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.

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.

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.

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

5.6.2 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

6.1 Provision 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.

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.

7.4 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.

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.

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)

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.

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

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:

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