The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.

1. QUALITY MANAGEMENT SYSTEM:
A set of co-ordinated activities to direct and control an organization in order to continually
improve the effectiveness and efficiency of its performance.
INTERNATIONAL ORGANIZATION FOR STANDARDS (ISO):
ISO is a worldwide federation of national standards bodies (ISO member bodies) established on
23rd Feb 1946 in Geneva, Switzerland.. The work of preparing International Standards is carried out
through ISO technical committees, in liaison with international organizations, governmental and
non-governmental bodies. ISO’s most recent family of standards for quality management systems
are:
 ISO 9000:2000 - Quality management systems – Fundamentals and vocabulary
 ISO 9001:2000 - Quality management systems – Requirements
 ISO 9004:2000 – Guidelines for performance improvement
They are built around business processes, with a strong emphasis on improvement and a focus
on meeting the needs of customers. The new standards originated from a regular six year review and
are intended to be generic and adaptable to all kinds of organizations.
The ISO 9002 and ISO 9003 are to be discontinued (but can still be used by those organizations
certified against them during the three year transition period), and ISO 9001and ISO 9004 are
designed to be used together, but can be used independently.
BENEFITS OF ISO REGISTRATION:
An ISO 9001 certificate will provide maximum benefit to your organization if it approaches SO
9001 implementation in a practical way. This will ensure that the quality management systems that
are adopted, work to improve the business and are not just a set of procedures that your employees
will find hard to manage.
By adopting an approach that starts out to implement more efficient working practices and
focuses on the organizations business objectives, you will achieve a system that will help and
support your staff, and improve customer satisfaction.
Whether you use an external assessor or allocate an internal resource to carry out the initial
assessments, you will need to ensure that they have buy-in from senior management to ensure all
areas of the organization are aware of the importance of the ISO accreditation process.
ISO 9001 certification is not just suitable for large organizations but also small businesses that
will benefit from adopting efficient quality management systems that will save time and cost,
improve efficiency and ultimately improve customer relationships.

2. Some of the benefits to your organization:
• Provides senior management with an efficient management process
• Sets out areas of responsibility across the organization
• Mandatory if you want to tender for some public sector work
• Communicates a positive message to staff and customers
• Identifies and encourages more efficient and time saving processes
• Highlights deficiencies
• Reduces your costs
• Provides continuous assessment and improvement
• Marketing opportunities
Some of the benefits to your customers:
• Improved quality and service
• Delivery on time
• Right first time attitude
• Fewer returned products and complaints
• Independent audit demonstrates commitment to quality
TL 9000:
TL 9000 is a quality management practice designed by the QuEST Forum in 1998. It was
created to focus on supply chain directives throughout the international telecommunications
industry. In 1998 QuEST Forum developed the TL 9000 quality management system (QMS) to meet
the supply chain quality requirements of the global communications industry. Built on ISO 9001 and
the eight quality principles, TL 9000 is designed specifically for the communications industry.
The purpose of TL 9000 is to define the unique communications quality system requirements
for design, development, production, delivery, and service. In addition, it specifies measurements for
companies to help evaluate the effectiveness of quality implementation and improvement programs.
AS 9001:
It is a Certification that your management system operates in compliance to external standards
for the Aerospace Industry. In essence the procedure for certification is the same as that for ISO
9001 (as the AS 9100 scheme is based on the prime document ISO 9001). However, there are some
key differences regarding the certification process.

3. ISO/TS 16949:
This standard is entitled as Quality System Automotive Supplier- Particular Requirements for
the Application of ISO 9001. It provides for continual improvement, emphasizing defect prevention
and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 and the first
edition was published in March 2002 as ISO/TS 16949:2002.
ISO Requirements (according to 2008 model):
1. Scope:
Need to demonstrate its ability to consistently provide product that meets customer and
applicable regulatory requirements.
2. Terms and Definitions:
Its aims are 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.
3. Normative Reference:
ISO 9000:2000 Quality Management System-Fundamentals and Vocabulary are a normative
reference that provides applicable concepts and definitions.
4.2 Documentation Requirements:
4.2.1 General Requirements:
Include in the quality management system documentation.
4.2.2 Quality Manual
Establish and maintain a quality manual with Scope of the quality management system
4.2.3 Control of Documents
Establish a document procedure to Approve documents for adequacy prior to issue
4.2.4 Control of Records:
Establish and control records as evidence of conformity to requirements and to demonstrate
the effective operation of the quality management system.

4. 5. Management Responsibility:
5.1 Management Commitment:
Provide evidence of management commitment to develop and implement the quality
management system, as well as, continually improve its effectiveness.
5.2 Customer Focus:
Ensure customer requirements are determined and met in order to improve customer
satisfaction.
5.3 Quality Policy
Ensure the quality policy is Appropriate to the purpose of the organization
5.4 Planning
5.4.1 Quality Objectives
Ensure quality objectives, including those needed to meet product requirements, are
established at the relevant functions and levels within the organization. Ensure quality objectives are
measurable and consistent with the quality policy.
5.4.2 Quality Management System Planning
Ensure that planning for the quality management system Meets the general requirements.
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
Ensure responsibilities and authorities are defined and communicated within the
organization.
5.5.2 Management Representative:
Appoint a member of your management who, irrespective of other duties, has the
responsibility and authority.
5.5.3 Internal Communication
Ensure the appropriate communication processes are established and carried out within the
organization regarding the effectiveness of the system.
5.6 Management Review
5.6.1 General
Review the quality management system at planned intervals to Ensure a suitable, adequate,
and effective system

5. 5.6.2 Review Input
Inputs for management review must include information on Results of audits
5.6.3Review Output:
Outputs from the management review must include any decisions and actions related to
Improvement of product related to customer requirements.
6. Resource Management
6.1Provision of Resources
Determine and provide the resources necessary to Implement and maintain the quality
management system.
6.2 Human Resources
6.2.1 General
Ensure people performing work affecting conformity to product requirements are competent
based on the appropriate education, training, skills, and experience.
6.2.2 Competence, Training, and Awareness
The organization must Determine the competency needs for personnel
6.3 Infrastructure:
Determine, provide, and maintain the necessary infrastructure to achieve product conformity.
Infrastructure includes Buildings, workspace, and associated utilities
6.4 Work Environment
Determine and manage the work environment needed to achieve product conformity.
7. Product Realization
7.1 Planning of Product Realization
Plan and develop the processes needed for product realization. Keep the planning consistent
with other requirements of the quality management system and document it in a suitable form for the
organization.

6. 7.2 Customer related Processes:
7.2.1 Determination of Requirements Related to the Product
Determine customer requirements Specified for the product (including delivery and post-
delivery activities).
7.2.2 Review of Requirements Related to the Product
Review the product requirements before committing to supply the product to the customer in
order to ensure product requirements are defined
7.2.3 Customer Communication
Determine and implement effective arrangements for communicating with customers on
Product information.
7.3 Design and Development
7.3.1 Design and Development Planning
Plan and control the product design and development
7.3.2 Design and Development Inputs
Determine product requirement inputs and maintain records
7.3.3 Design and Development Outputs
Document the outputs of the design and development process in a form suitable for
verification against the inputs to the process.
7.3.4 Design and Development Review
Perform systematic reviews of design and development at suitable stages in accordance with
planned arrangements
7.3.5 Design and Development Verification
Perform design and development verification in accordance with planned arrangements (see
7.3.1) to ensure the output meets the design and development input requirements.
7.3.6 Design and Development Validation
Perform validation in accordance with planned arrangements (see 7.3.1) to confirm the
resulting product is capable of meeting the requirements for its specified application or intended use,
where known.
7.3.7 Control of Design and Development Changes
Identify design and development changes and maintain records. Review, verify, and validate
(as appropriate) the changes and approve them before implementation. Evaluate the changes in terms
of their effect on constituent parts and products already delivered.

7. 7.4 Purchasing
7.4.1 Purchasing Process
Ensure that purchased product conforms to its specified purchase requirements. The type and
extent of control applied to the supplier and purchased product depends upon the effect of the
product on the subsequent realization processes or the final product.
7.4.2 Purchasing Information
Ensure the purchasing information contains information describing the product to be
purchased,
7.4.3 Verification of Purchased Product
Establish and implement the inspection or other necessary activities for ensuring the
purchased products meet the specified purchase requirements. If the organization or its customer
proposes to verify the product at the supplier location, state the intended verification arrangements
and method of product release in the purchasing information.
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
Plan and carry out production and service provision under controlled conditions to include, as
applicable.
7.5.2 Validation of Processes for Production and Service Provision
Validate any production or service provision where subsequent monitoring or measurement
cannot verify the output. This validation includes processes where deficiencies may become
apparent only after product use or service delivery. Demonstrate through the validation the ability of
processes to achieve the planned results.
7.5.3 Identification and Traceability
Identify, where appropriate, the product by suitable means during product realization.
Identify the product status with respect to monitoring and measurement requirements throughout
product realization. Where traceability is a requirement, control the unique identification of the
product and maintain records.
7.5.4 Customer Property
Exercise care with any customer property while it is under the control of, or being used by,
the organization. Identify, verify, protect, and safeguard customer property provided for use, or for
incorporation into the product. Record and report any lost, damaged, or unsuitable property to the
customer.

8. 7.5.5 Preservation of Product
Preserve the product during internal processing and delivery to the intended destination in
order to maintain conformity to requirements.
7.6 Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to
provide evidence of product conformity. Use and control the monitoring and measuring devices to
ensure that measurement capability is consistent with monitoring and measurement requirements.
8. Measurement, Analysis, and Improvement
8.1 General
Plan and implement the monitoring, measurement, analysis, and improvement processes
needed to demonstrate and ensure the conformity.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Monitor information on customer perception as to whether the organization is meeting
requirements (as one of the performance measurements of the quality management system). Define
the methods for obtaining and using this information.
8.2.2 Internal Audit
Conduct internal audits at planned intervals to determine if the quality management system
Conforms to planned arrangements and the requirements of ISO 9001.
8.2.3 Monitoring and Measurement of Processes
Apply suitable methods for monitoring and, where applicable, measurement of the quality
management system processes. Confirm through these methods the continuing ability of each
process to satisfy its intended purpose. When the planned results are not achieved, take correction
and corrective action, as appropriate.
8.2.4 Monitoring and Measurement of Product
Monitor and measure product characteristics to verify product requirements are being met.
Carry out the monitoring and measuring at the appropriate stages of product realization in
accordance with planned arrangements. Maintain evidence of conformity with the acceptance
criteria.

9. 8.3 Control of Nonconforming Product
Ensure any nonconforming product is identified and controlled to prevent its unintended use
or delivery. Establish a documented procedure to define the controls and related responsibilities and
authorities for dealing with nonconforming product.
8.4 Analysis of Data
Determine, collect, and analyze appropriate data to demonstrate the suitability and
effectiveness of the quality management system, as well as, evaluate where continual improvement
of the effectiveness of the quality management system can be made. Include in the analysis the data
generated by monitoring and measuring activities and from other relevant sources.
8.5 Improvement
8.5.1 Continual Improvement
Continually improve the effectiveness of the quality management system through Quality
policy, Quality objectives, Audit results, Analysis of data, Corrective and preventive action,
Management review.
8.5.2 Corrective Action
Take corrective action to eliminate the causes of nonconformities and prevent recurrence.
Corrective action must be appropriate to effects of the problem.
8.5.3 Preventive Action
Determine the action to eliminate the causes of potential nonconformities in order to prevent
their occurrence. Ensure preventive actions are appropriate to the anticipated effects of the potential
problem.
(Larry Whittington…www.whittingtonassociates.com/index.shtml)

10. IMPLEMENTATION:
1. Top Management Commitment:
The most important step in implementing a quality system will meet or exceed an ISO9000
standard is to acquire the full support of upper management. CEO must be willing the resources
necessary to achieve certification.
2. Appoint the Management Representative:
The next step is the appointment of a management representative. This person is responsible
for coordinating the implementation and maintenance of quality system and is the contact person for
all parties involved in the process.
3. Awareness;
This process will affect every person of the organization and their efforts also. It stands to
reason that everyone should understand the quality system.
4. Appoint an Implementation Team:
Implementation team should be drawn from all levels and areas of the organization so that it
is representative. It should identify the QMS process and their sequence and interaction.
5. Training;
This activity can be accomplished by sending team leaders for training or bringing htte
training-in-house for all team through a one or two days seminar.
6. Time Schedule:
This activity develops a time schedule for the implementation and registration of the system.
This time frame will vary, depending on the size of organization and the extent of its existing quality
system.
7. Select element Owners:
The implementation team selects owners for each of the system elements. Many of these
owners will be members of the implementation team.
8. Review The Present System:
Perform a review of the present quality system. Copies of all the quality manuals,
procedures, work instructions and forms are presently in use are obtained for the determination of
availability and the need.

11. 9. Write the Document:
Prepare written quality policy and procedure manuals. They can be combined into one
document. Write appropriate work instructions to maintain the quality of specific functions.
10. Install The New System:
Integrate the policies, procedures and work instructions into the day to day workings of the
organization and document what is being done. It is necessary for all elements to be implemented at
the same time.
11. Internal Audit:
Conduct an internal audit of the quality system. This step is necessary to ensure that the
system is working effectively and to provide management with information of the comprehensive
management review.
12. Management review:
Conduct a management review. The management review is used to determine the
effectiveness of the system in achieving the stated quality goals.
13. Pre-assessment;
This step is optional. If a good job has been done on the previous steps, pre-assessment is not
necessary.
14. Registration:
This step has three parts; choosing a registrar, submitting an application, and conducting the
registrar’s system audit.
DOCUMENTATION:
Quality system is the method used it ensure that the quality level of a product or service is
maintained. The system documentation can be viewed as the hierarchy containing four tiers. All
documentation moves from one level to the next in a descending order;
Policy
Procedure
Work Instructions
Records
Document Development

12. INTERNAL AUDITS:
After the policies, procedures and work instructions have been developed and implemented,
checks must be made to ensure that the system is being followed and the expected results are being
obtained. This activity is accomplished through the internal audit, which is one of the key elements
of the ISO 9000 standards. All elements should be audited at least once per year and some more
frequently, depending on need.
There are five objectives of Internal Audit:
 Determine the actual performance conforms to documented QMS.
 Initiate corrective action activities in response to deficiencies.
 Follow up on non-compliance items from previous audits.
 Provide continued improvement in the system through feedback to management.
 Cause the auditee to think about the process, thereby encouraging possible improvements.
Auditors:
Audits should be performed by qualified individuals who have received training in auditing
principles and procedures.
Auditors should be objective, honest and impartial. Of course, the auditors should be
prepared by being knowledgeable about the standards.
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.
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. 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
report.
REGISTRATION:
Quality system registration is the assessment and audit of a quality system by a third party,
known as a registrar. There are two parts: selecting a registrar and the registration process:

13. Selecting a registrar:
Registrar selection can be based on the following criteria:
 Qualification and Experience:
 Certificate Recognition
 The registration Process
 Time and cost Constraints
 Auditor Qualifications
Registration Process:
This process ha six basic steps:
 Application for registration
 Document review
 Pre-assessment
 Assessment
 Registration
 Follow-up Surveillance.
CLOSING COMMENTS:
No single standard has had more universal or worldwide results in increasing the awareness
of quality than the ISO 9000 series. According to the ISO survey of 2009,there were over 1,064,785
organizations registered from many countries of world. It must be pointed out that a quality system
is only one of the many tools of total quality management.
PSQCA:
The Pakistan Standards and Quality Control Authority, under the Ministry of Science and
Technology, is the national standardization body. In performing its duties and functions, PSQCA is
governed by the PSQCA Act, 1996. PSQCA came into operation since 1st December 2000, working
with 81 scientists/engineers and 254 supporting staff as self-finance organization, been given the
task of not only formulation of Pakistan Standards, but is also responsible for promulgation thereof.
PSQCA is a member of International Organization for Standardization (ISO), International Electro-
technical Commission (IEC), and International Organization of Legal Metrology (OIML). PSQCA
has also been established to advise the Government on standardization policies, programs and
activities to promote industrial efficiency and development, as well as for consumer protection.
The main function of the Department is to foster and promote standards and conformity
assessment as a means of advancing the national economy, promoting industrial efficiency and
development, ensuring the health and safety of the public, protecting the consumers, facilitating
domestic and international trade and furthering international co-operation in relation to standards and
conformity assessment