iso clause 4

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ISO 9001: 2008

1. Introduction

2. Quality Management Systems-Requirements


Quality Management Systems-Requirements

Clauses1. Scope2. Normative reference3. Terms and definitions4. Quality management system5. Management responsibility6. Resource management7. Product realization8. Measurement, analysis and improvement


4. Quality Management System

4.1. General requirements

4.2. Documentation requirements


4.2. Documentation requirements

4.2.1. General

4.2.2. Quality manual

4.2.3. Control of documents

4.2.4. Control of records


4.1 General requirements

The organizational shall :–a. identify the processes needed for the quality

management system and their application throughout the organization (see 1.2),

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,

d. ensure the availability of resources and information necessary to support the operation and monitoring of these processes,


…4.1 General requirements

e. monitor, measure and analyse these processes, and implement actions necessary to achieve planned results and continual improvement of these processes.

f. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.


4.1 General requirements

The educational organizations should:a. Define and manage those processes included in the

educational design, educational development, and the educational delivery processes, the procedures for implementation, and the measurement of results;

b. The conditions for the acceptance of the education at the time of delivery; and

c. Continual improvement of these processes and provision of resources.

EDUCATION


4.2.1 General

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, d. documents needed by the organization to ensure the

effective planning, operation and control of its processes, and

e. records required by this International Standard.


4.2.1 General

The institute must identify the documentation requirement in addition to the mandatory documents required by ISO 9001:2008.

This shall be done considering the size of the Institute (No. of Courses, no. of Students, no. of people etc.), competence of teaching and non-teaching personnel and type of processes and technology used in the institute.

EDUCATION


4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes :–

a. the scope of the quality management system, including details of and justification for any exclusions,

b. the documented procedures established for the quality management system, or reference to them,

c. and a description of the interaction between the processes of the quality management system.


4.2.2 Quality manual

The quality manual should describe the scope of the educational organization's quality management system and interactions of its educational and support processes.

It should include, or contain, references to all applicable documented procedures required by ISO 9001 and other criteria upon which the quality management system is based.

EDUCATION


4.2.3 Control of documents

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 re-approve

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,e. to ensure that documents remain legible and readily

identifiable,


…4.2.3 Control of documents

f. to ensure that documents of external origin are identified and their distribution controlled, and

g. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.


4.2.3 Control of documents

a. Documents used to define, direct, and control instruction and support activities should be controlled (see 7.1).

b. Information about the edition of textbooks or learning material, text supplements, workbooks or other Instruction resources should be controlled and traceable to the design and development process.

EDUCATION


…4.2.3 Control of documents

c. Procedures for course registration, formats for lesson plans, instructions on research report formats, etc. should be maintained to provide complete and current documents needed.

d. The document control system should include provisions for control of external document (for example, but not limited to, legislation, rules, government circulars, accreditation regulations).

EDUCATION


4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation 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, protection, retrieval, retention time and disposition of records.


4.2.4 Control of records

a. The educational organization should give attention to retention times and record disposal.

b. Student records and instructional records such as: instructor certifications or qualifications; student performance records and instruction

reviews; attendance; evidence of completion.

EDUCATION


Model of Process-based QMSValue-Adding Activity

Info Flow

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