This document provides a summary of the changes between the 2008 and 2015 versions of the ISO 9001 quality management system standard. It outlines the key changes to requirements, including an increased emphasis on risk-based thinking, leadership involvement, and flexibility in documenting processes. There is also a mapping of how requirements from the 2008 standard correspond to sections of the new 2015 version. Finally, there is a list of the minimum documented information now required by each clause of ISO 9001:2015.
The document outlines the key clauses of the ISO 9001:2015 quality management standard. It discusses the standard's scope and references in clauses 1-3. Clause 4 covers understanding the organization's context and interested parties. Clause 5 addresses leadership and management commitment. Clause 6 discusses quality planning. Clause 7 covers resource management and documentation. Clause 8 focuses on operational planning, design, and control of outputs. Clause 9 is about performance evaluation through monitoring, measurement, and management review. Finally, clause 10 covers improvement through nonconformity handling and continual improvement.
Typical Quality Management System Based On Iso 9001 2008Isidro Sid Calayag
This document outlines the key elements of a quality management system (QMS) based on ISO 9001:2008. It discusses the objectives of implementing a QMS, including achieving organizational success and meeting requirements. The QMS focuses on customer focus, leadership, involvement of people, process approach, and continual improvement. It addresses management responsibility, resource management, product realization, measurement and improvement to ensure a process-based approach that meets customer needs and enhances supplier relationships.
The document provides an overview of ISO 9001 and its evolution over time. It summarizes the key requirements of ISO 9001:2008, including developing, documenting, implementing and maintaining a quality management system. It outlines requirements for management responsibility, resource management, product realization, measurement and customer satisfaction.
Sample of the first 8-9 pages of the manual. The manual is available online at https://www.complianceresourcelibrary.co.uk/product-category/certified-business-resources/qms-iso-9001_2015/
The document discusses ISO 9000 standards for software quality assurance. It provides an overview of ISO 9000 and ISO 9000-3, including their scope and key principles. The certification process for ISO 9000-3 involves developing an organization's SQA system, implementing the system, reviewing documentation for compliance, performing audits, and receiving certification from an external body if requirements are met.
This document discusses the needs and expectations for revising the ISO 9001 standard in 2015. It provides background on the history of the ISO 9000 standards and outlines the requirements and design specifications for the 2015 revision, including making risk management more explicit, adopting a common high-level structure, and revising the quality management principles. It also examines some pros and cons of the international standardization process.
This document provides a summary of the changes between the 2008 and 2015 versions of the ISO 9001 quality management system standard. It outlines the key changes to requirements, including an increased emphasis on risk-based thinking, leadership involvement, and flexibility in documenting processes. There is also a mapping of how requirements from the 2008 standard correspond to sections of the new 2015 version. Finally, there is a list of the minimum documented information now required by each clause of ISO 9001:2015.
The document outlines the key clauses of the ISO 9001:2015 quality management standard. It discusses the standard's scope and references in clauses 1-3. Clause 4 covers understanding the organization's context and interested parties. Clause 5 addresses leadership and management commitment. Clause 6 discusses quality planning. Clause 7 covers resource management and documentation. Clause 8 focuses on operational planning, design, and control of outputs. Clause 9 is about performance evaluation through monitoring, measurement, and management review. Finally, clause 10 covers improvement through nonconformity handling and continual improvement.
Typical Quality Management System Based On Iso 9001 2008Isidro Sid Calayag
This document outlines the key elements of a quality management system (QMS) based on ISO 9001:2008. It discusses the objectives of implementing a QMS, including achieving organizational success and meeting requirements. The QMS focuses on customer focus, leadership, involvement of people, process approach, and continual improvement. It addresses management responsibility, resource management, product realization, measurement and improvement to ensure a process-based approach that meets customer needs and enhances supplier relationships.
The document provides an overview of ISO 9001 and its evolution over time. It summarizes the key requirements of ISO 9001:2008, including developing, documenting, implementing and maintaining a quality management system. It outlines requirements for management responsibility, resource management, product realization, measurement and customer satisfaction.
Sample of the first 8-9 pages of the manual. The manual is available online at https://www.complianceresourcelibrary.co.uk/product-category/certified-business-resources/qms-iso-9001_2015/
The document discusses ISO 9000 standards for software quality assurance. It provides an overview of ISO 9000 and ISO 9000-3, including their scope and key principles. The certification process for ISO 9000-3 involves developing an organization's SQA system, implementing the system, reviewing documentation for compliance, performing audits, and receiving certification from an external body if requirements are met.
This document discusses the needs and expectations for revising the ISO 9001 standard in 2015. It provides background on the history of the ISO 9000 standards and outlines the requirements and design specifications for the 2015 revision, including making risk management more explicit, adopting a common high-level structure, and revising the quality management principles. It also examines some pros and cons of the international standardization process.
This document provides an overview of the key aspects of ISO 9001:2015 requirements for quality management systems. It begins with describing the course objectives which are to understand ISO 9001 requirements, quality management systems, and risk-based approaches. It then provides details on the ISO 9001 standard including its structure, requirements for context, leadership, planning, support, operations, performance evaluation, and continual improvement. Key terms like process approach, PDCA cycle, and risk-based thinking are also explained.
This document provides an overview and summary of ISO 9001:2015 quality management standards. It discusses key aspects of the standard including quality management principles, a process approach, plan-do-check-act cycles, risk-based thinking, and the relationship to other standards. It also summarizes the 10 clauses of the quality management system covering topics such as leadership, planning, support, operations, performance evaluation, and improvement. The document is intended to provide awareness training on ISO 9001:2015 requirements.
The international Standard for Quality Management Systems, ISO 9001:2008, is being revised. ISO 9001:2015 is due to be published by the end of 2015. This slideshow is compiled from the first Committee Draft by Ian Hannah, Fellow of the Chartered Quality Institute; and was originally used for staff development purposes at his ISO Training and Consultancy firm, SQMC Ltd.
QMS_ISO 9001_Awareness by Management.pptxButchEnalpe
The document provides an introduction to ISO 9001:2015 and its requirements for a quality management system. It discusses key aspects of ISO 9001:2015 including an overview of the standard's requirements, a focus on risk-based thinking and management processes, and the use of a process approach involving continual planning, implementation, evaluation, and improvement (PDCA cycle). The summary highlights the main goal of ISO 9001:2015 is to keep customers satisfied by focusing on quality management principles and ensuring products and services meet customer needs and regulatory standards.
The document provides an overview of ISO 9001:2008, including its 8 quality management principles and the requirements of the standard. It discusses the benefits organizations can achieve by implementing the standard such as increased customer satisfaction, continual improvement processes, better integration and management of interrelated business functions, and gaining international recognition. The standard is designed to be applied generically in any organization to enhance performance and customer satisfaction.
This document provides an overview of an ISO 9001:2015 quality management system training program. It summarizes key aspects of the PDCA cycle and various ISO 9001 clauses related to planning, leadership, performance evaluation, and improvement. The clauses discussed include understanding organizational context, leadership responsibilities, internal audits, management reviews, corrective actions, and continual improvement processes. The training aims to help organizations understand and effectively implement the requirements of the ISO 9001 standard.
This document provides an overview of ISO 9001:2015 requirements for process owners. It begins by defining key terms like quality management system and total customer satisfaction. It then discusses the history and purpose of ISO and some key changes between the 2008 and 2015 versions. The core content reviews each clause of ISO 9001:2015 including the context of the organization, leadership responsibilities, planning processes, the PDCA cycle, and requirements for support functions. Several worked examples are provided to demonstrate how to map business processes, identify key metrics, and plan for risk mitigation and continual improvement as required by the standard.
The document summarizes key aspects of ISO quality standards including ISO 9000, ISO 14000, and environmental management systems. It provides an overview of what ISO standards are, their history and purpose in ensuring quality management systems. Key points covered include the requirements of ISO 9000 like management responsibility, quality planning, and internal audits. Advantages of ISO certification are improved marketability, reliability and customer satisfaction. ISO 14000 and environmental management systems are introduced as relating to managing environmental responsibilities through a plan-do-check-act model and standards like ISO 14001.
ISO 9001:2015 DIS Changes, Requirements and Implementation Govind Ramu
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
This document provides an overview and introduction to quality management systems and the ISO 9001:2015 and IATF 16949:2016 standards. It discusses key aspects of quality management including the basics of a QMS, requirements of the ISO and IATF standards, differences between the versions, transitioning processes, and implementing risk-based thinking. The document is intended to educate participants on quality management system requirements and certification.
This document provides an overview of ISO 9001:2015 quality management system standard. It discusses the key principles such as customer focus, leadership, process approach, and continual improvement. The main clauses of ISO 9001:2015 are summarized, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Planning addresses risk management, quality objectives, and managing changes. Support covers resources, competence, awareness, communication, and documented information. The document emphasizes that ISO 9001 employs the PDCA cycle and risk-based thinking for continual improvement of processes and meeting customer requirements.
This document discusses the changes between ISO 9001:2008 and ISO 9001:2015 quality management system standards. Some key changes include reorganizing clauses into a 10 clause structure for better alignment, adding requirements for determining organizational context and risks/opportunities, expanding the process approach, and changing terminology like replacing "preventative actions" with "risks and opportunities". Each clause is also analyzed in detail highlighting revisions and additional requirements in the 2015 version.
ISO 90012008 Understanding and Internal Auditing.pptFirozKhan158275
This document provides an overview of quality management systems and ISO 9001 certification. It discusses what ISO and ISO 9001 are, how ISO 9001 can help businesses, common misunderstandings about the standard, and the requirements and processes involved in achieving certification. The roles and responsibilities of different parties in the certification process are also outlined.
IATF 16949:2016 is an automotive quality management system standard that is based on ISO 9001:2015 with additional automotive industry requirements. It aims to prevent defects, reduce variation and waste, and promote continual improvement. The standard contains 10 clauses covering quality management principles, leadership involvement, risk-based planning, resource management, production control, performance evaluation, and continual improvement. Key aspects include supplier management, design and development processes, internal auditing, management reviews, and corrective and preventive action.
The document discusses quality management systems and ISO 9000 standards. It defines key terms like quality, quality management system, and describes the eight quality management principles. It explains the requirements of a quality management system including documentation requirements and the responsibilities of management.
Changes ISO 9001-2008 to ISO 9001-2015.pdfRealDairy2
The document provides an overview of the notable changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include adopting a common 10-clause structure across all ISO management system standards, placing more emphasis on leadership involvement and risk-based thinking, and introducing requirements for determining organizational context and interested party needs. The new version aims to make the standard more compatible with services and non-manufacturing users, strengthen the process approach, and increase flexibility for documented information.
This document provides a checklist for organizations transitioning from ISO 9001:2008 to ISO 13485:2016 and ISO 9001:2015. It contains tables to validate that an organization's integrated quality management system addresses new concepts in both standards. The tables list clauses from each standard and require evidence that requirements have been met without exceptions. It concludes that a recommendation for certification is dependent on submitting a corrective action plan to address any findings from the audit, or that a special on-site visit may be required if registration cannot be immediately recommended.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
1. The International Organization for Standardization (ISO) is responsible for creating quality standards, with over 800 new standards issued annually. ISO 9000 is the quality management system standard series.
2. ISO 9001:2008 provides requirements for a quality management system, including demonstrating the ability to consistently provide products that meet customer and regulatory requirements through effective processes and continual improvement.
3. A quality management system involves all organizational functions to direct and control an organization with respect to quality through activities like quality planning, assurance, and improvement. It defines the organization's quality environment.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
This document provides an overview of the key aspects of ISO 9001:2015 requirements for quality management systems. It begins with describing the course objectives which are to understand ISO 9001 requirements, quality management systems, and risk-based approaches. It then provides details on the ISO 9001 standard including its structure, requirements for context, leadership, planning, support, operations, performance evaluation, and continual improvement. Key terms like process approach, PDCA cycle, and risk-based thinking are also explained.
This document provides an overview and summary of ISO 9001:2015 quality management standards. It discusses key aspects of the standard including quality management principles, a process approach, plan-do-check-act cycles, risk-based thinking, and the relationship to other standards. It also summarizes the 10 clauses of the quality management system covering topics such as leadership, planning, support, operations, performance evaluation, and improvement. The document is intended to provide awareness training on ISO 9001:2015 requirements.
The international Standard for Quality Management Systems, ISO 9001:2008, is being revised. ISO 9001:2015 is due to be published by the end of 2015. This slideshow is compiled from the first Committee Draft by Ian Hannah, Fellow of the Chartered Quality Institute; and was originally used for staff development purposes at his ISO Training and Consultancy firm, SQMC Ltd.
QMS_ISO 9001_Awareness by Management.pptxButchEnalpe
The document provides an introduction to ISO 9001:2015 and its requirements for a quality management system. It discusses key aspects of ISO 9001:2015 including an overview of the standard's requirements, a focus on risk-based thinking and management processes, and the use of a process approach involving continual planning, implementation, evaluation, and improvement (PDCA cycle). The summary highlights the main goal of ISO 9001:2015 is to keep customers satisfied by focusing on quality management principles and ensuring products and services meet customer needs and regulatory standards.
The document provides an overview of ISO 9001:2008, including its 8 quality management principles and the requirements of the standard. It discusses the benefits organizations can achieve by implementing the standard such as increased customer satisfaction, continual improvement processes, better integration and management of interrelated business functions, and gaining international recognition. The standard is designed to be applied generically in any organization to enhance performance and customer satisfaction.
This document provides an overview of an ISO 9001:2015 quality management system training program. It summarizes key aspects of the PDCA cycle and various ISO 9001 clauses related to planning, leadership, performance evaluation, and improvement. The clauses discussed include understanding organizational context, leadership responsibilities, internal audits, management reviews, corrective actions, and continual improvement processes. The training aims to help organizations understand and effectively implement the requirements of the ISO 9001 standard.
This document provides an overview of ISO 9001:2015 requirements for process owners. It begins by defining key terms like quality management system and total customer satisfaction. It then discusses the history and purpose of ISO and some key changes between the 2008 and 2015 versions. The core content reviews each clause of ISO 9001:2015 including the context of the organization, leadership responsibilities, planning processes, the PDCA cycle, and requirements for support functions. Several worked examples are provided to demonstrate how to map business processes, identify key metrics, and plan for risk mitigation and continual improvement as required by the standard.
The document summarizes key aspects of ISO quality standards including ISO 9000, ISO 14000, and environmental management systems. It provides an overview of what ISO standards are, their history and purpose in ensuring quality management systems. Key points covered include the requirements of ISO 9000 like management responsibility, quality planning, and internal audits. Advantages of ISO certification are improved marketability, reliability and customer satisfaction. ISO 14000 and environmental management systems are introduced as relating to managing environmental responsibilities through a plan-do-check-act model and standards like ISO 14001.
ISO 9001:2015 DIS Changes, Requirements and Implementation Govind Ramu
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
This document provides an overview and introduction to quality management systems and the ISO 9001:2015 and IATF 16949:2016 standards. It discusses key aspects of quality management including the basics of a QMS, requirements of the ISO and IATF standards, differences between the versions, transitioning processes, and implementing risk-based thinking. The document is intended to educate participants on quality management system requirements and certification.
This document provides an overview of ISO 9001:2015 quality management system standard. It discusses the key principles such as customer focus, leadership, process approach, and continual improvement. The main clauses of ISO 9001:2015 are summarized, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Planning addresses risk management, quality objectives, and managing changes. Support covers resources, competence, awareness, communication, and documented information. The document emphasizes that ISO 9001 employs the PDCA cycle and risk-based thinking for continual improvement of processes and meeting customer requirements.
This document discusses the changes between ISO 9001:2008 and ISO 9001:2015 quality management system standards. Some key changes include reorganizing clauses into a 10 clause structure for better alignment, adding requirements for determining organizational context and risks/opportunities, expanding the process approach, and changing terminology like replacing "preventative actions" with "risks and opportunities". Each clause is also analyzed in detail highlighting revisions and additional requirements in the 2015 version.
ISO 90012008 Understanding and Internal Auditing.pptFirozKhan158275
This document provides an overview of quality management systems and ISO 9001 certification. It discusses what ISO and ISO 9001 are, how ISO 9001 can help businesses, common misunderstandings about the standard, and the requirements and processes involved in achieving certification. The roles and responsibilities of different parties in the certification process are also outlined.
IATF 16949:2016 is an automotive quality management system standard that is based on ISO 9001:2015 with additional automotive industry requirements. It aims to prevent defects, reduce variation and waste, and promote continual improvement. The standard contains 10 clauses covering quality management principles, leadership involvement, risk-based planning, resource management, production control, performance evaluation, and continual improvement. Key aspects include supplier management, design and development processes, internal auditing, management reviews, and corrective and preventive action.
The document discusses quality management systems and ISO 9000 standards. It defines key terms like quality, quality management system, and describes the eight quality management principles. It explains the requirements of a quality management system including documentation requirements and the responsibilities of management.
Changes ISO 9001-2008 to ISO 9001-2015.pdfRealDairy2
The document provides an overview of the notable changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include adopting a common 10-clause structure across all ISO management system standards, placing more emphasis on leadership involvement and risk-based thinking, and introducing requirements for determining organizational context and interested party needs. The new version aims to make the standard more compatible with services and non-manufacturing users, strengthen the process approach, and increase flexibility for documented information.
This document provides a checklist for organizations transitioning from ISO 9001:2008 to ISO 13485:2016 and ISO 9001:2015. It contains tables to validate that an organization's integrated quality management system addresses new concepts in both standards. The tables list clauses from each standard and require evidence that requirements have been met without exceptions. It concludes that a recommendation for certification is dependent on submitting a corrective action plan to address any findings from the audit, or that a special on-site visit may be required if registration cannot be immediately recommended.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
1. The International Organization for Standardization (ISO) is responsible for creating quality standards, with over 800 new standards issued annually. ISO 9000 is the quality management system standard series.
2. ISO 9001:2008 provides requirements for a quality management system, including demonstrating the ability to consistently provide products that meet customer and regulatory requirements through effective processes and continual improvement.
3. A quality management system involves all organizational functions to direct and control an organization with respect to quality through activities like quality planning, assurance, and improvement. It defines the organization's quality environment.
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How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
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1. Define Research Objectives and Scope
Clear Objectives: Define specific goals such as understanding market needs, identifying new opportunities, assessing risks, or refining pricing strategies.
Scope Definition: Clearly outline the boundaries of the research in terms of geographical focus, target demographics (e.g., age, socio-economic status), and industry sectors (e.g., healthcare IT).
3. Review Existing Literature and Resources
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Tools and Resources: Select tools like Google Forms for surveys, analytics platforms (e.g., SimilarWeb, Statista), and expert consultations.
5. Ethical Considerations and Compliance
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6. Budget and Resource Allocation
Resource Planning: Allocate resources including time, budget, and personnel required for each phase of the research.
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Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
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Example of Market Research working
Innovaccer, founded by Abhinav Shashank in 2014, focuses on improving healthcare delivery through data-driven insights and interoperability solutions. Before launching their platform, Innovaccer conducted extensive market research to understand the challenges faced by healthcare organizations and the potential for innovation in healthcare IT.
Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
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Customer Validation: Conducted pilot programs with several healthcare organizations to validate the platform's effectiveness in improving care outcomes and operational efficiency. Gathered feedback to refine features and user interface.
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ISO 9001 2015 Management Review Presentation
1. Terms and Concepts
• Context of the organization
– Combination of internal and external factors
and conditions that can have an effect on an
organization's approach to its products,
services and investments and interested
parties.
August 19, 2014 Quality Support Group, Inc. 1
2. Annex SL
• High-level structure developed
by the Joint Technical
Coordination Group (JTCG),
• All ISO technical committees
who develop management
system standards in future will
use this as their blueprint.
• Designed to align format, text,
terms and definitions
• It still gives standards
developers flexibility to
integrate their technical topics
and requirements.
Clause 1 Scope
Clause 2 Normative
References
Clause 3 Terms and
Definitions
Clause 4 Context of the
Organization
Clause 5 Leadership
Clause 6 Planning
Clause 7 Support
Clause 8 Operation
Clause 9 Performance
Evaluation
Clause 10 Improvement
August 19, 2014 Quality Support Group, Inc. 2
3. Model of a process-based quality management
system, showing the links to the clauses of the
International Standard (DIS)
August 19, 2014 Quality Support Group, Inc. 3
4. ISO 9001:2015 Structure
4 Context of
the
organization
5 Leadership 10 Improvement
6 Planning for the
quality management
system
7 Support 8 Operations 9 Performance
and evaluation
Understanding
of the
organization
and its context
Understanding
the needs and
expectations
Of interested
parties
Scope of
management
systems
QMS
Leadership
and
commitment
Quality policy
Organizational
roles,
responsibilities
and
authorities
Action to
address risk
and opportunity
Quality
objectives
Planning of
changes
Resources
Competence
Awareness
Communication
Documented
Information
Release of
products and
services
Operations
planning
and control
Determination
of requirements
for products
and services
Design and
development of
products and
services
Control of
externally
provided
products and
services
Production and
service
provisions
Control of non-
conforming
process
outputs,
products and
services
Monitoring,
measurement.
analysis and
evaluation
Internal audit
Management
review
Nonconformity
and corrective
action
Continual
Improvement
Plan
Do
Check Act
General
August 19, 2014 Quality Support Group, Inc. 4
5. 4. Context of the Organization
4.1 Understanding the organization and its
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the QMS
4.4 Quality management system
4.4.1 General
4.4.2 Process Approach
August 19, 2014 Quality Support Group, Inc. 5
6. 5. Leadership
5.1 Leadership and commitment
5.1.1 Leadership & commitment with
respect to QMS
5.1.2 Leadership & commitment with
respect to customers
5.2 Policy
5.3 Organizational roles, responsibilities and
authorities
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7. 6. Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
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8. 7. Support
7.1 Resources
7.1.1 General
7.1.2 Infrastructure
7.1.3 Process Environment
7.1.4 Monitoring and measuring devices
7.1.5 Knowledge
7.2 Competence
7.4 Awareness
7.5 Communication
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9. 7. Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
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10. Documentation Structure
• Level 1: Policies
– Quality Policy
• Level 2: Procedures
– Defines who will do what and
when
• Level 3: Work Instructions
– Defines how the work will be
completed
• Level 4: Records
– Shows evidence of
compliance to the standard or
customer requirements
Level 1
Level 2
Level 3
Level 4
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11. General – Documented
Information
The organization’s quality management
system shall include
a) documented information required by
this International Standard;
b) documented information determined by
the organization as being necessary
for the effectiveness of the quality
management system.
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12. General – Documented
Information (Cont.)
The extent of the quality management
system documented information can differ
from one organization to another due to:
• The size of the organization and type of
activities
• The complexity of processes and their
interaction
• The competence of personnel
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15. 8.Operation
8.1 Operational planning and control
8.2 Determination of market needs and
interactions with customers
8.2.1 Customer communicaton
8.2.2 Determination of requirements related to
products and services
8.2.3 Review of requirements related to
products and services
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16. 8.Operation
8.3 Design and development of products
and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
August 19, 2014 Quality Support Group, Inc. 16
17. 8.Operation
8.4 Control of externally provides products
and services
8.4.1 General
8.4.2 Type and extent of control of external
provisions
8.4.3 Information for external providers
August 19, 2014 Quality Support Group, Inc. 17
18. 8.Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or
external providers
8.5.4 Preservation
8.5.5 Post delivery activities
8.5.6 Control of changes
August 19, 2014 Quality Support Group, Inc. 18
19. 8.Operation
8.6 Release of products and services
8.7 Control of nonconforming process
outputs, products and services
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20. 9. Performance Evaluation
9.1 Monitoring, measurement, analysis, and
evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
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21. 10 Improvement
10.1 General
10.2 Non conformity and corrective action
10.3 Continual Improvement
August 19, 2014 Quality Support Group, Inc. 21
24. Quality Policy
Top management shall establish, review and maintain a
quality policy that
a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality
management system.
The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
August 19, 2014 Quality Support Group, Inc. 24
25. Quality Objectives
The organization shall establish quality objectives at relevant functions,
levels and processes.
The quality objectives shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and the
enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
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