Benefits for growing organizations

ISO 9001:2008

Standards Unit Measurement.1. Measuring Tapes :Ex-Meter, Kilo Meter Etc

2. Weighing Balance: Ex - Grams, Kg Etc

Standards

Indian Standards

: ISIIndian

Standards Institutes

International Standards: ISO

InternationalOrganization for

Standardization

Quality

Future of the product. Conformance to the requirement. Expectation of the customer. Inheritant characteristics of the

product.

Organizations already have established management systems

These systems do have some or the other operating problem• Inability to ensure consistency in quality

of inputs in processes of deliverables

• Ongoing confusions in employee functionalities• Repeating mistakes• Absence of customer satisfaction assurance• Employee unrest• Increasing ‘Cost of Poor Quality’ (cost incurred due to absence

of quality) Long term continuity can not be guaranteed with

traditional systems

Organizations need a Sustainable Operating System

A system which should be able to• Assure quality at all times• Increase productivity• Improve financial

performance• Keep all stakeholders,

employees and customers satisfied

• Ensure error-free operations• Sustain in the long run!

ISO 9001:2000 offers a sustainable management operating system

ISO 9001:2000 is an internationally recognized Quality Management System• With the process approach, it covers all aspects of

every organization – right from procurement to end service delivery

• It aligns businesses for long term sustainability• Generic in nature, it can fit into any environment

Commercial organizations – Manufacturers, service providers

Non Profit organizations – Trusts, Governments, NGOs• Best of all, it is a voluntary standard

NO legal enforcement One need to adopt it on will

The Quality Standard is a result of years of research

ISO (International Organization for Standardization)• Founded in 1947• Is a Non-Profit Organization• More than 150 countries are developing & promoting ISO

standards as members (India is one of them)

Till date ISO has published more than 4000 standards

The Quality Management System – ISO 9000 is in use for more than 18 years

• First released in 1987• Revised in 1994 and 2000

ISO 9000 is actually a series of standards

Reference ISO QUALITY SERIES Type ISO 9000:2000 Quality Management Systems ‑ Fundamentals and

Vocabulary Specifies the terminology for (9000:2000) quality management systems.

Support

ISO 9001:2000 Quality Management Systems– Requirements Outline requirements (9001:2000) which exhibits where an organization must evidence a focus on customer service and demonstrate its ability to provide products that meet customer and applicable regulatory requirements.

Primary

IS0 9004:2000 Quality Management System– Guidelines for performance improvements *ISO (9004:2000) is not a Conformance Standard. It is an internal quality management standard. Its elements are not intended for external quality assurance systems. The aim of this standard is to monitor the effectiveness and efficiency of the quality management system, focusing on overall performance, improvement, and customer satisfaction.

Secondary*

ISO 9001:2000 is a certifiable standard

The certification of ISO 9001:2000 demonstrates• The organization’s customer focus• Long term continuity aspect of the organization

Before the certification body audits the system, the organization must have• Documented the Quality Manual and Procedures• Evidence of system generated quality records• Conducted the internal audits and reviews• Ensured the smooth functioning of the system for a

specific period

Once certified to ISO 9001:2000, the organization enjoys lot of benefits

Internal Benefits• Clarity in organizational

roles, responsibilities and authorities

• No repetition of errors• Increased productivity• Increased employee

satisfaction• Better supplier co-

operation• Establishment of proper

control over processes• Timely availability of

critical information to key personnel

External Benefits

- Better brand image

- Improved customer trust level.

- Increased market opportunities due to international recognition.

Quality Management Systems – Requirements

1. Scope

1.1 General

This International standard specifies requirements for a quality management system where an organization.

a)Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements.

b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organisation and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organisation’s ability, or responsibility, to provide product that meets customer and applicable regularly requirements.

2 Terms and definitions

The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:

Supplier Organisation Customer

4 Quality Management System

The organisation shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organisation shall

a) identify the processes needed for the quality management system and their application throughout

the organisation (see 1.2).b) determine the sequence and interaction of these processes.c) determine criteria and methods needed to ensure that both the

operation and control of these processes are effective,

d) ensure the availability of resources and in formation necessary to support the operation and monitoring of these processes,

e) monitor, measure and analyse these processes, and f) Implement actions necessary to achieve planned results andcontinual improvement of these processes.

These processes shall be managed by the organisation in accordance with the requirements of this International Standard.

4.2 Documentation requirements

The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives,

b) a quality manual,

c) documented procedures required by this International Standard

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard (see 4.2.4)

4.2.2 Quality manual

The organisation shall establish and maintain a quality manual that includes

the scope of the quality management system, including details of and justification for any exclusions (see 1.2),

the documented procedures established for the quality management system, or reference to them, and

a description of the interaction between the processes of the quality management system.

4.2.3 Control of documentsDocuments required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall 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 ensure that changes and the current revision status of

documents are available at points of use. to ensure that changes and the current revision status of

documents are identified. to ensure that documents remain legible and ready

identifiable, to ensure that documents of external origin are identified

and their distribution controlled, and to prevent the unintended use of obsolete documents,

and to apply suitable identification to them it they are retained for any purpose.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

5 Management responsibility5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

establishing the quality policy,

ensuring that quality objectives are established,

conducting management reviews, and

ensuring the availability of resources.

5.2 Customer focus

Top management shall ensure that the customer requirements are determined and met with the aim of enhancing customer satisfaction ( see 7.2.3 and 8.2.1)

5.3 Quality Policy

Top management shall ensure that the Quality Policy

is appropriate to the purpose of the organisation, includes a commitment to comply with

requirements and continually improve the effectiveness of the quality management system,

provides a framework for establishing and reviewing quality objectives,

is communicated and understood within the organization, and

is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements, for product are established at relevant functions and levels within the organisation.

The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that

the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.