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AS 9100
This aerospace industry quality system was officially released by the Society
of Automotive Engineers in May 1997.
v Its development and release represents the first attempt to unify the
requirements of NASA, DOD, and FAA, while satisfying the aerospace
industry's business needs.
v In March 2001, the International Aerospace Quality Group (IAQG) aligned
AS9100 with ISO 9001:2000.
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TL 9000
The Quality Excellence for Suppliers of Telecommunications Forum wrote TL
9000 to consolidate the various quality system requirements within the
telecommunications industry.
v It is a specific set of requirements based on ISO 9001 that defines the design,
development,production,delivery,installation, maintenance of telecommunications
products and services.
v Figure shows the structure of the TL 9000 standard and its five layers. The first
layer is the ISO 9000 requirements
v The unique feature of the standard is the use of the metrics specified in the QSM
book to communicate and monitor actual results.
1. Scope
The purpose of the standard is for the organization to demonstrate its ability to
provide a product that meets customer and regulatory requirements and achieves
customer satisfaction.
• This purpose is accomplished by evaluating and continually improving the
system, rather than the product.
• The requirements of the standard are intended to be applicable to all types and
sizes of organizations.
• Requirements in Clause 7, Product Realization, that are not appropriate to the
organization, can be excluded.
2. Normative Reference
ISO 9000:2000 Quality Management Systems - Fundamentals and
vocabulary are a normative reference that provides applicable concepts and
definitions.
4.2 DOCUMENTATION
4.2.1 General Documentation shall include
• Statements of a quality policy and quality objectives,
• A quality manual,
• required documented procedures,
• needed documents to ensure effective planning, operation, and control of
processes,
• Required records.
A procedure or work instruction is needed if its absence could adversely affect
the product quality.
v The extent of the documentation will depend on the organization's size and type
of activities.
v For example: a small organization may verbally notify a manager of an
upcoming meeting, whereas a large organization would need written
notification.
v The standard should satisfy the contractual, statutory, and regulatory
requirements and the needs and expectations of customers and other
interested parties.
v Documentation may be in any form or type of medium.
4.2.2 Quality Manual
• The scope of the QMS with details and justification for any exclusions,
v Provide for the prompt removal of obsolete documents and suitably identify any
that may be retained.
5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management shall provide evidence of its commitment to the
development, implementation, and continual improvement of the QMS by
v Communicating the need to meet customer, legal, and regulatory
expectations,
v Establishing a quality policy,
v Ensuring that quality objectives are established,
v Conducting management reviews, and
v Ensuring the availability of resources.
v Top management is defined as the person or group of people who directs
and controls an organization.
QUALITY SYSTEMS 7 UNIT 5
5.4 PLANNING
5.4.1 Quality Objectives.
Top management shall ensure that quality objectives are established at
relevant function and levels within the organization and include product
requirements.
• They shall be measurable and consistent with the quality policy.
• In addition, they should ensure that customer expectations are met. Quality
objectives are something sought or aimed for related to quality.
5.4.2 Quality Management System Planning.
Top management shall ensure that the planning of the QMS is accomplished
in order to meet the requirements of the QMS as stated in the General
Requirements, Element 4.1, as well as the Quality Objectives, 5.4.1
• Ensuring that processes needed for the QMS system are established,
implemented, and maintained,
•
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• Reporting to top management on the performance of the QMS and any need for
improvement, and
v Results of audits,
v Customer feedback,
v Changes that could affect the QMS, and (g) recommendations for improvement.
• The output from the review shall include any decisions and actions related to (a)
Improvement of the effectiveness of the QMS and its processes,
6. Resource Management
6.1 PROVISION OF RESOURCES
The organization shall determine and provide the-resources needed
v To implement and maintain the QMS and continually improve its effectiveness,
and
v To enhance customer satisfaction by meeting customer requirements. Resources
may be people, infra- structure, work environment, information, suppliers, natural
resources, and financial resources.
v Resources can be aligned with quality objectives.
v Ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives,
and
6.3 INFRASTRUCTURE
The organization shall determine, provide, and maintain the infrastructure
needed to achieve conformity to product requirements.
• Buildings, workspace, and associated utilities,
• Process equipment (both hardware and software), and
• Supporting services (such as transport or communication).
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7. PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
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 QMS
v Quality objectives and requirements for the product;
v The need to establish processes, documents, and provide resources specific to
the product;
v Required verification, validation, monitoring, inspection, and test activities specific
to the product and the criteria for product acceptance; and
v Records needed to provide evidence that the realization processes and resulting
product or service meet requirements..
The organization shall review the requirements related to the product. This
review shall be conducted prior to the organization's commitment to supply a product
to the customer and shall ensure that
v Records of the results of the review and actions arising from the review shall be
maintained.
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• Product information,
•
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• Specify the characteristics of the product that are essential for its safe and
proper use.
v Records of the results of the reviews and any necessary actions shall be
maintained.
v . Records of the results of the verification and any necessary actions shall be
maintained. Verification confirms, through objective evidence, that the specified
requirements have been fulfilled.
7.3.6 Design and Development Validation.
7.4 PURCHASING
7.4.1 Purchasing Process.
The organization shall ensure that purchased product conforms to specified
purchase requirements.
• The type and extent of control applied to the supplier and the purchased
product shall be dependent upon the effect of the purchased product on
subsequent product realization or the final product.
• The organization shall evaluate and select suppliers based on their ability to
supply product in accordance with the organization's requirements
.
v QMS requirements.
v The organization shall identify the product status with respect to monitoring
and measurement requirements.
The organization shall preserve the conformity of product during internal processing
and delivery to the intended destination.
• 8.2.2 Internal Audit The organization shall conduct internal audits at planned
intervals to determine whether the QMS
v The organization shall apply suitable methods for monitoring and, where
applicable, measurement of the QMS processes.
v . When planned results are not achieved, correction and corrective action
shall be taken, as appropriate, to ensure conformity of the product.
• The organization shall monitor and measure the characteristics of the product
to verify that product requirements have been met.
8.5 IMPROVEMENT
8.5.1 Continual Improvement The organization shall continually improve the
effectiveness of the QMS through the use of the quality policy, quality objectives,
audit results, analysis of data, corrective and preventive actions, and management
review.
v 8.5.2 Corrective Action The organization shall take action to eliminate the cause
of non- conformities in order to prevent recurrence.
v Corrective actions shall be appropriate to the effects of the nonconformities
encountered.
v A documented procedure shall be established to define requirements for
reviewing nonconformities determining the causes of nonconformities action
taken.
• The representative can be a member of the top management group who is able
to ensure that the quality system is effectively implemented, documented, and
maintained
3. Awareness
This step requires an awareness program.
v Because the process is going to affect every member of the organization as well
as require their input, it stands to reason that everyone should understand the
quality system.
v They should know how it would affect day-to- day operations and the potential
benefits.
v This information can be relayed through short, one-hour awareness training
sessions.
5. Training
The implementation team, supervisors, and internal audit team should be trained.
This activity can be accomplished by sending team leaders for training and having
them train the other team members.
6. Time Schedule
This activity develops a time schedule for the implementation and registration of the
system.
v
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v This time frame will vary, depending on the size and type of organization and the
extent of its existing quality system
14. Registration
This step has three parts:
• choosing a registrar,
• submitting an application,
• Conducting the registrar's system audit.
A registrar's audit usually lasts one to three days and will consist of an opening
meeting to describe the process the auditors will follow, the audit itself, and a closing
meeting to discuss the findings of the audit.
• Over documentation or documentation that is too complex.
• Using external consultants without internal ownership and involvement. Limiting
documentation to text rather than other types of media.
• Neglecting to obtain top management's involvement.
• Developing a system that does not represent what actually occurs.
DOCUMENTATION
A quality system is the method used to ensure that the quality level of a product or
service is maintained.
Documentation Pyramid
Policy
The first tier of documentation is the policy manual. This is the document that defines
what will be done and why.
v A quality policy manual should be written so it is clear, precise, practical, and
easy to understand.
v The why can be stated just once as a quality policy statement?
v This statement should be a short, simple definition of the organization's quality
intentions.
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Procedure
The second tier of documentation is the quality procedures.
• These procedures describe methods that will be used to implement and
perform the stated policies.
• The procedures define who should perform specific tasks, when the task
should be done, and here documentation will be made showing that the task
was performed.
• Procedures should be oriented so that they apply to all areas within the
organization..
Work Instructions
Work instructions are usually department, machine, task, or product oriented and
spells out how a job will be done.
v These instructions are the most detailed of the documentation hierarchy.
v A work instruction may be in the form of a detailed drawing, recipe, routing sheet,
specific job function (for example, turn nut four turns clockwise), photograph,
video, or simply a sample for comparison of conformity
Records
Records are a way of documenting that the policies, procedures, and work
instructions have been followed.
• Records may be forms that are filled out, a stamp of approval on a product, or a
signature and date on some type of document, such as a routing sheet.
• Records are used to provide traceability of actions taken on a specific product
or batch of products..
Document Development
Although documentation is required by the system, its most important purpose
is to provide guidelines for internal quality management.
v In this respect it can be considered one approach to the road of continuing quality
improvement and business success.
v This preexisting documentation is the starting point for developing the documents
necessary for registration.
Writing the Documents
The basic thought to keep in mind when writing the documents is to create
simplicity out of complexity.
Format Example
• When designing the manuals, simplicity and ease of use should determine the
structure to be used.
• A cover page will list the organization name and location as well as the title of
the document. to determine that:
They are clearly defined and do not differ from the original proposal or sales offer.
• Any differences are resolved and any changes are appropriately recorded and
affected people notified.
• Wirco Castings Inc. has the ability to meet them.
After the policies, procedures, and work instructions have been developed and
implemented.
v This activity is accomplished through the internal audit, which is one of the key
elements of the ISO 9000 standard.
v All elements should be audited at least once per year and some more frequently,
depending on need.
Objectives
There are five objectives of the internal audit. They are to:
Techniques
During the actual audit, there are a number of techniques that the auditor should
employ.
• The objective is to collect evidence, and there are three methods: examination
of documents, observation of activities, and interviews.
• The easiest method is to examine the documents.
• The auditor should start with the quality manual to determine that the policies
cover the QMS standards, and that they are controlled and assessable.
• Next, the documents are examined in a systematic manner.
• . Document control ensures that documents are identified with a title, revision
date, and responsible owner;
• documents are readily available to users;
• a master list by department or function for procedures, work instructions, and
records is appropriately located;
• there are no obsolete documents at workstations; and
• Changes follow a prescribed procedure.
• Observation of activities is also an easy method that requires an aptitude for
detail.
• Use the appropriate type of question.
• There are open questions, closed questions, clarifying questions, leading
questions, and aggressive questions.
Procedure
Before the audit takes place, an audit plan and checklist should be prepared
by the lead auditor.
As much time is spent planning as doing.
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The contents of an audit plan should identify the activity or department
to be audited; list the procedures, documents, and regulatory requirements involved;
name the audit team; and list who is to be notified of the audit and who will receive
audit reports
v The purpose of the audit is to determine how well the quality system has been
implemented and maintained.
v In large organizations, an escort should be provided by the area being audited.
. Separate reports are prepared for each nonconformance and should include:
v The element title and a unique identification number such as NC 7.2.3, where the
NC stands for nonconformance and the other numbers give the element number.
v . Where the nonconformance was observed.
v Objective evidence used as a basis for the nonconformance.
v The nonconformance worded as closely as possible to the language of the
requirement.
At the closing meeting, the lead auditor presents a summary of the audit findings
along with the evidence that supports them.
• Have a cover sheet that includes the audit date, names of the audit team, areas
audited, distribution list, a statement that the audit is only a sample, and a unique
reference number.
• 2. List the non-conformances and copies of all nonconformance reports.
• Outline procedures for corrective action and subsequent follow-up.
ENVIRONMENTAL MANAGEMENT SYSTEM
In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE),
which led to the formation of Technical Committee (TC) 207 in 1992.
v The mission of TC 207 is to develop standards for an environmental
management system (EMS) which was identified as ISO 14000.
v Like the ISO 9000 standards, which do not address the performance of the
product or service, the committee used the concept that the standards addressed
the process rather than the end goal.
v Thus, they are process standards rather than performance standards.
v What are the environmental aspects of the organizations activities, products, and
services?
v . Do the organization's activities, products, or services create any significant
adverse environmental impacts?
v Does the organization have a procedure for evaluating the environmental
consideration, for example, sensitive environmental areas?
v Does the location of the organization require special environmental consideration,
for example, sensitive environmental aspects and their associated impacts?
v How will any intended changes or additions to activities, products, or services
affect the environmental aspects and their associated impacts?
v How significant or severe are the potential environmental impacts if a process
failure occurs?
v How frequently will the situation arise that could lead to the impact? 8. What are
the significant environmental aspects, considering impacts, likelihood, severity,
and frequency?
v Are the significant environmental impacts local, regional, or global in scope?
.
Registrar's audits will require these documented records, and they will be valuable
for internal operations and litigation defense if needed.
4.4.3 COMMUNICATION
• A key aspect of any management program is communication with all
stakeholders. The standard requires that procedures shall be established and
maintained for internal communication among all employees.
• Effective communication up, down, and laterally should ensure that questions
are answered and that understanding is complete and accurate.
• Internal environmental communication procedures should address reporting
on environmental activities to:
v The organization must show that it is actually practicing what the documentation
states. In other words, "Say what you do and do what you say."
This element requires that procedures be established and maintained to control all
EMS documents.
• Provisions must be made for the review and approval of documents for
adequacy before they are issued and after any changes.
Documentation Hierarchy
• Level 1 policy. There are 17 procedures and while only three are explicitly
required to be documented, it is best from an effectiveness standpoint to
document all 17.
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• Level 3, the practice level, describes the work instructions by
which operating personnel perform their tasks.
• They are step-by-step instructions dealing with activities required by the
standard. Organizations involved with TQM or ISO 9000 will already have
these activities documented.
• Level 4, the proof level, is the location of all forms, records, drawings, and so
forth that represent the objective evidence or proof of the performance of the
EMS.
• It is important to note that the system should be an efficient one and not a
bureaucratic one-keep it simple.
v Cover situations where their absence could lead to deviations from the policy and
the objectives and targets.
v Stipulate operating criteria which are the details and instructions that would
normally be included in any process, procedure, or step-by-step work instruction.
v They include equipment to be used, materials required, process settings,
maintenance program, and so forth.
v Cover the identification of environmental aspects of goods and services and
communicate relevant procedures and requirements to suppliers and contractors.
v Ford Motor Co., which has registered all 140 facilities in 26 countries, requires its
suppliers to be certified to ISO 14001. Other major companies such as IBM,
General Motors, Xerox, and Honda of America also have made the same
stipulation.3
These questions can also be asked after any emergency drill or simulation, which
would test the procedures for their effectiveness.
4.5 Checking and Corrective Action
This area contains four elements: monitoring and 'measuring, nonconformance and
corrective and preventative action, records, and EMS audit.
Since operating personnel are usually the most knowledgeable people concerning
the process, they should be involved in the corrective and preventative action
activity.
4.5.3 RECORDS
Procedures are required for the identification, maintenance, and disposition of
environmental records such as training, audits, equipment calibration, and reviews.
v Records shall be legible, identifiable, and traceable to the activity, product, or
service.
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v They should be readily retrievable; protected against damage,
deterioration, and loss; and provided with retention times.
MANAGEMENT REVIEW
Management review and revision, if applicable, is required to ensure the continuing
suitability, adequacy, and effectiveness of the EMS
A fixed schedule of reviews is required to cover all the elements. ISO 14004
recommends that the review include:
GLOBAL BENEFITS
There are three global benefits:
v Facilitate trade and remove trade barriers,
v Improve environmental performance of planet earth,
v Build consensus that there is a need for environmental management and a
common terminology for EMS.
. ORGANIZATIONAL BENEFITS.
According to ISO 14004, an organization benefits from an EMS in a number of ways
as given below:
Part B
1. Explain the various clauses available in ISO 9000:2000 version.
2. Explain in detail the various activities to be carried out by a manufacturing industry
to obtain ISO 9000:2000 versions.
3. Explain the various clauses available in ISO 9000:14000 version.
4. Explain in detail the various activities to be carried out by an educational institution
to obtain ISO 9000:2000 versions.
5. Explain the required behavior of internal auditors and Auditees and the process of
internal auditing.
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