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					QUALITY MANAGEMENT SYSTEM

ISO 9001-2008 & its Implementation

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What is ISO 9001-2008?
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The International Organization of Standardization, (ISO) is a worldwide organization that develops many different kinds of Standards. ISO 9001 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001 is one of the documents in this set; it contains the actual requirements an organization must be in compliance with to become ISO 9001 Registered. ISO 9001:2008 is the current version of the Standard. It was revised in the year8
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Eight quality management principles of ISO 9001:2008
These eight principles are:  Customer focused organization  Leadership  Involvement of people  Process approach  System approach to management  Continual improvement  Factual approach to decision making  Mutually beneficial supplier relationship
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So, how do we solve these problems?

ISO 9001:2008, of course!

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What is ISO 9001: 2008 – Fact of Fiction ?
ISO 9001:2008 is a “Best Practice” Quality Management System

“QUALITY” in business terms = Ability of an organisation to…

- Supply products/services

- Improve its products/services

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What is ISO 9001: 2008 – Fact of Fiction ?
In other words, Quality = Effective Business Operation

Hence,

ISO 9001:2008 is a “best practice” Business Management System

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How do we run an effective/efficient business/organisation?
What kind of characteristics must it have?

- Commitment from top management
- Realisation by top management the inseparability of “Quality Management” and “Business Management”

- Appreciation of the 8 basic management principles on which ISO 9001:2008 is based

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How do we run an effective/efficient business/organisation?
What kind of characteristics must it have? - Customer Focus:
(Worrying about what my boss will say/do affects my work)

- Leadership Involvement of People:
( - Lack of staff or lack of trained staff - “We’re a group of individuals rather than a supportive, effective team”
- Ideas and/or people are not fully appreciated. A lot of potential is wasted - Hostility and/or lack of communication amongst staff and/or departments)

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How do we run an effective/efficient business/organisation?
What kind of characteristics must it have? - Continual Improvement:
(- One issue after another keeps catching us - No sooner do we sit to relax after fixing one issue do we get another one!

- We seem to be in a constant fire-fighting mode
- We are always/mostly in a reactive mode rather than a proactive one)

- Factual Approach to Decision Making:
(- How can I show that I am effective? How can I be sure that I am effective?)

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ISO 9001:2008 – Process Model
Continual Improvement of the Quality Management System

CUSTOMER’S

5.Management Responsibility

CUSTOMER

ISO 9001:2008 Quality
Satisfaction

6. Resource Management

8. Measurement
Analysis and Improvements

Management System

Requirements

7. Product Realization

Product

Consumption 10

ISO 9001:2008 Requirements ISO 9001:2008  Clause 1, Scope
 

Clause 2, Clause 3,

Normative reference Terms and definitions

   

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Clause 4, Quality management system Clause 5, Management responsibility Clause 6, Resource management Clause 7, Product realization Clause 8, Measurement, analysis and improvement

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The ISO 9000:2008 requirements

EXPECTED QUALITY by the Customer Measurement of the Client’s satisfaction

PLANNED QUALITY by the Company Measurement of the Performance of the Company

PERCEIVED QUALITY by the Customer

PRODUCED QUALITY by the Company

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The principles of TQM …

Transition towards TQM

Quality Control
Past Detect faults Look for guilty persons Accuse Punish Micro-management

Quality Management
Future Prevent errors Look for defaults in the processes Help, Moderate, Facilitate Motivate Systematic and systemic management

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The principles of TQM …

Continuous improvement ?
Deming’s wheel (P.D.C.A.)

PLAN

DO

ACT
ISO 2008

CHECK

Continuous Improvement

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Beneficial application
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For For For For

policy and strategy formulation goal and target setting operational management human resource management

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Benefits of ISO 9001:2008
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Well defined and documented procedures improve the consistency of output Quality is constantly measured Procedures ensure corrective action is taken whenever defects occur Defect rates decrease Defects are caught earlier and are corrected at a lower cost Defining procedures identifies current practices that are obsolete or inefficient Documented procedures are easier for new employees to follow Organizations retain or increase market share, increasing sales or revenue
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ISO 9001:2008 Requirements

ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS

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ISO 9001:2008 Requirements

ISO 9001:2008, CLAUSE 4 QUALITY MANAGEMENT SYSTEM
General Requirements (4.1) Documentation Requirements (4.2)

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ISO 9001:2008, Clause 4, Quality management system

General requirements (4.1)
 The organization shall establish and document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international standard.
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QUALITY MANUAL
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Policy Department Procedures SOP/WI Forms and Rec

LEVEL I

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LEVEL II

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LEVEL III

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LEVEL IV

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WHY DOCUMENTATION
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It is necessary to monitor the performance of each process It is used for the monitoring of customer satisfaction levels Customer satisfaction levels are measured by customer satisfaction index.
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Systems Manual
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Quality Manual (ISO 9001) Environmental Manual (ISO 14001) Maintenance Manual (TPM)

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ISO 9001:2008, Clause 4, Quality management system
The organization shall: a) Identify the processes needed for the quality management system and their application throughout the organization, b) Determine the sequence and interaction of these processes, c) Determine criteria and methods needed to ensure that both the operation, and control of these processes are effective,



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ISO 9001:2008, Clause 4, Quality management system
d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) Monitor, measure and analyze these processes, and, f) Implement actions necessary to achieve planned results and continual improvement of these processes.
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  

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Identify the processes needed for the quality management system; Determine the sequence and interaction of these processes; Determine criteria and methods required to ensure the effective operation and control of these processes; Ensure the availability of information necessary to support the operation and monitoring of these processes; Measure, monitor and analyze these processes Implement actions necessary to achieve the planned results and continual improvement.
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ISO 9001:2008, Clause 4, Quality management system

Documentation requirements (4.2)
General (4.2.1)

The quality management system documentation shall include: a) Documented statements of a quality policy and quality objectives, b) A quality manual, c) Documented procedures required by this international standard,
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ISO 9001:2008, Clause 4, Quality management system

d)

e)

Documents needed by the organization to ensure the effective planning, operation and control of its processes, and Records required by this International Standard (4.2.4).

NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. 27

DOCUMENTATION REQUIREMENTS (Clause 4.2 of ISO 9001:2008) DOCUMENTATION REQUIREMENTS (Clause 4.2 of ISO 9001:2008) The company has prepared its quality management system documentation, which includes:

Quality System Manual (Clause 4.2.2 of ISO 9001:2008)
Quality System Manual is a top-level policy document outlining the structure and general principles of the quality management system. It includes: 1)The scope of the quality system, including details of and justification for any exclusion; 2)Reference to the Quality System Procedures, Departmental Procedures, or related documentation;
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3)A description of the sequence and interaction of the processes included in the quality management system

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Quality System Manual is prepared by the Management Representative and authorized by the Chief Executive. Controlled copies of Quality System Manual are distributed to all the concerned persons on Circulation Record.
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ISO 9001:2008, Clause 4, Quality management system
Quality manual (4.2.2)
The organization shall establish and maintain a quality manual that includes: The scope of the quality management system, including details of and justification for any exclusion (1.2), b) The documented procedures established for the quality management system, or reference to them, and c)A description of the interaction between the processes of the quality management system.
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ISO 9001:2008, Clause 4, Quality management system

Control of documents (4.2.3)
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4 of the standard.
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ISO 9001:2008, Clause 4, Quality management system

A documented procedure shall be established to define the controls needed:
a) To approve documents for adequacy prior to issue, b) To review and update as necessary and reapprove documents, c) To ensure that changes and the current revision status of documents are identified, d) To ensure that relevant versions of applicable documents are available at points of use,
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ISO 9001:2008, Clause 4, Quality management system
e)

To ensure that documents remain legible and readily identifiable,
To ensure that documents of external origins are identified and their distribution controlled, and The organization has established a procedure for controlling documents used in its quality management system.
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f)

ISO 9001:2008, Clause 4, Quality management system Control of records (4.2.4)
 Records shall be established and maintained to provide evidence of conformity to requirements and of the quality management system.



Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protections, retrieval, retention time and disposition of records.
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Control of Quality Records (Clause 4.2.4 of ISO 9001:2008)
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The organization has established and maintains quality management system procedures for record identification, storage, retrieval, protection, retention time and disposition of quality records. Supporting Documents: Instructions for Control of Records MR/2/002
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ISO 9001:2008, Requirements

ISO 9001:2008, CLAUSE 5, MANAGEMENT RESPONSIBILITY
    

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Management Commitment (5.1) Customer Focus (5.2) Quality Policy (5.3) Planning (5.4) Responsibility, Authority and Communication (5.5) Management Review (5.6)
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ISO 9001:2008, Clause 5, Management responsibility

Management Commitment (5.1) Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:
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ISO 9001:2008, Clause 5, Management responsibility
a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) Establishing the quality policy, c) Ensuring that quality objectives are established, d) Conducting management reviews, and e) Ensuring the availability of resources.
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MANAGEMENT COMMITMENT
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The company’s management is fully committed to Quality and demonstrates its commitment to the development and improvement of the quality management system

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ISO 9001:2008, Clause 5, Management responsibility

Customer focus (5.2) Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

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CUSTOMER FOCUS (Clause 5.2 of ISO 9001:2008
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The company’s management, at appropriate levels, determines appropriate customer needs and requirements, and converts them into the form of defined requirements with the goal of achieving customer confidence. Obligations related to product, including regulatory and legal requirements are properly considered while determining customer needs and 41 expectations.

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The priority of customer focus is ensured through Customer Surveys. The surveys are conducted on regular basis. Different methods are used to carry out Customer surveys, e.g.: Designing survey forms /questionnaires and circulating these forms to customers Establishing survey teams and conducting interviews
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ISO 9001:2008, Clause 5, Management responsibility

Quality policy (5.3) Top management shall ensure that the quality policy: a) Is appropriate to the purpose of the organization, b) Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
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ISO 9001:2008, Clause 5, Management responsibility

c) Provides a framework for

establishing and reviewing quality objectives, d) Is communicated and understood within the organization, and e) Is reviewed for continuing suitability.

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The quality policy is communicated and enforced through management reviews, training, displays in Urdu and English at appropriate locations in offices and factory premises. Management Representative / Concerned Departmental Head conducts regular sessions with new as well as existing employees to ensure that quality policy is understood by all. The quality policy is reviewed at least once in a year in the management review meetings for its continuous suitability and improvement.
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ISO 9001:2008, Clause 5, Management responsibility

Planning (5.4) Quality objectives (5.4.1)
Top management shall ensure that quality objectives, including those needed to meet requirements for product [7.1a)], are established at relevant functions and level within the organization. The quality objectives shall be measurable and consistent with the quality policy.

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These objectives are set and reviewed in the Management Review Meetings. These are consistent with the quality policy, and the commitment to continual improvement and meeting requirements for products.

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ISO 9001:2008, Clause 5, Management responsibility

Quality management system planning (5.4.2)
Top management shall ensure that:

a) The planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
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QUALITY PLANNING
These are planned activities for the improvement in the product and process quality resulting in improving the customer satisfaction level. Roles and responsibilities of each and every employee is defined in the planning stage.
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QUALITY PLANNING
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Process Flow Chart Who will perform that duty Who is responsible for checking and testing How to perform that task or duty How to check or test that task

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Quality plans are established to define how quality requirements are met during production process.

Supporting Documentation:
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Quality Plan (Spinning) QC/3/060 Quality Plan (Weaving) QCW/3/008

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ISO 9001:2008, Clause 5, Management responsibility
Responsibility, authority and communication (5.5)
Responsibility and authority (5.5.1)  Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

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ISO 9001:2008, Clause 5, Management responsibility

Management representative (5.5.2)

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) Ensuring that processes needed for the quality management system are established, implemented and maintained,

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ISO 9001:2008, Clause 5, Management responsibility
Reporting to top management on the performance of the quality management system and any need for improvement, and c) Ensuring the promotion of awareness of customer requirements throughout the organization. NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
b)
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ISO 9001:2008, Clause 5, Management responsibility Internal communication (5.5.3) Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
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Internal Communication (Clause 5.5.3 of ISO 9001:2008)
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The company has established and maintains a procedure for internal communication between various levels and functions of the organization regarding the quality management system and its effectiveness. This ensures that the quality policy, goals, procedures, and records are properly communicated to relevant persons on time to keep them fully aware.

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ISO 9001:2008, Clause 5, Management responsibility
Management review (5.6) General (5.6.1)
 Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.  This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.  Records from management review shall be maintained.

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General (Clause 5.6.1 of ISO 9001:2008)
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Management Review meetings are held after three months. Unscheduled meetings may be called at any time on the direction of Chief Executive. However, these meetings may be delayed or postponed if deemed necessary. These meetings are chaired by the Chief Executive or any other designated person. These reviews ensure the continuing suitability, adequacy and effectiveness of the whole Quality System.
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ISO 9001:2008, Clause 5, Management responsibility Review input (5.6.2)
The input to management review shall include information on:

Results of audits, Customers feedback, Process performance and product conformity, Status of preventive and corrective actions, Follow-up actions from previous management reviews, g) Changes that could affect the quality management system, and h) Recommendations for improvement.

a) b) c) d) e)

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ISO 9001:2008, Clause 5, Management responsibility
Review output (5.6.3)
The output from the management review shall include any decisions and actions related to:

a)
b) c)

Improvement of the effectiveness of the quality management system and its processes, Improvement of product related to customer requirements, and Resource needs.

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ISO 9001:2008 Requirements

ISO 9001:2008, CLAUSE 6, RESOURCE MANAGEMENT
 Provision of resources (6.1)  Human Resources (6.2)  Infrastructure (6.3)  Work environment (6.4)

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ISO 9001:2008, Clause 6, Resource management

Provision of resources (6.1)
The organization shall determine and provide the resources needed:
a) To implement and maintain the quality management system and continually improve its effectiveness, and To enhance customer satisfaction by meeting customer requirement.
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b)

ISO 9001:2008, Clause 6, Resource management

Human Resources (6.2)
General (6.2.1) Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

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ISO 9001:2008, Clause 6, Resource management
Competence, awareness and training (6.2.2) The organization shall: a) Determine the necessary competence for personnel performing work affecting product quality, b) Provide training or take other actions to satisfy these needs, c) Evaluated the effectiveness of the actions taken,

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ISO 9001:2008, Clause 6, Resource management

d) 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
e) Maintain appropriate records of education, training, skills and experience.

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ISO 9001:2008, Clause 6, Resource management Infrastructure (6.3)
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.
Infrastructure includes, as applicable: a) Buildings, workspace and associated utilities, b) Process equipment (both hardware and software), and c) Supporting services (such as transport or communication).

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ISO 9001:2008, Clause 6, Resource management

Work environment (6.4)
The organization shall determine and manage the work environment needed to achieve conformity to product requirement.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Planning of product realization (7.1)
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The organization shall plan and develop the process needed for product realization. Planning of product realization shall be consistent with requirement of the other processes of the quality management system In planning product realization the organization shall determine the following, as appropriate:
a) Quality objectives and requirements, for the product;



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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION b)The need to establish process, documents, and provide resources specific for the product; c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d)Records needed to provide evidence that the realization processes and resulting product meet requirements
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Customer-related processes (7.2) Determination of requirements related to the product (7.2.1) The organization shall determine:
a)

b)

c) d)

Requirements specified by the customer, including the requirements for delivery and post-delivery activities, Requirements not stated by the customer but necessary for specified or intended use, where known, Statutory and regulatory requirements related to the product, and Any additional requirements determined by the organization.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION Review of requirements related to the product (7.2.2)
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 (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:
a)

Product requirements are defined,
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

b)

Contract or order requirements differing from those previously expressed are resolved, and
The organization has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of equipment, the customer requirements shall be confirmed by the organization before acceptance.

c)

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

Customer communication
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The organization shall determine and implement effective arrangements for communicating with customers in relation to:
• •

•

Product information, Enquires, contracts or order handling, including amendments, and Customer feedback, including customer complaints.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

Design and development (7.3) Design and development planning (7.3.1)


The organization shall plan and control the design and development of product. During the design and development planning, organization shall determine: a) The design and development stages,
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
b) The review, verification and validation that are appropriate to each design and development stage, and
c) The responsibilities and authorities for design and development.
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The organization shall mange the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progress.
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Purchasing (7.4) Purchasing process (7.4.1)
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The organization shall ensure that purchased product conforms to specified purchase requirements.

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The type and extent of control applied to the supplier and the purchased products shall be dependent upon the effect of the purchased product on subsequent product realization of the final product.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

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The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and reevaluation shall be established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

Purchasing Information (7.4.2)
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Purchasing information shall describe the product to be purchased, including where appropriate:
a) b) c)

requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system.



The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Verification of purchased product (7.4.3)
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The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased products meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and methods of product release in the purchasing information.
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

ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Productions and service provision (7.5) Control of production and service provision (7.5.1) The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable. a) the availability of information that describes the characteristics of the product. b) the availability of work instructions, as necessary,

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION

c)

the use of suitable equipment,

d) the availability and use of monitoring and measuring devices,

e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post- delivery activities.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Validation of process for production and service provision (7.5.2)
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

The organization shall validate any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results.

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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Customer Property (7.5.4)
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The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.

NOTE: Customer property can include intellectual property.
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION Preservation of product (7.5.5)
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

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The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to constituent parts of a product.
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ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION
Control and monitoring of measuring devices (7.6)


The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of products to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
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

ISO 9001:2008, CLAUSE 7, PRODUCT REALIZATION


Where necessary to ensure valid results, measuring equipment shall: a) Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) Be adjusted or re-adjusted as necessary; c) Be identified to enable the calibration status to be determined; d) Be safeguarded from adjustments that would invalidate the measurement results; e) Be protected from damage and deterioration during handling, maintenance and storage.

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ISO 9001:2008 Requirements
ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT


   

General (8.1) Monitoring and measurement (8.2) Control of nonconforming product (8.3) Analysis of data (8.4) Improvement (8.5)

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ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT

General (8.1)


The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed: a) To demonstrate conformity of the product, b) To ensure conformity of the quality management system, and c) To continually improve the effectiveness of the quality management system.



This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

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ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT Monitoring and measurement (8.2) Customer satisfaction (8.2.1)
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As one of the measurements of the performance of the quality management system, the organisation shall monitor the information relating to customer perception as to whether the organisation has met customer requirements. The methods for obtaining and using this information shall be determined.



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ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT Internal audit (8.2.2)


The organisation shall conduct internal audits at planned intervals to determine whether the quality management system: a) Conforms to the planned arrangements (7.1), to the requirements of the ISO 9001 and to the quality management system requirements established by the organisation, and b) Is effectively implemented and maintained.

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ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT



 



An audit programme shall be planned, taking into consideration the status and importance of the process and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conducts of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.91

ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT



The responsibility and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined as in the documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification of results.
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ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT

Monitoring and measurement of process (8.2.3)
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



The organisation shall apply suitable methods of monitoring and, where applicable, measurement of the quality management system process. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective actions shall be taken, as appropriate, to ensure conformity 93

ISO 9001, CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT

Control of nonconforming product (8.3)
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

The organisation shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
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Conclusion
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



ISO 9001-2008 is very important for any organization because it assures customers that the company has a good Quality Management System (QMS) in place and meets the customer’s expectations. ISO leads company to better operations, improved performance and improved profitability. It leads to reduced cost and greater operating margins. So, According to my research Ghazi Fabrics International Ltd, meet Quality Assurance requirements as required in 95

WARNING !
ISO 9001:2008 is more than a useful certificate.

It can seriously improve your organisation!

Thank you for your time.

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CONCEPTUAL QUESTIONS
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



Explain the importance of Measurement, Analysis and improvement Compare the different clauses of ISO 9001 with eight QM Principles What are the responsibilities of top management in context with ISO 9000
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CONCEPTUAL QUESTIONS




Write down the procedures of any company Write the whole Quality manual of a company

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