International standards registraions 1 scope

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INTERNATIONAL STANDARDS REGISTRAIONS

ISO 9001-2015 STANDARD (Property of International Standards Registrations)

Contents

ISO 9001-2015

1 SCOPE ........................................................................................................................................1 2 NOMATIVE REFERENCES................................................................................................1 3 TERMS AND DEFINACTIONS ..................................................................................................1 4 CONTEXT OF THE ORGNIZATION .................................................................................... ....1

4.1 UNDERSTANDING THE ORGNIZATION AND ITS CONTEXT .................................... ....1 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTRESTED PARTIES ...... ...2 4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM......................2 4.4 QUALITY MENAGEMENT SYSTEMS AND ITS PROCESSES........................................... .2 5 LEADERSHIP ...........................................................................................................................3 5.1 LEADERSHIP AND COMMITMENT................................................................................ 3

5.1.1 GENERAL ..............................................................................................................3 5.1.2 CUSTOMER FOCUS .............................................................................................3 5.2 POLICY.................................................................................................................................. 4 5.2.1 ESTLABLISHING THE QUALITY POLICY .............................................4 5.2.2 COMMUNICATING THE QUALITY POLICY...........................................................4 5.3 ORGANIZATIONAL ROLES , RESPONSIBILITIES AND AUTHORITIES...............................4 6 PLANNING............................................................................................................................... 4 6.1 ACTION TO ADDRESS RISKS AND OPPORTUNITIES ........................................................4 6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM...........................................5 6.3 PLANNNING OF CHANGES..................................................................................................5 7 SUPPORT .................................................................................................................................6 7.1 RESOURCES..........................................................................................................................6 7.1.1 GENERAL...............................................................................................................6 7.1.2 PEOPLE..................................................................................................................6 7.1.3 INFRASTRUCTURE...............................................................................................6 7.1.4 ENVOIRMENT FOR THE OPERATION OF PROCESSES......................................6 7.1.5 MONITORING AND MEASURING RESOURCES ............................................. ..7 7.1.6 ORGNIZATIONAL KNOWLEDGE.........................................................................7 7.2 COMPETENCE......................................................................................................................8 7.3 AWARENESS ........................................................................................................................8



7.4 COMMUNICATION..............................................................................................................8 7.5 DOCUMENTED INFORMATION..........................................................................................9

7.5.1 GENERAL ....................................................................................................................9 7.5.2 CREATING AND UPDATING.......................................................................................9 7.5.3 CONTROL OF DOCUMENTED INNFORMATION .......................................................9 8 OPERATIONN .............................................................................................................................9 8.1 OPERATIONAL PLANNING AND CONTROL............................................................................9 8.2 REQUIRMENTS FOR PRODUCTS AND SERVICES..................................................................10 8.2.1 CUSTOMER COMMUNICATION........................................................................................10 8.2.2 DETERMINING THE REQUIRMENTS FOR PRODUCTS AND SERVICES...........................10 8.2.3 REVIEW OF THE REQUERMENTS FOR PRODUCT AND SERVICES................................. 10 8.2.4 CHANGES TO REQUERMENTS FOR PRODUCTS AND SERVICES ................................. ..11 8.3 DESIGN AND DEVALOPMENT OF PRODUCTS AND SERVICES.............................................11 8.3.1 GENERAL...............................................................................................................................11 8.3.2 DESIGN AND DEVELOPMENT PLANNING........................................................................ .11 8.3.3 DESIGN AND DEVELOPMENT INPUTS.................................................................................11 8.3.4 DESIGN AND DEVELOPMENT CONTROLS...........................................................................12 8.3.5 DESIGN AND DEVELOPMENT OUTPUTS.............................................................................12 8.3.6 DESIGN AND DEVELOPMENT CHANGES..............................................................................12 8.4 CONTROLOF EXTERNALLY PROVIDED PROCESSES PRODUCTS AND SERVICES................................13 8.4.1 GENRAL...........................................................................................................................................13 8.4.2 TYPE AND EXTENT OF CONTROL ................................................................................................13 8.4.3 INFORMATION FOR EXTERNAL PROVIDERS...............................................................................13 8.5 PRODUCTION AND SERVICE PROVISION ..............................................................................................14 8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION ..........................................................14 8.5.2 IDENTIFICATION AND TRACEABILITY...........................................................................................14 8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTRNAL PROVIDERS........................................15



8.5.4 PRESERVATION................................................................................................................................15 8.5.5 POST-DELEVERY ACTIVITES............................................................................................................15

8.5.6 CONTROL OF CHANGES......................................................................................................................15 8.6 RELEASE OF PRODUCTION AND SERVICES .........................................................................................15 8.7 CONTROL OF NONCONFOMING OUTPUTS......................................................................................... 16 9 PERFORMANCE EVALUTION.....................................................................................................................16 9.1 MONITORING , MEASUREMENT,ANALYSIS AND EVALUATION........................................................16

9.1.1 GENERAL...........................................................................................................................................16 9.1.2 CUSTOMER SATISFACTION.............................................................................................................17 9.1.3 ANALYSIS AND EVALUATION..........................................................................................................17 9.2 INTERNAL AUDIT.............................................................................................................................. ......17 9.3 MANAGEMENT REVIEW.........................................................................................................................18 9.3.1 GENREAL...........................................................................................................................................18 9.3.2 MANAGEMENT REVIEW INPUTS...................................................................................................18 9.3.3 MANAGMENT REVIEW OUTPUTS ............................................................................................... 18 10 IMPROVEMENT..........................................................................................................................................19 10.1 GENERAL.................................................................................................................................................19 10.2 NONCONFORMITY AND CORRECTIVE ACTION .................................................................................19 10.3 CONTINUAL IMPROVEMENT...............................................................................................................19 ANNEX A (INFORMATIVE) CLERIFICATION OF NEW STRUCTURE, TERMINOLOGY AND CONCEPT...........21 ANNEX B (INFORMATIVE) OTHER INTERNATIONAL STANDARDS ON QUALITY MANAGEMENT AND QUALITY MANAGEMENT SYSTEMS DVELOPED BY ISO/TC176......................................................................25 BIBLIOGRAHY......................................................................................................................................................28



INTRODUCTION

0.1 GENERAL

The adoption of a quality management is a strategic decision for an organization that can help to improve its overall performance and provide a sound basic for sustainable development initiatives.

The potential benefits to an organization of implementing a quality management system based on this international standard are:

a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;

b) facilitating opportunities to enhance customer satisfaction; c) addressing risk and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system

requirements. This International Standards can be used by internal and external parties. It is not the intent of this International Standards to imply the need for: ? uniformity in the structure of different quality management systems; ? alignment of documentation to the clause structure of this International

standards; ? the use of the specific terminology of this International Standards with the

organization.

The quality management systems requirements specified in this International Standards are complementary to requirements for products and services.

This International Standards employs the process approach, which incorporates the Plan-DoCheck-Act (PDCA) cycle and risk- based thinking.

The process approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.

Risk ? based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in



place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see clause A4). Consistently meeting requirements and future needs and expectation poses a challenge for organization in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and reorganization. In this International standards, the following verbal forms are used: ?? "shall" indicates a requirement; ??"should" indicates a recommendation; ??"may" indicates a permission; ??"can" indicates a possibility or a capability. Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement.

0.2 QUALITY MANAGEMENT PRINCIPLES

This International Standards is based on the quality management principles in ISO 9000.The descriptions Include a statement of each principle, a rationale of why the principle and examination of typical action to improve the organization's performance when applying the principle. The quality management principles are: ?? customers focus ?? leadership; ?? engagement of people; ?? process approach; ?? improvement; ?? evidence-based decision marking; ?? relationship management .



0.3 PROCESS APPROACH 0.3.1 GENERAL

The International Standards promotes the adoption of a process approach when developing, implementing and improving the effectiveness of quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements consider essential to the adoption of a process approach are included in 4.4 Understanding and meaning interrelated process as a system contributes to the organization's effectiveness and efficiency in achieving its intended result. This approach enables the organization's to control the interrelationship and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. The process approach involves the systematic definition and management of process, and their interaction, so as to achieve the intended result in accordance with the quality policy and strategic direction of the organization. Management of the process and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking see (0.3.3) aimed at taking advantage of opportunities and preventing undesirable results. The application of the process approach in a quality management system enables:

a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) The achievement of effective process performance; d) Improvement of processes based on evaluation of data and information. Figure -1 gives a schematic representation of any process and show the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.



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