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