Iso 9001 2008 qms

ISO 9001:2008 Requirements
4. Quality Management System
6. Resource
Mgmt
(QMS)
5. Management
Responsibility
7. Product
Realisation
Processes
8.
Measurement,
Analysis &
Improvement
ISO 9001-2008 QMS.PPT (Mar 09) Page 1 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

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

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*

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

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*

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

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

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

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 /
enhanced

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

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

5.5 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

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

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

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
 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

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

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

7.5.3 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

 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
 E.g. seal for taxi meter

 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*

 8.2.2 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

 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

 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

 8.5.2 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

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