6. Resource Management Management 7. Product Realisation Processes 5. Management Responsibility 8. Measurement, Analysis & Improvement 4. Quality Management

6. Resource

Management

7. Product RealisationProcesses

5. ManagementResponsibility

8. Measurement,

Analysis &Improvement

4. Quality Management System (QMS)

ISO 9001:2008 REQUIREMENTS

4 QUALITY MGMT SYSTEM (QMS) REQUIREMENTS Key processes documented

4.2.3 Control of Documents 4.2.4 Control of Records 8.2 Internal Audit 8.3 Control of Non-conforming Products 8.5.2 Corrective Actions 8.5.3 Preventive Actions Key business processes / activities

Document control in place Records properly maintained & retrievable


5 MANAGEMENT RESPONSIBILITY QMS development, implementation and

improvement commitment Customer-focus Quality policy / mission Quality objectives & planning Quality responsibility , authorities &

accountabilities Appoint QMR to implement & improve QMS Communicate QMS requirements QMS Mgmt review of deficiencies & possible

improvements


6 RESOURCE MANAGEMENT Provide adequate human resources Staff or personnel are competent &

properly trained for assigned duties Adequate supporting infrastructure &

facilities Work environment does not affect

performance


7 PRODUCT REALISATION PROCESSES Product realisation planning Determine product/customer requirements Channels for customer communication Design and development processes

Planning, inputs, outputs, review, verification, validation changes

Procurement Production and service operations

Include handling of customer property (include intellectual properties

Control of measuring and monitoring devices


8 MEASUREMENT, ANALYSIS & IMPROVEMENT Measurement and Analysis Planning Measures on customer satisfaction,

internal audits and other process/product measures

Control of non-conformity Analysis of data QMS Improvements, corrective and

preventive actions Verify effectiveness


4 QMS REQUIREMENTS (DOCUMENT KEY PROCESSES) 4.1 General QMS Requirements

Document sequence/interaction of key processes Document criteria & methods to ensure effective

operation

4.2.1 QMS documentation Quality policy & objectives, Quality Manual Control documents such as checklists & work instructions Required procedures and records Levels of details depends on competence of staff, size of

organisation & complexity of processes

4.2.2 Quality Manual Scope of QMS, including details of and justifications

for any exclusions


4.2.3 CONTROL OF DOCUMENTS Review & approve document before issue Identify changes & current revision status Relevant versions available at point of

use Documents legible & Identifiable Documents of external origins are

identified and distribution controlled


4.2.4 CONTROL OF RECORDS Records legible, readily identifiable &

retrievable Mgmt review records, training records,

purchase evaluation records, audit records, customer complaints and other process related records


5.1 MANAGEMENT COMMITMENT Development, implementation &

improvement of QMS Establish quality policy Ensure quality objectives are met Conduct mgmt review of QMS

deficiencies / improvements Ensure availability of resources for QMS

implementation and improvements


5.2 CUSTOMER FOCUS Top mgmt ensure customer

requirements are determined and fulfilled

Customer satisfaction is also achieved or enhanced


5.3 Quality Policy Appropriate to organization’s core purpose Include commitment to meet customer and

regulatory requirements Include commitment for continual

improvement & meeting quality objectives Communicated to all staff Reviewed for continuing adequacy

suitability and effectiveness


5.4 QUALITY OBJECTIVES / QMS PLANNING Quality objectives set at relevant

functions & levels Quality objectives measurable and

consistent with quality policy QMS Planning:

Ensure QMS requirements & quality objectives are met

Ensure integrity of QMS is maintained when changes are implemented


5.6 MANAGEMENT REVIEW Conducted at planned intervals to ensure

continuing suitability, adequacy and effectiveness of the QMS

Review inputs include: Audit results, customer complaint, customer

satisfaction, process performance & product conformity, follow-up actions, changes / improvement to QMS

Review Outputs: Improvement of the effective of the QMS & its

processes Improvement of products Resource needs


6 RESOURCE MANAGEMENT 6.1 Provision of Resources

Determine & provide resources to implement, maintain, improve the QMS & enhance customer satisfaction

6.2 Human Resources Ensure staff or other personnel are adequately competent &

trained for assigned roles Maintain training records

6.3 Infrastructure: Determine, provide & maintain infrastructure (include bldg,

workspace, equipment and supporting services) needed to achieve conformity to product requirements

6.4 Work Environment Determine & manage the work environment needed to achieve

conformity to product requirements


7.1 PLANNING OF PRODUCT REALISATION Plan & develop the product realisation

processes Determine quality objectives &

requirements for product Establish product-specific processes,

documents, resources Document required verification, validation

and criteria for product acceptance


7.2 CUSTOMER- RELATED PROCESSES Determine product requirements Review product requirements

Requirements are defined Requirements differing from what customer wants

are resolved Organisation has ability to fulfilled defined

requirements Customer Communication

Communication channels available to provide product information, answer queries, taking orders and amendments, customer feedback


7.3 DESIGN AND DEVELOPMENT Design and development planning

Update plan as design and development progresses

Design and development inputs Functional, performance and regulatory

requirements to be documented and reviewed

Design and development outputs In form suitable for verification against for design &

dev. Inputs* Include details for preservation of products*

Design and development review, verification, validation and changes

Procedures to be defined


7.4 PURCHASING Evaluate and select suppliers based on

their ability to meet purchase requirements Purchasing information to contain level of

adequate purchasing requirements Verification of purchased products Key Records:

Purchase specifications Supplier evaluation records Evidence of satisfaction receipt


7.5 PRODUCTION & SERVICE PROVISION 7.5.1 Control of Production & Service Provision

Plan and carry out production and service provision under controlled conditions - repeatable processes

Ensure availability of work instructions, as necessary

7.5.2 Validation of processes for production and service provision

Required when resulting output cannot be verified or tested (e.g. packing of parachutes)

Processes, equipment, personnel needs to be qualified


7.5 Production & Service Provision 7.5.3 Identification & Traceability

Identify product by suitable means throughout the product realisation

Also know as configuration mgmt for some industry sector

7.5.4 Customer property Exercise care of customer property (include

intellectual property Identify, verify, protect and safeguard customer

property If lost, damaged or otherwise found unsuitable

for use, this shall be reported to the customer & records maintained


7.5 PRODUCTION & SERVICE PROVISION 7.5.5 Preservation of product

Preserve conformity of product during internal processing and delivery to intended destination

Include identification, handling, packaging, storage & protection


7.6 MONITORING AND MEASURING DEVICES Measuring devices to be calibrated at

specific intervals Calibration records to be maintained

Equipment ID Calibration date Calibration accuracy Next calibration date

Calibration to be safeguarded from adjustments


5.5 RESPONSIBILITY, AUTHORITY & COMMUNICATION Responsibility ,authorities&

accountabilities for all various staff Quality Mgmt Representative appointed

Ensure QMS is established, implemented & maintained

Report to top mgmt on the performance of the QMS and any need for improvement

Promote awareness of customer requirements throughout the organisation

Effectiveness of QMS communicated through established channels


8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8.1 Monitoring and Measurement Planning

Required to demonstrate product conformity, conformity to QMS and continually improve the QMS

8.2 Monitoring and Measurements 8.2.1 Methods for obtaining measures on customer

satisfaction shall be determined which may be derived from

- Customer satisfaction survey- Customer data- User opinion- Lost business analysis- Compliments- Warranty claims- Dealer reports


8 Measurement, Analysis & Improvement

8.2.2 Internal audit Conducted at planned interval to

determine if QMS requirements have been implemented

Planned Audit programme Defined Audit criteria, scope and

methods Auditors shall not audit their own work Documented Audit results & follow-up

actions


8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8.2.3 Monitoring & measurement of processes

To monitor QMS processes, to verify conformity to product requirements & the effectiveness of the quality mgmt systems

8.2.4 Monitoring & measurement of product To monitor characteristics of product to verify if

the product requirements have been met

8.3 Control of non-conforming product Ensure that product which does not conforms to

product requirements is identified and prevented from unintended use or delivery


8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8.4 Analysis of Data

Determine, collect and analyse appropriate data to demonstrate suitability and effectiveness of the QMS

Evaluate where continual improvement can be made through trend analysis

8.5.1 Continual Improvement Continually improve the QMS through quality

policy, objectives, audit results, analysis of data, corrective / preventive actions and mgmt review


8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8.5.2 Corrective Action

Determine root cause of non-conformities in order to prevent recurrence

Effort should be proportionate to the effects of the non-conformities

Corrective actions taken to be recorded & their effectiveness verified

8.5.3 Preventive Action Determine root cause of potential non-conformities to

prevent their occurrence Effort should be proportionate to the effects of the

potential non-conformities Preventive actions taken to be recorded & their

effectiveness* verified
