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INTERPRETATION

OFISO 9001:2008

REQUIREMENTS

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1. SCOPE

2. NORMATIVE REFERENCE

3. TERMS AND DEFINITIONS

4. QUALITY MANAGEMENT SYSTEM

5. MANAGEMENT RESPONSIBILITY

6. RESOURCE MANAGEMENT

7. PRODUCT REALIZATION

8. MEASUREMENT, ANALYSIS AND IMPROVEMENT

ISO 9001:2008 CLAUSES

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ISO 9001: 2008QUALITY MANAGEMENT SYSTEMS - Requirements

4.1 General Requirements

4.2 Documentation Requirements

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, Authority andCommunication

5.6 Management Review

6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure6.4 Work Environment

7.1 Planning of ProductRealization

7.2 Customer-Related Processes

7.2 Customer-Related Processes

7.3 Design and Development

7.4 Purchasing

7.5 Production and ServiceProvision

7.6 Control of Monitoring and

Measuring Devices8.1 General of Measurement,

Analysis and Improvement

8.2 Monitoring andMeasurement

8.3 Control of Nonconforming

Product8.4 Analysis of Data

8.5 Improvement

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General requirements Establish, document, implement, maintain and

continually improve a Quality Management System in

accordance with the standard

Identify the processes including those for outsourcing

Determine the sequence and interaction of these

processes

Determine criteria and methods

Resources and information

CLAUSE 4 : QUALITY MANAGEMENT SYSTEM

PLAN

DOCHECK

ACTION

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General requirements (cont.d) Monitor, measure and analyze

processes

Continual improvement

Documentation is dependent on:- size and type of organization

- complexity and interaction of the processes

- competence of personnel

Documentation can be in any form or type ofmedium


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Quality Manual

Scope of QMS

Exclusions : Clause 7 Reference

Sequence and Interaction of Processes of the QMS

Procedures

Procedures


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PERMISSIBLE EXCLUSIONS

Quality Manual

May only exclude QMS requirements that ;

do not affect the organization's ability orresponsibility to provide product that meetscustomer and regulatory requirements.

are limited to clause 7, Product Realization.

Nature of an organization and its products

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Control of Documents

Approve, review, update

Current revision status

Available at points of use

Legible and readily identifiable

External documents

Obsolete documents Documented procedure


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DOCUMENT CONTROL

Include:Hardcopies, electronic media; external documents

Steps:

Assign document controller Provide storage and minimize vulnerability: e.g. electronic data Maintain register or master list of documents Review and approve documents by authorizedpersonnel Create unique identification for each document Maintain register or distribution list

Ensure accessibility and security: electronic media Maintain obsolete document Control document changes

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Control of records Identification

Storage

Legible

Retrieval

Protection

Retention time

Disposition Documented Procedure


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As objective evidence Compiling & analysing of data / trend Form of quality records

HardcopyLogsPrint-outMicro FilmFloppy Disk

Quality record register

Retention timeExtent of referenceRequirements by customer, contractual or statutory

regulation

CONTROL OF RECORDS

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Scope; e.g. Management Review Contract Review Design Review/Verification/Validation Evaluation of Vendor Inspection/Testing Calibration Non-Conformity Review Corrective Actions

Internal Audit Training etc. (as established by company)

CONTROL OF QUALITY RECORDS

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COMPARISON BETWEEN CONTROLLEDDOCUMENT & QUALITY RECORD

1. Established to guide operations

2. Subject to control on issue, change,distribution and withdrawal

3. Living document for use at the pointof application

4. Distributed to copy holders on a need-to-use basis

5. Being used until withdrawn

1. Generated as a result of activities

2. Subject to proper maintenance, storage and

disposal

3. Historical record to be filed or archived forreference or as documentary evidence of

quality assurance

4. Usually maintained at a fixed location by the

process owner and participants that generate

the record

5. Disposed off when exceeded specified

retention period

CONTROLLED DOCUMENT QUALITY RECORD

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Labelling of cabinet for easy retrieval

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Labelling of records for easy identification

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Proper identification of shelf for types of forms orrecords

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DOCUMENTS/QUALITY RECORDS

Quality manual/procedures/work instruction

Calibration reports

Purchase orders

Checklists

Drawings

Are these controlled documents or quality records?

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Questions and Answers ?

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5.0 MANAGEMENT RESPONSIBILITY

Productrealization

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CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Requiremen

ts

Managementresponsibility

Measurement,analysis,

improvement

Input

Resourcemanagement

Output

5.1 Managementcommitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.5 Responsibility, Authorityand Communication

5.6 Management review

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Management Commitment

Top management providescommitment

Communication : the importance ofmeeting customer, regulatory andstatutory requirements

Establish quality policy and objectives

Conduct management reviewAvailability of resources

CLAUSE 5 : MANAGEMENT RESPONSIBILITY

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Customer Focus

Determine customer requirements

Achieve customer satisfaction


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Quality Policy Meet requirements


Communicated and understood at appropriate

levels Review continuing suitabilityNotes:

a) Policy should be easy to understand

b) Set overall intentions and direction of an organizationrelated to quality as formally expressed by topmanagement


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QUALITY OBJECTIVES

Formulation of quality objectives transmits thepolicy intention of top management to alllevels of company

The objectives should be SMART:

Specific, Measurable,Achievable, Realisticand with a Time frame

e.g.

To reduce service time to 5 minutes percustomer by end 2001.

A maximum of 1 failure per 1,000,000 usagesof vending machine by end 2001.

SMART

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Quality Management System Planning Processes

Resources

Criteria and Methods

Monitor, measure and analyzeprocesses

Continual improvementofthe QMS

Change


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Responsibility and Authority

Functions and their interrelations

Define and communicated

This is your responsibilityand authority


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Management Representative

Member of the management

Promoting awareness of customerrequirements

Ensuring processes of the QMS areestablished; implemented and maintained

Reporting on the performance of the QMS

Liaison with Certification Body


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Internal Communication

Communication Processes

Effectiveness of QMS


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Management Review

Planned interval

Suitable, adequate & effective QMS

Changes to QMS, Quality Policy & Objectives

Review input:- Current performance

- Improvement opportunities

Review output

- Actions related to QMS,

processes, product, resources

Records


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MANAGEMENT REVIEW

Example

Management Review Team CEO as chairperson

Management Representativeas secretary

Heads of Departments as members

Minimum of one review per year

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Review Topics Internal/External Quality Audit

Outcomes Policy & System

Non-Conformances Corrective & Preventative Actions

Customer Complaints

Customer Feedback

Process Performance

Follow-up actions from previous reviews

Changes and recommendations for improvements

MANAGEMENT REVIEW

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Product

realization

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SatisfactIon


Measurement,analysis,

improvement

Input

Output Product

6.1 Provision of resources

6.2 Human resources

6.3 Infrastructure

6.4 Work Environment

CLAUSE 6 : RESOURCE MANAGEMENT

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Provision of Resources

- to implement, maintain and improve the QMS

- to enhance customer satisfaction

Human Resources

- Assignment of personnel

eg. Education, training, skills and

experience


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Training, Awareness and Competency

- Determine competence of personnel

- Provide training

- Evaluate the effectiveness of actions taken- Employee awareness

- Records


CLAUSE 6 RESOURCE MANAGEMENT

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Training and competence for employees

Employee Appraisal

CompetenceandTraining needs

Others

Training Program

New Employee

Special Task

Provide Training

Record

New Technology


CLAUSE 6 RESOURCE MANAGEMENT

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Infrastructure- Identify, provide and maintain

- Workspace, buildings, utilities

- Equipment, hardware and software

- Supporting services Work environment

- Identify and manage

- Suitable for conformity to productrequirements


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CLAUSE 7 : PRODUCT REALIZATION

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Productrealization

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Req

uiremen

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Measurement, analysis,

improvement

Input

Resourcemanageme

nt

7.1 Planning of productrealization

7.2 Customer-related

processes

7.3 Design anddevelopment

7.4 Purchasing

7.5 Production and service

provision

7.6 Control of measuringand monitoring

devices


Output

CLAUSE 7 PRODUCT REALIZATION

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Planning of product realization

Planning to determine:

Processes, documents and resources

Objectives for products, projects or

contracts Requirements

Verification monitoring and validationactivities

Criteria for acceptability Records


CLAUSE 7 PRODUCT REALIZATION

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Customer-related Processes

Determination of requirements related toproducts

- Customer requirements

- Product requirements not stated by customers

- Regulatory and statutory requirements



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Customer-related Processes (contd)

Review of requirement related to products- Prior to commitment to supply

- Requirements are defined

- Requirement differing from those in a tenderor quotation are resolved

- Ability to meet requirements

- No documented requirements : confirmedbefore acceptance

- Changed requirements



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Customer-related Processes (contd)

Customer communication

- Product

- Enquiries, contracts, orders

- Customer feedback & complaints

- Amendments



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Design and Development

Design and development planning- Stages

- Review, verification and validation

- Responsibilities and authorities

- Interfaces between different groups /functions

- Update planning output

- Manage effective communication

- Attention to safety, environment andregulatory requirements



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Design and Development (contd)

Design and development inputs

- Requirements e.g. performance, functions,

statutory etc.

- Resolve incomplete, ambiguous, conflictingrequirements

- Technical specifications for materials,

product and processes

- Review inputs for adequacy



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Design and Development (contd)

Design and development outputs

- Meet input requirements

- Product acceptance criteria

- Information for purchasing, production andservice operations

- Define product characteristics

- Conform to applicable regulatory requirements

- Approve output documents



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Design and Development(contd)

Design and development review

- Evaluate the design

- Identify problems

- Follow-up actions

- Records



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Design and/or Development (contd) Design and development verification

- Output meets inputs requirementse.g. Prototyping, testing, comparative studies etc. and

consider reliability, maintainability, packaging, etc.

- Records Design and development validation

- to ensure that product that meets

specified application or intended use.

e.g. Performed under defined operating conditions- Records



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Design and/or Development (contd)

Control of design and development changes

- Identified, documented and controlled

e.g. Engineering change request

- Evaluation of the effect of the changes onparts and products

- Review, verify and validation

- Records



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PurchasingPurchasing process

- Purchased product conforms to requirements

- Type of control depends on vendors control

- Evaluation and selection of suppliers

- Records of evaluation to be compiled



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PurchasingPurchasing information

- Describe the products to be purchased

- Where appropriate, other requirements

- Company to ensure adequacy prior to

communication to the supplier

- Handling changes to purchase orders



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Purchasing (contd) Verification of purchased product

- Verification activities at thesuppliers premises

- Company shall plan inspectionactivities to verify purchasedproducts



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Production and service provision Control of production and service provisions

- availability of information on productcharacteristics

- availability of work instructions- suitable equipment

- monitoring and measuring devices

- monitoring and measurement

- release, delivery and post-delivery activities

SERVICE PROVISION

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If Specified in contract

After sales services/post-project

Examples : Installation/commissioning

Warranty service/maintenanceservice

Spare-parts sales

Product upgrading

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Identification and traceability- Throughout production and service operations

- Status

PRODUCT IDENTIFICATION & TRACEABILITY

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Identification:e.g. for Project Number Proposals, account profiles Purchase requests Sales Department Reports Part no./batch (lot) no./ model no. Marking, tagging, physical segregation,

labels, bins cards Traceability (to the extend necessary)

Serial no.Date - code.Batch no.

Raw MaterialsHardware / SoftwareInspection/Test status

ProcessesPersonnelRecords

Accept /Reject, On-

hold, etc

IDENTIFICATION & TRACEABILITY

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Examples

Foods and Drinks- Specified mark or bar code

Pharmaceutical- Batch manufacturing records- Raw material batch numbers

Banking and Finance- Unique identification of all accounts, policies

shares certificatesetc.,


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Customer propertyCustomer property include intellectual property

- Exercise care

- Identify, verify, protect and maintain

- Lost, damage or unsuitable for use shall berecorded and reported to customer

CUSTOMER PROPERTY

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EXAMPLES:

Manufacturing

Parts, components, equipment, packingmaterials, tools-on-loan, documents

Retail

Items left for cleaning or repair

Hotel

Wines and wedding cakes during a function


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Preservation of productsHandling methods + means of handling that prevents damage ordeterioration

Pallets

Containers

Conveyors

Vehicles


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Preservation of products

Organization shall preserve conformity of products- Packaging, storage and protection

Preservation shall apply to constituents of products

PRESERVATION OF PRODUCTS

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Examples:

Handling Method(including safety) Equipment Pallets, containers, conveyors, vehicles, etc.

Storage Receiving & Issuing and storage procedures FIFO Monitor shelf-life items

Segregation of non-conforming goodsAssessment of condition

PRESERVATION OF PRODUCTS

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Examples:

Packaging Packaging Specification & Design Methods & Materials Identification Requirements / MarkingAnti-static packaging

Delivery Contractual requirements Time Environment (Temperature)

Protection of the quality of product Documentation

CONTROL OF MONITORING AND MEASURING DEVICES

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Control of monitoring and measuring devices Implement control for maintenance & calibration of inspection,

measuring and test equipment

Computer software


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Calibrate or verify at intervals

Traceable to national or international standards

Adjust or re-adjust

Calibration status

Safeguard from adjustments

Protected from damages or deterioration

Handling, maintenance and storage

Assess and record the validity of previous measuringresults when equipment is out of calibration


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Example: Check test hardwares(e.g. jigs, fixtures, templates, patterns)

and/or test software used as suitable forms of inspection

Equipment for measuring design data (for design control) Production equipment which are critical to product / service

characteristics Inspection, Measuring and Test Equipment which demonstrate

product / service conformance to specified requirements


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Examples:

Transportation, Storage, Distribution

Temperature gaugesPressure gauges

Retail

Bar code machineTemperature controlled equipment

Ship RepairRadiographic & non-destructive test equipmentGas detection equipment

Manufacturing

Dimensional instruments

Physical / Chemical Test equipmentHospitalPhysical Test equipment

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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

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Productrealization

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Requirements


Measurement, analysis,

improvement

Input

Resourcemanagement

Output

8.1 General

8.2 Measurement

and monitoring

8.3 Control of

nonconforming

product

8.4 Analysis of data

8.5 Improvement

Product


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General

- Define, plan and implement measurement andmonitoring activities

- ensure conformity of QMS

- continually improve the QMS- Methodologies including

statistical techniques


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Measurement and monitoring- Perception of customer in meeting

requirements

- Customer satisfaction and/or

dissatisfaction- Methodologies for obtaining and

using information

CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT

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Internal audit- Audit Program

- Conforms to plannedarrangement

- Quality management systemis effectively implementedand maintained

- Documented procedure

PREPARING AND REPORTING AN AUDIT

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STEPS: Define audit scope, criteria, frequency and methods

Select auditors - auditors shall not audit their own work Collect information Review documents Establish depth of audit Prepare audit schedule Allocate audit time Identify audit

Prepare Audit Checklists Execute audit Record and report Follow-up activities Close corrective action Management review

AUDIT STRATEGIES AND TECHNIQUES

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STRATEGIES TECHNIQUES

Trace Forward

Trace Backward

Task-based

ISO 9000 elements

Clarifying

Interviewing

Observing

Verifying

Collecting Objective

Evidence


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Monitoring and measurement of processes- Suitable methods for monitoring processes

- Method to demonstrate the ability of processto achieve requirements

- Corrective actions when results not achieved

- KeyProcesses


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Monitoring and measurement of product

- Measure the characteristics of products- Carried out at appropriate stages of

production

- Evidence of conformity to include the personauthorizing release

- Release shall only be allowed

after completion of

arrangement unless

authorized

INSPECTION & TESTING

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Example:

Receiving (Incoming)

NON-QC

(SUPPLIER CERT)

INCOMING MATERIALS, PARTS

SHIP-TO-STOCK

INCOMING QC

ACCEPTED REJECTED

RETURN TOVENDOR

REWORKED

SCRAPPED

STORAGE OR USE

INSPECTION & TESTING

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Examples:

In Process: Detailed in QC plan and/or Instructions Sampling, in-process monitoring Identify non-conforming product / service Records

e.g.. Hotel and Catering Industry- Inspection of rooms

- Kitchen hygieneRetail Industry- Inspect display of products

Final Inspect / test final product/ service as planned (QC

plan, instruction) Accept and deliver only conforming product / service


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Control of nonconforming product

- action to eliminate detected nonconformity

- records for concession

- re-verification of corrected products

- organization to take actions appropriate tothe effects of nonconformity after delivery

CONTROL OF NONCONFORMING PRODUCT

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INSPECT / TEST

ACCEPTED

USE

NONCONFORMING

IDENTIFY / SEGREGATE

RECORD

EVALUATE/ DISPOSITION

Objective : Prevent inadvertent use /installation

All stages of process/ service/projectEXAMPLE:

NONCONFORMING REVIEW AND DISPOSITION

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DISPOSITION

SCRAP

REGRADE CONCESSION (accepted)REWORK

RecordsResponsibility & Authority

REVIEW

Dispose Team


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Analysis of data

Data shall include information for customersatisfaction, conformity of productrequirements, characteristics and trend ofprocesses/ products and suppliers:

- Collect from monitoring and measurement- Analyze

- Suitability and effectiveness of the QMS

- Identify improvements

Analysis of Data

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Compile &Analyze data

Customerdata

Process

data

Supplier

data

Productdata

complaints

feedback

delivery

quality

rejection,repair

wastage

trends

failures

GENERAL INTENT

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Measurement & Monitoring

Analysis of DataImprovement

Opportunity from :

Quality Objectives

Internal Audit

Analysis of Data

Corrective Action

Preventive Action

Management

Review

Customer satisfaction

Internal Audit

Product/ services/ Process Control of Non-conforming

product


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- Continually improve effectiveness of qualitymanagement systems

- Corrective action

- Preventive action- Audits, analysis of data

- Management review

Corrective action


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Corrective action

Action taken to eliminate causes of non-conformities

A documented procedure is needed

Action may involve investigation, analysis, solutionimplementation and recording change

A system of achieving continual (step-by-step) improvement

Records Review

Preventive action


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Preventive action

Preventive action - action taken to eliminate potential non-conformities

Action may involve investigation, analysis, solutionimplementation and recording change

A documented procedure is needed

Records Review

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-03-ISO- Req.

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Transcript of -03-ISO- Req.