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ISO 9001:2008

AWARENESS TRAINING

ISO 14001 & OHSAS 18001

Vimal Patel

4C Consulting Private Limited


Risk Management through compliance

Management System Certification


 ISO 9001 - Quality Management System
 ISO 14001 - Environment Management System
 OHSAS 18001 - Occupational Health & Safety
 ISO 22000, BRC , HACCP - Food Safety Management
 ISO/TS 16949 Global Automotive Management System
 ISO 27001 - Information security Management System

Product Certification
A Business Associate of

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Risk Management through compliance

When asked about ISO, Dr. Deming said,

“You don’t have to do it.


Survival is not compulsory.”

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Risk Management through compliance

ISO 9001

Responsibility
Management

Improvement
Satisfaction

Continually
Customer

Three Pillers of ISO 9001

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Quality Management System
What is ISO 9001 ??

QMS ISO
9001:2008

QMS stands for


Quality Management System

ISO stands for


International Standardization Organization

9001 stands for


Quality Management Standard series

2008 stands for


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the year in which the standard was revised / m
Quality Management System
What is ISO 9001 ??

ISO 9001 SPECIFIC REQUIREMENTS ARE :

 FOR Quality Management System (QMS) &


NOT FOR PRODUCT

 GENERIC & APPLICABLE TO :


 ANY INDUSTRY
 ANY ECONOMIC SECTOR
 ANY SIZE
 ANY PRODUCT OFFERED
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Management System

Management System Model


 Based on Deming Cycle
• Plan – Do – Check - Act
 Comprising of Five Element
• Policy
• Planning (Plan)
• Implementation & Operation (D0)
• Checking & corrective action (Check)
• Management review (Act)
 Demonstrating a commitment to
• Continual Improvement

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QMS ISO 9001 - Definition
Quality

 Degree to which a set of inherent


characteristics meets requirements.

Quality Management System

 Quality Management means what the


organization does to ensure that its products /
services conform to the customer’s
requirements.

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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

Input Activity Output

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

Measurement of the Measurement of the


Client’s satisfaction Performance of the Company

PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company

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Management System

Management System Model - ISO 9001


CONTINUAL IMPROVEMENT
OF
QUALITY 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

2.0 Normative reference

3.0 Terms and definitions


4.0 QMS General Requirement

5.0 Mgmt. Responsibility


6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis
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& Improvements
4.0 Quality Management System
4.1 QMS - General Requirements

The Organization shall –

 Establish
 Document
 Implement
 Maintain

Quality Management System and


Continually improve its effectiveness
in accordance with the requirements
of this international standard

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4.0 Quality Management System
4.1 QMS - General Requirements

OUTSOURCING OF PROCESSES

Any process that affect product conformity


with requirements are outsourced, the
organization shall control such processes
and the control exercised shall be defined
and documented

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4.0 Quality Management System
4.1 QMS - General Requirements

OUTSOURCING OF PROCESSES

An “outsourced process” is a process that the


organization needs for its quality management system
and which the organization chooses to have performed
by an external party

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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)

Level 2 Quality Procedures ( 6 Mandatory )


Procedures
Departmental procedures –(Optional)

Work Instructions & Level 3 Documentation


Related Documents SOPs / WIs / QP

Master Records List & Level 4 Documentation


Related Documents Formats & Records

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4.2 Documentation Requirement
4.2.1 General Requirements (Procedural Requirement)

 Control of Documents…Clause 4.2.3

 Control of Records… Clause 4.2.4

 Internal Audit… Clause 8.2.2

 Control of Nonconforming product… Clause 8.3

 Corrective Action… Clause 8.5.2

 Preventive Action… Clause 8.5.3

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4.2 Documentation Requirement
4.2.1 General Requirements (Records Requirement)

 Management review (5.6.1)


 Education, Training, Competency & Training Effectiveness (6.2.2)
 Planning of product realization (7.1.d)
 Review of requirements related to product(7.2.2)
 Design and development inputs(7.3.2) , Design review(7.3.4)
Design verification(7.3.5), Design Validation(7.3.6), Design Changes(7.3.7)
 Purchasing process… results of evaluation and actions(7.4.1)
 Validation of processes(7.5.2.d)
 Identification and Traceability… where traceability is a requirement (7.5.3)

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4.2 Documentation Requirement
4.2.1 General Requirements (Records Requirement)

 Customer property…clause 7.5.4


 Control of Monitoring& Measuring devices…7.6
 Internal Audit…Clause 8.2.2
 Monitoring and measurement of product… record shall indicate person
authorizing release of product and evidence of conformity with acceptance
criteria…clause 8.2.4
 Control of Nonconforming product.. Records of the nature of non conformities
and any subsequent actions taken, including concessions… clause 8.3
 Corrective action…clause 8.5.2
 Preventive action…clause 8.5.3

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4.2 Documentation Requirement
4.2.2 Quality Manual

A Quality Manual shall be established and


maintained that includes the following:

 Scope of QMS - mention


exclusions & justification
 Documented procedures or
reference to them

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4.2 Documentation Requirement
4.2.2 Quality Manual

Exclusions allowed only in Clause 7.0

 7.3 – Design & Development

 7.5.2 – Validation of Processes

 7.4 – Customer Property

 7.5.1 – Post Delivery activities / Service

 7.6 – Calibration of Equipments

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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

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility , Authority and Communication

5.6 Management Review

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5.0 Management Responsibility
5.3 Quality Policy
Top Management shall ensure that the
Quality Policy has the following features:

• Appropriate to the purpose of the organization


• Commitment to meet requirements & continually
improve the effectiveness of QMS
• Quality Policy should provide the framework for
establishing and reviewing Quality objectives
• Quality Policy is communicated and understood
within the organization
• Quality Policy is reviewed for continued suitability
& shall be controlled

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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:

• Audit results ( Internal / External / Customer visit )


• Customer Feedback / Customer complaints
• Process Performance and Product Conformity
• Corrective and Preventive Action(s) Status
• Follow-up actions from earlier review
• Changes affecting QMS
• Recommendations for Improvement
• Suitability of Quality Policy

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Quality Management System
6.0 Resource Management

6.1 Provision of resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment

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6.2 Human Resources
6.2.1 General

Personnel performing work affecting Conformity to Product

requirements shall be COMPETENT ON THE BASIS of :

“APPROPRIATE”: Conformity to product


 EDUCATION requirements can be affected

 EXPERIENCE directly or indirectly by personnel

 TRAINING performing any task within the


Quality management system.
 SKILLS

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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

The organization shall determine, provide and maintain


the infrastructure, which includes, as below, for achieving
conformity to product requirements :

• Buildings, workspace and associated utilities

• Process Equipment - Hardware and software

• Supporting services - such as transport and

communication or information systems


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6.0 Resource Management
6.4 Work Environment

"work environment" relates to conditions under which

work is performed including physical, environmental

and other factors (such as noise, temperature, humidity,

lighting, or weather).

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6.0 Resource Management
6.4 Work Environment

The organization shall:

• Determine and manage the work environment

needed to achieve the conformity to product

requirements

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Quality Management System
7.0 Product Realization

7.1 Planning of Product Realization

7.2 Customer related Processes

7.3 Design and Development

7.4 Purchasing

7.5 Production and service provision

7.6 Control of monitoring and measuring devices

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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

The Organization shall determine :


• Product requirements specified by the customer
including requirements for delivery and post delivery
activities
• Product requirements not specified by the customer but
necessary for intended use
• Statutory and regulatory requirements applicable to the
product ( Applicable IS Standard / RSPCB consent etc.)
• Any other additional requirements considered necessary
by the organization

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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 )

The design and development clauses are as under:


7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
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7.4 Purchase
7.4.1 Purchase Process ( Outsourced / Critical services )

It has to be ensured that :


• Purchased product has to conform to specified
purchase requirements
• Type and extent of control is a function of
subsequent effect of the purchased product on the
product realization or the final product
• Evaluation and selection of suppliers
• Criteria of selection, evaluation and re-evaluation
shall be defined
• Records of evaluation and actions arising out of
evaluations shall be maintained
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7.4 Purchase
7.4.2 Purchasing Information
Purchasing information shall describe the product to be
purchased, where appropriate :
Requirements for :
 approval of Product
 approval of Procedures
 approval of processes
 approval of Equipment
 Personnel qualification
 Quality Management system requirements
Organization to ensure adequacy of specified
requirements prior to communication to
supplier
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7.4 Purchase
7.4.3 Verification of Purchase Product

• Establishment and implementation of Inspection


activities for suitable verification of Purchased product
• When verification is to be Performed at supplier’s
Premises :
 Clear statement of verification arrangements
 Method of product release has to be mentioned in
purchasing information

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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

The Validation of processes is required where:

• The resulting output cannot be verified by


subsequent monitoring and measurement
• The deficiencies may become apparent only after
the product is in use or service has been delivered
• Validation shall demonstrate the ability to achieve
planned results

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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 )

• Care to be exercised for customer’s property while


under organizations control or use
• Identification, verification, protection and
maintenance of customer property when provided for
use or incorporation into the product
• Recording and reporting of loss or damage to
customer’s property - information to customer
• Customer property may include intellectual property
& personal data (e.g. Pan card / Medical test reports )
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7.5 Production & Service Provision
7.5.5 Preservation of Product
• Preservation of the product during internal processing
and delivery in order to maintain conformity
requirements
• Product conformity to be maintained by a system of :
 Identification, Handling, Packaging, storage,
protection
• Preservation shall also apply to the constituents parts
of a product

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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

8.2 Monitoring and measurement

8.3 Control of nonconforming product

8.4 Analysis of Data

8.5 Improvements

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8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction

• Customer Complaints are a common indicator of low


customer satisfaction but their absence does not necessarily
imply high customer satisfaction
• Even when Customer requirements have been agreed with
the customer and fulfilled, this does not necessarily ensure
high customer satisfaction
• A customer can be internal or External to the organization

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8.2 Monitoring & Measurement
8.2.2 Internal Audit

A documented procedure shall be

established to

define the responsibilities and

requirements for planning and conducting audits,

establishing records and reporting results.

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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

A documented procedure shall be established to

define the controls and related responsibilities and

authorities for dealing with nonconforming product

It shall be intended for

 Identification of Non-Conforming Product

 Control to Prevent Unintended Use or Delivery


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8.0 Measurement, analysis & Improvements
8.4 Analysis of Data

Data sources shall be such in order to provide information


on :
 customer satisfaction

 Conformity to product requirements

 characteristics of trends of processes,


product including opportunities for
preventive action

 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

• Corrective and Preventive Actions

• Management Review

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8.5 Improvements
8.5.2 Corrective Action

• Corrective actions to be appropriate as per the impact of


NC’s encountered
• Determining the Causes of NC
• Evaluation of Actions to avoid recurrence
• Determining the C.A and its Implementation
• Recording the C.A. taken
• Review effectiveness of C.A taken
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8.5 Improvements
8.5.3 Preventive Action

• Preventive actions to eliminate causes of potential NCs and


to prevent occurrence
• Preventive actions to be appropriate as per the impact of
the potential problem
• Evaluating the need for action to prevent occurrence of NCs
• Determining the PA’s and its implementation
• Recording the PA’s taken
• Review effectiveness of PA’s take

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