Awareness ISO 9001-2008

1. AWARENESS PROGRAM Quality Management System ISO 9001:2008 BY ANKUR DHIR CERTIFIED LEAD AUDITOR FOR ISO 9001:2008, 14001:2004,ISO 22000:2005;ISO 27001:2005

2. INTRODUCTION In a highly competitive environment, managing performance poses the greatest challenge for managers within the context of continual change in customer needs, requirements, and expectations that shape performance requirements. To overcome this challenge, management practices need to be based on established principles. Developing a principle-based management system is therefore crucial to good management practices that can lead to desired performance.

3. INTRODUCTION After many years of quality assurance practices, the International Organization for Standardization, or commonly referred to as the ISO, has evolved eight key management principles as the basis for standardizing management system practices that meet the specified requirements. This resulted in the ISO 9001:2000 International Standard, and now the revised ISO 9001:2008 version of this International Standard.

4. QUALITY - CUSTOMER DEFINATION Customers define quality, they quality they want, need, expect or dream of. So much has been said on this point that it will be pointless to discuss it any longer. However, lets not forget that there is an explicit quality and an implied quality: explicit quality goes along with quality standards (see principle below) implied quality is specified nowhere, its quality that must just be there! A fridge is supposed to cool well, a book is supposed to be printed without spelling mistakes. Finite. Thats just given for granted.

5. PRINCIPLES OF QMS The eight key guiding principles to establish an integrated management system for achieving organizational performance are: 1. Leadership, 2. Customer focus, 3. Process approach, 4. System approach to management, 5. Involvement of people, 6. Factual approach to decision making, 7. Continual improvement, and 8. Mutually beneficial supplier relationships.

6. PRINCIPLE 1 LEADERSHIP Leadership is about establishing unity of purpose and direction in an organization. It also involves creating and maintaining an environment where people can be fully involved in achieving the organization's objectives. As such, someone has to get this started, to set the direction, to strategize and to plan the implementation of the business idea, to find the means and to provide the resources.

7. Quality means those features of products which meet customer needs and thereby provide customer satisfaction. In this sense, the meaning of quality is oriented to income. The purpose of such higher quality is to provide greater customer satisfaction and, one hopes, to increase income. However, providing more and/or better quality features usually requires an investment and hence usually involves increases in costs. Higher quality in this sense usually costs more. WHAT IS QUALITY ? Quality means freedom from deficienciesfreedom from errors that require doing work over again (rework) or that result in field failures, customer dissatisfaction, customer claims, and so on. In this sense, the meaning of quality is oriented to costs, and higher quality usually costs less.

8. LEADERSHIP IN ISO 9001:2008 Under the ISO 9001:2008 requirements, the leadership role is def ined as management responsibility in Clause 5,Management Responsibility. The standard requires that top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

9. RESPONSIBILTIES Herein top management holds five key responsibilities: a) communicating to all employees on the importance of meeting customer and other requirements, b) setting direction through a quality policy, c) defining expectations and monitoring results through the established quality objectives, d) reviewing the organization's overall performance by conducting management reviews, and e) providing resources to achieve desired outcomes.

10. LEADERSHIP- QUALITY POLICY A leader must be passionate about the purpose (objective) of the organization and what the leader has to do to achieve the desired outcomes. This requirement is categorically stated in Clause 5.3, Quality Policy, that the top management is responsible to establish, document and communicate to all employees and other interested parties.

11. PRINCIPLE 2 CUSTOMER FOCUS In customer focus, the ISO 9001:2008 requirement is inclined towards the underlying concept of customer responsiveness, which is defined as giving customers what they have contracted to receive. This is defined in Clause 5.2, Customer focus, as Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

12. CUSTOMER FOCUS ISO CLAUSES Conformance to customer requirements and achieving customer satisfaction are crucial concepts in managing performance. The whole performance management of the business idea is focused on these two concepts in the ISO 9001:2008 Standard. This is defined in Clause 7.2 as Customer-related processes under the main Clause 7 on Product realization. The requirements of product realization are all focused on meeting customer requirements and achieving customer satisfaction, starting with Clause 7.2.1, Determination of requirements related to the product. This requirement covers specified and implied requirements of the customer and also covers other requirements including statutory and regulatory requirements and additional requirements as determined by the organization.

13. Applying Principle of Customer focus Organizations depend on their customers and therefore should understand current and future customer needs and should meet customer requirements and strive to exceed customer expectation. (ISO 9004:2000)

14. REQUIREMENTS- Customer Focus 1. Meeting customer requirements. 2. Product/service requirements. 3. Customer communication. 4. Customer satisfaction. 5. Other customer-focused activities

15. PRINCIPLE 3 THE PROCESS APPROACH To respond to a customer request, the organization has to be concerned with processes within the organization. A work process is a series of operations (steps) or activities that transform input into intermediate output at each step until the final output that meets the customer specified requirements.

16. ISO CLAUSES- PROCESS APPROACH It is the responsibility of management to identify processes needed to produce and deliver the products or services to satisfy the requirements of the customers and other interested parties (suppliers, employees and other affected parties). In the ISO 9001:2008 Standard, Clause 4.1(a) requires the organization to determine the processes needed for QMS and their application throughout the organization. The requirements for the core business processes of the organization are defined under Clause 7, Product realization.

17. Requirements a) identifying work process titles, b) creating a standard method for carrying out the work and for monitoring process performance over time, c) addressing problems that arise, d) continually improving the work operations, e) identifying opportunities for continual improvement, f) disseminating work process information, and g) facilitating the training of new personnel.

18. PROCESS APPROACH - MRM The review on the performance of the processes and the actions taken to improve them are specified in the requirements for management review as defined in Clause 5.6, Management review. The review of the processes covers: Status and results of quality objectives, Results of audits and self-assessment of the organization, Feedback and satisfaction of customers and other stakeholders, Process performance and product nonconformities, Status of corrective actions and preventive actions, Continual improvement initiatives, and Unresolved issues relating to meeting customer requirements.

19. Applying the process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. (ISO 9004:2000) The ISO 9001:2008 also identifies six mandatory procedures to manage the integrity of QMS. These processes are: a) Control of documents used in QMS, including documents of external origin. These documents can be in any medium,

20. PROCEDURES REQUIREMENT b) Control of records. Records are generated to provide evidence of implementation, monitoring and control of QMS processes, c) Internal audits. Audits carried out at planned intervals to ensure the maintenance, improvement and integrity of QMS and its processes, d) Control of non-conforming product. This ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery, e) Corrective action. This is action taken to eliminate the causes of nonconformities in order to prevent recurrence, and f) Preventive action. This is action taken to eliminate the causes of potential nonconformities in order to prevent their occurrence.

21. PRINCIPLE 4 SYSTEM APPROACH TO MANAGEMENT A system is an organization of resources to achieve an intended objective. Within a large system, there are sub-systems with their own objectives which are aligned to the overall objective of the organization. A system itself is a sub-system of a larger system. One can conceptually view a system as an interaction of several elements.

22. SYSTEM APPROACH TO MANAGEMENT IN ISO 9001:2008 The system approach is a crucial concept for maintaining the integrity of the management system when improvement changes are made to QMS, as it can provide the mental picture on the interactions of the parts in the system. The ISO 9001:2008 Standard requires that an organization establishes, documents, implements and maintains a quality management system and continually improves its effectiveness, as reflected in Clause 4.1, General requirements of a QMS.

23. REQUIREMENTS The QMS documented to meet the requirements in Clause 4.1 General requirements, will preserve the integrity of QMS and facilitate communication of policies, procedures and instructions. Typically, as defined in Clause 4.2, Documentation requirements", the system requirements are documented at four levels: a. Documented statements of quality policy and quality objectives, b. A quality manual, c. Documented procedures and other documents needed to ensure effective planning, operation and control of processes, and d. Quality records.

24. Applying the principle of system approach to management. Identifying, understanding and managing interrelated processes as a system contribute to the organization's effectiveness and efficiency in achieving its objectives. 1) Determined Processes. 2) Relationships of Processes. 3) Requirements of ISO 9001:2008. 4) System Concept. 5) Resources and Information.

25. PRINCIPLE 5 INVOLVEMENT OF PEOPLE Communication is particularly crucial to ensuring involvement of all employees. Under Clause 5.5.3, Internal communication, top management must ensure that appropriate communication channels are established within the organization and that communication really takes place regarding the effectiveness of QMS.

26. ISO CLAUSES for Involvement of People The activities for communication encompass: Top management-led meetings at functional areas and levels, Team briefings and other meetings at various levels, Notice-boards, in-house journals/magazines, Audio-visual, electronic media, such as e-mail and websites, and Employee satisfaction surveys and suggestion scheme.

27. CLAUSES Contd Under Clause 5.5.1, Responsibility and authority, the top management has to define and communicate the responsibility and authority to implement and maintain QMS. Only then will the employees be clear about their involvements and how they are expected to contribute to the organization's overall mission and objectives. Under Clause 6.2.2 Competence, training and awareness, it is the responsibility of management to determine the necessary competence of personnel performing work that will affect product quality, and to provide the necessary training to achieve the necessary competence.

28. Applying Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. The following are required. Top-down communication. Responsibility and authority. Training. Empowerment and involvement. Communication.

29. Principle 6 Factual Approach to decision making. A QMS that meets the requirements of the ISO 9001:2008 Standard is established to be results- oriented. In other words, the system must be able to evaluate and monitor the planned results and to take necessary actions to ensure its achievement. Under Clause 8, Measurement, analysis and improvement, the organization must plan and implement the monitoring, measurement, analysis and improvement processes to ensure that QMS is effectively implemented and continually being improved.

30. ISO CLAUSES Factual Approach to decision making. QMS focuses on three key areas: a) to ensure that the product meets customer specified requirements, b) to ensure discipline in implementing QMS, and c) to ensure continual improvement of the effectiveness of QMS. This calls for the use of data and analysis for decision-making and for initiating actions to achieve planned results and improvements. On the performance management of QMS, the system audits, particularly the internal quality audits as in Clause 8.2.2, Internal audit, will provide objective evidence for decisions on improvement of QMS and its processes.

31. Clauses Contd Besides, there must be evidence records of statistical analysis to monitor the stability of processes, and actions initiated to prevent potential causes of nonconformity. This requirement is defined in Clause 8.4, Analysis of data.

32. Applying the principle of factual approach to decision making Effective decisions are based on the analysis of data and information. The following are required Management Reviews. Quality objectives. Use of Data Analysis. Monitoring and measurement of production. Maintaining and improving QMS.

33. PRINCIPLE 7- Continual Improvement In the ISO 9001:2008 Standard, the requirement for continual improvement (CI) is defined in Clause 8.5.1, Continual improvement. CI can be initiated through the use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. This requirement covers both the reactive and proactive actions of improvement.

34. Continual Improvement In process management, the basis for CI is in the managing of variation. Variation is the fluctuation of the output of a process, sometimes called noise. Every repeatable process exhibits variation. Improvement of any process is to reduce variation so that the process can consistently meet expectations of either the internal customers (employees responsible for the subsequent processes) or the external customers. Studying variation leads to managing it, as this will help to identify the source of a problem and to establish the action most likely to resolve it. CI drives the organization to continually address ways to reduce costs, improve organizational performance and customer satisfaction.

35. CONTINUAL IMPROVEMENT- ISO CLAUSES The systematic approach to CI is based on the Plan- Do-Check-Act cycle (PDCA). The PDCA cycle ensures rigour that is necessary to understand all aspects of the improvement opportunities and for considering multiple options. Apart from the data analysis tools, CI tools include creativity tools, quality function deployment, and what-if analysis. In the context of CI, it is necessary to focus on customer wants and needs in more depth in order to be able to develop improvement options.

36. Applying the principle of continual improvement Continual improvement (CI) is applied in Clause 8.5 of the Standard CI is achieved from three different actions; 1) CI projects, 2) corrective actions taken to eliminate causes of nonconformity, and 3) preventive actions taken to eliminate the causes of potential nonconformity. The opportunities for continually improving QMS can be identified through the use of the quality policy, quality objectives, audit results, analysis of data and management review. 1.Continual improvement. 2. Corrective Action. 3. Preventive Action.

37. Principle 8 mutually Beneficial supplier relationships The role of the supplier constitutes a crucial relationship in the value creation chain in QMS. The ISO 9001:2008 Standard defines this relationship under Clause 7.4, Purchasing. In dealing with suppliers, the standard is focused on the control of the purchased items and the reliability and capability of the supplier in relation to the requirements of the customers. The first element of control is to ensure that the supplier has the capability to supply and deliver to the specified requirements of the organization. This calls for the assessment of the supplier or sub-contractor on many criteria, including the relevant experience for the job, the performance of the supplier against other competing suppliers, the product quality, price, delivery performance,

38. ISO CLAUSES The second element of control is the purchasing process control, from the request for purchase and the issuance of the purchase order to the delivery and receipt of the inputs. Clause 7.4.3, Verification of purchased product clearly specified the requirement for this control. The tendering process will look at all the requirements specified under Clause 7.4, Purchasing, and will include the development of the project quality plan for implementation after the award of the tender.

39. Applying the principle of Mutually beneficial supplier relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. The following requirements provide the opportunities to build mutually beneficial supplier relationships: Supplier evaluation. Supplier re-evaluation. Outsourcing. Information requirements. Improvement opportunities.

40. Conclusion Several shortcomings are apparent in the applications of these eight principles in many organizations which have implemented the ISO 9001:2008 Standard. The most obvious is that the principle of CI of product, process and service is not pervasive in this field of performance practice. Organizations are more concerned with achieving conformance to requirements, and once that is achieved there is no motivation for further improvement. These shortcomings undermine the ability of managers to exploit the potentials of their established QMS. Managers must continue to study these eight principles of performance management to be able to appreciate the strength and potential that can be harnessed from the application of the ISO 9001:2008 Standards.

Awareness ISO 9001-2008

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