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ISO 9001:2008 Awareness Presentation

ISO 9001:2008 Awareness Presentation. Suitable for all kinds of interested audiences. Empty your cup and enjoy the presentation . Facts about ISO 9001 ISO 9001 is being implemented in 175 countries around the world Over 1.2 million certificates issued worldwide

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ISO 9001:2008 Awareness Presentation

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  1. ISO 9001:2008 Awareness Presentation

  2. Suitable for all kinds of interested audiences

  3. Empty your cup and enjoy the presentation  Facts about ISO 9001 ISO 9001 is being implemented in 175 countries around the world Over 1.2 million certificates issued worldwide ISO has 163 member countries

  4. What is ISO 9001? • It’s a quality management system that can be adopted by any kind of organization • The system is focused towards the meeting of customer requirements and enhancing of customer satisfaction Keywords: Quality Management system Customer requirements Customer satisfaction

  5. What is ISO 9001? • This system has 4 components or elements and they are applied within your business management: • Management responsibility • Resource management • Product realization • Measurement, analysis and improvement • Before we explore these elements, why is ISO 9001 necessary for your organization?

  6. Why do we need ISO 9001? • To be effective in whatever we do, we need a system of doing things to be consistent. Just like craftsmen, managers need a good management tool to get the job done. • There are too many activities in any organization. Easy to lose track of things and focus. Easy to get distracted. Managers need a good system to keep things in order. • Systemizing of activities is a natural phenomenon. We do it all the time – privately, publicly or commercially

  7. Why do we need ISO 9001? • A business faces great risks – big investments, customer expectations, jobs, credibility, etc. The business owner must do all he can to ensure success, or he/she will fail. • Every major economy in the world adopts it! Governments give recognition to it. Because it works.

  8. Global Issuance of ISO 9001 Certificates

  9. ISO Survey 2010ISO 9001 Certificates issued by region

  10. You already have a system of doing things too! • But is it effective? If you keep doing what you always do, you will always get the same result. • ISO 9001 is an option, a good one. It requires your organization to document your business processes (QMS), monitor, measure, analyze and improve it. • Business owners and top management need to make a strategic decision on whether to implement the ISO 9001 QMS.

  11. Planning is the key Biggest benefit • The ISO 9001:2008 Standard provides managers with a tool that is designed to continually improve their business performance. • ISO 9001 requires you to: • Plan what you want to do, • Follow that plan, • Monitor, measure and analyze your execution of the plan, and • Improve the plan. P D C A

  12. A well-designed and well-implemented quality management system can and should eliminate • Ineffectiveness • Inefficiencies • Problems • Errors • Inconsistencies • Malicious practices • Uncertainties • Bad culture

  13. What is ISO 9001? • ISO = International Organization for Standardization • isos = Greek = equal • 9001 = unique ID number • 2008 = Year it was published Formation 23 February 1947 Type NGO Purpose Int’l standardization HQ Geneva Membership 63 countries Website www.iso.org No. of stds over 18,000

  14. ISO 9000 Family • ISO 9001:2008 Quality Management Systems – Requirements • ISO 9000:2005 Fundamentals and vocabulary • ISO 19011:2011 Guidelines for auditing management systems • ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach • The term “ISO 9000” is frequently used to refer to the ISO 9001 standard • Only ISO 9001 is auditable. The rest serves as references only.

  15. ISO 9001 History It all started when the US Military were getting sub-par products from their suppliers. Then it caught on.

  16. What is ISO 9001:2008 Quality Management Systems - Requirements? • Quality = degree to which customer requirements have been met • Management = coordinated activities to direct and control an organization • System = set of interrelated or interacting elements • Quality management system = a system to direct and control an organization with regard to quality • Requirements = a set of management parameters your QMS

  17. More about quality • How do you know requirements have been met? • Review = confirm that requirements are accurate • Verify = measure accuracy of output against requirements • Validate = Get feedback from customer/end-user • Nonconformance = failure to fulfill requirements • Nonconformance = error • All forms of nonconformances require corrections and corrective action to prevent recurrences • Correction = Elimination of error • Corrective action = Elimination of the root causes of the error (Ask WHY 5 times)

  18. Root cause analysis Why did the nonconformity occur? Why did the direct cause occur? Why did effect 3 occur? Why did effect 2 occur? Why did effect 1 occur?

  19. 8 Quality Management Principles Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships The ISO 9001 Standard is based on these principles

  20. System approach • Quality must be managed by a system to be effective • This system is done for you, as represented by the ISO 9001:2008 standard • Recall: A system is a set of interrelated or interacting elements • System approach is described in Clause 4.1 • The description of Clause 4.1 matches the PDCA approach to process management - Plan, Do, Check, Act

  21. System and process approach • Quality must be managed by a system • The system must be managed using the process approach because the system is made up of processes • These processes are linked to each other • A process has inputs , resources, activities, outputs and customers. Manage them all.

  22. ISO Lingo • Product = Any output- physical product or services • Output = product • Product = result of a process • Process = a set of inter-relating activities focused towards producing the output • Input = requirements

  23. Process approach Can be applied to any other process that you manage

  24. Process approach • Every process require specific inputs, resources, activities, outputs and customers • What you can do now is: • Define and document the inputs • Define and document the kinds of resources that your process use • Define and document the activities and their interactions • Define and document the responsibilities • Define and document the outputs • You can name this document as Department Control Plan • Then execute this plan, and monitor, measure, analyze and improve its performance (KPI) • Thus, Plan – Do - Check – Act (Edward Demmings)

  25. Anatomy of a process Every process has an owner

  26. Process management

  27. ISO 9001:2008 ELEMENTS

  28. ISO 9001:2008 Structure • Clause 1 Scope • Clause 2 Normative references • Clause 3 Terms and definitions • Clause 4 Quality management system • Clause 5 Management responsibility • Clause 6 Resource management • Clause 7 Product realization • Clause 8 Measurement, analysis and improvement

  29. Clause 1 Scope • Your organization should consider to adopt the ISO 9001 standard if it  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

  30. In this International Standard, the term “product” only applies to  • product intended for, or required by, a customer, • any intended output resulting from the product realization processes. • All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

  31. Clause 1.2 Application • Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7. • And such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. • Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

  32. Clause 2 Normative references • This document is indispensable in the application of the ISO 9001 standard: • ISO 9000 – Fundamentals and vocabulary

  33. Clause 3 Terms and definitions • Wherever the term “product” occurs, it can also mean “service”.

  34. 4.1 QMS General Requirements • Determine the QMS processes • Determine the sequence and interactions • Determine the methods of operations and control • Provide resources to ensure effective operations (Clause 6) • Monitor, measure and analyze processes (Clause 8.2 to 8.4) • Improve the effectiveness of the processes (Clause 8.5)

  35. QMS processes are in the circle

  36. Clause 4.2 Documentation requirements • Control of Nonconforming Product • Corrective Action Procedure • Preventive Action Procedure • Quality Plan • Control plans • Other documents, as necessary • Records (to show evidence of work performed in all QMS processes) • Quality Policy • Quality Manual – to describe the system • Quality Objectives Register – to document your quality objectives • Control of Documents Procedure • Control of Records Procedure • Internal Audit Procedure • Note: Templates are available. 

  37. Control of documents

  38. Clause 4.2.4 Control of records • Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. • Process owners must identify, classify and maintain all process records in good and secure conditions throughout retention period. • Records shall remain legible, readily identifiable and retrievable.

  39. Good records management • Enables you to • conduct business in an orderly, efficient and accountable manner • support and document decision making • provide continuity in the event of a disaster • meet legislative and regulatory requirements • protect the interests of customers, employees and stakeholders

  40. Types of records to maintain • Go through the ISO 9001 standard or your Quality Manual • Identify the following phrases where they appear: “Records …… shall be maintained (see 4.2.4)” • Most of the records requirements are readily available, such as product planning records, product design records, purchasing records, production records, monitoring records, analysis records, employee performance appraisal and training records, job descriptions, organization chart, infra maintenance records, contract/sales records, marketing records, customer complaints records, etc. • Records pertaining to the mandatory SOP’s and quality objectives shall be created.

  41. Clause 5 Management Responsibility • Top management must • Be committed to the QMS • Be customer focused • Establish a quality policy • Plan for the QMS in terms of establishing quality objectives and management of change • Assign responsibility, authority and provide suitable communication channels • Review the QMS performance

  42. What to do • Read the ISO 9001:2008 Standard • Establish a Quality Policy • Appoint a Management Representative (from mgt rank) • Establish a QMS Committee • Establish your Quality Manual • Establish the 6 mandatory procedures (Clause 4.2) • Establish your Quality Plan • Establish your Department/Process Control Plans • Establish and document your quality objectives • Establish your KPI’s and start collecting data • Implement all the procedures

  43. Key Performance Indicators • Ask this question when determining KPI’s: • As the CEO/Manager of this organization, what data will instantly give me the ability to assess overall performance at any given point of time? • Then list all them down and select your desired KPI’s.

  44. Quality objectives • Can be used to benchmark performance based on input requirements (customer wants 100 units per month, so give them 100 units per month) • Can be used to improve KPI performance levels – decision must be based on past performance data and existing capacity to be realistic • You can use existing performance levels to establish your quality objectives • Use quality objectives to improve on productivity levels, decrease errors, improve speed, reduce costs, reduce complaints, etc.

  45. Employee responsibility • Know the Quality Policy • Aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives • Comply with the requirements of the QMS, as stated in the Quality Manual, procedures, Quality Plan, etc. • Provide feedbacks or ideas about the QMS • Report any nonconformities

  46. Clause 6 Resource management • Clause 6.1 Provision of resources • The organization shall determine and provide the resources needed • to implement and maintain the quality management system and continually improve its effectiveness, and • to enhance customer satisfaction by meeting customer requirements.

  47. Types of resources • Determine , provide and manage the following: • Clause 6.2 Competent human resources (competency assessment, training needs analysis) • Clause 6.3 Suitable and well-maintained infrastructures (maintenance of buildings, hardware, software, transportation, utilities) • Clause 6.4 Suitable and well-maintained work environment (5S program) • Consider including financial management in your QMS to ensure product conformity

  48. Clause 6.2.1 • Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

  49. Sometimes, work activities are not defined. So there’s a lot of confusion • Create a survey form which contains these columns: • Employee’s name • Job position • List of routine activities • List of non-routine activities • Key performance indicators • Skills required • Competency assessment per skill (use score ratings) • Recommendation for training • Employees fill in columns 1 to 4 • Manager fills in columns 5 to 8 • Benefits: Manager can identify work redundancies, activity gaps, competency gaps, need for training and maybe the need to re-engineer the work processes • Output: ? Defining staff duties and responsibilities and analyzing training needs to ensure competence is essential

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