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ISO 9001:2008
Awareness Program
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Purpose of Program
Awareness of ISO 9001:2008.
Self Improvement
Improvements in routine working
To improve the health of organizations
Quality Management System
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FAQ?
What is ISO?
From where it comes?
How it is helpful for us?
How it works?What we have to do?
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Contents Of Program
Background of ISO
ISO Family
Quality Management Principle
Process Approach
ISO 9001:2008 Overview
Detail Of Different Clauses Of ISO
9001:2008
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What is ISO 9001:2008?
ISO = International Organization for
Standardization
ISO has representation from 162 countriesand has issued many standards
ISO 9001:2008 is a model for a quality
management system.
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Who created the standard?
International Organization for
Standardization - Geneva
Standards created in 1987 To eliminate country to country differences
To eliminate terminology confusion To increase quality awareness
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ISO 9000:2005 Consists of 3 AreasISO 9000:2005 Consists of 3 Areas
ISO 9000:2005 Quality Management Systems:
fundamentals and vocabulary
ISO 9001:2008 Quality Management Systems
Requirements (required for certification)
Management responsibility
Resource management
Product/service realizationMeasurement, analysis, improvement
ISO 9004-2009 Quality Management Systems
Guidelines for performance improvement
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Generic standards
ISO 9001 is a generic standards.
Generic means that the same standards can
be applied: to any organization, large or small,
whatever its product or service,
in any sectorof activity, and whether it is a business enterprise, a public
administration, or a government department.
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Generic standards (cont.)
Generic also signifies that
no matter what the organization's scope of
activity if it wants to establish a quality
management system, ISO 9001 gives the
essential features
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Certification and registration
Certification is known in some countries asregistration.
It means that an independent, external
body has audited an organization'smanagement system and verified that itconforms to the requirements specified in the
standard (ISO 9001). ISO does not carry out certification and
does not issue or approve certificates,
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Accreditation
Accreditation is like certification of the certificationbody.
It means the formal approval by a specialized body -
an accreditation body - that a certification body iscompetent to carry out ISO 9001:2008 certification inspecified business sectors.
Certificates issued by accredited certification bodies- and known as accredited certificates - may beperceived on the market as having increasedcredibility.
ISO does not carry out or approve accreditation.
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Certification not a requirement
Certification is not a requirement of ISO
9001.
The organization can implement and takebenefit from an ISO 9001 system without
having it certified.
The organization can implement them for theinternal benefits without spending money
on a certification programme.
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Certification is a businessdecision
Certification is a decision to be taken for
business reasons:
if it is a contractual, regulatory, or market
requirement,
If it meets customer preferences if it will motivate staff by setting a clear goal.
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Ten Steps to ISO RegistrationTen Steps to ISO Registration
2. Select the appropriate standard
1. Set the registration objective
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!
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What is a Quality ManagementSystem?
A Quality Management System is aweb of interconnected processes
that are used to manage a
business.
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Operating Cycle of ISO.
The Plan Do Check Act (PDCA) cycle is theoperating principle of ISO's management systemstandards
Plan establish objectives and make plans (analyze yourorganization's situation, establish your overall objectivesand set your interim targets, and develop plans toachieve them).
Do implement your plans (do what you planned to). Check measure your results (measure/monitor how far
your actual achievements meet your planned objectives).
Act correct and improve your plans and how you put
them into practice (correct and learn from your mistakesto improve your plans in order to achieve better resultsnext time).
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ISO 9001:2008
CONTINUAL IMPROVEMENT OF THE QUALITYMANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF THE QUALITYMANAGEMENT SYSTEM
Measurement,analysis andimprovement
Measurement,analysis andimprovement
ProductProduct
InputOutput
Managementresponsibility
Resourcemanagement
Resourcemanagement
Clause 5Clause 6
Clause
8
Clause 7
Requirements
Product
realization
Satisfaction
Value adding activities
Information flow
Customers
Customers
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Inputs
With What?(Materials / Equipment)
How?(Methods / Procedure)
Measure
WHO?Special Skills? / Competence?
Outputs
ProcessLinkages
Objectivesand
Targets
Process
PROCESS REQUIREMENTS
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Management Principles
A Quality Management Principle is a
comprehensive and fundamental rule or
belief, for leading and operating anorganization, aimed at continually improving
performance over the long term by focusing
on customers while addressing the needs ofall stakeholders.
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8 Management Principles
Principle 1 : Customer Focus
Principle 2 : Leadership
Principle 3 : Involvement Of People Principle 4 : Process Approach
Principle 5 : System approach to management
Principle 6 : Continual Improvement
Principle 7 : Factual approach to decision making
Principle 8 : Mutually beneficial supplierrelationships
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Principle 1 : Customer Focus
Organizations depend on their customers &
therefore should understand current & future
customer needs, should meet customerrequirements & strive to exceed customer
expectations
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Principle 2 : Leadership
Leaders establish unity & direction of the
organization. They should create & maintain
the internal environment in which people canbecome fully involved in achieving the
organization's objectives.
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Principle 3 : Involvement OfPeople
People at all levels are the essence of an
organization and their full involvement
enables their abilities to be utilized for theorganization's mutual benefit.
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Principle 4 : Process Approach
The application of a system of processes within
an organization, together with the identification
and interaction of these processes, and theirmanagement to produce the desired outcome,
can be called Process Approach
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Principle 5 : System approach tomanagement
Identifying, understanding & managing
interrelated processes as a system
contributes to the organization'seffectiveness & efficiency in achieving its
objectives.
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Principle 6 : ContinualImprovement
Continual Improvement of the organization's overallperformance should be the primary driver of the
organizations Quality Management System.
ContinuousImprovement
Continual Improvement
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Principle 7 : Factual approach todecision making
Effective decisions are based on the analysis
of data & information
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Principle 8 : Mutually beneficialsupplier relationships
An organization & its suppliers are
interdependent, and a mutually beneficial
relationship enhances the ability of both tocreate value
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Clauses of ISO 9001-2008
1.Scope
2.Normative References
3.Term & Definitions 4.Quality Management System
5.Management Responsibility. 6.Resources Management
7.Product Realization
8.Measurment,Analysis and Improvement
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SCOPE OF STANDARD
1. Scope
General
Application
2. Normative reference
3. Terms and definition
e.g., Supplier Organization Customer
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QUALITY MANAGEMENT SYSTEMREQUIREMENTS
4.1 General requirementsDocument, implement, maintain and
continually improve
Identify and determine sequence andinteraction of processes
Determine criteria and methods needed
Ensure availability of resources
Monitor, measure and analyze processes
Implement actions to achieve plannedresults
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QUALITY MANAGEMENT SYSTEMREQUIREMENTS
4.2 Documentation requirements
Management system documentation
Quality ManualControl of documents
Control of records
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QUALITY SYSTEMDOCUMENTATION STRUCTURE
1st Level
Quality Manual
2nd LevelProcedures
3rd LevelWork Instructions
Machine instructions Computer inputs Detailed work instructions
4th LevelTechnical Data
International standards Computer operating manuals Detailed product specifications
Policy and Objectives
What the company wishes toachieve
How the company
implements its policyStructured to reflectprocess flow of events
Detailed instructions
How to completea job or task
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MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
Must be documented
Must be used for setting objectives
5.4 Planning
Document objectives- Must be Measurable Quality management system planning
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MANAGEMENT RESPONSIBILITY
5.5 Responsibility, authority and
communication Responsibility and authority
Management representative
Internal communication
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MANAGEMENT RESPONSIBILITY
5.6 Management Review General
Review input
Review output
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RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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PRODUCT REALIZATION
7.1 Planning of productrealization
7.2 Customer-related processes Determination of requirements related to the
product
Review of requirements related to the product
Customer communication
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PRODUCT REALIZATION
7.3 Design and developmentPlanning, inputs, outputs, systematic
reviews, verification and validation, controlof changes
7.4 PurchasingSupplier evaluation and selection
Relevant purchasing information
Verification of purchased product- receiving, source
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PRODUCT REALIZATION
7.5 Production and service provisionControlled conditions including product
characteristics, work instructions (as necessary),
suitable equipment, monitoring and measuringdevices, monitoring and measurement, andrelease, delivery and post- delivery activities
Validation of processes when no other method
Identification and traceability of product and itsstatus
Care of customer property
Preservation of product
Includes constituent arts
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PRODUCT REALIZATION
7.6 Control of monitoring and measuringdevices
Calibrated or verified where necessaryAdjusted and re-adjusted as necessary
Identified to enable calibration status
Safeguarded from invalid adjustmentProtected from damage and
deterioration
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MEASUREMENT, ANALYSIS, ANDIMPROVEMENT
8.1 General
8.2 Monitoring and measurement
Customer satisfaction Internal audit
Monitoring and measurement of
processes
Monitoring and measurement of product
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MEASUREMENT, ANALYSIS, ANDIMPROVEMENT
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 ImprovementContinual improvement
Corrective action
Preventive action
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Any Questions or
Query?
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ThanksVarinder SandhuAbhived Bhardwaj
Balram Sharma