Iso9000&14000

1. Session: ISO 9000 & 14000
ISO 9000 series of standards
ISO 9000 is an internationally accepted standard for effective quality systems. They stand for
system standardization and certification rather than product standardization. They do not
replace but complement the product standards.
Brief History
ISO 9000:1987 had three 'models' for quality management systems, the selection of
which was based on the scope of activities of the organization:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing
was for companies and organizations whose activities included the creation of new products.
• ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same
material as ISO 9001 but without covering the creation of new products.
• ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of
finished product, with no concern for how the product was produced.
ISO 9001:2000 combined the three standards 9001, 9002, and 9003 into one, called 9001.
Design and development procedures are required only if a company does in fact engage
in the creation of new products
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO
9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
There are no new requirements
ISO 9000 includes the following standards:
• ISO 9001:2008 Quality management systems – Requirements is intended for use in any
organization regardless of size, type or product (including service). It provides a number
of requirements which an organization needs to fulfill to achieve customer satisfaction
through consistent products and services which meet customer expectations. It includes
a requirement for continual (i.e. planned) improvement of the Quality Management
System, for which ISO 9004:2000 provides many hints.
This is the only implementation for which third-party auditors can grant certification.
• ISO 9004:2000 Quality management systems - Guidelines for performance
improvements covers continual improvement. This gives you advice on what you could
do to enhance a mature system. This document very specifically states that it is not
intended as a guide to implementation.

2. Note that the previous members of the ISO 9000 series 9002 and 9003 have been
integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered"
is referring to ISO 9001.
Certification
ISO does not itself certify organizations. Many countries have formed accreditation
bodies to authorize certification bodies, which audit organizations applying for ISO
9001 compliance certification. Although commonly referred to as ISO 9000:2000
certification, the actual standard to which an organization's quality management can be
certified is ISO 9001:2000. Both the accreditation bodies and the certification bodies
charge fees for their services. The various accreditation bodies have mutual agreements
with each other to ensure that certificates issued by one of the Accredited Certification
Bodies (CB) are accepted worldwide.
Certification involves an independent assessment of the quality system to confirm that it
meets the requirements of ISO 9001.
• The quality system cannot be audited until the organisation generated documentary
evidence to show that it is meeting the standard.
Many certification bodies will not conduct a formal assessment until the system has
been operating for at least three months.
. Visit from the certification body’s auditors.
• They will seek objective evidence of complying with each of the clauses of the ISO
9001 standard.
They will not tell the client how to meet the standard but can offer advice.
The auditors will inform of any shortcomings in the system.
• If the organisation satisfies the standard, the auditors put forward recommendation for
certification
Certification is possible if the auditors only identify a small number of ‘minor’ problems.
It will be required to correct these problems within a specified timeframe.
• If the auditors identify more serious ‘major’ problems, it will be required to correct
these before certification.
Once certificated, the organisation can display the certification body's logo
All certification bodies are required to revisit registered companies to ensure they still
meet the requirements of the standard.
These surveillance visits normally take place twice a year at agreed dates.
The organisation will be given time to deal with any minor or major problems which are
identified before any action is taken to withdraw the certificate.
Most companies that wish to, will eventually achieve certification
The applying organization is assessed and a list of problems ("action requests" or "non-
compliances") is made known to the management. If there are no major problems on this

3. list, or after it receives a satisfactory improvement plan from the management showing
how any problems will be resolved, the certification body will issue an ISO 9001
certificate for each geographical site it has visited.
An ISO certificate is not a once-and-for-all award, but must be renewed at regular
intervals recommended by the certification body, usually around three years. There are no
grades of competence within ISO 9001.
Auditing
Two types of auditing are required to become registered to the standard, auditing by an
external certification body (external audit) and audits by internal staff trained for this
process (internal audits). The aim is a continual process of review and assessment, to
verify that the system is working as it's supposed to, find out where it can improve and to
correct or prevent problems identified. It is considered healthier for internal auditors to
audit outside their usual management line, so as to bring a degree of independence to
their judgments.
Advantages of Implementing ISO 9000
1. It is widely acknowledged that proper quality management improves business, often
having a positive effect on investment, market share, sales growth, sales margins,
competitive advantage, and avoidance of litigation
2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increases profit
8. Reduce waste and increases productivity
In today's service-sector driven economy, more and more companies are using ISO 9000
as a business tool. Through the use of properly stated quality objectives, customer
satisfaction surveys and a well-defined continual improvement program companies are
using ISO 9000 processes to increase their efficiency and profitability.
Problems
A common criticism of ISO 9001 is the amount of money, time and paperwork required
for registration. The standard is seen as especially prone to failure when a company is

4. interested in certification before quality.[8]
Certifications are in fact often based on
customer contractual requirements rather than a desire to actually improve quality.
Another problem reported is the competition among the numerous certifying bodies,
leading to a softer approach to the defects noticed in the operation of the Quality System
of a firm.
Many companies see the introduction of a quality management system as a major step
forward in controlling and improving their key processes. Other companies simply react
to customer demands that their suppliers should have suitable systems.
Documentation:
1. Quality manual: is the document which describes the quality
management system of the organization
2. Quality policy: Direction of the organization towards quality
3. Operation procedure: : lays down procedure for management to
control the system
4. Work Instructions : day to day operating instructions to provide
control of quality
5. Forms, records, etc
Implementing ISO 9000 Quality Management System
Implementation of ISO 9000 affects the entire organization right from the start. If pursued
with total dedication, it results in 'cultural transition' to an atmosphere of continuous
improvement.
The process of implementing ISO 9000 depends on:
􀂃The sophistication of your existing quality program,
􀂃The size of your organization, and
􀂃The complexity of your process.
The 14 essential steps, briefly described below, are to be followed through in order to
implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit

5. Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement
The 14 steps in detail
Step 1: Top Management Commitment
The top management (managing director or chief executive) should demonstrate a
commitment and a determination to implement an ISO 9000 quality management
system in the organization. Without top management commitment, no quality initiative
can succeed. Top management must be convinced that registration and certification
will enable the organization to demonstrate to its customers a visible commitment to
quality. It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system.
The top management should provide evidence of its commitment to the development
and implementation of the quality management system and continually improve its
effectiveness by:
􀂃Communicating to the organization the importance of meeting customer as well as
statutory and regulatory requirements,
􀂃Defining the organization's quality policy and make this known to every employee,
􀂃Ensuring that quality objectives are established at all levels and functions,
􀂃Ensuring the availability of resources required for the development and implementation
of the quality management system,
􀂃Appointing a management representative to coordinate quality management system
activities, and
􀂃Conducting management review.
Step 2. Establish Implementation Team
ISO 9000 is implemented by people. The first phase of implementation calls for the
commitment of top management - the CEO and perhaps a handful of other key people.
The next step is to establish implementation team and appoint a Management
Representative (MR) as its coordinator to plan and oversee implementation. Its
members should include representatives of all functions of the organization -
Marketing, Design and development, Planning, Production, Quality control, etc. In the
context of the standard, the 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 organization’s "quality
management system champion," and must be a person with:
􀂃Total backing from the CEO,
􀂃Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular,
􀂃The dignity - resulting from rank, seniority, or both - to influence managers and others

6. of all levels and functions,
􀂃Detailed knowledge of quality methods in general and ISO 9000 in particular.
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization.
Step 3. Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to 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 and
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.
Step 4. Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel
in the organization, training programs should be structured for different categories of
employees - senior managers, middle-level managers, supervisors and workers.
The training should cover the basic concepts of quality management systems and the
standard and their overall impact on the strategic goals of the organization, the changed
processes, and the likely work culture implications of the system. In addition, initial
training may also be necessary on writing quality manuals, procedures and work
instruction; auditing principles; techniques of laboratory management; calibration; testing
procedures, etc.
Step 5. Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system. The goal of ISO
9000 is to create a quality management system that conforms to the standard. This does
not preclude incorporating, adapting, and adding onto quality programs already in place.
So the next step in the implementation process is to compare the organization’s existing
quality management system, if there is one -- with the requirements of the standard (ISO
9001:2000)..
Unless they are very much out of date, these documents should not be discarded.
Rather, they should be incorporated into the new quality management system.
Documents requiring modification or elaboration should be identified and listed. This
exercise is some times referred to as " gap analysis''. During these review processes,
wide consultation with executives and representatives of various unions and
associations within the organization is required to enlist their active cooperation.

7. The basic approach is to determine and record how a process is currently carried out.
We can do this by identifying the people involved and obtaining information from them
during individual interviews. Unfortunately, it often happens that different people will give
different, contradicting versions of a process. Each one may refer to oral instructions that
are not accurate or clear. This is why the facts are often not described correctly the first
time around, and have to be revised several times.
Once it has been agreed how to describe the current process, this process has to be
adapted, supplemented and implemented according to the requirements of the quality
standard (ISO 9001:2000). This requires organizational arrangements, the drawing up of
additional documents and possible removal of existing documentation (e.g. procedures,
inspection/test plans, inspection/test instructions) and records (e.g. inspection/test
reports, inspection/test certificates).
Step 6. Create a Documented Implementation Plan
Once the organization has obtained a clear picture of how its 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 should be thorough and specific, detailing:
􀂃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.
Step 7. Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations
wishing to implement ISO 9000 quality management systems.
Documentation of the quality management system should include:
􀂃Documented statements of a quality policy and quality objectives,
􀂃A quality manual,
􀂃Documented procedures and records required by the standard ISO 9001:2000, and

8. 􀂃Documents needed by the organization to ensure the effective planning, operation and
control of its processes.
Quality documentation is generally prepared in the three levels:
Level A: Quality manual
􀂃States the scope of the quality management system, including exclusions and details of
their justification; and describes the processes of the quality management system and
their interaction. Generally gives an organization profile; presents the organizational
relationships and responsibilities of persons whose work affects quality and outlines the
main procedures. It may also describe organization's quality policy and quality
objectives.
Level B: Quality management system procedures
􀂃Describes the activities of individual departments, how quality is controlled in each
department and the checks that are carried out.
Level C: Quality documents (forms, reports, work instructions, etc.)
􀂃Work instructions describe in detail how specific tasks are performed; include drawing
standards, methods of tests, customer's specifications, etc.
􀂃Presents forms to be used for recording observations, etc. In small companies, the
above levels of documentation could be presented in one manual; otherwise, separate
manuals should be prepared.
A list of the documents to be prepared should be drawn up and the responsibility for
writing the documents should be assigned to the persons concerned in various
functional departments. They should be advised to prepare the drafts within a specific
time frame.
Step 8: Document Control
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 systems should be as simple and as
easy to operate as possible -- sufficient to meet ISO 9001:2000 requirements and that is
all.
Document control should include:
􀂃Approval for adequacy by authorized person (s) before issue,
􀂃Review, updating and re-approval of documents by authorized person (s),
􀂃Identification of changes and of the revision status of documents,
􀂃Availability of relevant versions of documents at points of use,
􀂃Identification and control of documents of external origin,
􀂃Assurance of legibility and identifability of documents, and
􀂃Prevention of unintended use of obsolete documents.
The principle of ISO 9000 document control is that employees should have access to the
documentation and records needed to fulfil their responsibilities.

9. Step 9. Implementation
It is good practice to implement the quality management system being documented as
the documentation is developed, although this may be more effective in larger firms. In
smaller companies, the quality management system is often implemented all at once
throughout the organization. Where phased implementation takes place, the
effectiveness of the system in selected areas can be evaluated.
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.
Step 10. Internal Quality Audit
As 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:
􀂃Conform to the planned arrangements, to the requirements of the standard (ISO
9001:2000) and to the quality management system requirements established by the
organization, and
􀂃Is effectively implemented and maintained.
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 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.
Management reviews should also address the pitfalls to effective implementation,
including lack of CEO commitment, failure to involve everyone in the process, and
failure to monitor progress and enforce deadlines.
Step 12. Pre-assessment Audit
When system deficiencies are no longer visible, it is normally time to apply for
certification. However, before doing so, a pre-assessment audit should be arranged

10. with an independent and qualified auditor. Sometimes certification bodies provide this
service for a nominal charge. The pre-assessment audit would provide a degree of
confidence for formally going ahead with an application for certification.
Step 13. Certification and Registration
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
to 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.
Step 14: Continual Improvement
Certification to ISO 9000 should not be an end. You 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
ISO 9004:2000 provides a methodology for continual improvement.
ISO 14000
The family ISO 14000 addresses various aspects of environmental management.
The very first two standards, ISO 14001:2004 and ISO14004:2004 deal with
environmental management systems (EMS). ISO14001:2004 provides the
requirements for an EMS and ISO14004:2004 gives general EMS guidelines.
An EMS meeting the requirements of ISO 14001:2004 is a management tool
enabling an organization of any size or type to:
 identify and control the environmental impact of its activities, products or
services, and to
 improve its environmental performance continually, and to
 implement a systematic approach to setting environmental objectives and
targets, to achieving these and to demonstrating that they have been achieved.
How it works

11. ISO:14001:2004 does not specify levels of environmental performance. If it
specified levels of environmental performance, they would have to be specific to
each business activity and this would require a specific EMS standard for each
business. That is not the intention.
ISOhas many other standards dealing with specific environmental issues. The
intention of ISO14001:2004 is to provide a framework for a holistic, strategic
approach to the organization's environmental policy, plans and actions.
ISO 14001:2004 gives the generic requirements for an environmental
management system. The underlying philosophy is that whatever the
organization's activity, the requirements of an effective EMS are the same.
This has the effect of establishing a common reference for communicating
about environmental management issues between organizations and their
customers, regulators, the public and other stakeholders.
Because ISO14001:2004 does not lay down levels of environmental performance, the
standard can to be implemented by a wide variety of organizations, whatever their
current level of environmental maturity. However, a commitment to compliance with
applicable environmental legislation and regulations is required, along with a
commitment to continual improvement – for which the EMS provides the framework
What can be achieved
ISO14001:2004 is a tool that can be used to meet internal objectives:
 provide assurance to management that it is in control of the organizational
processes and activities having an impact on the environment
 assure employees that they are working for an environmentally responsible
organization.
ISO14001:2004 can also be used to meet external objectives:
 provide assurance on environmental issues to external stakeholders – such
as customers, the community and regulatory agencies
 comply with environmental regulations
 support the organization's claims and communication about its own
environmental policies, plans and actions
 provides a framework for demonstrating conformity via suppliers'
declarations of conformity, assessment of conformity by an external stakeholder
- such as a business client - and for certification of conformity by an
independent certification body.