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Workshop
BY:
CHRD,
HYDERABAD.
Welcome
and
Greetings to the
Delegates
Attending
The
Workshop on ISO9001:2008
INTRODUCTION
Your Tutor
Your name
Your organisation
Your current level of QMS knowledge
Your expectations from this event
Internal Audits
QUALITY
and
QUALITY MANAGEMENT
What is ‘ Quality’:
Historical evolution
Description and definitions
What is ‘quality’:
The ISO 9000:2005 definition
Degree to which a set of inherent characteristics fulfils
requirements
Inherent characteristics can be physical, sensory, behavioral,
temporal, ergonomic and functional……
Requirements are the needs or expectations that are stated,
generally implied or obligatory
QMS
QUALITY
MANAGEMENT SYSTEMS
ISO
International Organisation for Standardization
Who is ISO?
Why is standardization needed?
How does ISO function?
The roles of
ISO
Certification bodies
Accreditation bodies
IRCA (International Registration Certification of Auditors)
Evolution of standards
Initiation
Technical committee ISO/TC 176
Quality management and Quality assurance
Sub committee SC2,Quality Systems
Various stages of drafts
Approval by voting
Issue of standard
Periodic review of the standard
Certified Organizations
Foreword
About ISO
Fourth edition cancels and rejects the third edition
The amendments are to clarify points in text and to
enhance compatibility with ISO 14001:2004
Introduction
0.1 General
• Quality management, a strategy
• The design of QMS depends on
• The organizational environment,
• Changes in that environment,
• And risk associated with that environment
• Uniformity of systems across organizations not intended
• Standard can be used by internal and external parties
• Including certification bodies
0.2 Processes:
Controls
(e.g. procedure)
Process
Activities
Input +
Output
Resources
Introduction
1.1 General
Standard specifies QMS requirements for use to :
NOTE
“Product” –
Applies only to product intended for, or required by, a
customer
Requirement:
Intent:
Requirement:
NOTE1:
Where the term “documented procedure” appears within this
International Standard, this means the procedure is to be
established, documented, implemented and maintained.
i.e. MANDATORY PROCEDURE
NOTE2:
The extent of quality management documentation can differ
from one organization to another due to:
The size of organization and type of activities
The complexity of processes and their interactions
The competence of personnel
NOTE3:
The documentation can be in any form or type of medium
Intent:
Documentation of
Examples
Work procedures or work instructions(Wls)
Operating instructions or operating procedures
(SOPs)
Production schedules
Specifications (Specs)
Drawings
Requirement:
Intent:
Requirements:
Intent:
Examples:
Requirement :
Intent:
Requirement:
Intent:
Requirement:
Intent:
Examples:
Requirement:
Intent:
Example:
Requirement:
Top management shall ensure that quality objectives, including those
needed to meet requirements for product (section 7.1 a), are established
at relevant functions and levels within the organisation. The Quality
objectives shall be measurable and consistent with the Quality policy.
Intent :
Establishment of clearly defined quality objectives at Organization and/or
functional levels, including those for products and services, which
should be SMART and in line with the organization’s quality policy.
Examples:
Requirement:
Intent:
Example:
Strategic plans
Production plans
Resource plans/ records
Documented procedures/process descriptions
Work and test schedules
Quality objective realization /action plans
Requirement:
Top management shall ensure that the responsibilities and authorities are
defined and communicated within the organization.
Intent:
Top management to ensure that everyone knows what they are expected
to do (responsibilities), what they are allowed to do (authorities), and
that they understand how these responsibilities and authorities relate
to each other.
There should be a formal communication of the same to employees.
Requirement:
Note:
Intent:
Requirement:
Intent:
Requirement:
Intent:
Example:
Strategic review
Project based review
Operational review
Requirement:
Intent:
Agenda or the points to be discussed with the management during the
review to assess the suitability, adequacy and effectiveness of the
Quality Management system of the organization
Requirement:
The outputs from the management review shall include any decision and
actions related to:
Improvement of the effectiveness of the quality management system
and its processes;
Improvement of product related to customer requirements;
Resource needs.
Requirement:
Intent:
Ensure that the organization has the resources needed to both maintain
and improve its quality management system and also carry out the
work required in a manner that will satisfy customer’s requirements.
Examples:
Requirement:
Intent:
Requirement:
Intent:
Requirement:
Intent:
Example:
Requirement:
Intent:
Requirements:
Requirement:
The organization shall plan and develop the processes needed for product
realization.
Planning of product realization shall be consistent with the requirements
of the other processes of the quality management system(see 4.1)
In planning product realization, the organization shall determine the
following, as appropriate:
Quality objectives and requirements for the product;
The need to establish processes, documents, and provide resources
specific to the product;
Requirement:
NOTE 1
NOTE 2
The organization may also apply the requirements given in 7.3 to the
development of product realization processes.
Intent:
Standard requires to plan how all the activities necessary for concept to
delivery of the product / services.
Extent:
The organization needs to plan how all the activities for product
realization to be planned and performed e.g.
To consider what the customer requires- stated needs and implied
needs.
To decide the objectives related to productivity and quality
To determine the resource needed.
To make budget, purchase machinery etc.
To review design output against the requirement.
Requirement:
Intent:
Requirement:
Records of the results of the review and actions arising from the review
shall be maintained (see 4.2.4)
Intent:
The manner in which a customer provides the order can vary in form
and could be, for example, a written order, a verbal agreement, a
telephone order or via e- business.
Where changes to an order or tender, or both, arise for what ever
reason, the changes need to be reviewed and agreed in the same
manner as the original order / tender. If the changes are accepted, it is
essential that every one in your business who is affected by the
changes is informed.
The relevant documents affected by these changes will need to be
amended as well
Requirement:
Product information,
Enquires, contracts or order handling, including amendments, and
Customer feed back, including customer complaints.
Intent: