1. 4. Quality Management System (QMS)
ISO 9001:2008 Requirements
4. Quality Management System (QMS)
5. Management
Responsibility
7. Product Realisation
Processes
6. Resource Mgmt
8. Measurement,
Analysis &
Improvement
ISO 9001 Std: 1) Scope & application, 2) References, 3) Terms & Definitions
There are four key elements forming the QMS
Mgmt Responsibility
Resource Mgmt
Product Realisation Processes
Measurements, Analysis & Improvement
Mgmt Responsibility is very important for ISO 9001 implementation
Mgmt to provide adequate Resource for the establishment, implementation and improvement of the QMS / Product Realisation Processes
The major portion of the QMS should cover the Product Realisation processes or the organisation’s business activities
Measurements & Monitoring is required for effective QMS implementation; Many of the procedures in such a QMS will not be followed and are used merely as guidelines if there is no regular monitoring or audit
After the monitoring process, deficiencies are analysed and improvements are recommended to top mgmt for implementation
Top mgmt will then allocate the resources for the improvements (& changes to the QMS) and the cycle continues.

2. 4 Quality Mgmt System (QMS) Requirements
ISO 9001:2008 Requirements
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
To cover why various ISO 9001 requirements are present and common deficiencies encountered
External training ISO 9001 requires 2 full days – Can only summarise the key requirements during today’s briefing
The basic QMS requirements are to
Have the processes for key business activities documented
Documented procedures are also under proper document control
Documented procedures have been reviewed and approved by appropriate mgmt staff
Proper versioning and effective implementation date have been established
Records also have to be properly filed and easily retrievable
Key business process activities may include purchasing, training, infrastructure supt activities, etc.

3. 5 Management Responsibility
ISO 9001:2008 Requirements
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
Top mgmt has many responsibility for effective QMS implementation
Question: Who has the ultimate responsibility of the final quality of the delivered product/service
top mgmt (answer)
middle mgmt
staff level
everyone
The quality of the final delivered product / service is dependent on the top mgmt direction and emphasis
Quality policy and objectives to be established by top mgmt staff to provide direction to staff
Top mgmt have to ensure roles and responsibility are clearly defined to reduce the level of ambiguity in the required scope of work (although quite difficult in today’s complex world)
The mgmt representative is accountable for the successful and effective implementation of the QMS
Regular mgmt review is required to ensure the suitability and effectiveness of the QMS.

4. ISO 9001:2008 Requirements 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*
Resource mgmt is important in the context of ISO 9001 implementation
Staff needs adequate resources to get their work done
For example, it is considered a non-conformance to have a staff who consistently work 20% over-time over a period of more than 6 months as this is likely tp affect the quality of the work done by the staff
Staff or other personnel (temp staff, supplier, etc.) also have to be properly trained to performed their assigned tasks
Adequate facilities, equipment and supporting services also have to be provided for the employee
The work environment must also be managed to enable the employee to work productively / effectively (e.g. furnace inspection: appropriate protective clothings and materials to be provided; safety boots to be provided at warehouse, etc.)
These requirements will benefit each employee in the organisation

5. 7 Product Realisation Processes
ISO 9001:2008 Requirements
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
Documentation of key business processes
Product realisation planning are more applicable for one-time projects where customised product requirements and processes are adopted (e.g. e.g. Project Document, Work Instruction documents, etc.)
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
This new ISO 9001:2008 requirement is meant more for the application teams
Also need to consider recycling or final disposal requirements for procured IT equipment
Channels for customer communications include helpdesk phone number, fax number, address, web-site, etc.
Purchasing process will also have to be controlled if it affects the final quality of the delivered product or service
Production and service operations will have to be performed under controlled conditions - meaning the same production or servicing operations can be repeated with minimal variance
Monitoring and measuring devices also have to be verified to ensure that they are working properly (otherwise they may give us problems; e.g. pressure gauge at oil refinery not working properly, giving rise to explosion which could otherwise be prevented

6. 8 Measurement, Analysis & Improvement
ISO 9001:2008 Requirements
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*
Measurement, analysis and improvement is an important part of the QMS implementation
Ensure QMS is suitable and effective for current use
Measurements to be collected and analysed must be pre-defined. The statistical technique for analysing the measures should also be pre-determined
It is mandatory to collect and analyse measures on customer satisfaction and internal audits
There must also be mechanism to ensure that non-conforming products are prevented from inadvertent use or delivery (e.g. through segregation)
Appropriate data should be analysed to determine characteristics or trends of products or processes
QMS improvements, correvtive and prevetive actions are usually derived from the analysis of data

7. 4 QMS Requirements (Document Key Processes)
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
The type & extend of controls to be applied for outsourced processes shall be defined within the Quality Mgmt System*
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
Quality Manual
Scope of QMS, including details of and justifications for any exclusions
One of the key ISO 9001 requirements is ensure that all key business activities are properly documented in terms of sequence / interactions of key processes
A business process is normally documented from start to end
The following should be used to guide the documentation of the business process:
WHO perform the activity
WHEN is the activity performed
WHAT record is produced
For important situation, the following areas can be covered:
HOW is the activity performed
WHY is the activity performed
Any exclusion to the ISO 9001 implementation must be justified (partial ISO 9001 certification is discouraged)
in the past, partial ISO 9001 certification is allowed through the use of the ISO 9001, 9002 and 9003 standard
this is no longer allowed and most companies do not make use of partial certification anyway
a complete product or service must be certified (partial not allowed)

8. ISO 9001:2008 Requirements 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
Document control is important because we need to
ensure that staff are following only approved and the correct version of the procedures
Normal a document will need to have a
unique title for unique identification
an issue date and/or issue number
page numbering and total page numbering to eliminate possibility of not being aware of missing pages
approval signature/record indicating that the document has been approved for use
Superceded documents must also be indicated as such

9. ISO 9001:2008 Requirements 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
All records should have a title and a date to make it readily identifiable
Filed records should also be indexed to make the records readily retrievable (through through use of the File Index form)
All important records provide evidence that the business processes have been properly carried out should be maintained (e.g. end-products and intermediate end-products)
product mkg plans
quotations
customer ‘s PO
invoices and delivery notes, etc.

10. 5.1 Management Commitment
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
As emphasized earlier, top mgmt commitment is very important for effective ISO 9001 implementation
Top mgmt is required to provide evidence of their commitment to the development, implementation & improvement of the QMS through their actions (e.g. send staff for training, directing staff on relevant corrective/preventive actions, etc.)
Top mgmt also to establish the quality policy or company mission statement so that staff know their key work objective the moment they step into the company
E.g. To continually improve all business processes so as to meet changing requirements and expectations of all internal and external customers
To provide customers with quality and cost-effective solutions (product/service) in a timely manner
Top mgmt should be set quality related objectives for middle mgmt to achieve (e.g. based on efficiency and effectiveness measures)
Efficiency: Amount of work done per unit time
Effectiveness: Number of mistakes made per month
Top mgmt should allocate resources to areas that can improve the capability of the organisation
It is easy to increase revenues or production level by elimination all long term measures such as maintenance, R&D, continual improvements
It is more difficult to improve the capability of the organisation

11. ISO 9001:2008 Requirements 5.2 Customer Focus
Top mgmt ensure customer requirements are determined and fulfilled
Customer satisfaction is also achieved / enhanced
Being customer-focus is important to the survival of an organisation
The customer is the reason which a company exists
Old Trend: Let the customer beware
Buy the goods at your own risk
Supplier takes no responsibility for poor quality goods produced
Customers have little choice as there are limited suppliers for the same product / service
New Trend: Let the Suppliers Beware
Many suppliers can now provide the same product/services
The supplier that provide poor quality product/services have to be careful; It will steadily lose its market share if nothing is done

12. ISO 9001:2008 Requirements 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
Regulatory requirements is emphasised or given more attention in the new ISO 9001:2000 standard
Quality policy must include commitment for continual improvement
status quo is no longer okay in the new ISO 9001:2000 standard
The rest are implied in the old ISO 9001 standard

13. 5.4 Quality Objectives / QMS Planning
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
Quality objectives now have to be set at all functions and level (high level objectives no longer adequate)
Objectives should be SMART to meet the ISO 9001 requirements
QMS planning refers more on resource and schedule planning for improvement activities

14. 5.5 Responsibility, Authority & Communication
ISO 9001:2008 Requirements
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
Responsibility and authorities for all staff to be defined
Good to have a job specification for all job designation; Job specification can contain:
Educational, job experience, skill and/or training requirements
Key required work activities
Mgmt representative is accountable for the successful implementation of the ISO 9001 standard
member of top mgmt should be appointed for this to improve chances of successful ISO 9001 implementation
Communication channels must be established to highlight quality problems and required follow-up actions

15. ISO 9001:2008 Requirements 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
Mgmt review is an important process to facilitate continual improvement of the QMS
Many measures (e.g. customer satisfaction, complaints, audit results, etc.) are analysed to identify required corrective and preventive actions to improve the QMS
The review process will highlight key QMS deficiencies and required corrective and preventive actions
strengths of QMS are also sometimes highlighted to inform staff to continue to do what we have done well
Resource and schedule plan for improvements should also be made

16. ISO 9001:2008 Requirements 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

17. 7.1 Planning of Product Realisation
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

18. 7.2 Customer Related Processes
ISO 9001:2008 Requirements
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

19. 7.3 Design and Development
ISO 9001:2008 Requirements
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

20. 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

21. 7.5 Production & Service Provision
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

22. 7.5 Production & Service Provision
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 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

23. 7.5 Production & Service Provision
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

24. 7.6 Monitoring and Measuring Devices
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
E.g. seal for taxi meter

25. 8 Measurement, Analysis & Improvement
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*

26. 8 Measurement, Analysis & Improvement
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
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

27. 8 Measurement, Analysis & Improvement
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
E.g. segregation of non-conforming products

28. 8 Measurement, Analysis & Improvement
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

29. 8 Measurement, Analysis & Improvement
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