9001 Awareness for best 9001 presetation an

ISO TRAINING

1. 1

2. What is ISO Management Systems ISO 9001:2015 Principles Learn more on the standard clauses of the ISO standards PDCA Cycle Learn more on the Mandatory Documents and Records SMART Objectives Risk Management (Operational, Environmental, Health and Safety) 2 Learning Objectives

3. International Organization for Standardization Most Common ISO Standards: ISO 9001:2015 ------- Quality Management System ISO 14001:2015 ------ Environment management System ISO 22001:2018 ------ Food Safety Management System ISO 45001:2018 ------ Occupational Health and Safety ISO 27001:2005 ------ Information Security Management System 21,834 STANDARDS

4. Does ISO Standard require extra work and huge paper work effort? Elephant represent ISO standards

5. What is Quality ? Quality is the extent to which the characteristics of something achieve the requirements!

6. ISO Management system QMS: Is a set of policies, processes and procedures required or planning and execution (production/development/service) in the core business area of an organization that can impact the it's ability to meet customer requirements.

7. ISO9001:2015 Principles:

8. Leadership It is the ability to move people towards the target! All the leaders responsibility is to insure : Set a unity target Guide people Create the conditions that will get the whole staff involved in achieving the company goals and targets.

9. 2. Engagement of people “ To win in the marketplace you must first win in the workplace ” Doug conant “ Engagement of people is the art and science that will transfer work into results ” David Zinger

10. 4. Evidence Based Decision Making EBDM EBDM

11. 5. Improvements “ Even if you are the #1 in the market, act as you are #2 “

12. 6. Relationship management Build the relation ship inside and outside the organization based on WIN-WIN Situation

13. 7. Process Approach the process that transfer input to output. This will help in: Well understanding and implementation of the process Focus on the added value of each step. Better control on the process steps.

14. ISO 9001:2015 Structure: It is designed upon the Annex SL

15. Administrative clauses : Scope Any company no matter what its scope and size could be ISO9001:2015 Certified 2. Normative references Which is IS0 9000 3. Terms and definitions

16. Plan clauses :

17. 4.1 Understanding the organization and its context: SWOT ANALYSIS

18. 20 Needs and Expectations

19. 21 Needs and Expectations Interested Party Needs Expectations Addressing the needs and expectations Shareholders/Stakeholders Profitability Achieving Project Goals Performance Report, Financial Report Staff/Workers On time salary Safety and Security at Workplace Recognition Job Security Medical Benefits Insurance Policy Worker's welfare (Adequate accommodation facility, transportation, recreation and amenities) Career Growth Personal Development Worker's grievances Behavioral Related Procedures Customers Accurate and timely response of inquiry and complaints Products in good condition and without damage Providing satisfaction and quality service Competitive price On time delivery of service Proper handling and protection of products during storage and delivery Provides information in case of delay in service Related procedure

20. Plan clauses :

21. 23 Top Management provides leadership by accepting the responsibility of the Management System Roles and Responsibilities must be assigned in the organization (a TEAM LEADER ) can be appointed to report the performance to the Top Management Leadership

22. 24 A policy is a commitment, direction, or intention and is formally stated by the top management of an organization Policy must be established and must be evident (through Poster, email communication, etc.) It should be based on ISO’s quality management principles and should be compatible with your organization’s other policies and be consistent with its vision and mission It must be communicated as indicates commitment to the Management System It is a MANDATORY DOCUMENT Establishing Organization’s Policy

23. Plan clauses :

24. 26 It is what people regularly do to make decision Organizations face external and internal risks that endanger the possibility of achieving their goals and objectives. Establishment of the Risk Assessment What is Risk Based Thinking?

25. 27 Parts of Risk Register

26. C

27. 30 Setting OBJECTIVES is a specific management tool that creates a target for business owners to achieve Objectives can be a company-wide goals, specific to the division, or department and individual employee expectation It is a MANDATORY DOCUMENT Objectives Setting

28. 31 Direction: provides guidelines for the organization Coordination: triggers the efforts of managers at lower level and their subordinates to focus their efforts towards achieving the common goal Form Standards : it becomes measuring points of the achievements or failures of organization Legitimacy: helps to establish legal existence and to continue its operations Motivators: it kindles enthusiasm and spirits of employees Importance of Objectives

29. 32 Objective: Qualitative, inspiring goal for a quarter – what you aspire about Key Result: Quantitative outcomes for the objective – what success looks like Actions : Execution required to achieve key results – what needs to be done Insight: Results and learning from execution – what we can do better DEFINE

30. Plan clauses :

31. <<PREVIOUS NEXT>> 34 Resources : Measurement and Measuring Resources All equipment that is use to measure the weight, capacity of the products (i.e. weighing scales, thermometer, forklift) It is a MANDATORY DOCUMENT Required records to be maintained are: Monitoring records Equipment calibration records

32. <<PREVIOUS NEXT>> 35 Resources – People Competent people must be provided Job Description Resources – Infrastructure Proper monitoring of the building and/or facilities, equipment PM Plan PM Checklist / Breakdown Maintenance Records / Service Reports from contractors

33. <<PREVIOUS NEXT>> 36 Competence Demonstrate that the people to be hire is suitable for the job Required records to be maintained are: Records of training (training plan, training attendance/ training certificates, training feedback, training evaluation) Awareness Organization must be aware of their Policies and quality objectives, incidents, practices, and performances

34. <<PREVIOUS NEXT>> 37 Communication Establish your communication process (Communication Matrix) Establish what topics to communicate (Internal and external) Schedule (monthly, annually, weekly) Responsibility (who is responsible to communicate) audience (whom to communicate) Method (display boards, email communication, toolbox, etc.)

35. 38 Documented Information Process involved in the organization needs to be controlled New release, update, and obsolete Process Owner, Reviewer, Approver, and Implementation Date Details of Revision / Changes Controlled Reference A proper review must be conducted Retention Period of the documented information must be established

36. 39

37. 40

38. 8. Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs Do clauses 9001:2015 :

39. Requirements of the Products and Services Customer communication (Sales Operations – handling of the inquiries, complaints handling, customer feedback) <<PREVIOUS NEXT>> 42 Operations - ISO 9001:2015 Design and development The entire process must be established (inputs – output) A verification controls must also established (example, QC inspection / sample testing / lab testing) to ensure that any potential deviation will be covered Change process must be establish to ensure that there will be no impact on the requirement

40. <<PREVIOUS NEXT>> 43 Operations - ISO 9001:2015 How to establish controls to External Providers? Criteria selection: company profile (which includes legal documentation and financial capabilities); competencies and qualifications of the staffs; additional certification acquired. Validate or verify the information gathered Once approved, register in the APPROVED SUPPLIER’S LIST Re-evaluate the performance of the suppliers regularly

41. <<PREVIOUS NEXT>> 44 Operations - ISO 9001:2015 Identification and traceability The organization should have a means to identify the products when traceability requires to Unique identifier must be establish for each of the products to be handled Operational Planning and Control Response action to the risk assessment conduct Procedures / resources are created to ensure controls are in place

42. 9. Performance Evaluation 9.1 Monitoring, Measurement, Analysis And Evaluation 9.2 Internal Audit 9.3 Management review Check clauses :

43. It is a Different types of analysis and evaluations Risk Assessment Customer Satisfaction Performance Evaluation Vendor Evaluation Internal Audit MANDATORY RECORD Audit Plan Internal Audit Report Corrective Action Report <<PREVIOUS NEXT>> 46 Monitoring, measurement, analysis and evaluation

44. INPUTS customer satisfaction and feedback from relevant interested parties quality objectives nonconformities and corrective actions monitoring and measurement results Results from the internal and external audit Previous MR agendas <<PREVIOUS NEXT>> 47 Management Review OUTPUTS opportunities for improvement any need for changes to the management system (initiative such as process integrations, additional sites, etc.) resource needs

45. 10. Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Act clauses :

46. It is a MANDATORY RECORD Results of corrective actions (Risk Management) Actions to be taken for the nonconformities <<PREVIOUS NEXT>> 49 Improvement

47. <<PREVIOUS NEXT>> 50