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ISO 9001:2008 QMS

COURSE Materials
Introduction of the Resource Person

Engr. Bilal Haider


Lecturer
Institute of Chemical Engg. & Tech.
University of the Punjab, Lahore

Qualification: B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000

Professional Affiliations: PNAC & NA

Professional Trainings:

ISO/IEC 17025 Assessor Course, Norwegian Accreditation (Norway)


IRCA Qualified ISO 9000 Auditor
National Quality Award Assessor (NQAA) Course organized by Asian Productivity
Organization (APO), Japan.
Evaluation of Measurement Uncertainty, Norwegian Accreditation (Norway)
ISO 17020 General criteria for the operation of various types of bodies performing
inspection organized by PNAC
Discussion Topics
Introduction to Quality and Standardization

Evolution of Quality Management System


(ISO 9000)

Quality Management System - Requirements


(ISO 9001:2008)
Introduction to Quality and
Standardization
What is Quality after all?
Quality!
Fitness for use Juran

Conformance to requirements Crosby

Customer satisfaction/delight Deming

Degree to which a set of inherent characteristics


fulfils requirements - ISO 9000:2000
Customer Satisfaction
Degree to which the customers requirements have been
fulfilled

Performance < 1 - Dissatisfaction


Satisfaction = = 1 - Satisfaction
Expectation > 1 - Delight
Standardization
The process of developing and agreeing upon Standards.
Aims of Standardization
Fitness for purpose
Interchangeability
Variety reduction
Compatibility
Guarding against factors that affect the
health and safety of consumers
Environmental protection
Better utilization of resources
Better communication and
understanding
Better communication and
understanding
Removal of trade barriers
Standard?

Standards are documented agreements


containing technical specifications or precise
criteria to be used consistently as a
guideline of characteristics, to ensure that
materials, products, processes and services
are fit for their intended purpose.
TYPES OF STANDARDS
Vocabulary standards:
Glossaries, signs and symbols; A few examples are Paper Vocabulary, List of
Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory
Industry and Vocabulary of Information Processing.

Measurement standards:
Material measure or physical property that defines or reproduces the unit of
measurement of a base or derived quantity. Such as units of measures; The seven
basic units of the SI system e.g. meter, Kg, Ampere etc.

Product standards:
Cover specifications for dimensions, performance, health, safety, environmental
protection and documentation; Standards for inspection, test methods and analysis.

Management Standards:
Standards that focus on organization, such as for logistics, maintenance,
inventory management, quality management, project management and production
management such as ISO 9000, ISO 14000, ISO 17025, SA 8000, HACCP etc.
Attributes of a standard

A standard generally has three attributes:

1. Level: such as at the company, national or international level.

2. Subject: such as engineering, food, textile or management.

3. Aspect: such as specification, testing and analysis, packaging and


labeling (more than one aspect may be covered in a single standard: a
standard may include specification of items such as the product, its
sampling and inspection, related tests and analysis, packaging and
labeling).

For example the term Pakistan Standard Specification of Biscuits,


means that the standard is a national standard (level), in the food area
(subject), and provides specifications (aspect) for the biscuits.
Infrastructure for Standardization in Pakistan

ILAC ISO
Legal framework in Pakistan BIPM
IAF

Accreditation Board Standards Institute OIML


PNAC PSQCA
An institution for training and monitoring Auditors

System System System Laboratory


certifiers.. auditors consultants accreditation N NPSL
ISO 17025 ATIO
IB R
L
CA

ATION
HACCP ISO14000 ISO 9000 LABORATORIES

Legal
metrology

CALIBR
Microbe Chemical Textile

TESTING SERVICES

Factory Trade
metrology transaction
lab

ENTERPRISES
Renowned Standardization Bodies
ISO International Organization for Standardization
ASTM American Society for Testing and Materials
DIN Deutsches Institut fr Normung
EN European Norms

IEC International Electrotechnical Commission


BSI British Standards Institute
Certification
1. Means Compliance with a standard or
specification (e.g. Systems or Product
Standards).
2. May be general in the scope of
recognition
3. Considers total business .
Accreditation
1. It means recognition of competence in a
specific area and scope.
2. Its scope is highly specific.
3. Evaluates people, skills and knowledge.
Evolution of Quality Management
System ISO 9001:2008

1987 First Published ISO 9001, 9002 & 9003

1994 First revision ISO 9001, 9002 & 9003

2000 Second revision - ISO 9001

2008 Third revision ISO 9001


Quality Management System

Management System to direct & control an organization


with regard to quality.
Quality management Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process Approach
5. System approach to management
6. Continuous Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier
relationships
Quality Management Principle No.1
Customer Focus
Organizations depend on their customers
and therefore should understand current and
future customer needs, should meet
customer requirements and strive to exceed
customer expectations.

Application of this principle is reflected in


ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1
Customer Focus...

Application of this principle involves :


Researching and understanding customer needs
and expectations.
Ensuring that the objectives of the organization are
linked to customer needs and expectations.
Communicating customer needs and expectations
throughout the organization.
Measuring customer satisfaction and acting on the
results
Systematically managing customer relationships.
Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole)
Quality Management Principle No.2
Leadership
Leaders establish unity of purpose and
direction of the organization. They
should create and maintain the internal
environment in which people can
become fully involved in achieving the
organizations objectives.

This principle is reflected in ISO


9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2
Leadership...

Application of this principle involves:


Considering the needs of all interested parties including
customers, owners, employees, suppliers, financiers,
local communities and society as a whole.
Establishing a clear vision of the organizations future.
Setting challenging goals and targets.
Creating and sustaining shared values, fairness and
ethical role models at all levels of the organization.
Establishing trust and eliminating fear.
Providing people with the required resources, training
and freedom to act with responsibility and accountability.
Inspiring, encouraging and recognizing peoples
contributions.
Quality Management Principle No.3
Involvement of people

People at all levels are essence of an organization


and their full involvement enables their abilities to be
used for the organizations benefit. This principle is
reflected in ISO 9001:2008 clauses 5.3(d) and 6.2.
Involvement of people...

Application of this principle involves:


People understanding the importance of their
contribution and role in the organization.
People identifying constraints to their performance.
People accepting ownership of processes and
problems and their responsibility for solving them.
Involvement of people...

People evaluating their performance against their


personal goals and objectives.
People actively seeking opportunities to enhance their
competence, knowledge and experience.
People freely sharing knowledge and experience.
People openly discussing problems and issues.
Quality Management Principle No.4
Process Approach

A desired result is achieved more efficiently when


activities and related resources are managed as a
process.

This principle is reflected in almost all clauses of


ISO 9001
Process Approach...

Application of this principle involves:

Systematically defining the activities necessary to obtain a desired


result.
Establishing clear responsibility and accountability for managing key
activities.
Analyzing and measuring of the capability of key activities.
Process Approach...

Identifying the interfaces of key activities within and


between the functions of the organization.
Focusing on the factors - such as resources, methods,
and materials - that will improve key activities of the
organization.
Evaluating risks, consequences and impacts of activities
on customers, suppliers and other interested parties.
Quality Management Principle No.5
System approach to management

Identifying, understanding and managing inter-


related processes as a system contributes to the
organizations effectiveness and efficiency in
achieving its objectives. This principle is reflected in
ISO 9001:2008clauses 4.1& 4.2.
System approach to management...

Application of this principle involves:


Structuring a system to achieve the organizations
objectives in the most effective and efficient way.
Understanding the inter-dependencies between the
processes of the system.
Structured approaches that harmonize and integrate
processes.
System approach to management...

Proving a better understanding of the roles and responsibilities necessary for


achieving common objectives and thereby reducing cross-functional barriers.
Understanding organizational capabilities and establishing resource constraints
prior to action.
Targeting and defining how specific activities within a system should operate.
Continually improving the system through measurement and evaluation.
Quality Management Principle No.6
Continual Improvement

Continual improvement of the organizations overall


performance should be a permanent objective of the
organization.

This principle is reflected in ISO 9001 clause 8.5.


Continual Improvement...

Application of this principle involves:


Employing a consistent organization-wide approach
to continual improvement of the organizations
performance.
Providing people with training in the methods and
tools of continual improvement.
Continual Improvement...

Making continual improvement of products,


processes and systems an objective for every
individual in the organization.
Establishing goals to guide, and measures to track,
continual improvement.
Recognizing and acknowledging improvements.
Quality Management Principle No.7
Factual approach to decision making

Effective decisions are based on the analysis of


data and information.

This principle is reflected in ISO 9001:2008


clauses 5.4.1, 5.6.2, 7.3 and 8.4
Factual approach to decision making

Application of this principle involves:


Ensuring that data and information are sufficiently
accurate and reliable.
Making data accessible to those who need it.
Analyzing data and information using valid methods.
Making decisions and taking action based on actual
analysis, balanced with experience and intuition
Quality Management Principle No.8
Mutually beneficial supplier relationships

An organization and its suppliers are inter-


dependent and a mutually beneficial
relationship enhances the ability of both to
create value.
This principle is reflected in ISO 9001:2008
clause 7.4
Mutually beneficial supplier relationships

Application of this principle involves:


Establishing relationships that balance short-term
gains with long-term considerations.
Pooling of expertise and resources with partners.
Identifying and selecting key suppliers.
Clear and open communication.
Mutually beneficial supplier relationships

Sharing information and future plans.


Establishing joint development and improvement
activities.
Inspiring, encouraging and recognizing improvements
and achievements by suppliers.
ISO 9000 standards
Three important standards in the family of ISO 9000
International Standard are:

ISO 9000: Concepts, Principles, Fundamentals and


Vocabulary

ISO 9001: Sets the QMS Requirements to be met

ISO 9004: Provides guidance for Continual improvement of


organizations overall performance
ISO 9001:2008
Internationally accepted management standard that
has become a world benchmark for good
management practice
Generic standard i.e. any industry sector viz.
manufacturing or service (education, hospitals,
hotels, banks, transport, accountancy, etc.) can use
it.
Any type (private, public, government enterprise,
etc) and any size of enterprise can use it (big, small
or tiny)
PDCA Methodology
Plan

Act
Do

check
Model of Process based Quality Management System
Continual Improvement of the quality
management system

R S
E A
Q Management
T
C responsibility C
U I
U U
I S
S S
R F
T Measurement, T
E Resource
A
O management
analysis &
O
M improvement C
M M
E T
E E
N I
R Product R
T Product O
realization
S N
ISO 9001:2008
Quality Management System - Requirements

1.0 Scope
2.0 Normative References
3.0 Terms and Definitions
4.0 Quality Management System Requirements
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis & Improvement
Quality Management System - 1
4.1 General Requirements
a) Identification of the processes for the QMS
b) Determine the sequence of these processes
c) Determine criteria for effective operation &
control of these processes
d) Ensure the availability of resources
e) Monitor, measure (where applicable) and
analyze these processes
f) Implement actions necessary for achieving
planned results and continual improvement
Quality Management System - 2
4.2 Documentation Requirements - 1
4.2.1 General
The QMS Documentation shall include:
a) Quality Policy & Quality Objectives
b) Quality Manual
c) Documented procedures and records required
by this Standard
d) Documents needed for planning, operation and
control of processes
e) Records required by this Standard
Quality Management System - 3
4.2 Documentation Requirements - 2
4.2.2 Quality Manual
a) Scope of QMS / Justification of the Exclusions
b) Documented procedures or reference to them
c) Description of interaction between the processes
of the QMS
Quality Management System - 4
4.2 Documentation Requirements - 3
4.2.3 Control of documents
Establish documented procedure to define method to:
a) Approve documents
b) Review, update and re-approve documents
c) Identify the revision status / changes
d) Ensure availability of relevant versions at point of
use
e) Ensure documents are legible and readily
identifiable
f) Identification and Control the external documents
g) Identification and Control of obsolete documents
Quality Management System - 5
4.2 Documentation Requirements - 4
4.2.4 Control of records
a) Establish / Maintain records to demonstrate
conformity to this International Standard
b) Keep records legible, readily identifiable and
retrievable
c) Establish documented procedure for
identification, storage, protection, retrieval,
specify retention time and their disposition
Documentation Requirements
Clause 4
Documents
Quality manual
Flow chart of major processes and their
interaction
Document control procedure
Record control procedure.
Description of out sourced services and their
control procedure.
Records
Document updating records
Disposal of quality records
Management Responsibility - 1
5.1 Management Commitment
a) Communication to the organization the
importance of meeting customer, statutory
and regularity requirements
b) Establish Quality Policy & Quality Objectives
c) Conducting Management Reviews
d) Ensuring the availability of resources

5.2 Customer Focus

Determine and meet the customer requirements


for enhancing customer satisfaction
Management Responsibility - 2
5.3 Quality Policy

a) Is appropriate to the purpose of the


organization
b) Includes a commitment to comply with and
continually improve the QMS
c) Provides framework of establishing and
reviewing Quality Objectives
d) Is communicated and understood within
organization
e) Is reviewed for continuing suitability
Management Responsibility - 3
5.4 Planning - 1
5.4.1 Quality Objectives
a) Needed to meet the requirements of the
product are established at relevant functions
within the organization
b) Are measurable and consistent with the
Quality Policy
Management Responsibility - 4
SMART Objectives

Specific
Measurable
Achievable
Results orientated
Time bound
Management Responsibility - 5
5.4 Planning - 2
5.4.2 Quality Management System Planning
Top Management shall ensure that
a) Planning is done for meeting the requirements
of this standard (4.1) and Quality Objectives
b) Integrity of the QMS is maintained when
changes to QMS are planned and implemented
Management Responsibility - 6
5.5 Responsibility, Authority and Communication - 1
5.5.1 Responsibility and Authority
Are defined and communicated
5.5.2 Management Representative
The Management Shall appoint a Management
Representative responsible to :
a) Ensure that processes for QMS are established,
implemented and maintained
b) Reporting to top management on performance of QMS
and any need for improvement
c) Ensure the promotion of awareness of customer
requirements throughout the organization
Management Responsibility - 7
5.5 Responsibility, Authority and Communication - 2
5.5.3 Internal Communication
Top management shall ensure that
appropriate communication processes are
established within the organization and that
communication takes place regarding the
effectiveness of quality management system.
Management Responsibility - 8
5.6 Management Review - 1
5.6.1 General
The management shall review the QMS at
planned intervals to ensure its continued
suitability, adequacy and effectiveness
The review shall include :
a) Assessing opportunities for improvement
and need for changes to the QMS
b) Review of the Quality Policy and Quality
Objectives
Records of the reviews must be kept
Management Responsibility - 9
5.6 Management Review - 2
5.6.2 Review Inputs
The Inputs shall include information on:
a) Results of audits
b) Customer feedback
c) Process performance and product conformity
d) Status of preventive and corrective action
e) Follow-up actions from previous
management review
f) Changes which could affect the QMS
g) Recommendations for improvement
Management Responsibility - 10
5.6 Management Review - 3
5.6.3 Review Outputs
The Outputs shall include any decisions and
actions on:
a) Improvement of the effectiveness of quality
management system and processes,
b) Improvement of product related to customer
requirements
c) Resources needs
Documentation Requirements
Clause 5
Documents
Quality objectives at organizational and
functional level.
Organization structure and responsibilities of
management representative and key
functionaries whose job affects product
quality.
Description of internal communication channel. (
This could be specified in quality manual)
Procedure for management review
Records
Evidence of quality planning
Record of management review
Resource Management - 1
6.1 Provision of Resources
The Organization shall determine and provide
resources needed to :
a) Implement and maintain the QMS and
continually improve its effectiveness
b) Enhance customer satisfaction by meeting
customer requirements.
Resource Management - 2
6.2 Human Resources
6.2.1 General
Competent persons should perform work effecting quality
6.2.2 Competence, awareness and training
a) Determine the necessary competence for the
personnel performing work effecting quality
b) Provide training and take action to satisfy these
needs
c) Evaluate the effectiveness of the action taken
d) Ensure that its personnel are aware of relevance and
importance of their activities and how they contribute
to the achievement of the quality objectives
e) Maintain appropriate records of education, training,
skills and experience
Resource Management - 3
6.3 Infrastructure
The organization shall determine, provide and
maintain the infrastructure needed to achieve
product conformity, it includes:

a) Building, workplace and associated utilities


b) Process equipment (both hardware and
software)
c) Supporting services(such as transport or
communication)
Resource Management - 4
6.4 Work Environment

The organization shall determine and manage


the work environment needed to achieve
conformity to product requirements
Documentation Requirements
Clause 6
Documents
Specific requirement of qualification and
competence of personnel
Procedure for identifying training needs and
yearly training plan
List of special facilities or work environments
affecting quality
Procedure for maintenance of buildings
equipment and facilities
Record
Record of training and experience of personnel
Maintenance record
Product Realization - 1
7.1 Planning of Product Realization
Organization shall plan and develop the processes
needed for product realization, while considering the
Following factors as appropriate:

a) Quality objective and requirements for the product


b) Need to establish processes, documents, and
provide resources specific to the product
c) Required verification, validation, monitoring,
inspection and test activities specific to the product
and the criteria for product acceptance
d) Records needed to provide evidence that the
realization processes and resulting product meet
requirements (see 4.2.4)
Product Realization - 2
7.2 Customer Related Processes - 1
7.2.1 Determination of requirements related to the product
The organization shall determine:
a) Requirements specified by customer including
(delivery conditions & post Delivery activities)
b) Requirements not stated but necessary for the
intended use, where known
c) Statutory & regulatory requirements related to
product
d) Any additional requirement determined by the
organization
Product Realization - 3
7.2 Customer Related Processes - 2
7.2.2 Review of Requirements Related to the Product
Review following before the acceptance of contract :
a) Product requirements are defined
b) Contract or order requirements differing from those
previously expressed are resolved
c) The organization has the ability to meet the defined
requirements.

Results of the reviews must be maintained


Any change in requirements is communicated to all
Product Realization - 4
7.2 Customer Related Processes - 3
7.2.2 Customer Communication
The organization shall define and implement
Effective arrangements for communicating with
customers in relation to :
a) Product information
b) Enquiries, contracts or order handling,
including amendments, and
c) Customer feedback, including customer
complaints
Product Realization - 5
7.3 Design and Development - 1
7.3.1 Design and Development Planning
Organization shall determine the
a) Design and development stages,
b) Review, verification and validation that are
appropriate to each design and development
stage, and
c) Responsibilities and authorities for design
and development Planning output shall be
updated, as appropriate, as the design and
development progresses
Product Realization - 6
7.3 Design and Development - 2
7.3.2 Design and Development Inputs
Inputs related to product requirements including following
shall be determined,
a) Functional and performance requirements,
b) Applicable statutory and regulatory requirements,
c) Where applicable, information derived from previous
similar design, and
d) Other requirements essential for design and
development

The requirements must be complete, unambiguous and


not in conflict in each other

The requirements must be reviewed for adequacy and


records must be maintained
Product Realization - 7
7.3 Design and Development - 3
7.3.3 Design and Development Outputs
The design and development outputs shall:
a) Meet the input requirements for design and
development
b) Provide appropriate information for
purchasing, production and for services
provision
c) Contain or reference product acceptance
criteria
d) Specify the characteristics of the product
that are essential for its safe and proper use
Product Realization - 8
7.3 Design and Development - 4
7.3.4 Design and Development Review

Reviews by representatives of the functions


concerned shall be performed in accordance with
planned arrangements (see 7.3.1) to :

a) Evaluate the ability of the results of design


and development to meet requirements, and
b) Identify any problems and propose necessary
actions.
Records of reviews and any necessary actions
shall be maintained
Product Realization - 9
7.3 Design and Development - 5
7.3.5 Design and development verification

Verification shall be performed in accordance


with planned arrangements (7.3.1) to ensure
that design and development outputs have
met the design and development input
requirements.
Records of the results and any actions shall
be maintained.
Product Realization - 10
7.3 Design and Development - 6
7.3.6 Design and development validation
Validation shall be performed in accordance
with planned arrangements (7.3.1) to ensure
that Resulting product is capable of meeting
requirements for intended use, where known.
Where practicable, validation shall be
completed prior to the delivery or
implementation of the product
Records of the results and any actions shall
be maintained.
Product Realization - 11
7.3 Design and Development - 7
7.3.7 Control of design and development changes
The changes will be reviewed, verified and
validated as appropriate and approved before
implementation.
The review for change shall include evaluation
of the effects of the change on constituent
parts and product already delivered.
Records of the changes and any actions shall
be maintained.
Product Realization - 12
7.4 Purchasing - 1
7.4.1 Purchasing Process
The organization shall ensure that purchased
product conforms to specified purchase
requirements
The type and extent of control applied shall
be dependent upon the effect on the final
product
Product Realization - 13
7.4 Purchasing - 2
7.4.2 Purchasing Information
Purchasing information shall describe the
purchased product, including where appropriate:
a) Requirement for approval of product,
procedures, process and equipment
b) Requirement for qualification of personnel
c) Quality management system requirements
Product Realization - 14
7.4 Purchasing - 3
7.4.3 Verification of the Purchased Product
Establish and implement the inspection
activities necessary for ensuring
conformance of purchased product to
purchase information.
Where verification at the suppliers premises
is required by organization / customer, it
shall be indicated so in the purchase
information.
Product Realization - 15
7.5 Production and Service Provision - 1
7.5.1Control of Production and Service Provision
Production and service provision shall be carried out
under controlled conditions, as applicable:
a) Availability of information that describes the
characteristics of the product,
b) Availability of work instructions, as necessary,
c) Use of suitable equipment,
d) Availability and use of monitoring and measuring
devices,
e) Implementation of monitoring and measurement, and
f) Implementation of release, delivery and post-delivery
activities.
Product Realization - 16
7.5 Production and Service Provision - 2
7.5.2Validation of processes for production and service
provision
Validation of process shall be done where the resulting
output cannot be verified by subsequent monitoring or
measurement, the following shall be addressed:
a) Defined criteria for review and approval of the
processes
b) Approval of equipment and qualification of personnel
c) Use of specific methods and procedures
d) Requirements for records
e) Revalidation
Product Realization - 17
7.5 Production and Service Provision - 3
7.5.3Identification and Traceability

Identification of product by suitable means


throughout product realization
Identification of the product status with
respect to the monitoring and measurement
requirements
Where traceability is required the
organization shall control and record the
unique identification of the product
Product Realization - 18
7.5 Production and Service Provision - 4
7.5.4Customer Property
The organization shall
a) Identify, verify, protect and safeguard
customer property
b) In case of loss, damage or unsuitable for use
customer must be informed
c) Records must be maintained
Product Realization - 19
7.5 Production and Service Provision - 5
7.5.5Preservation of Product
The organization shall preserve the
conformity of product during internal
processing and delivery to the intended
destination.
This preservation shall include identification,
handling, packing, storage and protection.
Preservation shall also apply to the
constituent parts of product
Product Realization - 20
7.6 Control of Monitoring and Measuring Equipments
The equipments Shall be:
a) Calibrated or verified at specific intervals, or prior to use,
against measurement standards traceable to international or
national measurement standards, where no such standards
exist, the basis used for calibration or verification shall be
recorded
b) Adjusted or re-adjusted as necessary
c) Identified to enable the calibration status to be determined
d) Safeguarded from adjustments that would invalidate the
measurement result
e) Protected from damage and deterioration during handling,
maintenance and storage
f) Records shall be maintained
Documentation Requirements
Clause 7
Documents
Quality plan or other documents showing how
quality is planned in products/projects
Method of capturing customer requirements
Review of orders or contracts to assess
capability to meet customers requirements
Specifications for companys products
Procedure for design and development
Specifications for purchased materials
Documentation Requirements
Clause 7 contnd..
Documents
Procedure for selection and approval of
suppliers
Procedure for review of suppliers performance
Procedure for verification of purchased products
and dealing with non conforming supplies.
Procedures or work instruction for critical
processes.
Procedure for assessing process capability and
approval of processes.
Qualification of operators and processes where
quality cannot be verified after work is
finished.
Documentation Requirements
Clause 7 contd
Documents
Procedure for maintenance of critical equipment.
Procedure for identification and traceability of
materials (where required).
Inspection and testing plans/instructions.
Procedure for showing inspection/test status of
materials/equipment.
Procedure for calibration measuring devices.
Procedure for handling customer property.
Procedure for preservation, packaging and
storage of product.
Documentation Requirements
Clause 7
Records
Contract review of major contracts
Design review record
Results of design verification/validation
Inspection results of purchased materials.
Record of qualification of operators and
processes where output cannot be assessed
for non conformity.
Inspection and testing records
Record of rework and rejection
Calibration record of measuring devices.
Record of damaged or lost customer property
(where applicable).
Measurement, Analysis and Improvement - 1
8.1 General
Organization must plan and implement the
monitoring
measurement, analysis and improvement
processes
needed to :
a) Demonstrate conformity of the product
b) Ensure conformity of the QMS
c) Continually improve the effectiveness of QMS

Determine applicable method including Statistical


Techniques and extent of their use
Measurement, Analysis and Improvement - 2

8.2 Monitoring & Measurement - 1


8.2.1 Customer Satisfaction

Establish a method for obtaining and using


the information about customer perception
as to whether the organization has met
customer requirements
Measurement, Analysis and Improvement - 3
8.2 Monitoring & Measurement - 2
8.2.2 Internal Audit
Documented procedures Shall be established and
internal audits shall be conducted at regular intervals
to determine whether the QMS :
a) Conforms to standard and other requirements
determined by organization
b) Is effectively implemented and maintained

Audit shall be:


1. Planned, Criteria / Scope / Frequency and method be
defined.
2. Selection / conduct of audit shall ensure impartiality
3. Follow-up activities shall be performed
4. Records shall be maintained
Measurement, Analysis and Improvement - 4

8.2 Monitoring & Measurement - 3


8.2.3 Monitoring and measurement of processes
Apply methods for monitoring and where
applicable measurement of QMS processes.
Methods shall demonstrate the ability of the
processes to achieve the planned results.
In case planned results are not obtained
Corrective / Preventive actions must be taken
to ensure the conformity to the product.
Measurement, Analysis and Improvement - 5

8.2 Monitoring & Measurement - 4


8.2.4 Monitoring and measurement of product
Monitor the characteristics of the product at
appropriate stages in accordance with
planned arrangements (see 7.1)
Evidence of conformity and acceptance
criteria must be defined.
No product or service delivery shall not
proceed until the planed arrangement are
satisfactorily completed and approved by
authorized person.
Records shall also be maintained.
Measurement, Analysis and Improvement - 6
8.3 Control of Nonconforming Product - 1

The nonconforming products must be


identified and controlled to prevent unintended
use or delivery.
Documented procedure stating responsibility
and authority to deal with nonconforming
products shall be defined.
Measurement, Analysis and Improvement - 7
8.3 Control of Nonconforming Product - 2

The organization shall deal with nonconforming products


by :

a) Taking action to eliminate the detected non


conformity
b) Authorizing its use, release / acceptance under
concession by relevant authority if allowed by
customer.
c) Take action to prevent its original intended use

Records and actions taken shall be recorded.


Incase of rework product shall be re-verified
Incase the product has been delivered appropriate
actions shall be taken
Measurement, Analysis and Improvement - 8
8.4 Analysis of Data
Determine, collect and analyze appropriate data
to demonstrate the suitability and effectiveness
of the QMS and to evaluate where continual
improvement of the QMS can be made.
Analysis of data shall provide information
relating to:
a) Customer Satisfaction (see 8.2.1)
b) Conformity of product requirements (see 7.2.1)
c) Characteristics and trends of processes and
and products including opportunities of
Corrective action
d) Suppliers
Measurement, Analysis and Improvement - 9

8.5 Improvement - 1
8.5.1 Continual Improvement
The organization shall continually improve the
effectiveness of QMS through the use of :

Quality Policy
Quality Objectives,
Audit Results
Analysis of data,
Corrective and Preventive Actions
Management Review
Measurement, Analysis and Improvement - 10
8.5 Improvement - 2
8.5.2 Corrective Action

Corrective actions shall be taken to eliminate


causes
of nonconformities to prevent their recurrence.
Documented procedure shall be established to
define requirements for:

a) Reviewing nonconformities (including


customer complaints)
b) Determining the causes of nonconformities
c) Evaluating the need for action to ensure that
nonconformities do not recur
Measurement, Analysis and Improvement - 11
8.5 Improvement - 3

d) Determining and implementing action needed


e) Records of the action taken results
f) Reviewing corrective action taken
Measurement, Analysis and Improvement - 12
8.5 Improvement - 4
8.5.3 Preventive Action

Preventive actions shall be taken to eliminate


causes
of potential nonconformities to prevent their
occurrence. Documented procedure shall be
established to define requirements for:
a) Determining potential nonconformities and
their causes
b) Evaluating the need for action to prevent
occurrence of nonconformities
c) Determining and implementing action needed
Measurement, Analysis and Improvement - 13
8.5 Improvement - 5

d) Records of results action taken


e) Reviewing preventive action taken
Documentation Requirements
Clause 8
Documents
Procedure for measurement and monitoring of
processes for effective control.
Methods for use of statistical techniques for
process control and data analysis for
improvement.
Procedure for inspection and release of final
product.
Procedure for dealing with non conforming
product and use of material under
concession.
Procedure for monitoring customer satisfaction
and dealing with customer complaints.
Documentation Requirements
Clause 8 contnd..
Documents
Procedure of internal audit of QMS, along with
check list.
Procedure for corrective and preventive action.
Procedure for collection and analysis of data for
effectiveness and improvement of QMS.
Records
Process monitoring data and corrective action
taken for process control
Record of product non conformities and
products accepted on concession.
Documentation Requirements
Clause 8 contnd..
Records
Data analysis and activities for continual
improvement.
Result of internal audits and follow up action.
Data on customer feedback and action taken on
customer complaints.
No body
Can Achieve

QUALITY
Without
U
Thank you !!!