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QMS Implementation Guide Ebute

The document summarizes ISO 9001:2008, which contains requirements for quality management systems. It is approximately 30 pages and outlines 8 sections that specify requirements including management responsibility, resource management, product realization, measurement and improvement. Key requirements include establishing a quality policy, controlling documents and records, conducting internal audits, handling nonconforming products, taking corrective and preventive actions, and continually improving processes. Organizations must address all sections but only need to implement sections 4 to 8 within their quality management system.

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53 views7 pages

QMS Implementation Guide Ebute

The document summarizes ISO 9001:2008, which contains requirements for quality management systems. It is approximately 30 pages and outlines 8 sections that specify requirements including management responsibility, resource management, product realization, measurement and improvement. Key requirements include establishing a quality policy, controlling documents and records, conducting internal audits, handling nonconforming products, taking corrective and preventive actions, and continually improving processes. Organizations must address all sections but only need to implement sections 4 to 8 within their quality management system.

Uploaded by

uche eke
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is availabl

organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems —
and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach, which do n
requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:

Page iv: Foreword


Pages v to vii: Section 0 Intro
Pages 1 to 14: Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
Pages 2 to 14 132 1
Section 4: Quality Management System
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.

Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography

The standard specifies six compulsory documents:

Control of Documents (4.2.3)


Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above

Summary of ISO 9001:2008 in informal language

The quality policy is a formal statement from management, closely linked to the business and marketing plan and to custo
The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable
The business makes decisions about the quality system based on recorded data.
The quality system is regularly audited and evaluated for conformance and effectiveness.
Records show how and where raw materials and products were processed to allow products and problems to be traced to
The business determines customer requirements.

The business has created systems for communicating with customers about product information, inquiries, contracts, orde
When developing new products, the business plans the stages of development, with appropriate testing at each stage. It t
meets design requirements, regulatory requirements, and user needs.
The business regularly reviews performance through internal audits and meetings. The business determines whether the q
improvements can be made. It has a documented procedure for internal audits.

The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisio

The business has documented procedures for dealing with actual and potential nonconformances (problems involving sup

The business (1) makes sure no one uses bad product, (2) determines what to do with bad product, (3) deals with the root
to use as a tool to improve the system.

ISO9001.2008 Clauses and Gap Analysis


Title Action Required By Who
0.0 Foreward
0.1 Introduction
0.1.1 Quality Managment Principles
0.2 Process Approach
0.2 Types Of Business Processes
0.2 Process Characteristics
0.2 Process Plan - Do - Check - Act
0.3 Relationship With ISO 9004
0.4 Compatibility With Other Management Systems
1.1 ISO 9001 QMS Scope
1.2, - 3 QMS Application
4.1 QMS General Requirements
4.1 QMS General Requirements - Continued
4.2.1 Documentation Requirements
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.3 Control of Documents -Continued
4.2.4 Control of Records
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
6.1 Provision of Resources
6.2 Human Resources
6.3-4 Infrastructure and Work Environment
7.1 Planning of Product Realization
7.1 Planning of Product Realization - 2
7.2 Customer-Related Processes
7.2 Customer-Related Processes - Cont'd
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.5-7 Verification, Validation & Changes
7.4 Purchasing Process
7.4.2-3 Purchasing Information & Verification of Purchased Product
7.5.1 Control of Production and Service Provision
7.5.2 Production Process Validation
7.5.3 Identification and Traceability
7.5.4-5 Customer Property and Preservation of Product
7.6 Control of Monitoring and Measuring Equipment
7.6 Control of Monitoring and Measuring Equipment 2
8.1 Measurement, Analysis and Improvement - General
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
imately 30 pages which is available from the national standards
Quality management systems — Fundamentals and vocabulary
management approach, which do not contain specific
e as follows:

thin a QMS.

may or may not include the above documents).

s and marketing plan and to customer needs.


ployee works towards measurable objectives.

s.
ucts and problems to be traced to the source.

ormation, inquiries, contracts, orders, feedback, and complaints.


propriate testing at each stage. It tests and documents whether the product
business determines whether the quality system is working and what

activities and the resulting decisions, and monitors their effectiveness.

ormances (problems involving suppliers, customers, or internal problems).

ad product, (3) deals with the root cause of problems, and (4) keeps records

Target Date
Control of Document.
Department Procedure Identification Number
Business Manager BM SOP
Technicla and Operations Manager TOM
Human Resources HR
Operations OPS
Mechanical MM
EC&I ECI
Finanace FIN
Procurement PROC
Inventory INV

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