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AWARENESS TRAINING
Vimal Patel
Product Certification
A Business Associate of
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Risk Management through compliance
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Risk Management through compliance
ISO 9001
Responsibility
Management
Improvement
Satisfaction
Continually
Customer
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Quality Management System
What is ISO 9001 ??
QMS ISO
9001:2008
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QMS ISO 9001 - Definition
Quality
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QMS ISO 9001
Monitor & Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed
Right Resources:
Desired Results:
Competent People
Quality Products/
Right Facilities/Equipment
Quality Services
Correct Materials
Customer Satisfaction
Proven Methods
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QMS ISO 9001
EXPECTED PLANNED
QUALITY QUALITY
by the Customer by the Company
PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company
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Management System
R
S
E Management A
C Q C
U
Responsibility T
U
U I
S I Measurement, S S
T R Resource QMS Analysis & F T
O E Management General A O
M M Requireme Improvement C M
E E nt T E
R N Input Product Output I R
T Realization Product O
s N
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Quality Management System
THE 8 CLAUSES OF ISO 9001
1.0 Scope
Establish
Document
Implement
Maintain
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4.0 Quality Management System
4.1 QMS - General Requirements
OUTSOURCING OF PROCESSES
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4.0 Quality Management System
4.1 QMS - General Requirements
OUTSOURCING OF PROCESSES
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4.2 Documentation Requirement
4.2.1 General Requirements
The QMS documentation shall include:
Level 1 Quality Manual
QM
(Policy and objective)
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4.2 Documentation Requirement
4.2.1 General Requirements (Procedural Requirement)
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4.2 Documentation Requirement
4.2.1 General Requirements (Records Requirement)
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4.2 Documentation Requirement
4.2.1 General Requirements (Records Requirement)
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4.2 Documentation Requirement
4.2.2 Quality Manual
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4.2 Documentation Requirement
4.2.2 Quality Manual
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4.2 Documentation Requirement
4.2.3 Control of Documents
Documented procedure need to be established
to define the controls needed-
• To approve documents for adequacy prior to issue
• To review and update as necessary and re –approve
documents
• To identify the current revision status of documents
• To ensure that relevant version of applicable
documents are available at points of use
• To ensure documents remain legible, readily
identifiable and retrievable
• To ensure that external origin documents are
determined and document controlled
• To prevent unintended use of obsolete documents, their
method of identification and retention
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4.2 Documentation Requirement
4.2.3 Control of Records
Documented procedure for Control of Records shall
be maintained to ensure: :
• Identification
• Storage
• Protection
• Retrieval
• Retention time
• Disposal of Records
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Quality Management System
5.0 Management Responsibility
5.4 Planning
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5.0 Management Responsibility
5.3 Quality Policy
Top Management shall ensure that the
Quality Policy has the following features:
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5.4 Planning
5.4.1 Quality Objectives
Top Management shall ensure Quality objectives, including those
needed to meet product requirements should be:
• Measurable
• Consistent with the Quality policy
• established at relevant functions
and levels within the organization
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5.4 Planning
5.4.1 Quality Objectives
SMART Objective
Specific: is the objective described in concrete, actionable detail?
Measurable: what quantitative measurements will tell us when
the objective has been achieved?
Attainable: is the objective really achievable within budget and
schedule constraints?
Results-oriented: what tangible work output does the objective
produce? (i.e., not just conversations and ideas)
Time-driven: what is the due date for the objective?
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5.6 Management Review
5.6.2 Review Input
Inputs to Management Review will come from:
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Quality Management System
6.0 Resource Management
6.3 Infrastructure
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6.2 Human Resources
6.2.1 General
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6.2 Human Resources
6.2.2 Competency, Training & Awareness
The organization shall ensure:
• Determine the necessary competence for personnel
performing work affecting Conformity to Product
requirements
• Where applicable Provide training or take action to
achieve necessary competence
• Evaluate the effectiveness of actions taken
• Ensure employee awareness regarding relevance and
importance of their activities & their contribution to
Quality objectives
• Records of Education, Training, Experience and
Qualifications are maintained
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6.0 Resource Management
6.3 Infrastructure
lighting, or weather).
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6.0 Resource Management
6.4 Work Environment
requirements
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Quality Management System
7.0 Product Realization
7.4 Purchasing
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7.0 Product Realization
7.1 Planning of Product Realization
Planning of Product Realization shall include :
• Quality objectives and requirements for the product
• Need to establish processes & documents and to provide
resources specific to product
• Verification, validation, monitoring, measurement,
inspection and test activities specific to product
• Criteria for product acceptance
• Conformity records to provide evidence that realization
processes and resulting product meet requirements
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7.2 Customer – related process
7.2.1 Determination of requirements related to product
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7.2 Customer – related process
7.2.2 Review of requirements related to product
The Contract review shall include :
• Review of identified Customer requirements and
additional requirements to be conducted - prior to the
commitment to supply a product (e.g.. submission of a
tender, acceptance of order)
• For proper review, it has to be ensured that :
Product requirements are defined
Differences shall be resolved
Capability to meet customer requirements
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7.0 Product Realization
7.3 Design & Development ( Not applicable )
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7.5 Production & Service Provision
7.5.1 Control of Production and service Provision
Production / service provision is carried out under controlled
conditions, which shall include :
• Availability of information specifying
product characteristics
• Availability of work instructions as necessary
• Usage of suitable equipments
• Availability and use of monitoring and
measuring equipment
• Implementation of Monitoring and
measurement activities
• Implementation of defined processes for
product release, delivery and post delivery
activities
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7.5 Production & Service Provision
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7.5 Production & Service Provision
7.5.3 Identification & Traceability
• Identification of product by suitable means
throughout product realization, where appropriate
• Identification of the status of product with respect to
monitoring and measurement requirement throughout
• Wherever Traceability is a requirement, Controlling
and unique identity of product is done & maintain
records
• Configuration Management is a means by which
identification and traceability can be maintained
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7.5 Production & Service Provision
7.5.4 Customer Property ( Physical / Intellectual )
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7.5 Production & Service Provision
7.5.6 Control of Monitoring & Measuring Device
• Identification of measurements, measuring and
monitoring equipments for product conformity
• Control of Measuring and monitoring equipments to
ensure consistency of measurement capability with
the measured requirements
• Wherever necessary to ensure valid results, the
measuring equipment:
Shall be calibrated
Safeguarded, protected from damage and
deterioration
Reassessment of results if out of calibration
Calibration records to be available
• Software used shall be validated prior to use
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Quality Management System
8.0 Measurement, analysis and improvement
8.1 General
8.5 Improvements
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8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction
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8.2 Monitoring & Measurement
8.2.2 Internal Audit
established to
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8.2.3 Monitoring & Measurement – QMS Process
––Satisfaction
Satisfactionsurveys
surveysfor
forcustomers
customersand
andother
otherinterested
interested
parties
parties
•Feedback
•Feedbackononproducts
products
•Customer
•Customer&&market
marketrequirements
requirements
––Financial
Financialmeasurements
measurements
•Prevention
•Preventioncost
cost
System
System •Non
•Nonconforming
conforming/ /failure
failurecost
cost
performanc
performanc •Lifecycle
•Lifecyclecost
cost
ee
Self
Self
assessment
assessment
––Internal
Internalaudits
audits
•Effectiveness
•Effectiveness&&efficiency
efficiencyofofprocesses
processes
•Opportunities
•Opportunitiesfor forimprovements
improvements
•Use
•Useofofdata
data/ /information
information
•Effective
•Effective&&efficient
efficientuseuseofofresources
resources
•Adequacy,
•Adequacy, accuracy
accuracyand andperformance
performanceofofmeasurements
measurements
•Relationships
•Relationshipswithwithcustomers/
customers/suppliers/
suppliers/other
otherinterested
interestedparties
parties
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8.2 Monitoring & Measurement
8.2.4 Monitoring and Measurement of Product
• At appropriate stages of Product Realization Process, the
verification of product characteristics shall be done by
measurement and monitoring
• Evidence of conformity with the Acceptance Criteria shall
be maintained
• Authorization for release of product for delivery to
customer - Records shall indicate
• Product Release and Service Delivery to the customer shall
not proceed till planned arrangements (7.1) have been
satisfactorily completed ( Exception only on customer –
approval )
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8.0 Measurement, analysis & Improvements
8.3 Control of Non-conforming Product
suppliers
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8.5 Improvements
8.5.1 Continual Improvements
Organization shall continually improve the effectiveness of the QMS
Continual Improvement to be facilitated through
the use of :
Quality Policy and Objectives
• Audit Results
• Analysis of Data
• Management Review
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8.5 Improvements
8.5.2 Corrective Action
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