Iso 9000

Quality Management Quality Management
Agenda

Quality Management Introduction to ISO 9000 Introduction to QS 9000 & TS 16949 Comparison of ISO 9001 & TS 16949 Requirements Documentation Requirement Types of Audits Need for Certification
NaP/QMM 24 | 12/01/2009 | Bosch Limited 2009. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.
What is Quality
Quality :
Degree to which a set of inherent characteristics fulfils requirements (As per ISO 9000)
Inherent Characteristics means permanent characteristics E.g. Reliability the mean time between failure Durability - how long the product lasts Aesthetics how the product looks Cost, Serviceability
Requirement : - Need or expectation that is stated or implied - Requirements can be different for end user.
What is Quality
Quality :
The quality of something can be determined by comparing a set of inherent characteristics against a set of requirements. If those inherent characteristics meet all requirements, good quality is achieved. If those characteristics do not meet all requirements, a low or poor level of quality is achieved. According to this definition, quality is a relative concept. Quality is always relative to a set of requirements.
What is Quality
Quality Concepts:

OLD - Quality relates only to the final product NEW - Quality is determined by every process, function, and subproduct and Customer Satisfaction.
OLD - Quality is the responsibility of the Quality Assurance department NEW - Quality is everyones job, on every task to perform
Quality Management
Quality management - Coordinated activities to direct and control an organization with regard to quality. Coordinated activities include - Establishment of Quality Policy
- Establishment of Quality Objectives - Quality Planning - Quality Control & Improvement
Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements.
Quality Management
QM is about removing the reasons for problems, not about solving or accommodating the same problem over and over again A Quality Management System will:
Meet stated or implied CUSTOMERS NEEDS; Give CUSTOMERS CONFIDENCE that intended quality will be achieved; Give MANAGEMENT CERTAINTIY that quality is being maintained and improved.
What is ISO
ISO Stands for International Organization for Standardization. ISO Was established in 1947. ISO is a worldwide federation of National Standards Bodies (ISO member bodies) from over 150 countries. Its Head Quarters is at Geneva, Switzerland. The Object of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services. ISO is the world largest standards developing organization. ISO has published more than 17,000 International Standards, ranging from standards for activities such as agriculture, construction, mechanical engineering, medical devices, information technology etc.
ISO In Figures
Members 157
Technical Committees
208
International Standards Developed 08)
17765 (Till Dec.
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ISO Standard Development Process
International Standards are drafted in accordance with the rules given in ISO Directive
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting
Publication as international Standard requires approval by at lease 75% of the member bodies casting a vote.
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What is ISO 9000
ISO 9000 contains the basic requirements of the quality management for all industries It is important to note ISO 9000 is not a Product Standard. Rather it is a System Standard. (It does not specify how to control your product. It specifies to control processes by means of a System)
Its primary purpose is to provide organizations with useful internationally recognized models for operating a quality management system. (i.e. Structure of the QMS should remain same thought the world.)
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What is ISO 9000
ISO 9000 was released in 1987 ISO 9000 was developed by ISO Technical Committee TC 176 The first update in ISO 9000 Series published in 1994 known as ISO 9000:1994, the Second revision released in December 2000, now referred to as ISO 9000:2000 series. ISO 9000 Series (1994) ISO 9001, ISO 9002 & ISO 9003 (All are Certification Standards) ISO 9000 Series (2000) ISO 9000, ISO 9001 & ISO 9004 (ISO 9001 is the Certification Standards)
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ISO 9000 : 1994 Series

Standard
Description
ISO 9001 Model for quality assurance in design, development, production, installation and Servicing. ISO 9002 installation Model for quality assurance in production, and Servicing.
ISO 9003 testing.
Model for quality assurance in final Inspection and
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ISO 9001 : 1994 (20 Elements)

4.1 - Management Responsibility 4.2 - Quality System 4.3 - Contract Review 4.4 - Design Control 4.5 - Document and Data Control 4.6 - Purchasing 4.7 - Control of Customer Supplied Product 4.8 - Product Identification and Traceability 4.9 - Process control 4.10- Inspection and Testing 4.11 - Control of Inspection, Measuring & Test Equipments 4.12 - Inspection and Test Status 4.13 - Control of Nonconforming Product 4.14 - Corrective and Preventive Action 4.15 - Handling , Storage , Packing , Preservation and Delivery 4.16 - Control of Quality Records 4.17 - Internal Quality Audits 4.18 - Training 4.19 - Servicing 4.20 - Statistical Techniques
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ISO 9000 : 2000 Family of Standards

ISO 9000 : Quality Management Systems Fundamentals and Vocabulary ISO 9001 : Quality Management Systems Requirements ISO 9004 : Quality Management Systems Guidelines for Performance Improvement
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System Requirements ISO 9001:2000
4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement
General requirements
Management Commitment Customer focus
Provision of resources Human resources Infrastructures Work environment
Planning Customer related processes Design & development Purchasing
General Monitoring & measurement Control of NCP Analysis of data Improvements
Documentation Requirements
Quality policy Planning Responsibility, authority & communication Management Reviews
Production & service provision
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Quality Management Quality Management Why Revision ?
ISO has a standard review cycle for every Five Year. To simplify the structure of QMS and to develop an unique standard that will be equally applicable to small as well as medium and large organizations To reduce amount and detail of documentation and allow flexibility for documentation. To focus on customer satisfaction, process approach & continual improvement.
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ISO 9000 : 2000
Released on 15th December 2000. 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Standard Known as ISO 9001 Quality Management System Requirements Applicable to all organization with possible permissible omissions of certain requirements
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Important Changes
ISO 9000:1994 1. Core standard ISO9001, 9002, 9003 2. Product based approach 3. Requirements detailed in Clauses 4.1 - 4.20 4. Management Role not descriptive 5. 6. ------permitted) Process based approach Clauses rearranged. Requirements detailed in Clauses 4,5,6,7,8 Identifies greater management involvement More focus on CIP More focus on Customer Satisfaction Only 6 Mandatory procedures required ISO 9000:2000 Only ISO 9001 (Exclusions in Cl.7
7. Procedure required for all processes
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Continual Improvement of the Quality Management System
Management Responsibility
Resource Management
Measurement, Analysis, Improvement
Inputs
Product Realization
Outputs
Product
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Process
Process Any Activity or Set of Activities which takes input, Use resources and transforms Input to output is referred to as a Process.
Resources
PROCESS
INPUTS
Cust. Order Product is the output receiving
OUTPUTS
Product
Purchasing
Manufacturing (E.g. Machining, Grinding)
Inspection & Testing
Product
of processes
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Purchasing Process Process Approach
Purchasing Purchasing Need // Need Purchase Purchase Indent Indent
Inputs Inputs
Purchasing Purchasing Process Process
Set of Activities Set of Activities To select suppliers To select suppliers To prepare P.O. To prepare P.O. To prepare GRN To prepare GRN To communicate to To communicate to supp. supp. To inspect incoming To inspect incoming goods goods
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Storage Storage Inspection and Inspection and Testing Testing Manufacturing Manufacturing Finance Finance
Interactions to Interactions to
Outputs Outputs Receipt of Receipt of Material in Material in Right Quality Right Quality & Quantity at & Quantity at Right Time Right Time
Resources Resources Manpower Manpower Stationary / /Invoice Stationary Invoice Measuring equipments Measuring equipments P.C. / /Phone P.C. Phone

Turning Process Process Approach Resources : Consumables, Machines, Tools, Instruments, Trained Operators, Power, Working Space
Raw Material
TURNING
Turned Component
Interaction Purchase, Maintenance, Inspection
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Training Process Process Approach
Trainer, LCD Projector, Computer, Sitting Arrangement, Backup Power etc.
Training Need
Training Process
Implementation of New learning
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Internal Audit Process Process Approach Resources : Train Auditor, PC, Audit Observation sheet, Audit Checklist
Audit Plan
Internal Audit
Audit findings, Audit Report
Interaction Management Review, Training, Customer Communication
Set of Activities
To do Audit as per checklist To communicate audit findings To prepare audit report.
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Process Approach
Process Approach The application of a system of processes within an organization, Together with the identification, interactions and management Of the Processes can be referred to as the Process Approach Process approach is to be applied for managing organization in order to meet customer requirements and enhance customer satisfaction.
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Process Approach
Maintenanc e
Receive Order
Identify Purchase Needs
Purchasing
Production
Storage
Inspection & Testing
Logistics
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Quality Management Quality Management QMS Principles

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QMS Principles
Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
Top Management should establish a customer oriented organization By defining systems & processes that can be clearly understood, managed & improved By communicating customer requirements throught the organization by ensuring effective & efficient operation and control of processes and monitor and measure data to determine customer satisfaction Main Clauses 5.6.2, 7.2.1, 7.2.2, 7.2.3, 8.2.1
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QMS Principles
Leadership
Leaders provide direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.
Top Management should take leadership, should commit and involve in establishing and implementing Quality Management System. Top Management should direct the organization to achieve customer satisfaction and continual improvement. Main Clauses 5.1, 5.6.1
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QMS Principles
Involvement of People
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.
Organization should encourage involvement & development of its people By By By By By defining their responsibilities and authorities providing ongoing training participating in improvement projects, new methods & solutions creating an environment to encourage innovation using measurement of peoples satisfaction.
Main Clauses 5.5.1, 6.2.2
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QMS Principles
Process Approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Main Clauses 8.2.3, 5.6.2, 8.4
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QMS Principles
System Approach to Management
Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives.
The organization should define the system by identifying and developing the processes and their interactions towards continual improvement. Taking an example, the important characteristics of a Bus is to carry out passengers from one place to other. From an users angle, the engine body, seats, tyre & other parts all together carry out the aim. Nobody can say that only engine do this job. Main Clauses 4.1, 5.6, 8.2.3
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QMS Principles
Continual Improvement
Continual improvement of the organizations overall performance should be a permanent objective of the organization
Management should continually seek to improve processes of the organization rather than wait for a problem to reveal opportunities for improvement. Continual improvement should be make through establishing policy, Quality Objectives, involvement of people, review of processes & taking corrective & preventive actions. Main Clauses 8.5.1, 8.5.2
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QMS Principles
Factual Approach to decision making
Effective decisions are based on the analysis of data and information.
This principle requires the organization to manage the information, make decisions and take appropriate actions based on the results of analyses of data. Competitive process benchmarking, measuring cost of quality, measuring customer satisfaction and similar actions can help the organization to take decisions based on facts. Main Clauses 8.4
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QMS Principles
Mutually Beneficial Supplier Relationship
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Mutually Beneficial supplier relationship means benefits to the organization & suppliers This organization should establish relationship / partnership with suppliers to promote & Improve processes. The relationship should be developed by 1) Communicating customer requirements to the suppliers 2) Carry out supplier evaluation 3) to take part in supplier Main Clauses 7.4.1, 7.4.3
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QS 9000 Approach
QS 9000 Quality System Requirements QS 9000 is a harmonization of General Motor, Ford and Chryslers Quality System Requirements QS 9000 was published in 1994 and based on ISO 9001:1994 QS 9000 = (ISO 9001:1994 + Automotive Quality System Requirements) QS 9000 has been withdrawn & replaced by ISO/TS 16949 (Validity of Standard has been expired after 14th Dec. 2006)
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QS 9000
QS-9000
W.e.f Dec 2006
ISO 9000:1994
W.e.f 15.12.2003
ISO / TS16949
ISO 9000:2000
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QS 9000 Demerits
A lot of Documentation required in order to implement Standard
Focus of Product Quality as standard was based on ISO 9001:1994
Difficult to implement in small organization.
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ISO/TS 16949
ISO/TS 16949 Technical Specification (Quality Management System Requirements for Automotive Production & Relevant Production & Service Part Organization)
The ISO/TS 16949 was prepared by IATF (International Automobile Task Force) and JAMA (Japan Automobile Manufacture Association) with Support from ISO/ TC 176. ISO/TS 16949:2002 was published in 2002 and based on ISO 9001:2001 ISO/TS 16949 = (ISO 9001:2000 + Automotive Quality System Requirements)
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ISO/TS 16949
IATF is the International Automobile Task Force. IATF Consists of an international group of Vehicle Manufacturers & national trade associations: - General Motors Corporation - Ford - Daimler Chrysler - BMW Group - Fiat Auto - PSA - Renault - Volkswagen - National Trade Associations such as AIAG (USA), VDA (Germany), SMMT (UK) & ANFIA (Italy)
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Eligibility Requirements for ISO/TS 16949
ISO/TS 16949:2002 is applicable to automotive production and service part organizations only. It is applicable only to sites where production or service parts are manufactured. (A site is defined as a location at which value added manufacturing processes occur.) Supporting functions whether on-site of remote such as Design Centers, Corporate Headquarters & Distribution Centers, Form part of the site as they support the site, but can not obtain stand alone Certification.
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ISO/TS 16949 is applicable to the Automotive Supply Chain Automotive shall be understood as including the following : - Cars, Trucks, Buses & Motorcycles Automotive shall be understood as exclude the following : - Industrial, Agricultural, Off-Highway (Mining, Forestry, Construction etc.)
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Organizations which have automotive and non-automotive product will require separate certification for these separate groups. They would have ISO/TS 16949 Certification for their automotive activities and ISO 9001:2000 for non-automotive business
E.g. A company Mfg. Bearings for Automotive & Industrial Applications For Automotive Application TS 16949:2002 For Industrial Application ISO 9001:2000
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Comparison ISO 9001:2000 & TS 16949:2002 Requirements
ISO 9001:2000 4.2.3 Control of documents

Documents required by the quality management system shall be controlled. A documented procedure shall be established to define the controls needed to approve, review, Updating, changes, distribution and to ensure current revision level TS 16949:2002 4.2.3.1 Engineering specifications
The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.
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ISO 9001:2000 5.5.1 Responsibility and authority
Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization. TS 16949:2002 5.5.1.1 Responsibility for quality
Personnel responsible for product quality shall have the authority to stop production to correct quality problems. Production operations across all shifts shall be staffed with personnel in charge of for ensuring product quality.
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ISO 9001:2000 5.5.2 Management representative
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, b) reporting to top management on the performance of the quality management system and any need for improvement, and TS 16949:2002
5.5.2 1 Customer representative
Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
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ISO 9001:2000 7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
TS 16949:2002 7.4.1.2 Supplier quality management system development
Suppliers to the organization shall be third party registered to ISO 9001 : 2000 by an accredited third party certification body. (Priority of ISO 9001:2000 Certification depends upon Criticality of the Item Supplied and supplier quality performance)
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ISO 9001:2000 7.5.1 Control of production and service provision
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, TS 16949:2002
7.5.1.1 Control Plans
The organization shall develop Control Plans for Components / System / Product The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality
7.5.1.2 Work Instructions
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ISO 9001: 2008
ISO 9001:2008 was developed (in 2005). The purpose of the revision was specified to be limited to:
Enhance the clarity of ISO 9001:2000, without introducing new requirements
ISO 9001:2008 was published November 15th, 2008. Content of ISO 9001 (2008):

No new requirements introduced in ISO 9001:2000. Some useful clarifications to existing requirements
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Changes ISO 9001: 2008
6.4 Work environment ISO 9001:2008
The organization shall determine and manage the work environment needed to achieve conformity to product requirements. ISO 9001:2008 NOTE The term work environment relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
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8.2.1 Customer satisfaction ISO 9001:2000
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. ISO 9001:2008 NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.
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8.2.2 Internal Audits ISO 9001:2000

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. ISO 9001:2008
Addition of a requirement that the management team in the area being audited is responsible for necessary corrections and corrective actions.
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Transition Period ISO 9001: 2008 Changes
24 months after publication by ISO of ISO 9001:2008 (i.e. Nov. 15th 2010), any existing certification issued to ISO 9001:2000 shall not be valid.
Transition can be done during any scheduled re-certification or periodical audit in the 24 months period, but preferably during a recertification audit to avoid additional costs.
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Document
Document :
Information and its supporting medium (ISO 9000) Information

Procedure Specification Record Drawings Standard
Medium
Paper Magnetic Electronic Photographic Master Sample
(Documents are not always in Paper Forms. A CD Containing Organization drawings is also a document)
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Documents & Records

Record :
Document stating results achieved or providing evidence of activities performed (ISO 9000) - Generally Records need not be under revision control. Records are one type of documents. Documents
Control Plan Work Instructions Preventive Maintenance Plan Record Drawings TS Standard / Audit Checklist
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Records
Incoming Inspection Record SPC Chart Preventive / Breakdown Maintenance In Process Inspection Report System / Product Audit Report
Purpose of Documents
Communication of information
It helps to communicate relevant information to different levels / functions.

E.g. Customer Order (Customer Mktg. Production) Final Inspection Report (Quality Dept. Customer) Work Instructions (Production dept Operator)
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Evidence of Conformity
Provision of evidence that what was planned has actually been done.
E.g. Work Instruction / Preventive Maintenance Plan says when to do Preventive Maintenance of M/c Preventive Maintenance Record is the evidence of Maintenance done.
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Knowledge Sharing
In order to increase awareness and preserve the organizations experiences. Example: a technical specification, which can be used as a base for design and development of a new product.
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Typical QMS Documentation Structure
Quality Manual Procedures
QMS Scope, Exclusion, Process interaction
Specified way to carry out processes
Documents such as work instructions Control Plans, Standard, Drawings
Provide Reference to process carry out
Records
Evidence of Result achieved
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Documents Required by ISO 9001:2000
Clause 4.1 - General Requirements
Documented statements of quality policy and quality objectives A quality manual Documented procedures required by the international standard Documents needed by the organization to ensure effective planning, operation and control of its processes (e.g. Drawings, Work instructions, Control Plans, Standards etc.) Records required by the international standard
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Additional Documents Required by TS 16949
Example - Additional Documents required TS 11111 Control Plans, Work instructions Product Approval Process (PPAP As per customer requirement) MSA Study, Risk Analysis - FMEA Laboratory Scope (Defined methods, competency of personnel, Work environment Checklist for System, Process & Product Audit
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Documented Procedures Required by ISO 9001:2000
Control of documents (Clause 4.2.3) Control of records (Clause 4.2.4) Internal Audit (Clause 8.2.2) Control of nonconforming product (Clause 8.3) Corrective action (Clause 8.5.2) Preventive Action (Clause 8.5.3)
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Documented Procedures Required by ISO/TS 16949:2002
Control of documents (Clause 4.2.3) Control of records (Clause 4.2.4) Internal Audit (Clause 8.2.2) Control of nonconforming product (Clause 8.3) Corrective action (Clause 8.5.2) Preventive Action (Clause 8.5.3) Training (6.2.2.2)
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Why Audits ?
ISO 9001 and ISO/TS 16949 Systems contains a specific mandatory requirement for Internal Quality Audits to be conducted. The requirements is :
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements and b ) is effectively implemented and maintained
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Purpose of Audits
FACT FINDING & NOT FAULT FINDING
To Collect objective evidence on deficiencies observed ( Identify System Weakness ) To Facilitate auditee for initiating corrective action in order to ensure that nonconformities do not recur again. ( Thus, Overall System Improvement )
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Types of Audit
First Party Audits
Internal audits, sometimes called first-party audits, are conducted by organization for internal system assessment and may form the basis for an organization's self-declaration of conformity. E.g. System Audits, Process Audits & Product Audits
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Types of Audit
Second Party Audits
Second-party audits are conducted by Customers to their Suppliers in order to verify system assessment. E.g. Mahindra conducts audit on Bosch OR Bosch conducts audit on suppliers
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Types of Audit
Third Party Audits
Third-party audits are conducted by external, independent auditing organizations, such as those providing registration or certification of conformity to the requirements of ISO 9001 or TS 16949 Conducted by Certification Body Only (E.g. ISO 9001, TS 16949, ISO 14001, OHSAS 18001)
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Categories of Audit
System Audits
System audit refers to the audits conducted to determine whether execution follows plans , policies , procedures, instructions , etc. Focus on Achievement of Quality Objectives, Meeting top management perceptions, Analysis of Data, Customer Satisfaction & Continual Improvement & Process Interactions Conducted on All organizations QMS Processes (Mfg., Purchasing, Marketing, Servicing, Design etc.)
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Categories of Audit
Process Audits
Process Audit is conducted on Manufacturing Processes only and focused on manufacturing Process Control. Focus on Process Control Parameters, Control Plan, Work Instructions, Competence of Operator, Maintenance instructions adherence to the Process. In depth QMS Audit for Manufacturing Processes
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Categories of Audit
Product Audits
Product audit is an Independent evaluation of product quality to determine its fitness for use and conformance to specification. e.g. Fit , form , function
Focus on Product Characteristics & Inspection & test parameters adherence to Drawing / Customer Specification. (e.g. Product Dimensions & Test Parameters)
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Certification
Certification is known in some countries as registration. It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001). ISO does not carry out certification and does not issue or approve certificates. Only Certification Bodies having accreditation (national / international) can issue Certificate.
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Accreditation
Accreditation is like certification/approval of the certification body. Accreditation means the formal approval by a specialized body in order to ensure that a certification body is competent to carry out Certification (ISO 9001:2000 or ISO 14001:2004) in specified business sectors. Accreditation body controls Certification Bodies (E.g. Audit of Certification Bodies, Audit at Clients site, Checking Audit Reports of certification bodies)
Accreditation Body Certification Body Organization to be certified

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Accreditation
Accreditation Bodies

UKAS (United Kingdom Accreditation Services) JAS (Japan Accreditation Services) ANAB (American National Accreditation Body) NABCB (National Accreditation Board for Certification & Training) ISO develops standards and guides to encourage good practice in accreditation and certification (ISO 17021). ISO does not approve or control certification bodies.
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Need for Certification
Customer Requirement (E.g. TS 16949 organization requires their suppliers should be certified to ISO 9001) International Recognization to the organization. Thus common system to understand Organizations QMS. Competitive Advantage. Enhance Customer Satisfaction which in turn can lead to business needs.
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Journey to Certification
STEP 1: Preparation
Preparation means Understanding of Standard requirements and implement in the organization. STEP 2: Application
After implementation & review found satisfactory, can go for application for certification to a certification body. STEP 3: Stage 1 Audit (Documentation Audit)
Stage 1 Audit to check completeness of documents related to QMS. STEP 4: Stage 2 Audit (Implementation Audit)
Audit Assessment covers audits of documents and QMS Processes.
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Journey to Certification
STEP 1: Registration & Certification
After Closure of all NCRs, Certification body issue certificate to the Organization. Certification means Conformity of Organizations QMS to Standard requirements.
STEP 6: Continual Assessment
Annual Surveillance audit in order to check whether quality management system is maintained and improved.
Application Stage 1 Audit Stage 2 Audit Certification
Contract Review Scope Time Scale for Audit Audit Team
Surveillance
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Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

Quality Management Quality Management

International Standards Developed 08)

17765 (Till Dec.

Quality Management Quality Management

ISO Standard Development Process

Quality Management Quality Management

What is ISO 9000

Quality Management Quality Management

What is ISO 9000

Quality Management Quality Management

ISO 9000 : 1994 Series

ISO 9003 testing.

Model for quality assurance in final Inspection and

Quality Management Quality Management

ISO 9001 : 1994 (20 Elements)

Quality Management Quality Management

ISO 9000 : 2000 Family of Standards

Quality Management Quality Management

Management Commitment Customer focus

Provision of resources Human resources Infrastructures Work environment

Planning Customer related processes Design & development Purchasing

General Monitoring & measurement Control of NCP Analysis of data Improvements

Quality policy Planning Responsibility, authority & communication Management Reviews

Production & service provision

Quality Management Quality Management Why Revision ?

Quality Management Quality Management

ISO 9000 : 2000

Quality Management Quality Management

7. Procedure required for all processes

Quality Management Quality Management

Measurement, Analysis, Improvement

Quality Management Quality Management

Manufacturing (E.g. Machining, Grinding)

Inspection & Testing

Quality Management Quality Management

Purchasing Purchasing Process Process

Quality Management Quality Management

Interaction Purchase, Maintenance, Inspection

Quality Management Quality Management

Trainer, LCD Projector, Computer, Sitting Arrangement, Backup Power etc.

Implementation of New learning

Quality Management Quality Management

Audit findings, Audit Report

Interaction Management Review, Training, Customer Communication

Quality Management Quality Management

Quality Management Quality Management

Identify Purchase Needs

Inspection & Testing

Quality Management Quality Management QMS Principles

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actual FFactual ppr r ach to aappooach to ecision ddecision king maaking m

cess Proocess Pr ppr r ach aappooach

ntinual Coontinual C ement r imppovvement im ro

stem Syystem S ch to ppr r a aappooach to nagement Maanagement M