying the procedure

 Provide evidence of activities performance

 May be available in any form or medium.

Documentation that needs to be consulted

Benefits of documentation include:

Drawback of documentation include: