Clause 4 - Quality Management System

4.1 General Requirements

4.2 Documentation Requirements

4.2.1 4.2.2 4.2.3 4.2.4 General Requirement QP, QO, QM Procedure, records Quality Manual Scope- exclusion Procedures/ references Business flow chart Control of documents Approval/ reapproval Changes & revision status Availibility, legibility of docs External/ obsolete doc Control of records Identification, storage, protection, retrieval, retention, disposition

Process & its Linkages Criteria and methods for control Resources & information Monitor, measure, analyse Implementation

4.1 General requirements (1)

Organization shall establish, document, implement & maintain QMS & continually improve its effectiveness in accordance with the requirements of the Standard

ISO 9001:2000

4.1 General requirements (2)

Identify process needed

determine the sequence and interaction of processes

determine criteria and methods for effectiveness of operations and control of processes ensure the availability of information, resources monitor, measure and analyse process

implement action necessary to achieve planned results

and continual improvement

Verb Focus Determine offering Design product Acquire order Produce product Distribute product Service product

Noun Focus Marketing Design Production Sales Distribution Servicing

Needs

Process A

Process B

Process C

Satisfaction

- doc control process - material handling process - data storage process - resource mgt process

Verification process

4.1 General requirements (3)

OUTSOURCING (SUBCONTRACTING)

CONTROL

QMS

People, Process

4.2 Documentation requirements

4.2.1 General

Documented statements of

- Quality Policy
- Quality Objectives - Quality Manual
ISO 9001 STANDARD

- Procedures, records
ORGANIZATION

Documented Procedure required by ISO9001

(1) Document Control

(2) Record Control (3) Internal Audit

(4) Nonconformity Control

(5) Corrective Action (6) Preventive Action

Documented Procedure required by Organization

Standard Guideline

Policies Practices
Datas;
Customer

SOP

Records Reports Plans Test Specs Procurement

Supplier
Industry

External Ref

Derived Doc

4.2.2 Quality manual

( Document specifying QMS of an organization )

A Quality manual shall be established that includes

scope ( any exclusions ) - Under Clause 7 documented procedure or reference description of the interaction of the process in the quality system

QM Framework - Specimen
Introduction
(Purpose, Scope, Definition)

Business Overview
(Profile, Vision, Mission)

Organization chart Process Flow Standard requirement Procedure/ Approval

4.2.3 Control of documents Documented procedure for

approval prior to issue review, update and re-approve documents changes and status of are identified available at points of use legible and readily identifiable external origin are identified and controlled prevent the unintended use of obsolete documents, and identification to them

DOCUMENTS
CONTROLLED UNCONTROLLED

Policies & Practices Specification

Memos / Letters

Diaries
Note books

Plans/ Schedule/Procedure/W I
Reference Documents (standards, guides, contracts)

Intentions (proposals, brochures)

Records (results, certificates, reports, meeting minutes)

4.2.4 Control of quality records

Documented Procedure - Legible - Readily Identifiable - Retrievable Control : Identification Storge Protection Retrieval Retention time Disposition

5.1 Mgt Commitment - QO, QP, Mgt review, resource, communication

5.2 Customer focus Customer satisfaction

5.3 Quality Policy

Clause 5 Management Responsibility

- Align with purpose, framework of objectives, - commitment, communicate, review - measurable QO, consistent with QP - to meet QMS, QO, - to maintain integrity for changes

5.4 Planning

5.5 Res, Authority, communication- Clearly define

- Fully aware

At planned interval Audit result, customer, product, process, CA, 5.6 Management Review PA, follow up, changes, recommendation Improvement

5.1 Management commitment Top Management (person/group - direct/control organisation) show commitment communicate the importance of meeting

customer requirements
statutory and regulatory requirements establishing a quality policy and quality objectives conducting management reviews availability of resources

Statutory & Regulatory requirement

Directly / Indirectly related to product
- Environmental, OHSAS, financial laws - Relationship building

- Availability of key personnel - Information sharing

Customer satisfaction

By Making employees understand priorities of organization. Pay attention, understanding, acceptance, correct action of workforce

5.2 Customer focus

Top management must ensure that customer needs and expectations

determined and fulfilled
enhancing customer satisfaction

5.3 Quality policy

(set of guiding principles)

appropriate to the purpose of the organisation

include a commitment to meeting requirements and continually improve effectiveness of system provide a framework for establishing and reviewing quality objectives Communication & Understanding Review for continuing suitability

ORG Purpose

To create customer

Who are customer? Where they are?

What they buy?

What they need? What they regard as value?

ORG Goal

To achieve ISO9001-2000

QP states

To give customer satisfaction in everything we do HOW ?

5.4 Planning
5.4.1 Quality objectives Quality Objectives at relevant functions and levels within organisation be measurable and consistent with quality policy

include those needed to meet product requirements

QUALITY OBJECTIVE

Corporate Process Product Departmental/ Functional Personal

5.4.2 Quality management system planning

Top management shall ensure that

the planning of the system is carried out in order to meet the requirements
(Corporate Plan, Dept Plan, Product Plan)

the integrity of the system is maintained when changes to system are planned and implemented
( Tech, plant, machinery, process, culture, competency level of staff )

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Define responsibilities , and authorities

Communicate within organization

5.5.2 Management representative

Responsibility and authority for ensuring the processes are established, implemented and maintained promoting awareness of customer requirements through out the organisation reporting on performance of the system and the needs for improvement

5.5.3 Internal communication

appropriate communication process are established within organisation & communication takes place regarding the effectiveness of QMS

5.6 Management review

5.6.1 General

review QMS at planned intervals for its continuing - suitability - adequacy - effectiveness
( include assessing opportunities for improvement and the need for changes)

Records maintained

5.6.2 Review input

Current Performance + improvement opportunities
audit results customer feedback process performance and product performance status of preventive and corrective actions follow-up actions from earlier reviews changes that could affect the QMS recommendations for improvement

5.6.3 Review output

The outputs from the review shall include
Improvements of quality management system and its processes product related to customer requirements resource needs

Clause 6 - Resource Management

6.1 Provision of resources Human Resources 6.2 6.2.1 General

6.4 Work environment 6.3 Infrastructure

6.2.2 Competence, awareness and training

6.1 Provision of resources

The organisation shall determine and provide the resources needed to

implement, maintain and improve effectiveness of the system enhance customer satisfaction

6.2 Human resources

6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of

applicable education training skills experience

6.2.2 Competence, awareness and training

The organisation shall determine the necessary competence
provide training or other actions evaluate effectiveness employees awareness of the relevance and importance of their activities and how they contribute to the achievement of quality maintain records

6.3 Infrastructure
( basic facilities, equipment, service, installation needed for growth and functioning of org)

Infrastructure needed to achieve product conformity shall be identified, provided and maintained, including
building, workspace and associated facilities process equipment supporting services

6.4 Work environment

( set of conditions under which people operate)

The organisation shall identify and manage the work environment needed to achieve conformity of product

Physical, Social, Psychological factors --> Behavior

QO Product, 7.1 Planning of product realization Process, Resource requirement Monitoring & Control Records for evidence
7.2 Customer-related process Customer communication

Know, review Customer Requirement related to product

Design and Development planning

Clause 7 Product Realization

7.3 Design and Development

Design and Development inputs Design and Development outputs Design and Development review
Design and Development verification Design and Development validation Control of design & development changes

Purchasing process
7.4 Purchasing

Purchasing information Verification of purchased product

Control of production and service provision Validation of processes for production and service provision Identification and traceability 7.5 Production & service provision Customer property Preservation of product Control of monitoring & measuring devices

Clause 7 Product Realization

7.6 Control of monitoring and measuring devices

7. Product realization
7.1 Planning of product realization

Sales process Contract process Design process Procurement process Production process Installation process Supporting process After sale process

7. Product realization
7.1 Planning of product realization

Determine quality objectives Determine products requirements Establish processes,documentation Provide resources specific to the product Establish verification, validation, monitoring, inspection and test, and its criteria Maintain necessary records

7.2 Customer-related process 7.2.1 Determination of requirements related to product Customer Necessary for use Statutory and regulatory requirements
(eg. Health & Safety issue, Environmental, Discharge of wastage, Safe working condition)

Additional requirements
(eg. Style, appearance, maintainability, reliability)

7.2.2 Review of requirements related to the product

Prior committing to supply product, the organisation shall review

product requirements
resolve differences ability to meet defined requirements the results of the review shall be recorded

CHANGES
Document - Amend/ Update/ Approval Persons - Notify

7.2.3 Customer communication

Arrangement to be identified and implemented

product information enquiries, contracts or order handling, amendments customer feedback, including complaints

7.3 Design and development

7.3.1 Design and development planning
Organization shall determine the design and development stages the review, verification and validation that are appropriate to each design and development stage responsibilities & authorities for Design & development manage interfaces between different groups involved in D&D. update planning output

Feasibility stage

Feasibility study (time, cost) proposed obj Vs practical solution ideas - conceived theories - tested design layout risk assessment uncertainty resolved design detail characteristic method - production/delivery establish

Conceptual stage

Design definition stage

Detail design stage

Development stage

design development

7.3.2 Design and development inputs

Inputs shall include functional and performance requirements
Functional Performance - speed, power, capacity - reliability, durability, safety, portability

statutory and regulatory requirements

Statutory Regulatory - power supply rating, marking, security - health, safety, environmental emission, certification of compliance required by some country.

information derived from similar previous designs other requirements

7.3.3 Design and development outputs (info, model, specimen)

Provide in a form that enables verification and approve prior release meet the input requirements for design and development

provide appropriate information for purchasing, production and for service provision
contain or reference product acceptance criteria specify the characteristics of the product that are essential for its safe and proper use

7.3.4 Design and development reviews

evaluate the ability to meet requirements

identify problems and propose actions participants shall include representatives of functions concerned records

7.3.5 Design and development verification

Product requirement Design Input Design Output Design Verification Design Validation

ensure that the outputs have satisfied the input requirements records maintain

7.3.6 Design and development validation

To ensure resulting product is capable of fulfilling the requirements for the specified application or intended use where practical validation to be completed prior to the delivery or implementation of the product

Record shall be maintained

7.3.7 Control of design and development changes

changes shall be identical and records maintained verify and validate changes as appropriate evaluation of changes to include the effect of changes on constituent parts and delivered products records and actions maintain

7.4 Purchasing
7.4.1 Purchasing process
ensure purchased product conforms to specified purchase requirements evaluate and select suppliers based on their ability to supply product that meet requirements

criteria for selection, evaluation and re - evaluation shall be established

7.4.2 Purchasing information

Purchasing information shall describe
requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel

quality management system requirements

7.4.3 Verification of purchased product

To ensure purchased product meets requirements

the inspection or other activities verification at the suppliers premises (Arrangement, Method --- Purchasing Info)

7.5 Production and Service provision

7.5.1 Control of production and service provision (1)
Plan and carry out production and service provision under controlled conditions availability of information that describes the characteristics of the product availability of work instruction as necessary

7.5.1 Control of production and service provision (2)

use of suitable equipment availability and use of monitoring and measuring devices implementation of monitoring and measurement implementation of release, delivery and post-delivery activities

7.5.2 Validation of processes for production and service provision (1)

Where the resulting output cannot be verified by subsequent monitoring or measurement Validation shall demonstrate the ability of these processed to achieve planned results

7.5.2 Validation of processes for production and service provision (2)

defined criteria for review and approval

approval of equipment and qualification of personnel use of specific methods and procedures records revalidation

7.5.3 Identification and traceability

identify the product by suitable means throughout

product realization identify the product status with respect to monitoring

and measurement requirement control and record the unique identification of the
product for traceability purpose

7.5.4 Customer property

identify, verify, protect and safeguard customer property

if any customer property found to be unsuitable for use, this shall be reported to the customer include intellectual property

7.5.5 Preservation of product

preserve the conformity of product and constituent of a product include identification, handling, packaging, storage and protection

7.6 Control of measuring and monitoring devices (1)

The organisation shall identify measurements that need to be made and monitoring devices required to assure conformity of product to specified requirements

Monitoring devices to be used and controlled to ensure that measurement capability is consistent with measurement requirements

7.6 Control of measuring and monitoring devices (2)

Monitoring devices, where applicable shall be
calibrated and adjusted periodically or prior to use traceable to international or national standards identify the calibrations status safeguarded from invalid adjustments

7.6 Control of measuring and monitoring devices (3)

protected from damage and deterioration

take action when the equipment is found not to conform to requirements results recorded

8.1 General 8.2 Monitoring & measurement Customer satisfaction Internal Audit Monitoring & measurement of processes Monitoring & measurement of product

Clause 8 Measurement, analysis and improvement

8.3 Control of non-conforming product 8.4 Analysis of data 8.5 Improvement Continual Improvement Corrective action Preventive action

8. Measurement, analysis and improvement

8.1 General (1)
Plan and implement the monitoring, measurement, analysis and improvement processes needed include demonstrate conformity of the product

8.1 General (2)

ensure conformity of the quality management system

continually improve the effectiveness of system determination of applicable methods, including statistical techniques

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

monitor information relating to customer perception

methods for obtaining and using this information

8.2.2 Internal audit (1)

Conduct internal audits at planned intervals to determine that

conforms to the planned arrangements and to the quality management system requirements effectively implemented and maintained

8.2.2 Internal audit (2)

program shall be planned, taking into consideration the status and importance of the processes and the results of previous audits the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure

8.2.3 Monitoring and measurement of process

apply suitable methods for monitoring and measurement

of the processes
demonstrate the ability of the processes to achieve

planned results
when results are not achieved, correction and preventive

action shall be taken

8.2.4 Monitoring and measurement of product

monitor and measure the characteristics of the product to verify that product requirements are fulfilled evidence shall be maintained

8.3 Control of nonconforming product

ensure that non conforming product is identified and

controlled to prevent its unintended use or delivery responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure

8.3 Control of nonconforming product

Deal with nonconforming product by the following taking action to eliminate the detected nonconformity authorizing its use, release or acceptance under

concession
taking action to preclude its original intended use or application

records of the nature of non conformities and any

subsequent actions taken

8.4 Analysis of data

Appropriate data shall be collected and analysed to determine:

the suitability and effectiveness of the QMS to identify improvements that can be made to provide information on - customer satisfaction and/or dissatisfaction - conformance to customer requirements - characteristics of processes, product and trends - suppliers

8.5 Improvement
8.5.1 Continual improvement
Continual improvement to be planned and managed by use of:
the quality policy

objectives audit results analysis of data corrective and preventive action management review

8.5.2 Corrective action

take action to eliminate the cause of non conformities in order to prevent recurrence documented procedure shall be established reviewing non conformities determining the causes of non conformities evaluating the need for action determining and implementing action needed records of the results of action taken reviewing corrective action taken

8.5.3 Preventive action

determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence documented procedure shall be established determining potential non conformities and their causes evaluating the need for action determining and implementing action needed records of the results of action taken reviewing corrective action taken