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Draft BY QI organization June 2014

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1 Draft BY QI organization June 2014
ISO 9001:2015 Draft BY QI organization June 2014

2 Introduction Purpose of the session New standard main elements
The high structure context Review main body of the draft The different between the ISO 9001:2008 and CD ISO 9001:2105

3 Purpose of the session To review the new draft for ISO 9001:2015 and discuss the implementation of the new standard To have open discussion and exchange idea about the implementation requirements in the Egyptian market To discuss the required qualification of the auditors and the consultants How to improve the current QMS to comply with the new requirements

4 New standard new elements
7. Support Resources Competence Awareness Communication Documented information 8. Operation Operational planning and control 9. Performance evaluation Monitoring, measurement, analysis & evaluation Internal audit Management review 10. Improvement Non conformity and corrective action Continual Improvement 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization Understanding the organization and its context Needs and requirements Scope Management System 5. Leadership General Management commitment Policy Roles, responsibility and authority 6. Planning Actions to address risks & opportunities Objectives and plans to achieve them

5 0.1 General Brief about the committee draft , the CD version is not the final ISO 9001:2015 standard , the final draft may include or may not include the given modification

6 0.2 Annex SL Annex SL appendix 2 set out the high level structure , identical core text and common terms and core definitions that are to form , when possible , the nucleus of future and revised management system standard such as ISO 9001. All MSS shall , in principle use consistent structure , common text and terminology so that they are easy to use and compliable with each other

7 0.3 significant changes Redrafting to make the standard more generic and more easily applicable by service industries. (product  goods & services) Context (framework & environment) of organization 4.1 understanding the organization and its context 4.2 understanding the needs and expectations of interested parties 4.4.2 Process approach 4.1 Risk and 6.1 preventive action (there is no requirement for formal risk management) Documented information .(document and records  documented information) 8.6 Control of external provision of goods and services NEW These clause require the organization to determined the issue and requirements that can impact on the planning of the quality management system. There is a requirements for goods and services to meet external parties other than those identified in the ISO 9001:2008 Require an assessment of the organization’s external and internal issue that are relevant to its purpose and that affect its ability to achieve the intent outcome Address all forms of external provision (purchasing from suppliers-> through associated company or outsource. The organization is required to take risk based approach to determined the type and extend of controls appropriate to each external provider and all external provision of goods and services

8 1 scope Used by organization to demonstrate its ability to provide goods and services that meets customer and legal and other requirements and to improve the customer satisfaction as well as the conformity with legal and other requirements

9 2 Normative references ISO 9000:2015

10 3 terms and definitions Give definitions that apply to the standard about 22 terms , such as organization ,requirements , policy, objective , documented information etc.

11 4 context of the organization
NEW 4.1 understanding the organization and its context Organization Shall determined External & internal issues affect to achieve the outcome and consider : Change and trend impacts on objectives Relationships with, and perceptions and values of relevant interested parties Governance issues , strategic priorities , internal policies and commitment resource availability and technological change Update such determination when needed

12 4.2 understanding the needs and expectations of interested parties
NEW The organization shall determined The relevant interested parties such as (direct customer , end-user, supply chain , regulator and any others) The requirements of these interested parties Update these needs

13 4.3 determining the scope of the quality management system
NEW The organization shall determined Boundary Applicability of the QMS Requirement of 4.1 and 4.2 Scope shall be documented information Exclusion from the standard only apply to clauses and 8 Exclusion shall be documented and justified The justification shall not affect the organization ability or responsibility to assure conformity of goods and services NOTE external provider can be a supplier or sister company.

14 4.4 Quality management system
4.4.1 general The organization shall establish , implement and maintain and improve its QMS 4.4.2 Process approach Organization shall determined: Processes needed, Input , output , resources , control for identified processes Processes interactions Risks to conformity (goods, services and in-effective interaction) Key performance indicator Responsibility and authority Improvement ISO 9001:2008 C4.1

15 5 Leadership 5.1 Leadership and commitment
5.1.1 Leadership and commitment with respect to the quality management system Top management shall demonstrate its commitment by Quality policy and objectives are established Quality policy is understood within organization Integrity of the QMS Awareness of process approach Resources are available Communicating the importance of conforming to QMS and requirements of goods and services Supporting persons to contribute to the effectiveness of the QMS Supporting other management roles Improvement and innovation ISO 9001:2008 C5.1

16 5.2 Quality policy Top management shall establish quality policy that
Appropriate to the purpose of organization Provide frame work for setting the objectives Include commitment to satisfy applicable requirements Includes commitment to improvement Policy shall be documented information Communicated within organization Available to interested parties as appropriate Reviewed ISO 9001:2008 C5.3

17 5.3 Organization roles , responsibility and authorities
Top management shall ensure responsibility and authorities are assigned and communicated Top management shall assign responsibility and authority for QMS conforms to the requirements Processes are interact and provide the intend output Reporting on the QMS performance Awareness for customer requirements No Clear definition for the MR , however still exist without any exact requirements ISO 9001:2008 C & C5.5.2

18 6 Planning 6.1 Actions to address risks and opportunities
QI NEW TQM SW NEW 6.1 Actions to address risks and opportunities Organization shall consider 4.1 and 4.2 when planning Determined risks and opportunities that need to be addressed: Assure QMS can achieve its intend outcome Assure conformity of goods and services and customer satisfaction Prevent and reduce undesired effect Achieve improvement Organization shall plan actions to address these risks and opportunities Organization shall implement such actions to the QMS The organization shall evaluate the effectiveness of these actions Actions taken shall be appropriate for the effect

19 6.2 Quality Objectives and planning to achieve them
The organization shall establish quality objectives Consistent with policy Relevant to conformity of goods and services and customer satisfaction Measurable, take into account applicable legal requirements Monitored , communicated Updated as appropriate Documented information Determined how shall the organization achieve such objectives ISO 9001:2008 C5.4.1

20 Simply , evaluate before implementation
6.3 Planning of change NEW Organization shall determined the needs and opportunity to maintain and improve the QMS Organization shall undertake changes Planned systematic manner Identify risks Opportunity Reviewing the potential consequence of change Simply , evaluate before implementation

21 Review from previous ISO 9001:2000
7 Support 7.1 Resources 7.1.1 General The organization shall provide resources needed to QMS 7.1.2 infrastructure Organization shall provide and maintain infrastructure needed for operation 7.1.3 process environment Organization shall provide the working environment for each process 7.1.4 monitoring and measuring devices Organization shall determined the monitoring and measurement devices 7.1.5 knowledge Knowledge of conformity shall be available ISO 9001:2008 C6.1 & 6.2& C6.3 Review from previous ISO 9001:2000

22 7.2 Competence Organization shall
Determined the necessary competence of persons Ensure persons are competent based on appropriate education, training or experience Where applicable take action to acquire the necessary competence and evaluate the effectiveness of actions taken ISO 9001:2008 C 6.2

23 7.3 Awareness Persons doing work under control of organization shall be aware of Quality policy Relevant quality objective Contribution to the effective to management system Implication of not conforming with QMS ISO 9001:2008 C 6.1 & C6.2

24 7.4 Communication Organization shall determined the need s for internal and external communication ISO 9001:2008 C 5.5.3

25 7.5 Documented information
7.5.1 General Organization QMS shall include: Documented information required by the standard Documented information required by organization 7.5.2 Creating and updating Organization shall ensure when creating or updating documented information : Identification , description, format, review for approval. 7.5.3 control of documented information Organization ensure DI are available and suitable when needed and protected DI shall be controlled for distribution , access , retrieval , use , preservation , changes and retention and disposition External origin DI shall be identified and controlled ISO 9001:2008 C4.2.3 & C4.2.4

26 8 Operation 8.1 Operational planning and control
Organization shall plan and implement and control processes by determined actions in 6.1 Establish criteria for the process Implement control of the processes IAW criteria DI to give confidence that process carried out as planned Organization controlled planed change Any process by external providers is controlled ISO 9001:2008 C 7.1

27 8.2 Determination of market needs and interactions with customers
8.2.1 General Organization shall implement process to determined customer requirements 8.2.2 determination of requirements related to the goods and services stated by the customer Not stated by the customer Legal and other requirements applicable to the goods and services any additional requirements ISO 9001:2008 C7.2.1

28 8.2.3 Review of requirements related to the goods and services
Organization shall review the requirements related to goods and services before supply Results of review shall be DI Organization shall ensure requirements where customer doesn't provide documented statement If requirements are changed the organization shall ensure the implementation is done and relevant person become aware of that ISO 9001:2008 C7.2.2

29 8.2.4 Customer communication
Organization shall determined and implement planned to communicate with customer in relation to: Goods and services Enquiries , contract or order Customer feed back Handling of customer property The specific requirements for contingency actions , where relevant ISO 9001:2008 C7.2.3

30 8.3 Operational planning process
Organization determined the following as appropriate: Requirements for goods and services take into account quality objectives Actions to identify and address risks related to goods and services conformity Required recourses Acceptance criteria Required verification , validation, monitoring, measurement , inspection and test Performance data embellishing and communicated Requirements for tractability , preservations , delivery and post delivery Output in form suitable to the organization ISO 9001:2008 C 7.1

31 8.4 Control of external provision of goods and services
8.4.1 General Organization shall ensure that externally provided goods are conforms with requirements 8.4.2 type and extent of control of external provision Types and extent control applied depend up on Risks identified and potential impact Degree of shared control between organization and providers The capability of potential control organization shall have criteria for selection , evaluation and reevaluation DI for monitoring result DI shall provided to provider as appropriate include data about the goods and services , requirements , provider monitoring , any required verification ISO 9001:2008 C7.4.1

32 8.4.3 Documented information for external providers
NEW Documented information shall be provided to the external provider describing, where appropriate: goods and services to be provided or the process to be performed, requirements for approval or release requirements for competence quality management system requirements, control and monitoring of the external provider’s performance any verification activities that the organization, or its customer, intends to perform at the external provider’s premises requirements for handling of external provider’s property provided to the organization. Documented information describing on the results of monitoring shall be maintained.

33 8.5 Development of goods and services
8.5.1 Development processes The organization shall plan and implement processes for the development of goods and services consistent with the process approach. In determining the stages and controls for the development processes, the organization shall take account of: nature, duration and complexity customer, statutory and regulatory requirements requirements specified by the organization determined risks and opportunities associated with the development (nature , level of control and impacts) internal and external resource, need for clarity with respect to the responsibilities and authorities need for the management of the interfaces between individuals and parties need for involvement of customer groups, the necessary documented information activities needed to transfer from development to production ISO 9001:2008 C7.3 –C7.3.6

34 8.5.2 Development controls The controls applied to the development process shall ensure that the result to be achieved by the development activities is clearly defined, inputs are defined outputs are in a form suitable for subsequent use for production problems and issues arising during the development process are resolved the planned development processes have been followed, goods produced or services provided are fit for purpose, appropriate change control is maintained throughout the development ISO 9001:2008 C

35 8.5.3 Development transfer The organization shall ensure that transfer from development to production or service takes place when customer requirements, statutory or regulatory requirements are met ISO 9001:2008 C7.3.3

36 8.6 Production of goods and provision of services
8.6.1 Control of production of goods and provision of services The organization shall implement production of goods and provision of services under controlled conditions. Controlled conditions shall include, as applicable: the availability of documented information, the implementation of controls; use of suitable equipment; use of monitoring and measuring devices; competence of personnel validation and approval, and periodic revalidation, of any process for production implementation of goods and services release, delivery and post-delivery activities; nonconformity due to human error, ISO 9001:2008 C7.5.1 & C7.5.2

37 8.6.2 Identification and traceability
Where appropriate, the organization shall identify process outputs by suitable means. Where traceability is a requirement, the organization shall control the unique identification of the process outputs, and maintain it as documented information. ISO 9001:2008 C7.5.3

38 8.6.3 Property belonging to customers or external providers.
The organization shall exercise care with property belonging to the customer or external providers ISO 9001:2008 C7.5.4

39 8.6.4 Preservation of Goods and services
Organization shall ensure preservation of goods and services include any process output during processing and delivery to the intend destination in order to meet the requirements ISO 9001:2008 C7.5.5

40 8.6.5 Post delivery activities
Where applicable , the organization shall determined and meet requirements for post delivery activities associated with the nature and intended lifetime of the goods and services Required shall take into account Risks associated with goods and services Customer feedback Legal and other requirements ISO 9001:2008 C7.5.1

41 8.6.6 control of changes The organization shall undertake change in a planned and systematic manner , taking account of the review of the potential consequences of changes Maintain documented information describing the results of review and the person who authorized the change. ISO 9001:2008 C7.3.7

42 8.7 Release of goods and services
The organization shall implement the planned activities at appropriate stages to verify that goods and services requirements have been met. Evidence of conformity with acceptance criteria shall be maintained. All planned arrangement shall be finished before release or by other authorities Documented information shall indicate the person who release the goods and services ISO 9001:2008 C8.2.4

43 8.8 nonconformity goods and services
The organization shall ensure that goods and services which do not conform to requirements are identified and controlled to prevent their unintended use or delivery that will have a negative impact on the customer. The organization shall take actions to nature of the NCR Documented information describing the nature of NCR and any action taken shall be maintained ISO 9001:2008 C8.3

44 9 Performance evaluation
9.1 monitoring , measurement , analysis and evaluation 9.1.1 General the organization shall take into consideration the determined risks and opportunities and shall: Determined what needs to be monitored and measured Evaluate the performance of external provider Determined the methods for monitoring , measuring , analysis and evaluation as applicable , to ensure valid results Determined when the monitoring and measuring shall be performed Determined when the results shall be analyzed Determined the QMS indicators needed The organization shall maintained appropriate documented information The organization shall evaluate the QMS performance and effectiveness NEW

45 9.1.2 Customer satisfaction
The organization shall monitor data relating to customer perceptions of the degree to which requirements have been met ISO 9001:2008 C8.2.1

46 9.1.3 Analysis and evaluation of data
The organization shall analyzed and evaluate appropriate data arising from monitoring , measurement and other relevant sources. This shall include determination of applicable methods ISO 9001:2008 C8.4

47 9.2 Internal audit The organization shall conduct IA at planned intervals to provide information on whether the QMS comply with requirements and effectively implemented The organization shall plan establish , implement and maintain audit program determined taking into account objectives, risks importance and result of pervious audit Take appropriate action without undue delay Retain documented information as evidence of implementation of audit program and the audit results ISO 9001:2008 C8.2.2

48 9.3 Management review Top management shall review the organization quality management system , at planned intervals , to insure its continuing stability , adequacy and effectiveness. Input to management review Output to management review Documented information from management review shall be maintained ISO 9001:2008 C5.6

49 10 improvement 10.1 NCR and corrective action
When NCR occurred , the organization shall React to the NCR and as applicable and correct it and deal with the consequence Evaluate the need for corrective actions or preventive actions Implemented actions needed Review the effectiveness of any corrective actions taken Make changes to QMS if necessary ISO 9001:2008 C8.5.2&C8.5.3

50 10.2 improvement The organization shall improve the suitability , adequacy and effectiveness of the QMS The organization shall QMS processes , goods and services The organization shall evaluate , priorities and determined the improvement to be implemented ISO 9001:2008 C8.5.1

51 Appendix NEW The draft include appendix with full definition of the eight quality principle The eight quality principle are the core of the new standard , that is evident from one of the clauses is one of the eight principles(leadership)

52 Thank you

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