Page 1 of 29 ISO 9001-2008 QMS.PPT (Mar 09) 6. Resource Mgmt 7. Product Realisation Processes 5....

of 29

ISO 9001-2008 QMS.PPT (Mar 09)

6. 6. Resource MgmtResource Mgmt 7. 7. Product Product RealisationRealisationProcessesProcesses

5. 5. ManagementManagementResponsibilityResponsibility

8. 8. Measurement, Measurement, Analysis &Analysis &

ImprovementImprovement

4. 4. Quality Management SystemQuality Management System (QMS) (QMS)

ISO 9001:2008 RequirementsISO 9001:2008 Requirements

of 29


4 Quality Mgmt System (QMS) Requirements Key processes documented

4.2.3 Control of Document 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


of 29


5 Management Responsibility Commitment to development, implementation and

improvement of QMS Customer-focus Establish quality policy / mission for organisation Quality objectives & planning Ensure responsibility & authorities are defined Appoint mgmt representative (member of orgn mgmt

*) for the implementation and improvement of the QMS

Ensure QMS requirements are communicated Mgmt review of QMS deficiencies & possible

improvements


of 29


6 Resource Mgmt

Provide adequate manpower resources

Staff or personnel* are competent & properly trained for assigned duties

Adequate supporting infrastructure & facilities

Work environment does not affect performance Lighting, noise, temperature, humidity, weather*


of 29


7 Product Realisation Processes Product realisation planning (mainly for projects) Determine product/customer requirements

Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal*

Channels for customer communication Design and development processes

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

Purchasing Production and service operations

Include handling of customer property (include intellectual properties & personal data*)

Control of measuring and monitoring devices


of 29


8 Measurement, Analysis & Improvement Measurement and Analysis Planning

Measures on customer satisfactions*, internal audits and other process/product measures*

Control of non-conformity

Analysis of data (determine characteristics or trends)

QMS Improvements, corrective and preventive actions

Verify effectiveness*


of 29


4 QMS Requirements (Document Key Processes)

4.1 General QMS Requirements Document sequence/interaction of key processes Document criteria & methods to ensure effective operation The type & extend of controls to be applied for outsourced

processes shall be defined within the Quality Mgmt System*

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


of 29


4.2.3 Control of Documents

Review & approve document before issue

Changes & current revision status identified

Relevant versions are available at point of use

Documents are legible & Identifiable

Documents of external origins are identified and distribution controlled


of 29


4.2.4 Control of Records

Are records legible, readily identifiable & retrievable

E.g. mgmt review records, training records, purchase evaluation records, audit records, customer complaints and other process related records


of 29


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


of 29


5.2 Customer Focus

Top mgmt ensure customer requirements are determined and fulfilled

Customer satisfaction is also achieved / enhanced


of 29


5.3 Quality Policy

Appropriate to purpose of organisation (e.g. mission)

Include commitment to meet customer and regulatory requirements

Include commitment for continual improvement & meeting quality objectives

Is communicated to all staff

Is reviewed for continuing suitability


of 29


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


of 29


5.5 Responsibility, Authority & Communication

Responsibility and authorities for various staff defined

Mgmt Representative (shall be a member from within organisation’s management*) appointed to: 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


of 29


5.6 Mgmt 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


of 29


6 Resource Mgmt 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 (include factors such as

noise, lighting, temperature, humidity and weather*) needed to achieve conformity to product requirements


of 29


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


of 29


7.2 Customer Related Processes Determine product requirements

Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal*

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


of 29


7.3 Design and Development Design and development planning

Update plan as design and development progresses Design and Development Review, Verification, Validation have

distinct purposes* They can be conducted and recorded separately or in any

combination, as suitable for the product and the organization*

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


of 29


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


of 29


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


of 29


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 and personal data*) 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


of 29


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


of 29


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 E.g. seal for taxi meter


of 29


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*


of 29


8 Measurement, Analysis & Improvement 8.2.2 Internal audit

Conducted at planned interval to determine if QMS requirements have been implemented

Audit programme to be planned Audit criteria, scope and methods shall be defined Auditors shall not audit their own work Audit results & follow-up actions to be recorded


of 29


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

E.g. segregation of non-conforming products


of 29


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


of 29


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


Page 1 of 29 ISO 9001-2008 QMS.PPT (Mar 09) 6. Resource Mgmt 7. Product Realisation Processes 5....

Documents

Transcript of Page 1 of 29 ISO 9001-2008 QMS.PPT (Mar 09) 6. Resource Mgmt 7. Product Realisation Processes 5....