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UNDERSTANDING OF

ISO 9000 DOCUMENTATIONREQUIREMENTS

By :SHAJRUDDIN.

MBA AMU (MALAPPURAM CENTRE )

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INTRODUCTION It allows organization’s flexibility in the way it chooses

to document its Quality Management System.Allows individual organizations to demonstrate the

◦ Planning

◦ Operations and

◦ Control

It allows organizations to develop minimum requirements needed.

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What is document?

A document is : A written or drawn representation of thoughts. Any concrete or symbolic indication Eg: Thesis, journals, balance sheet etc.

What is Documentation? A set of documents provided on

◦ Papers◦ Online◦ Digital◦ Analog media

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TYPES

It can be one of the following◦ Paper ◦ Magnetic ◦ Electronic or computer optical discs◦ Photographs◦ Master samples

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Requirements

General (4.2.1)

Defines the general requirements in clause 4.2.1 like – Documented statements of quality policy and quality

objectives A quality manual Documented procedures required by the international

standards Documents needs to ensure effective planning, operation

and control Records required by international standards

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Quality policy and quality objective

Quality Policy(4.1.1)Clause 4.1.1 defines a quality policy is:• A brief statement• A document defining organization’s quality objective

and goals• A commitment to meeting them• Provides outline for creating, stating and measuring the

performance.• E.g: “We will consistently provide products that meet

the requirements and expectations of our customers”

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Quality objective(4.1.1)

Clause 4.1.1 defines quality objective as

The measurable steps towards achieving the quality policy.

E.g: % of on time deliveries% of internal scrap% of defects

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Quality manual

Clause 4.2.2 defines quality manual as a document defining the scope of quality

management system (QMS) i.e. what should included in the quality system.

Complete detail and explanations of exclusions i.e. what should be eliminated in the quality system.

Contains references for quality proceduresInteractions of key business procedures

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Quality records

It is defined in clause 4.2.2 of documentation requirements

Very necessary and important requirementWorks as work instructionsVerifies activitiesMakes operations effective

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Six procedures

Includes six specific procedures like

A. Control of documents (4.2.3)It is necessary for the following

Approvement of document for adequacyReview and update as necessary Identify the changeTo make available the relevant documentsTo prevent obsolete documents

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B. Control of records(4.2.4) Necessary for the evidence of conformity To demonstrate the effective operations of quality

management systems (QMS)

It includes the following Storage Retention Identification protection

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C. Internal Audit(8.2.2)Clause 8.2.2 defines internal audit as The assessment of conformity, effectiveness evaluation

and opportunity for improvement. A comparison between organization’s quality systems

and required quality systems by the international standards.

Done through the internal auditors from within the organization.

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D. control of non-conforming productsClause 8.3 define the non conformation control as

A documented procedure for Identifying the non conforming products by

Their tags Their labels Their containers that it is in

Describing how organization will disposing it Identity required records

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E. corrective actions(8.5.2)Clause 8.5.2 defines corrective actions as

Actions required to eliminate the cause of detected non-conformity like What is big deal What is the chance it will happen again Eliminate future threats

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F. preventive Actions(8.5.3)

Clause 8.5.3 of ISO 9000 documentation defines

All those actions that are necessary for preventing the non-conformity like:15151515 Check list FEMA-Failure mode and effective analysis Hazards and operability analysis (Hazop) Fault tree analysis (FTA)

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