qms (final)
TRANSCRIPT
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PRESENTED TO: SIR ALI ZUQARNAIN
PRESENTED BY:
SHEHR BANO YAWAR ALI (10585)
MUHAMMAD SAAD AWAN (10302)
QAMROSH ZAHEER (10443)
SYED MUHAMMAD FAHAD (8165)
M N GEMENT
SYSTEM
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What Is Quality?
Degree to which a set of inherent characteristics
fulfils requirements
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Identify, understand and agree customer requirements
Plan to achieve them
Measure, monitor & control processes/activities
Requires A System
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Meeting Our Customers Requirements
Doing Things Right the First Time; Freedom from Failure(Defects)
Consistency (Reduction in Variation)
Continuous Improvement
Quality in Everything We Do
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A belief in the employees ability
to solve problems
A belief that people doing the
work are best able to improve it
A belief that everyone isresponsible for quality
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MANAGEMENT SYSTEM
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Management Support
Mission Statement
Proper Planning
Customer and Bottom Line Focus
Measurement
Empowerment
Teamwork/Effective Meetings
Continuous Process Improvement
Dedicated Resources
ELEMENTS FOR
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Quality Techniques & QMS Standards
Quality
Control
Quality
Assurance
Quality
Management
(Detection) (Prevention) (Direction)
BS 5750
1979-1987ISO
9001/2/3
1987-2000 ISO 9001
2000
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Why Document in
Quality ManagementCommunication Tool
Manage Change
Aids consistency
Record of Best Practice
Enables Effective Audit
ISO 9001 Pre-requisite
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Documented Q.M.S.
POLICY
QUALITY
MANUAL
PROCEDURES
LOCAL/WORK INSTRUCTIONS
RECORDS / FORMS
INTENT
WHAT?
PROOF
HOW?
WHY?
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ISO 9001 - Q.M.S. Requirements
ISO 9004 - Q.M.S. Guidelines on Performance Improvement
ISO 9000 - Q.M.S. Fundamentals & Vocabulary
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The Structure of Quality Standards
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1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
ISO 9001:2000
Based on the 8 Quality Management Principles:
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Continual improvement ofthe quality management system
Requirements
Satisfaction
Customers Customers
Resourcemanagement
Measurement,analysis andimprovement
ProductRealisation
ManagementResponsibility
Input Output
Product
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ISO9001defines what the organization does toensure that its products or services satisfy thecustomer's quality requirements and complywith any regulations applicable to those
products or services.
ISO 14000is primarily concerned with
"environmental management". In plainlanguage, this means what the organizationdoes to minimize harmful effects on theenvironment caused by its activities.
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ISO 14001 is an internationally recognised standard for environmental
management system which can be applied by any organisation.
It has much in common with ISO 9001, in particular the PLAN - DO -CHECK- ACT concept.
As a minimum, ISO 14001 requires a commitment to legal compliance,continual improvement and pollution prevention.
It involves the identification and assessment of all environmental aspectsand impacts in order to determine which are significant.
These must then be managed so as to minimise harm to the environment.
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ISO14001 - Environmental management system model
for the international standard
Environmental Policy
Planning
Environmental aspects
Legal and other requirements
Objectives and targets
Environmental managementprogrammes
Implementation and Operation
Structure and responsibility
Training, awareness and competence
CommunicationEMS documentation
Document control
Operational control
Emergency preparedness and response
Checking and Corrective Action
Monitoring and measurement
Non-conformance and corrective
and preventative action
Records
EMS audits
Continual
improvement
Management Review
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ISO 14001Fundamental requirements
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From
Motivation through fear and loyalty
To
Motivation through shared vision
Attitude: Its their problem Ownership of every problem affectingthe customer
Attitude: the way weve always done it Continuous improvement
Decisions based on assumptions/ judgmentcalls
Decisions based on data and facts
Everything begins and ends withmanagement
Everything begins and ends withcustomers
Crisis management and recovery Doing it right the first time
Choosing participative OR scientificmanagement
Choosing scientific AND participativemanagement
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Control
&
Improvement
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Process set-up?
Risks?
Objectives of the process?
Which contributes to the goals of theorganization?
Resources and
conditions?
Results of the process?
Measurement and steering?
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The ISO 9000:2000 series consists of 3 Primarystandards
ISO 9000: QMS concepts and vocabulary
ISO 9001: QMS requirements
ISO 9004: QMS guidelines
This is supported by an additional standard
ISO 10011: QMS auditing guidelines
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ISO 9001 specifies the requirements for a
quality management system that may be
used for internal application by
organizations, certification, or contractual
purposes.
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ISO 9004 gives guidance on a wider
range of objectives of a quality
management system to improve the
organisations overall performance.
It is not a guideline for implementing
ISO 9001 and is not intended for
certification or contractual use.
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ISO 9001:2008 is divided into 8 sections:
the first 3 are introductory
The requirements begin at section 4 and have the
following headings: Quality management system
Management responsibility
Resource management Product realisation
Measurement, analysis and improvement
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QUALITY MANAGEMENT
PRINCIPLES
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Quality Management System
The organisational structure, responsibilities,procedures, processes and resources
for implementing quality management.
ISO 9001:2000 Process model
Customersatisfaction
Customer Customer? Delivery of
Services
Management
Resources Measurement
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1. SCOPE
Includes the design and construction of clean room, ventilation
and air conditioning system, metal finishing system,
environmental control system for automotive and otherindustrial or commercial applications. Exclusion Design and
development validation.
2. Normative References :
- ISO 9000:2005- ISO 9001: 2008 QMS
- ISO 9001:2000 QMS
- ISO 9002:1994
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3. Terms and Definition
Definitions Terms used by an organization;Processes, interaction,
improvement The focus is on looking at: What we do. Who we aredoing it for. Improving how we provide service.
4. General requirements
Documentation requirements Control of document Documents must
show a control number, adoption and revision dates, in order toensure use of the most recent information. Control of records Each
record must be controlled in order to ensure uniform quality.
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4. General requirements
- General Documents
- Quality Manual
- Control of Documents
- Control of Records
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5. Management Responsibility
- Commitment
- Focus
- Policy
- Objectives
- PlanningThese correspond to the following
principles: Customer focus
Leadership
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6. Resource Management
- Provide quality resources
- Provide quality personnel
- Provide quality infrastructure- Provide quality environment
This corresponds to the following principle: Involvement of People
7. Product Realization
Control of the following process realization, planning, customer, communication,
product development, purchasing, function, operation, monitoring
These correspond to: Get the facts before you decide Focus on customers Use aprocess approach Work with your suppliers
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8. Measurement, Analysis and Improvement
- Perform remedial processes Monitor and measure quality Control
- nonconforming products
- Analyze quality information
- Make quality improvements
This corresponds to: Get the facts before you decide Encourage continual
improvement
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International, expert consensus on state-of-the-art
practices for quality and environnemental management. Common language for dealing with customers and
suppliers worldwide in B2B.
Increase efficiency and effectiveness.
Model for continual improvement. Model for satisfying customers and other stakeholders.
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Documented procedures required by this standard andthose needed by the organisation to control its
processes.
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ISO 9001 IS SIMPLY
A SYSTEM FORCREATINGPAPERWORK!!!
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The extent of the QMS documentation depends on the
following:
a) size and type of the organisation
b) complexity and interaction of the processes
c) competence of personnel
Note: The documented procedu res may be in any
form o r type of medium.
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QMS documents shall be controlled.
A do cumented p rocedure shall be
establ ished:
to approve documents prior to use
to review/update & re-approve as
necessary
to identify changes and current revision
status
to ensure relevant versions are available
to ensure legibility and identification
to control documents of external origin to control obsolete documents
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QMS records shall be maintained to provide evidence of
conformance to requirements and effective QMS
operation.
A documented p rocedure shal l be establ ished for: Identification,
storage
retrieval
protection
retention time and
disposition of records.
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Determine team, set budget Internal auditor(s) training if using in-house resources Hire consulting firm if applicable Gap Assessment Implement requirements of standard to meet your business
needs against the gap assessment Go-Live Hold Management Review Meeting Conduct Internal Audit Refine documentation
Employee involvement training System adjustment Registration auditStage 1 System adjustment Registration auditStage 2
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Submit application to registrar
Stage 1: Assessment of readiness
Stage 2: Assessment for registration audit
Registration/certification awarded for 3 years
Surveillance audits (at least annually)
Recertification audit at the end of 3rdyear
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