ISO 9000 is a globally recognized series of International Standards of Quality Management System (QMS) For Manufacturing as well as Service Sector Has been developed by a Swiss based International Organization for Standardization (ISO)
services meeting customer requirements Enables continuous improvement in achieving defined objectives
PDCA Methodology
Plan
Act
Do
check
ISO 9000:2000
Standard Requirements
Standard Requirements Elements of ISO 9001:2000 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System
5.
6. 7. 8.
Management Responsibility
Resource Management Product Realization Measurement, Analysis and Improvement
Quality Management System - 1 4.1 General Requirements a) Identification of the processes for the QMS b) Determine the sequence of these processes c) Determine criteria for effective operation & control of these processes d) Ensure the availability of resources e) Monitor, measure and analyze these processes f) Implement actions necessary for achieving planned results and continual improvement
4.2
Documentation Requirements - 1
4.2.1 General The QMS Documentation shall include: a) Quality Policy & Quality Objectives b) Quality Manual c) Documented procedures required by this Standard d) Documents needed for planning, operation and control of processes e) Records required by this Standard
4.2
Documentation Requirements - 2
4.2.2 Quality Manual a) Scope of QMS / Justification of the Exclusions b) Documented procedures or reference to them c) Description of interaction between the processes of the QMS
4.2
Documentation Requirements - 3
4.2
Documentation Requirements - 4
4.2.4 Control of records a) Establish / Maintain records to demonstrate conformity to this International Standard b) Keep records legible, readily identifiable and retrievable c) Establish documented procedure for identification, storage, protection, retrieval, specify retention time and their disposition
a) Communication to the organization the importance of meeting customer, statutory and regularity requirements b) Establish Quality Policy & Quality Objectives c) Conducting Management Reviews d) Ensuring the availability of resources
5.2 Customer Focus Determine and meet the customer requirements for enhancing customer satisfaction
5.4.1 Quality Objectives a) Needed to meet the requirements of the product are established at relevant functions within the organization
5.4.2 Quality Management System Planning Top Management shall ensure that a) Planning is done for meeting the requirements of this standard (4.1) and Quality Objectives
b) Integrity of the QMS is maintained when changes to QMS are planned and implemented
Management Responsibility - 5
5.5 Responsibility, Authority and Communication - 1
a)
b)
c)
Management Responsibility - 6
5.5 Responsibility, Authority and Communication - 2
5.5.3 Internal Communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of quality management system.
Management Responsibility - 7 5.6 Management Review - 1 5.6.1 General The management shall review the QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness The review shall include : a) Assessing opportunities for improvement and need for changes to the QMS b) Review of the Quality Policy and Quality Objectives Records of the reviews must be kept
Management Responsibility - 8 5.6 Management Review - 2 5.6.2 Review Inputs The Inputs shall include information on: a) Results of audits b) Customer feedback c) Process performance and product conformity d) Status of preventive and corrective action e) Follow-up actions from previous management review f) Changes which could affect the QMS g) Recommendations for improvement
5.6.3 Review Outputs The Outputs shall include any decisions and actions on: a) Improvement of the effectiveness of quality management system and processes, b) Improvement of product related to customer requirements c) Resources needs
The Organization shall determine and provide resources needed to : a) Implement and maintain the QMS and continually improve its effectiveness b) Enhance customer satisfaction by meeting customer requirements.
e)
The organization shall determine, provide and maintain the infrastructure needed to achieve product conformity, it includes: a) Building, workplace and associated utilities b) Process equipment (both hardware and software) c) Supporting services(such as transport or communication)
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
Product Realization - 1
7.1
Organization shall plan and develop the processes needed for product realization, while considering the Following factors as appropriate:
a) Quality objective and requirements for the product b) Need to establish processes, documents, and provide resources specific to 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 (see 4.2.4)
Product Realization - 2
7.2
The organization shall determine: a) Requirements specified by customer including (delivery conditions & post Delivery activities) b) Requirements not stated but necessary for the intended use, where known c) Statutory & regulatory requirements related to product d) Any additional requirement determined by the organization
Product Realization - 3
7.2
7.2.2 Review of Requirements Related to the Product Review following before the acceptance of contract : a) b) c) Product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has the ability to meet the defined requirements.
Results of the reviews must be maintained Any change in requirements is communicated to all
Product Realization - 4
7.2
The organization shall define and implement Effective arrangements for communicating with customers in relation to : a) Product information b) Enquiries, contracts or order handling, including amendments, and c) Customer feedback, including customer complaints
Product Realization - 5
7.3
Organization shall determine the a) Design and development stages, b) Review, verification and validation that are appropriate to each design and development stage, and c) Responsibilities and authorities for design and development Planning output shall be updated, as appropriate, as the design and development progresses
Product Realization - 6 7.3 Design and Development - 2 7.3.2 Design and Development Inputs
Inputs related to product requirements including following shall be determined, a) Functional and performance requirements, b) Applicable statutory and regulatory requirements, c) Where applicable, information derived from previous similar design, and d) Other requirements essential for design and development The requirements must be complete, unambiguous and not in conflict in each other The requirements must be reviewed for adequacy and records must be maintained
Product Realization - 7
7.3
7.3.3 Design and Development Outputs The design and development outputs shall: a) Meet the input requirements for design and development b) Provide appropriate information for purchasing, production and for services provision c) Contain or reference product acceptance criteria d) Specify the characteristics of the product that are essential for its safe and proper use
Product Realization - 8
7.3
7.3.4 Design and Development Review Reviews by representatives of the functions concerned shall be performed in accordance with planned arrangements (see 7.3.1) to :
a)
Evaluate the ability of the results of design and development to meet requirements, and
b) Identify any problems and propose necessary actions. Records of reviews and any necessary actions shall be maintained
7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that design and development outputs have met the design and development input requirements. Records of the results and any actions shall be maintained.
The changes will be reviewed, verified and validated as appropriate and approved before implementation. The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered. Records of the changes and any actions shall be maintained.
Product Realization - 12
7.4
Purchasing - 1
7.4.1 Purchasing Process The organization shall ensure that purchased product conforms to specified purchase requirements
The type and extent of control applied shall be dependent upon the effect on the final product
Product Realization - 13
7.4
Purchasing - 2
7.4.2 Purchasing Information Purchasing information shall describe the purchased product, including where appropriate: a) Requirement for approval of product, procedures, process and equipment Quality management system requirements
Product Realization - 14
7.4
Purchasing - 3
7.4.3 Verification of the Purchased Product Establish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information. Where verification at the suppliers premises is required by organization / customer, it shall be indicated so in the purchase information.
Product Realization - 15
7.5
7.5.1Control of Production and Service Provision Production and service provision shall be carried out under controlled conditions, as applicable: a) Availability of information that describes the characteristics of the product, b) Availability of work instructions, as necessary, c) Use of suitable equipment, d) Availability and use of monitoring and measuring devices, e) Implementation of monitoring and measurement, and f) Implementation of release, delivery and post-delivery activities.
Product Realization - 16
7.5
Validation of process shall be done where the resulting output cannot be verified by subsequent monitoring or measurement, the following shall be addressed: a) Defined criteria for review and approval of the processes b) Approval of equipment and qualification of personnel c) Use of specific methods and procedures d) Requirements for records e) Revalidation
Identification of product by suitable means throughout product realization Identification of the product status with respect to the monitoring and measurement requirements
Where traceability is required the organization shall control and record the unique identification of the product
Product Realization - 18
7.5
7.5.4Customer Property
The organization shall a) Identify, verify, protect and safeguard customer property
b)
c)
Product Realization - 19
7.5
7.5.5Preservation of Product
This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product
Product Realization - 20
7.6 Control of Monitoring and Measuring Devices The equipment Shall be:
a) Calibrated or verified at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded
e) Protected from damage and deterioration during handling, maintenance and storage
f) Records shall be maintained
8.1
General
Organization must plan and implement the monitoring measurement, analysis and improvement processes needed to : a) Demonstrate conformity of the product b) Ensure conformity of the QMS c) Continually improve the effectiveness of QMS Determine applicable method including Statistical Techniques and extent of their use
8.2
Establish a method for obtaining and using the information about customer perception as to whether the organization has met customer requirements
Documented procedures Shall be established and internal audits shall be conducted at regular intervals to determine whether the QMS : a) Conforms to standard and other requirements determined by organization b) Is effectively implemented and maintained Audit shall be:
1. 2. 3. 4. Planned, Criteria / Scope / Frequency and method be defined. Selection / conduct of audit shall ensure impartiality Follow-up activities shall be performed Records shall be maintained
8.2
8.2
8.2.4
Monitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.1) Evidence of conformity and acceptance criteria must be defined. No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person. Records shall also be maintained.
Determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made. Analysis of data shall provide information relating to:
a) Customer Satisfaction (see 8.2.1) b) Conformity of product requirements (see 7.2.1) c) Characteristics and trends of processes and and products including opportunities of Corrective action d) Suppliers
8.5
Improvement - 1
The organization shall continually improve the effectiveness of QMS through the use of : Quality Policy Quality Objectives, Audit Results Analysis of data, Corrective and Preventive Actions Management Review
8.5
Improvement - 2
Corrective actions shall be taken to eliminate causes of nonconformities to prevent their recurrence. Documented procedure shall be established to define requirements for: a) Reviewing nonconformities (including customer complaints) b) Determining the causes of nonconformities c) Evaluating the need for action to ensure that nonconformities do not recur
8.5
Improvement - 3
d) Determining and implementing action needed e) Records of the action taken results f) Reviewing corrective action taken
Preventive actions shall be taken to eliminate causes of potential nonconformities to prevent their occurrence. Documented procedure shall be established to define requirements for: a) Determining potential nonconformities and their causes b) Evaluating the need for action to prevent occurrence of nonconformities c) Determining and implementing action needed
Documentation Requirements Clause 8 Documents Procedure for measurement and monitoring of processes for effective control. Methods for use of statistical techniques for process control and data analysis for improvement. Procedure for inspection and release of final product. Procedure for dealing with non conforming product and use of material under concession. Procedure for monitoring customer satisfaction and dealing with customer complaints.
ISO 9000:2000
Documentation Requirements Clause 8 contnd.. Documents Procedure of internal audit of QMS, along with check list. Procedure for corrective and preventive action. Procedure for collection and analysis of data for effectiveness and improvement of QMS. Records Process monitoring data and corrective action taken for process control Record of product non conformities and products accepted on concession.
ISO 9000:2000
Documentation Requirements Clause 8 contnd.. Records Data analysis and activities for continual improvement. Result of internal audits and follow up action. Data on customer feedback and action taken on customer complaints.
ISO 9000:2000
Documentation Requirements Clause 8 contnd.. Records Data analysis and activities for continual improvement. Result of internal audits and follow up action. Data on customer feedback and action taken on customer complaints.
ISO 9000:2000
No body
Can Achieve
QUALITY
Without
U
ISO 9000:2000