1. ISO9001 Pre Assessment Team 10 PT Han Jian Da, Alphy Thomas Kanatt, Xia Xi, Wu Jun, May Lwin, Chit Khun, Mohit Srivastava, Kovalan Venkatesan

2. Agenda SWOT analysis Parts of relevant ISO9001 Expected level of compliance Actual level of compliance

3. Strengths Top management has quality process in mind. Top management wants to improve on the company process Employees are experienced and applied knowledge based on experience Basic process are present (SDLC) and artefact documentations are created. Employees are committed to make things work and deliver products on time and on budget to customer

4. Weakness No proper documentation and definition of the processes. No proper verification (review) of requirements. No proper validation and acceptance (testing) of requirements. Processes and roles are not communicated properly.

5. Opportunities Many opportunities for change QMS system to be setup Processes to be defined and documented. Control of the processes Verification and Validation of the requirements.

6. Threats If the proper processes are not defined to produce the product, accompanied by the properly controlled artefacts, Traceability is difficult when problems arises Whether the product meets customer expectation - cannot be determined Unable to find the root cause of non conformity of the product. … list goes on

7. 4. Quality Management System ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 4.1General RequirementsF/CN/CNo formal QMS, only processes but not documented. Proper QMS to be setup. 4.2Documentation Requirements 4.2.1GeneralF/CN/CQuality Policy and Objectives are not documented. Quality Policy and Objectives must be present and documented 4.2.2Quality ManualF/CN/CNo Quality Manual. One must be present. 4.2.3Control of DocumentsF/CN/CNo proper control of documents. Agreement Contracts are MOM agreed and signed on the same day it is produced. Documents must be filed and maintained. 4.2.4Control of RecordsF/CN/CNo proper control of records. Example: No proper test plans and reports for all testing. May even skip the testing phase (UAT) if there is no time. Records generated should be filed and maintained.

8. 5. Management Responsibility ISO Para # ISO RequirementsExpected Compliance Actual ComplianceDescription / Recommendations 5.1Management CommitmentF/CN/CNo QMS setup. MD and PM is supportive of quality initiatives. A QMS must be present. 5.2Customer FocusF/CP/CMD is involved in the customer requirements fulfilment and satisfaction but there is no proper feedback as to how satisfied the customers are and whether requirements are met. (See 7.2.1, 8.2.1) 5.3Quality PolicyF/CN/CQuality Policy not documented. It is present and assumed. Quality Policy must be defined and documented. 5.4Planning 5.4.1Quality ObjectivesF/CN/CNo proper quality objectives are defined or documented. Although the focus of meeting customer requirements and making them delight is part of their objectives, this need to be expanded to individual functions and levels and documented. 5.4.2Quality Management System PlanningF/CN/CNo QMS. No planning and maintenance. Set up one, document it and maintain (improvement) it.

9. 5. Management Responsibility (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual ComplianceDescription / Recommendations 5.5Responsibility, Authority & Communication 5.5.1Responsibility & AuthorityF/CN/CNo proper definition and communication of it. They are assumed and do based on experience. Proper definition and communication of it must be present and documented. 5.5.2Management RepresentativeF/CN/CNo representative to handle the QMS matters because no QMS is present. Setup QMS and appoint a management representative. 5.5.3Internal CommunicationF/CN/CNo QMS and no steps taken. Once QMS setup, communication process (both channels) must be established. 5.6Management Review 5.6.1GeneralF/CN/CNo QMS. Setup one and follow the guidelines 5.6.2Review of InputF/CN/CNo QMS. Setup one and follow the guidelines 5.6.3Review OutputF/CN/CNo QMS. Setup one and follow the guidelines

10. 6. Resource Management ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 6.1Provision of ResourcesF/CP/CMD willing to put in dedicated resources into QMS but finds it challenging. Customer Satisfaction is met when the product is delivered and customer accepts the system and makes the payment. There must be resources put in to assist in enhancing customer satisfaction by meeting requirements. 6.2Human Resources 6.2.1GeneralF/CN/CPersonnel are assigned based on availability. No training occurs when project starts. They employ experienced personnel only. Should have proper procedures on resource assignment and training based on project needs 6.2.2Competence, Training & Awareness F/CN/CNo training given once project starts. Should have proper procedures on training based on project needs 6.3InfrastructureF/CP/CInfrastructure is provided but no specific mention of the provision and maintenance of equipment and supporting services to achieve conformity of product 6.4Work EnvironmentF/C The organisation is assumed to have conformed to that.

11. 7. Product Realisation ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.1Planning of Product RealisationF/CP/CProduct (Software) realization is planned but quality objectives are not set to realize a product. Project Plan artefact shows very basic planning. Setup QMS and determine processes. Document and record the processes. 7.2Customer Related Processes 7.2.1Determination of RequirementsF/CP/CMeetings are held to gather requirements. Requirements are based on MOM and signed off. Proper documentation and review is required. 7.2.2Review of RequirementsF/CN/CNo further reviews are conducted after MOM. Review is required to confirm the requirements with the customer. 7.2.3Customer CommunicationF/CP/CCustomer communication is done during meetings and by MD and/or PM for requirements gathering. Effective methods are not determined and proper feedback channels are not defined.

12. 7. Product Realisation (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.3Design & Development 7.3.1Design & Development PlanningF/CP/CProper lifecycle process is present. V & V stage is missing. Lifecycle stages may be skipped if schedule does not permits. Once the QMS setup and processes documented, lifecycle must be complete and followed. 7.3.2Design & Development InputsF/CP/CDocument artefacts are present but no proper procedure or templates as to how to produce them. Process procedures must be determined. 7.3.3Design & Development OutputsF/CN/CNo proper verification process is present. Process procedures must be determined. 7.3.4Design & Development ReviewF/CN/CNo proper review process is present. Process procedures must be determined.

13. 7. Product Realisation (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.3.5Design & Development Verification F/CN/CNo proper verification process. Process procedures must be determined. 7.3.6Design & Development ValidationF/CN/CNo proper validation process. Process procedures must be determined. 7.3.7Control of Design & Development Changes F/CN/CChanges are informally managed. Minor changes are “absorbed” by PL and developers. Major Changes are discussed with PL and evaluated case by case. No formal process for Change Control

14. 7. Product Realisation (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.4Purchasing 7.4.1Purchasing ProcessF/CN/CNo formal process and procedures for purchases and acceptance are set. Purchases are usually done at start of project. Formal process is required. 7.4.2Purchasing InformationF/CN/CPurchase information is basic and described in the artefact. More details would be required. 7.4.3Verification of Purchased Product F/CN/CNo formal acceptance of purchased product is made. Such process are to be determined and defined.

15. 7. Product Realisation (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.5Product & Service Provision 7.5.1Control of Production & Service ProvisionF/CN/CThe product information and work instructions are not defined and is by words of mouth. No metrics are defined for the production. Proper operations and maintenance process needs to be defined. 7.5.2Validation of Processes for Production & Service Provision F/CN/CNo properly defined processes (documented) and no proper validation of the processes (informal) available. 7.5.3Identification & TraceabilityF/CN/CNo identification and traceability to the requirements identified in the MOM in the later artefacts. 7.5.4Customer PropertyF/CN/CDeployment does makes use of Customer Property at the industrial site. Proper handing/taking over procedures must be defined 7.5.5Preservation of ProductN/A Not required as the product is software and does not require special preservation.

16. 7. Product Realisation (Con’t) ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 7.6Control of Monitoring & Measuring Equipment N/A No monitoring and measuring equipment for the product that is created by the company.

17. 8. Measurement, Analysis and Improvement ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 8.1GeneralNo proper metrics for monitoring, measurement, analysis and improvement processes are present. 8.2Monitoring & MeasurementF/CN/C 8.2.1Customer SatisfactionF/CN/CCustomer acceptance is done but optionally when they have time. Customer Satisfaction is also not based on surveys but by words of mouth and complaints. 8.2.2Internal AuditF/CN/CNo internal audit is done. 8.2.3Monitoring & Measurement of ProcessesF/CN/CNo measurement is done for processes since processes are not clearly defined and documented 8.2.4Monitoring & Measurement of ProductF/CN/CNo measurement is done for products since products output are not clearly defined and documented

18. 8. Measurement, Analysis and Improvement ISO Para # ISO RequirementsExpected Compliance Actual Compliance Description / Recommendations 8.3Control of Nonconforming ProductF/CN/CInformal rectification of the product problem. No formal control of nonconforming product. 8.4Analysis of DataF/CN/CNo data collected for analysis 8.5Improvement 8.5.1Continual ImprovementF/CN/CNo proper QMS to improve on. 8.5.2Corrective ActionF/CN/CNon conformities are recorded in their personal experience and applied the next time it occur. 8.5.3Preventive ActionF/CN/CPreventive action are assumed to be derived by the experience of the employees.

19. Other Improvements or Observations “Priced/Bid to Win” mentality must be improved. This resulted in the low budget and short schedule. Should discuss with PL and developers on the feasibility of the tender proposal before bidding Communication within the organization seem to have broken down. MD assumes PM, PL and developers know their job because they’re highly experienced people. PM leaves the quality and handling project problems to the PL. They should all be highlighting the problems and communicating them more often and help out to resolve any issues instead of assuming they know the job. No proper handing over of job to newly employed personnel. They are assumed to know what their roles are since they are more experienced.

20. Rationale for ISO9001:2008 QMS Company Procedures can be documented, communicated and made available to all staff of the organization Follows an international standard and is in line with the market. Customer’s confidence would increase when doing business with the organization. Implementation Guidelines or procedures are present to guide the production and services.