Iso 9000 Quality Management System
Iso 9000 Quality Management System
Iso 9000 Quality Management System
(ANSI).
ISO 9000 is a set of quality systems standards that may be tailored to almost any
organization choosing to adopt the model, regardless of size or industry. The standards are used
on an international scale for quality management and quality assurance. The ISO 9000 objective
is to lay a foundation for a standard language in documenting an organization's quality
procedures and requirements. It requires a system to track and manage evidence that quality
control practices are instituted throughout the organization. (1)The quality system is required to be
documented and employees are expected to follow the documented procedures. After the quality
system is implemented the firms can obtain registration through an audit preformed by an
independent (third- party) registrar.
ISO 9000 - Quality Management and Quality Assurance Standards - Guidelines for Selection
and Use. This subsection contains guidelines to be used in conjunction with the other four
standards in the series.
ISO 9001 - Quality Systems - Model for Quality Assurance in Design/Development, Production,
Installation, and Servicing. This is the most comprehensive standard and is used by organizations
who want to show competencies in all areas of their operations from design and manufacturing
to distribution and packaging.
ISO 9002 - Quality Systems - Model for Quality Assurance in Production and Installation. This
model is less stringent than ISO 9001 and is commonly adopted by general manufacturing firms.
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ISO 9003 - Quality Systems - Model for Quality Assurance in Final Inspection and Test. This
model, the most limited and least used one in the series, is used in organizations who wish to
document their inspection and testing policies and procedures. It is estimated that less than 5% of
organizations who follow the ISO 9000 Series use this model.
ISO 9004 - Quality Management and Quality System Elements - Guidelines. This model
provides insight with regard to the various elements to be included in a quality system as well as
the system's expected structure.
Development of the ISO 9000 Series began in 1979. That year, the ISO formed Technical
Committee (TC) 176 to address the topic of quality management and quality assurance with
respect to the worldwide trend of increasingly stringent customer demands for high quality. The
committee also wished to lessen the growing confusion in international trade that resulted from
differing national and sub national quality system requirements.
The ISO 9000 Standards Series on quality management and assurance was published in 1987 and
revised in 1994. It was based on the work of TC 176 and considerable input from many
countries, especially the United States, Canada, and the United Kingdom. In particular, the ISO
9000 standards reflected the British Standards Institution's BS 5750 Series Quality Systems. The
standards are scheduled to be reviewed every five years to keep them up to date.
Currently, ISO 9000 is the national standard for over 60 countries (Breitenberg, 1993), including
Canada, Japan, Mexico, and the United States. Adoption of the standards by the countries does
not mean they are a government enforced requirement. It means customers or buyers in these
countries are requiting ISO 9000 of their suppliers. (1) Criticism of ISO 9000 generally relates to
the high level of paper work and documentation, a rigid system that does not support creativity
or empowerment, a standard that aims for consistency but not continuous quality improvement,
etc.
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Implementation of ISO affects the entire organization right from the start. This
implementation results in “cultural transition” to an atmosphere of “continuous improvement”.
The process of implementing ISO 9000 depends on:
Sophistication of the existing quality program.
Size of the organization
Complexity of the process.
There are 14 steps which has to be followed in order to successfully implement ISO 9000
Quality management system.
The second step deals with establishing the implementation team and appoint
Management Representative (MR) and its co-coordinators to oversee the implementation. The
team should include representative from all function such as marketing, design & development,
planning, production, quality control etc. MR is the person within the Organization who acts
as interface between organization management and the ISO 9000 registrar. His role
is, in fact, much broader than that. The MR should also act as the organizations
"Quality management system champion".
The main reason behind the ISO 9000 awareness programs is to communicate the
employees
The aim of the ISO 9000 quality management system.
The advantage it offers to employees, customers and the organization.
How it will work, and their roles
Responsibilities within the system.
Suppliers of materials and components should also participate in these programs.
The awareness program should emphasize the benefits that the organization expects to realize
through its ISO 9000 quality management system. The program should also stress the higher
levels of participation and self-direction that the quality management system renders to
employees. Such a focus will go far to enlist employee support and commitment. The programs
could be run either by the implementation team or by experts hired to talk to different levels of
employees.
The next step in the implementation process is to compare the organization’s existing quality
management system with the requirements of the standard (ISO 9001:2000). For this purpose, an
organization flow chart showing how information actually flows from order placement by the
customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow
chart of activities in each department should be prepared. With the aid of the flow charts, a
record of existing quality management system should be established. This document should be
incorporated into the new quality management system. This is referred to as " gap analysis''. In
this analysis these things are analyzed
What is the present operation/process? What already exists?
Analyze the relevant sections of the quality standard - ISO 9001:2000.
What is actually required?
If necessary, supplement and change operational arrangements in accordance with the
standard, develop documents and records, and describe operations/processes.
What is the desired operation/process?
Once the organization has obtained a clear picture of how the quality management system
compares with the ISO 9001:2000 standard, all non-conformances must be addressed with a
documented implementation plan. Usually, the plan calls for identifying and describing
processes to make the organization’s quality management system fully in compliance with the
standard.
The implementation plan contains the following
Quality documentation to be developed
Objective of the system
Pertinent ISO 9001:2000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart, to be reviewed and approved. The
plan should define the responsibilities of different departments and personnel and set target dates
for the completion of activities. Once approved, the Management Representative should control,
review and update the plan as the implementation process proceeds.
Once the necessary quality management system documentation has been generated,
a documented system must be created to control it. Control is simply a means of
managing the creation, approval, distribution, revision, storage, and disposal of the
various types of documentation.
Document control should include
The principle of ISO 9000 document control is that employees should have access to
the documentation and records needed to fulfill their responsibilities.
Step 9: IMPLEMENTATION
Once the documentation is over it is a good practice to implement the quality
management system. This step is more effective in larger firms. In smaller firms quality
management system is implemented all at once throughout the organization. In larger
organization phased implementation takes place in order to evaluate the effectiveness in the
particular area.
It would be a good idea initially to evaluate areas where the chances of a positive
evaluation are high, to maintain the confidence of both management and staff in the merits of
implementing the quality management system. The implementation progress should be
monitored to ensure that the quality management system is effective and conforms to the
standard. These activities include internal quality audit, formal corrective action and
management review.
Once the system is being installed, its effectiveness should be checked by regular internal
quality audits. Internal quality audits are conducted to verify that the installed quality
management system:
Even after the system stabilizes and starts functioning, internal audits should be
planned and performed as part of an ongoing strategy. A few staff members should be trained to
carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and
programmes.
Step 11: MANAGEMENT REVIEW
When the installed quality management system has been operating for three to six
months, an internal audit and management review should be conducted and corrective
actions are implemented. The management reviews are conducted to ensure the
continuing suitability, adequacy and effectiveness of the quality management system.
The review should include assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and quality
objectives.
Once the quality management system has been in operation for a few months and has
stabilized, a formal application for certification could be made to a selected certification agency.
The certification agency first carries out an audit of the documents (referred as an "adequacy
audit"). If the documents conform to the requirements of the quality standard, then on-site audit
is carried out. If the certification body finds the system to be working satisfactorily, it awards the
organization a certificate, generally for a period of three years. During this three-year period, it
will carry out periodic surveillance audits to ensure that the system is continuing to operate
satisfactorily.
Certification to ISO 9000 should not be an end. The company should continually seek to
improve the effectiveness and suitability of the quality management system through the use of:
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
Books:
Journals:
Websites:
http://www.iso.org/iso/home.htm
http://www.thefreelibrary.com/Understanding+and+implementing+ISO+9000%3A+a+manager
%27s+guide.-a018194396
http://www.theriac.org/pdfs/startsheets/iso9000.pdf