6. resource management management 7. product realisation processes 5. management responsibility 8....
TRANSCRIPT
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
5.2 CUSTOMER FOCUS Top mgmt ensure customer
requirements are determined and fulfilled
Customer satisfaction is also achieved or enhanced
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS
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
ISO 9001:2008 REQUIREMENTS