ผศ.ดร.มนตชุลี นิตพิ น ภาควิชาเภสัชอุตสาหกรรม คณะเภสัชศาสตร มหาวิทยาลัยมหิดล Monechoulie NITIBHON
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Quality Management System ( ตาม C GMP )
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ISO 9001 ISO 13485 : 2003
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Why is the short name of the International Organization for Standardization "ISO" rather than "IOS"? (1/2)
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Many people will have noticed a seeming lack of correspondence between the official title when used in full, International Organization for Standardization, and the short form, ISO. Shouldn't the acronym be "IOS"? Yes, if it were an acronym – which it is not. In fact, "ISO" is a word, derived from the Greek isos, meaning "equal", which is the root of the prefix "iso-" that occurs in a host of terms, such as "isometric" (of equal measure or dimensions) and "isonomy" (equality of laws, or of people before the 3 law).
Why is the short name of the International Organization for Standardization "ISO" rather than "IOS"? (2/2)
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From "equal" to "standard", the line of thinking that led to the choice of "ISO" as the name of the organization is easy to follow. In addition, the name ISO is used around the world to denote the organization, thus avoiding the plethora of acronyms resulting from the translation of "International Organization for Standardization" into the different national languages of members, e.g. IOS in English, OIN in French (from Organisation internationale de normalisation). Whatever the country, the short form of the Organization's name is always ISO. 4
About ISO ISO : the International Organization for Standardization = IOS (Eng) Organization International de Normalisation = OIN (French) ISO = equal (Greek)
www.iso.org www.tisi.go.th Monechoulie NITIBHON
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ISO ISO ISO ISO ISO ISO ISO
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9000 14000 18000 17025 14644 14698 13485
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Quality management principles Introduction This document introduces the eight quality management principles on which the quality management system standards of the revised ISO 9000 : 2000 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee Quality management and ISO / TC quality assurance, which is responsible for developing and maintaining the ISO 9000 7 standards.
176,
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Quality management principles The eight quality management principles are defined in ISO 9000:2000, Quality management systems - Fundamentals and vocabulary. ISO 9001:2000, Quality management systems - Requirements ISO 9004:2000, Quality management systems - Guidelines for performance improvements.
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Quality management principles This document gives the standardized descriptions of the principles as they appear in ISO 9000:2000 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance. Monechoulie NITIBHON
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Quality management principles Principle 1. Customer focus (1/5)
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Monechoulie NITIBHON
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Quality management principles Principle 1. Customer focus (2/5) Key benefits: Increased revenue and market share obtained through flexible and fast responses to market opportunities. Increased effectiveness in the use of the organization's resources to enhance customer satisfaction. Improved customer loyalty leading to repeat business. Monechoulie NITIBHON
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Quality management principles Principle 1. Customer focus (3/5)
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Applying the principle of customer focus typically leads to: Researching and understanding customer needs and expectations. Ensuring that the objectives of the organization are linked to customer needs and expectations. 12
Quality management principles Principle 1. Customer focus (4/5) Communicating
customer needs and expectations throughout the organization. Measuring customer satisfaction and acting on the results. Monechoulie NITIBHON
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Quality management principles Principle 1. Customer focus (5/5) Systematically managing customer relationships. Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole). Monechoulie NITIBHON
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Quality management principles Principle 2. Leadership (1/5)
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Monechoulie NITIBHON
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Quality management principles Principle 2. Leadership (2/5) Key benefits: People will understand and be motivated towards the organization's goals and objectives. Activities are evaluated, aligned and implemented in a unified way. Miscommunication between levels of an organization will be minimized. Monechoulie NITIBHON
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Quality management principles Principle 2. Leadership (3/5) Applying the principle of leadership typically leads to: Considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole. Establishing a clear vision of the organization's future. Monechoulie NITIBHON
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Quality management principles Principle 2. Leadership (4/5) Setting
challenging goals and targets. Creating and sustaining shared values, fairness and ethical role models at all levels of the organization. Establishing trust and eliminating fear. Monechoulie NITIBHON
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Quality management principles Principle 2. Leadership (5/5)
Providing people with the required resources, training and freedom to act with responsibility and accountability. Inspiring, encouraging and recognizing people's contributions. Monechoulie NITIBHON
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Quality management principles Principle 3. Involvement of people (1/5)
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. Monechoulie NITIBHON
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Quality management principles Principle 3. Involvement of people (2/5) Key benefits: Motivated, committed and involved people within the organization. Innovation and creativity in furthering the organization's objectives. People being accountable for their own performance.
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People eager to participate in and contribute to continual improvement. 21
Quality management principles Principle 3. Involvement of people (3/5) Applying the principle of involvement of people typically leads to: People understanding the importance of their contribution and role in the organization. People identifying constraints to their performance. Monechoulie NITIBHON
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Quality management principles Principle 3. Involvement of people (4/5)
People accepting ownership of problems and their responsibility for solving them.
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People evaluating their performance against their persor objectives. People actively seeking opportunities to enhance their competence, knowledge and experience. 23
Quality management principles Principle 3. Involvement of people (5/5)
People freely sharing knowledge and experience. People openly discussing problems and issues.
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Quality management principles Principle 4. Process approach (1/5)
A desired result is achieved more efficiently when activities and related resources are managed as a process.
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Quality management principles Principle 4 . Process approach (2/5)
Key benefits: Lower costs and shorter cycle times through effective use of resources. Improved, consistent and predictable results. Focused and prioritized improvement opportunities. Monechoulie NITIBHON
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Quality management principles Principle 4 . Process approach (3/5) Applying the principle of process approach typically leads to: Systematically defining the activities necessary to obtain a desired result. Establishing clear responsibility and accountability for managing key activities. Monechoulie NITIBHON
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Quality management principles Principle 4 . Process approach (4/5) Analysing and measuring of the capability of key activities. Identifying the interfaces of key activities within and between the functions of the organization.
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Quality management principles Principle 4 . Process approach (5/5)
Focusing on the factors such as resources, methods, and materials that will improve key activities of the organization. Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties. Monechoulie NITIBHON
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Quality management principles Principle 5. System approach to management (1/5)
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. Monechoulie NITIBHON
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Quality management principles Principle 5. System approach to management (2/5) Key benefits: Integration and alignment of the processes that will best achieve the desired results. Ability to focus effort on the key processes. Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization. Monechoulie NITIBHON
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Quality management principles Principle 5. System approach to management (3/5) Applying the principle of system approach to management typically leads to: Structuring a system to achieve the organization's objectives in the most effective and efficient way. interdependencies Understanding the between the processes of the system. Structured approaches that harmonize and integrate processes. Monechoulie NITIBHON
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Quality management principles Principle 5. System approach to management (4/5) Providing a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers. Understanding organizational capabilities and establishing resource constraints prior to action. Monechoulie NITIBHON
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Quality management principles Principle 5. System approach to management (5/5)
Targeting and defining how specific activities within a system should operate. Continually improving the system through measurement and evaluation. Monechoulie NITIBHON
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Quality management principles Principle 6. Continual improvement (1/4)
Continual improvement of the organization's overall performance should be a permanent objective of the organization.
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Quality management principles Principle 6. Continual improvement (2/4) Key benefits: Performance advantage through improved organizational capabilities. Alignment of improvement activities at all levels to an organization's strategic intent..
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Flexibility to react quickly to opportunities.
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Quality management principles Principle 6. Continual improvement (3/4) Applying the principle of continual improvement typically leads to: Employing
a consistent organization-wide approach to continual improvement of the organization's performance.
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Providing people with training in the methods and tools of continual improvement. 37
Quality management principles Principle 6. Continual improvement (4/4) Making continual improvement of products, processes and systems an objective for every individual in the organization. Establishing goals to guide, and measures to track, continual improvement.. Recognizing and acknowledging improvements. Monechoulie NITIBHON
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Quality management principles Principle 7. Factual approach to decision making (1/4)
Effective decisions are based on the analysis of data and information.
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Quality management principles Principle 7. Factual approach to decision making (2/4) Key benefits: Informed
decisions.
An
increased ability to demonstrate the effectiveness of past decisions through reference to factual records.
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Increased ability to review, challenge and change opinions and decisions. 40
Quality management principles Principle 7. Factual approach to decision making (3/4) Applying the principle of factual approach to decision making typically leads to: Ensuring
that data and information are sufficiently accurate and reliable.
Making
data accessible to those who need it.
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Quality management principles Principle 7. Factual approach to decision making (4/4) Analysing data and information using valid methods. Making decisions and taking action based on factual analysis, balanced with experience and intuition.
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Quality management principles Principle 8. Mutually beneficial supplier relationships (1/5)
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value .
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Quality management principles Principle 8. Mutually beneficial supplier relationships (2/5) Key benefits: Increased ability to create value for both parties. Flexibility and speed of joint responses to changing market or customer needs and expectations. Optimization of costs and resources.
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Quality management principles Principle 8. Mutually beneficial supplier relationships (3/5) Applying the principles of mutually beneficial supplier relationships typically leads to: Establishing
relationships that balance short-term gains with long-term considerations.
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Pooling of expertise and resources with partners. 45
Quality management principles Principle 8. Mutually beneficial supplier relationships (4/5)
Identifying and selecting key suppliers. Clear and opencommunication. Sharing information and future plans. Monechoulie NITIBHON
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Quality management principles Principle 8. Mutually beneficial supplier relationships (5/5)
Establishing joint development and improvement activities. Inspiring, encouraging and recognizing improvements and achievements by suppliers. Monechoulie NITIBHON
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ISO 9000 Quality Mnagement and quality assurance
การบริหารงานคุณภาพและการประกันคุณภาพ ¾
ISO 9000 – 1994
แบงออกเปน 5 อนุกรม
¾
ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004
ISO 9000 version 2000 draft ISO 9000 : 2008
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ISO 9000 : 1994
ซึ่งแบงออกเปน 5 อนุกรม คือ ¾
ISO 9000 – 1987
การบริหารงานคุณภาพและการประกันคุณภาพ : แนว ทางการเลือกและการใช Standard for quality management and quality assurance : guidelines for selection and use Monechoulie NITIBHON
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ISO 9001 : 1994 ¾
ระบบคุณภาพ : แบบการประกันคุณภาพ ในการออกแบบ การพัฒนา การผลิต การติดตัง้ และการบริการ Quality systems : model for quality assurance in design, development, production, installation and servicing.
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ISO 9002 : 1994 ¾
ระบบคุณภาพ : แบบการประกันคุณภาพ ในการผลิต การติดตั้งและการบริการ Quality systems : model for quality assurance in production, installation and servicing. Monechoulie NITIBHON
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ISO 9003 : 1994 ¾
ระบบคุณภาพ : แบบการประกันคุณภาพ ในการตรวจสอบและการทดสอบขั้นสุดทาย Quality systems : model for quality assurance in final inspection and test
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ISO 9004 : 1994 – Quality
management and quality system element (1/2)
ซึ่งแบงออกเปน 8 part 1. Guideline 2. Guidelines for services 3. Guidelines for processed materials 4. Guidelines for quality improvements
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ISO 9004 : 1994 - Quality management and quality system element (2/2) 5. Guidelines for quality plans. 6. Guidelines for quality assurance for project management. 7. Guidelines for configuration management 8. Guidelines on quality principles and their application to management practices
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ISO 14000 Environmental management systems
มาตรฐานการจัดการสิ่งแวดลอม
มาตรฐานระบบการบริหาร มาตรฐานการตรวจประเมินและวัดผล มาตรฐานเกี่ยวกับผลิตภัณฑ
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ISO 18000 Occupational health and safety management system
มาตรฐานระบบการจัดการอาชีวอนามัยและ ความปลอดภัย
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ISO 17025 General requirements for the competence of testing and calibration laboratories
ขอกําหนดทัว่ ไปวาดวยความสามารถของ หองปฏิบัติการสอบเทียบและหองปฏิบัติการทดสอบ
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ISO 14644 Cleanroom and associated controlled environments (replace Federal Standard 209 E) ISO 14698 Cleanroom and associated controlled environments – Biocontamiration control (replace Federal Standard 209 E) Monechoulie NITIBHON
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ISO 13485 : 2003E Technical Committee ISO/TC 210
Quality management and corresponding general aspects for medical device first edition ISO 13485 : 1996 ISO 13488 : 1996
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ISO 13485 : 2003 E reviced title quality assurance of product, customer requirements and other elements of quality system management
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ISO 9000 : 1994 (1/2) 1. Management Responsibility 2. Quality System 3. Control Review 4. Design Control 5. Document control 6. Purchasing 7. Customer-Supplied Products 8. Product Identification and Traceability 9. Process Control 10.Inspection and Testing Monechoulie NITIBHON
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ISO 9000 : 1994 (2/2) 11.Inspection,Measusing and Testing Equipment 12.Inspection and Test Status 13.Control of Non-Conforming Products 14.Correction and Preventive Action 15.Handling, Storage, Packing, Preservation and Delivery 16.Quality Records 17.Internal Quality Audits 18.Training 19.Servicing 20.Statistical Techniques Monechoulie NITIBHON
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ISO 9000 : 2000 Quality management systems-Fundamentals and vocabulary 1. Scope 2. References 3. Terminology 4. Quality System 5. Management Responsibility 6. Resource Management 7. Process Management 8. Measurement, Analysis and Improvement Monechoulie NITIBHON
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ISO 9000 : 2000 (1/3) 1.Change in scope ISO 9000 มีเพียง 3 อนุกรม ISO 9000 , ISO 9001 , ISO 9004 และตองกําหนด activity 2. Process model
แตเดิมขอกําหนดมี 20 ขอ จัดระบบใหมเปน process model และรวมกัน เหลือเพียง 8 ขอ
3. Sequence
จัดระบบใหมเรียงเปน process orientation
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ISO 9000 : 2000 (2/3) 4. Continual Improvement 5. Customer Satisfaction 6. Resources
กําหนด resources ที่สําคัญ เชน
information,communication,infrastructures, work environments protection
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ISO 9000 : 2000 (3/3) 7.Terminology ใหงายตอการเขาใจ quality management system แทน quality system , organization แทน supplier supplier แทน subcontractor 8.Compatibilitity with ISO 14001 ใช auditing standard
รวมกันคือ ISO 19011: 2001 9.User-friendly ใหงายตอการเขาใจ งายตอการนําเอาไปใช Monechoulie NITIBHON
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ISO 9001 : 2000 Quality Management systems - Requirements 0. 1. 2. 3. 4. 5. 6. 7. 8.
Introduction Scope Normative reference Terms and definition Quality management system Management responsibility Resource management Product realization Measurement , analysis and improvement
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ISO 9001 : 2000 0 Introduction 0.1 General 0.2 Process approach * continual improvement “Plan-Do-Check-Act” (PDCA) 0.3 Relationship with ISO 9004 0.4 Compatibility with other management system ISO 14001 : 1996 Monechoulie NITIBHON
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ISO 9001 : 2000 1. Scope 1.1
General ÂŞ product : meets customer and applicable regulatory requirements ÂŞ customer satisfaction continual improvement
1.2 Application requirements : generic Monechoulie NITIBHON
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ISO 9001 : 2000 2. Normative reference International standard : most recent edition ISO and IEC (International Electrotechnical Commission) ISO 9000 : 2000
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ISO 9001 : 2000 3. Terms and definitions Change supplier organization subcontractor supplier product ~ service
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customer
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4 Quality management system 4.1 General requirement 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records Monechoulie NITIBHON
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4.1 General requirement The organization shall establish , document , implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard
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4.2 Documentation requirements (1/2) 4.2.1 General Quality management system documentation 他
quality policy , quality objectives
他
quality manual
他
documented procedures required by this International Standard procedure is established, documented, implemented and maintained
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4.2 Documentation requirements (2/2)
to ensure the effective planning, operation, control of its processes 他 records required by this International Standard 他
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4.2.2 Quality manual scope of the quality management system 他 documented procedures established for the quality management system 他 description of the interaction between the process of the quality management system 他
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4.2.3 Control of documents (1/2) approve documents for adequacy prior to issue ¾ review and update and reap prove ¾ identified current revision status ¾ documents are available at points of use ¾ documents remain legible and readily identifiable ¾
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4.2.3 Control of documents (2/2) documents of external origin are identified and their distribution controlled 他 to prevent the unintended use of obsolete documents , and to apply suitable identification to them if they are retained for any purpose 他
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4.2.4 Control of records (1/2) Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.
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4.2.4 Control of records (2/2) Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the control weeded for the identification, storage, protection, retrieval, retention time and disposition of records Monechoulie NITIBHON
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5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility , authority and communication 5.6 Management review Monechoulie NITIBHON
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5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness Monechoulie NITIBHON
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5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction Monechoulie NITIBHON
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5.3 Quality policy (1/2) Top management shall ensure that the quality policy ™ appropriate to the purpose of the organization ™ include a commitment to comply with requirement and continually improve the effectiveness of the quality management system Monechoulie NITIBHON
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5.3 Quality policy (2/2)
provides a framework for establishing and reviewing quality objectives Communicated and understood within the organization reviewed for continuing suitability
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5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning
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5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative
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5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization Monechoulie NITIBHON
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5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority.
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5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
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5.6.1 General Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Monechoulie NITIBHON
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5.6.2 Review input (1/2) The input to management review shall include information Ö results of audits Ö process performance and product conformity Ö status of preventive and corrective action
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5.6.2 Review input (2/2) Ö follow up actions from previous
management reviews Ö changes that could affect the
quality management system Ö recommendations for improvement
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5.6.3 Review output The out put from management review shall include and decisions and action related to
— improvement of the effectiveness of the quality management system and its processes
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5.6.3 Review output — improvement of product related to customer requirements — resource needs
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6. Resource management 6.1 6.2 6.3 6.4
Provision of resources Human resources Infrastructure Work environment
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6.1 Provision of resources The organization shall determine and provide the resources needed F
F
to implement and maintain the quality management system and continually improve its effectiveness to enhance customer satisfaction by meeting customer requirements
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6.2 Human resources 6.2.1 Assignment of personnel competent, education, training, skills, experience 6.2.2 Competence, training, qualification and awareness
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6.3 Infrastructure M building, workspace and
associated utilities M process equipment (hardware & software) M supporting services (transport & communication) Monechoulie NITIBHON
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6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements Monechoulie NITIBHON
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7 Product realization 7.1 Planning of product realization 7.2 Customer – related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices Monechoulie NITIBHON
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7.1 Planning of product realization quality objectives and requirements for establish processes, documents, and provide resources specific to the product
verification, validation, monitoring , inspection, test activities specific to the product and the criteria for product acceptance
records Monechoulie NITIBHON
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7.2 Customer – related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication Monechoulie NITIBHON
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7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation Monechoulie NITIBHON
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7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product
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7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of property Monechoulie NITIBHON
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7.6 Control of monitoring and measuring devices
6 calibrate at specified intervals, or prior to use
6 adjusted or re-adjusted 6 identified to enable the calibration status to be determined
6 Safe guarded from adjustments 6 protect from damage and deterioration during handling, maintenance and storage Monechoulie NITIBHON
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8 Measurement , analysis and improvement 8.1 8.2 8.3 8.4 8.5
General Monitoring and measurement Control of nonconforming product Analysis of data Improvement
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8 Measurement, analysis and improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
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8.2 Monitoring and measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product Monechoulie NITIBHON
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8.3 Control of nonconforming product taking action to eliminate the detected nonconformity  authorizing its use , release or acceptance  preclude its original intended use or application when nonconforming product is corrected @ re -verification Â
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8.4 Analysis of data determine , collect and analyse data @ suitability , effectiveness of the quality management system evaluate @ continual improvement
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The analysis of data shall provide information relating to Â
customer satisfaction
Â
conformity to product requirements
Â
Â
characteristics and trends of processes and product including opportunities for preventive action suppliers
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8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action
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8.5 Improvement 8.5.1 Continual improvement The organization shall continually improve the effectiveness of the quality management system : ß quality policy ß quality objectives ß audit results ß analysis of data ß corrective and preventive actions ß management review Monechoulie NITIBHON
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8.5.2 Corrective action Take action to eliminate the cause of nonconformities Documented procedure
reviewing nonconformities (customer complaints) Ă&#x; determining the causes of nonconformities Ă&#x;
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evaluating the need for action to ensure that nonconformities do not recur ß implementing action ß records of the results of action taken ß reviewing corrective action taken ß
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8.5.3 Preventive action Determine action to eliminate the cause of potential nonconformities Documented procedure
determining potential nonconformities and their causes Ă&#x; evaluating the need for action to prevent occurrence of nonconformities Ă&#x;
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ß determining and
implementing action needed ß records of the results of action taken ß reviewing preventive action taken
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ISO 13485 : 2003 E Medical devices – Quality management system – Requirements for regulatory purposes Contents 0 Introduction 1 Scope 2 Normative references 3 Terms and definitions Monechoulie NITIBHON
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4 5 6 7 8
Quality management system Management responsibility Resource management Product realization Measurement , analysis and improvement
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0 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with other standards 0.4 Compatibility with other management systems
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ISO 13485 : 2003 E 1. Scope 1.1 General 1.2 Application 2. Normative references
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3. Terms and definitions 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 Monechoulie NITIBHON
active implantable medical device active medical device advisory notice customer complaint implantable medical device labeling medical device sterile medical device 124
4. Quality management system 4.1 General requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records
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ISO 13485 : 2003 E 5. Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning Monechoulie NITIBHON
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5.5 Responsibility authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication
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5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
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6.Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence , awareness and training 6.3 Infrastructures 6.4 Work environment Monechoulie NITIBHON
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7 Product realization 7.1 Planning of product realization 7.2 Customer – related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication
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7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes Monechoulie NITIBHON
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7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product
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7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.1.1 General requirements 7.5.1. 2 Control of product and service provision – Specific requirements 7.5.1.2.1 Cleanliness of product and contamination control 7.5.1.2.2 Installation activities 7.5.1.2.3 Servicing activities Monechoulie NITIBHON
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7.5.1.3 Particular requirements for sterile medical devices 7.5.2. Validation of processes for production and service provision 7.5.2.1 General requirements 7.5.2.2 Particular requirements for sterile medical devices Monechoulie NITIBHON
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7.5.3 Identification and traceability 7.5.3.1 Identification 7.5.3.2 Traceability 7.5.3.2.1 General 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices 7.5.3.3 Status identification Monechoulie NITIBHON
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7.5.4 Customer property 7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
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8 Measurement , analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Feedback 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes
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8.2.4 Monitoring and measurement of product 8.2.4.1 General requirements 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices Monechoulie NITIBHON
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8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 General 8.5.2 Corrective action 8.5.3 Preventive action
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ISO 9001 : 2000
ISO 13485 : 2003
0 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004
0 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with other standards 0.3.1 Relationship with ISO 9001 : 2000 0.3.2 Relationship with ISO / TR 14969 ( Technical Report intended to provide for the application of ISO 13485 )
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ISO 9001 : 2000 0.4 Compatibility with other management system ISO 14001 : 1996 environmental management occupational health and safety management, financial management, risk management Monechoulie NITIBHON
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1 Scope 1.1 General 1.2 Application 2 Normative reference ISO 9000 : 2000 3 Terms and definitions supplier @ organization @ customer 4 Quality management system
1 Scope 1.1 General 1.2 Application 2 Normative reference ISO 9000 : 2000 3 Terms and definitions supplier @ organization @ customer 4 Quality management system
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ISO 9001 : 2000
ISO 13485 : 2003
4.1 General requirement 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records
4.1 General requirement 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records
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ISO 9001 : 2000 5 Management 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility , authority and communication Monechoulie NITIBHON
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5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
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ISO 13485 : 2003
6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence , awareness and training 6.3 Infrastructure 6.4 Work environment
6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence , awareness and training 6.3 Infrastructure 6.4 Work environment
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ISO 13485 : 2003
7 Product realization 7.1 Planning of product realization 7.2 Customer – related processes 7.2.1 Determination of requirements related to the product
7 Product realization 7.1 Planning of product realization 7.2 Customer – related processes 7.2.1 Determination of requirements related to the product
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ISO 13485 : 2003
7.2.2 Review of requirements related to the product 7.2.3 Customer communication 7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs
7.2.2 Review of requirements related to the product 7.2.3 Customer communication 7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs
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ISO 13485 : 2003
7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes
7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes
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7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product
7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product
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ISO 9001 : 2000
ISO 13485 : 2003
7.5 Production and service provision 7.5.1 Control of production and service provision
7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.1.1 General requirements 7.5.1.2 Control of production and service provision – specific requirements
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ISO 9001 : 2000
ISO 13485 : 2003
7.5.1 Control of production and service provision
7.5.1 Control of production and service provision 7.5.1.2.1 Cleanliness of product and contamination control 7.5.1.2.2 Installation activities 7.5.1.2.3 Servicing activities 7.5.1.3 Particular requirements for sterile medical devices
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ISO 9001 : 2000
ISO 13485 : 2003
7.5.2 Validation of processes for production and service provision
7.5.2 Validation of processes for production and service provision 7.5.2.1 General requirements 7.5.2.2 Particular requirements for sterile medical devices
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ISO 9001 : 2000
ISO 13485 : 2003
7.5.3 Identification and traceability
7.5.3 Identification and traceability 7.5.3.1 Identification 7.5.3.2 Traceability 7.5.3.2.1 General 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices 7.5.3.3 Status identification
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7.5.4 Customer property 7.5.5 Preservation of property 7.6 Control of monitoring and measuring devices
7.5.4 Customer property 7.5.5 Preservation of property 7.6 Control of monitoring and measuring devices
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8 Measurement , analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit
8 Measurement , analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Feedback
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8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product
8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 8.2.4.1 General requirements 8.2.4.2 Particular requirements for active implantable devices and implantable devices
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8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action
8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 General
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กระบวนการจัดทํามาตรฐาน ISO
การพัฒนามาตรฐาน ISO แบงออกเปน 6 ขั้นตอน 1. Proposal stage Participating – member (P-member) 5 ประเทศเห็นชอบ
2. Preparatory stage Technical committee (TC) Sub committee (SC)
จัดทํา working draft (WD) Monechoulie NITIBHON
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3. Committee stage ยกราง committee draft (CD) ทําการเวียนใหประเทศทีเ่ ปน P-member ดู หากยอมรับจะเปน draft International standard (DIS)
4. Enquiry stage เวียน DIS เปนระยะเวลา 5 เดือน และใหลงคะแนน เสียงหาก P-member TC/SC จํานวน 2/3 ยอมรับ จะเปน Final draft International Standard (FDIS) Monechoulie NITIBHON
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5. Approval stage
เวียน FDIS 2 เดือน ลงคะแนนเสียง P-member TC/SC จํานวน 2/3 ยอมรับ จะเปน International Standard 6. Publication stage เผยแพร International Standard ISO
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International Standard ISO
จะทําการ revice ทุก 5 ป ISO 9000 version 2000 In accordance with the recommendation of ISO Guide 72 , this Design Specification is being circulated to the member of ISO/TC 176/SC 2 for ballot , to determine if there is approval for the basis of this work , prior to the start of any drafting work for the amendment ( 30 September 2005 ) Monechoulie NITIBHON
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Design Specification for an amendment of ISO 9001 0. Introduction 1. Use needs and evaluation of impacts and benefits 2. Purpose and scope of the amendment 3. Scope, purpose, title, fields of application of the revised standard and guiding principles 4. Compatibility 5. Consistency Monechoulie NITIBHON
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6. Model and its features 7. Structure of the standard 8. Subjects to be addressed in the text of the amended standard 9. Guidance on drafting 10. Liaisons
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ในป 2004 ISO/TC 176/SC2 ทําการ formal Systematic Review ISO 9001 : 2000 withdrawn, left unchanged, amended or revice คําตอบกลับมาคือ amended Monechoulie NITIBHON
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ISO / Guide 72 : 2001 Guidelines for the justification and development of management system standard, ISO / TC 176 / SC 2 จัดดําเนินการ
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Standard @ generic applicable to all sizes and types of organization operating in any sector purpose of the amendment is to enhance the clarity of ISO 9001 : 2000 and to enhance its compatibility with ISO 14001:2004 Monechoulie NITIBHON
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ISO 9000 version 2008 General- eliminate introduction - review terminology * 4.2 documentation 6.4 work environment 7.3 review, verification, validation
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7.5 product and service provision 7.5.1 ( f ) post delivery activities 7.6 calibration 7.6 monitoring and measuring device Relationship of 8.3 non conforming product and 8.5.2 nonconformities - methods used throughout document Monechoulie NITIBHON
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Clarify whether documents (procedure, quality manual) can be combined Clarify the different styles for identifying required documented procedures (8.5.2 , 4.2.3) (8.5.2 Corrective action , 4.2.3 control of documents)
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1.1 Clarify the scope 1.2 Clarify the intent of this clause 4.1 Clarify the requirement for “control required of outsourced processes” 4.2.3 Clarify the meaning of “review” Clarify “ identification ”, “ identified ”, “ identifiable ” 4.2.4 Clarify the need for record Monechoulie NITIBHON
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5 Consider clarification of application of the process approach to top management activities 5.4.2 Clarification of QMS planning in order to meet the Quality Objectives (5.4.1) 5.5.2 Clarify the requirement for “ appoint a member of management....� 5.6.2 Clarify that inputs to the management review are not limited to the one listed in this clause Monechoulie NITIBHON
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6.2.1
Clarify “ personnel performing work affecting product quality ”
6.2.2 c Clarify “ the effectiveness of the action taken ” 6.4
Clarify work environment in relation to the achievement of conformity to product requirements
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7.
Clarify the relationship of clause 7 to Clause 8
7.2.1
Clarify statutory and regulatory requirements
7.2.1 c Clarify “ requirement related to the product ” 7.2.1 d Clarify “ any additional requirements determined by the organization ” 7.2.3
Clarify “ effective arrangements ”
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7.3
Clarify “ service oriented organizations � Clarify relationship of the requirements for 7.3.4 , 7.3.5 , 7.3.6 ( 7.3.4 design and development review 7.3.5 design and development verification 7.3.6 design and development validation )
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7.4.1 Clarify the requirement for evaluation of supplier and associated records (small business) 7.5.2 Clarify for when this clause should be applied , including relation with special processes 7.5.4 Clarify the difference between protect and safeguard Clarify what is intellectual property Monechoulie NITIBHON
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7.5.5 Preservation of property Clarify application of this requirement for all product types 7.6 Control of monitoring and measuring device Clarify the requirement for “ when used in the monitoring and measurement of specified requirements , the ability of computer software to satisfy the intended application shall be confirmed � Monechoulie NITIBHON
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7.6 a equipment shall be calibrated or verified intervals , or prior to use Clarify the requirement that uses the word “ or �
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8.2.1 Customer satisfaction Clarify the requirement for “ methods shall be determined � 8.2.2 Note revice from ISO 10011 to ISO 19011 ISO 10011 Auditing standard ISO 19011 Environment Management system Auditing Monechoulie NITIBHON
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8.2.3 Monitoring and measurement of processes Clarify 8.2.3 focuses on processes Clarify relationship with 8.2.4 (monitoring and measurement of product) Clarify relationship between QMS processes and product Monechoulie NITIBHON
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8.2.4 Monitoring and measurement of product Clarify “ the release of product ”
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8.3 Control of nonconforming product Clarify relation to service organizations 8.4 Analysis of data review for redundancy and / or links to other clauses for possible conflicts
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8.5 Improvement Clarify relationship between 8.5.1 , 8.5.2 and 8.5.3 (8.5.1 continual improvement , 8.5.2 Corrective action, 8.5.3 Preventive action) 8.5.1 Clarify the requirement for product improvement in relation to continual improvement and clause 5.6.3.6 (improvement of product related to customer requirements)
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8.5.2 f reviewing corrective action taken Clarify review 8.5.3
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In order to maintain and further improve clarity , terminology and presentation style, and to increase user friendliness of the standard
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the original intent of the standard is maintained ¾ the standard is free from cultural bias ¾ the standard is written in a clear style ¾ the standard is written to give a common understanding ¾ sentenses are kept short ¾ consistent use of terminology ¾
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the effect of any proposed change on the other requirements of ISO 9001:2000 is considered before it is implemented 他 requirement are written @ audit 他 standard can be translated 他 compatibility with other management system standards (ISO/CASCO) 他
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Quality management principles The next step: This document provides a general perspective on the quality management principles underlying the ISO 9000:2000 series. It gives an overview of these principles and shows how, collectively, they can form a basis for performance improvement and organizational excellence. Monechoulie NITIBHON
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Quality management principles There are many different ways of applying these quality management principles. The nature of the organization and the specific challenges it faces will determine how to implement them. Many organizations will find it beneficial to set up quality management systems based on these principles. Monechoulie NITIBHON
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Quality management principles The requirements of quality management systems and supporting guidelines are given in the ISO 9000-Selection and use. Further information on the ISO 9000 standards is available.
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Quality management principles ISO publishes the bimonthly ISO Management Systems, which provides updates on these families of standards and news on their implementation around the world.
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ISO 9000 The ISO 9000 family is primarily concerned with "quality management". This means what the organization does to fulfil: - the customer's quality requirements, and - applicable regulatory requirements, while aiming to - enhance customer satisfaction, and - achieve continual improvement of its performance in pursuit of these objectives.
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ISO 9000 “Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives. Monechoulie NITIBHON
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Quality management This means what the organization does to enhance customer satisfaction by meeting customer and applicable regulatory requirements and continually to improve its performance in this regard.
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ISO 9000 / ISO 14000 Evaluating the competence of QMS and EMS auditors Some certification bodies have encountered difficulty in making a smooth transition from the QMS and EMS auditor/audit team qualification approach previously specified respectively in ISO 10011-2 and ISO 14012, to the new competence approach now specified in ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing . Monechoulie NITIBHON
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ISO 10002:2004.Quality management- Customer satisfaction Guidelines for complaints handling in organizations (1/6) Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations ISO 10002:2004 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. Monechoulie NITIBHON
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ISO 10002 : 2004.Quality managementCustomer satisfaction Guidelines for complaints handling in organizations (2/6) ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.
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ISO 10002 : 2004.Quality managementCustomer satisfaction Guidelines for complaints handling in organizations (3/6)
It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses.
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ISO 10002 : 2004 Quality managementCustomer satisfaction Guidelines for complaints handling in organizations (4/6) ISO 10002:2004 addresses the following aspects of complaints handling: enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service; Monechoulie NITIBHON
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ISO 10002 : 2004. Quality management- Customer satisfaction Guidelines for complaints handling in organizations (5/6) -- analysing and evaluating complaints in order to improve the product and customer service quality; -- auditing of the complaints-handling process; -- reviewing the effectiveness and efficiency of the complaints-handling process. Monechoulie NITIBHON
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ISO 10002 : 2004. Quality managementCustomer satisfaction Guidelines for complaints handling in organizations (6/6) top management involvement and commitment through adequate acquisition— --recognizing and addressing the needs and expectations of complainants; -- providing complainants with an open, effective and easy-to-use complaints process;
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ISO 10013 : 2001 Guidelines for quality management system : documentation
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IWA1:2001 Quality management systems -- Guidelines for process improvements in health service organizations
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IWA2:2003 (1/2) „
Quality management systems - Guidelines for the application of ISO 9001:2000 in education
„
International Workshop Agreement IWA 2:2003 provides guidelines for the application of ISO 9001:2000 in educational organizations providing educational products.
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IWA2:2003 (2/2) „
„
These guidelines do not add to, change or modify the requirements of ISO 9001:2000, and are not intended for use in contracts for compliance assessments or for certification. Each clause of ISO 9001:2000 is included before the corresponding text of IWA 2:2003. The whole text of ISO 9004:2000 is also included to provide a complete vision of the continual performance improvement of organizations Monechoulie NITIBHON
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ISO 10005 : 2005. Quality management systems Guidelines for quality plans (1/2) ISO 10005 : 2005 provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001. Monechoulie NITIBHON
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ISO 10005:2005 (2/2) „
„
ISO 10005:2005 is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning. ISO 10005:2005 is a guidance document and is not intended to be used for certification or registration purposes. Monechoulie NITIBHON
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ISO 10006:2003. Quality management systems Guidelines for quality management in projects (1/2) ISO 10006:2003 gives guidance on the application of quality management in projects.It is applicable to projects of varying complexity, small or large, of short or long duration, in different environments, and irrespective of the kind of product or process involved. This can necessitate some tailoring of the guidance to suit a particular project. Monechoulie NITIBHON
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ISO 10006:2003. Quality management systems Guidelines for quality management in projects (2/2) ISO 10006:2003 is not a guide to "project management" itself. Guidance on quality in project management processes is discussed in this International Standard. Guidance on quality in a project's product-related processes, and on the "process approach", is covered in ISO 9004.Since ISO 10006:2003 is a guidance document, it is not intended to be used for certification/registration purposes. Monechoulie NITIBHON
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ISO 10007:2003 .Quality management systems Guidelines for configuration management (1/2)
ISO 10007:2003 gives guidance on the use of configuration management within an organization. It is applicable to the support of products from concept to disposal.
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ISO 10007:2003. Quality management systems Guidelines for configuration management (2/2) It first outlines the responsibilities and authorities before describing the configuration management process that includes configuration management planning, configuration identification, change control, configuration status accounting and configuration audit. Since ISO 10007:2003 is a guidance document, it is not intended to be used for certification/registration purposes. Monechoulie NITIBHON
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ISO 10012:2003. Measurement management systemsRequirements for measurement processes and measuring equipment (1/4) ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements.
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ISO 10012:2003 Measurement management systems -Requirements for measurement processes and measuring equipment (2/4) It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met. Monechoulie NITIBHON
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ISO 10012:2003 Measurement management systems -Requirements for measurement processes and measuring equipment (3/4) ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities.
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ISO 10012:2003 Measurement management systems -Requirements for measurement processes and measuring equipment (4/4) Other standards and guides exist for particular
elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons. ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025. Monechoulie NITIBHON
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ISO/TR 10014:1998 Guidelines for managing the economics of quality No abstract available
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ISO 10015:1999
Quality management -Guidelines for training No abstract available
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ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000 (1/4) provides guidance on the selection of appropriate statistical techniques that may be useful to an organization in developing, implementing, maintaining and improving a quality management system in compliance with ISO 9001. Monechoulie NITIBHON
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ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000 (2/4) This is done by examining those requirements of ISO 9001 that involve the use of quantitative data, and then identifying and describing the statistical techniques that can be useful when applied to such data.
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ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:20009(3/4) The list of statistical techniques cited in ISO/TR 10017:2003 is neither complete nor exhaustive, and does not preclude the use of any other techniques (statistical or otherwise) that are deemed to be beneficial to the organization. Furthermore, ISO/TR 10017:2003 does not attempt to prescribe which statistical technique(s) are to be used; nor does it attempt to advise on how the technique(s) are to be implemented. Monechoulie NITIBHON
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ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000(4/4) ISO/TR 10017:2003 is not intended for contractual, regulatory or certification/registration purposes. It is not intended to be used as a mandatory checklist for compliance with ISO 9001:2000 requirements. The justification for using statistical techniques is that their application would help to improve the effectiveness of the quality management system. Monechoulie NITIBHON
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ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services ISO 10019:2005 provides guidance for the selection of quality management system consultants and the use of their services.
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ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services It is intended to assist organizations when selecting a quality management system consultant. It gives guidance on the process for evaluating the competence of a quality management system consultant and provides confidence that the organization's needs and expectations for the consultant's services will be met. Monechoulie NITIBHON
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ISO 13485:1996. Quality systems -- Medical devices--Particular requirements for the application of ISO 9001 Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of medical devices.
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ISO 13485:2003.Medical devices --Quality management systems- Requirements for regulatory purposes (1/8 ) ISO 13485:2003 specifies requirements for a
quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services Monechoulie NITIBHON
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (2/8) The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Monechoulie NITIBHON
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (3/8) Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 Monechoulie NITIBHON
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (4/8) All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (5/8) If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (6/8) These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (7/8) If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. Monechoulie NITIBHON
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ISO 13485:2003.Medical devices -- Quality management systems -- Requirements for regulatory purposes (8/8) The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
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ISO 13488 : 1996.Quality systems -Medical devices -- Particular requirements for the application of ISO 9002 Specifies, in conjunction with the application of ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.
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ISO/TR 14969:2004 Medical devices -- Quality mangement systems -Guidance on the application of ISO 13485 : 2003 (1/2) ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. Monechoulie NITIBHON
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ISO/TR 14969:2004 Medical devices -- Quality mangement systems -Guidance on the application of ISO 13485 : 2003(2/2)
This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
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ISO 19011:2002. Guidelines for quality and/or environmental management systems auditing (1/2) ISO 19011:2002 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors. Monechoulie NITIBHON
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ISO 19011:2002 . Guidelines for quality and/or environmental management systems auditing (2/2) It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme.The application of ISO 19011 to other types of audits is possible in principle provided that special consideration is paid to identifying the competence needed by the audit team members in such cases. Monechoulie NITIBHON
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ISO/IEC 90003:2004. Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software (1/5) ISO/IEC 90003:2004 provides guidance for organizations in the application of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of computer software and related support services. ISO/IEC 90003:2004 does not add to or otherwise change the requirements of ISO 9001:2000. Monechoulie NITIBHON
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ISO/IEC 90003:2004 Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software (2/5) The guidelines provided in ISO/IEC 90003:2004 are not intended to be used as assessment criteria in quality management system registration/certification. The application of ISO/IEC 90003:2004 is appropriate to software that is Monechoulie NITIBHON
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ISO/IEC 90003:2004 Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software (3/5)
part of a commercial contract with another organization, a product available for a market sector, used to support the processes of an organization, embedded in a hardware product, or related to software services.
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ISO/IEC 90003:2004 Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software (4/5) Some organizations may be involved in all the above activities; others may specialize in one area. Whatever the situation, the organization's quality management system should cover all aspects (software related and non-software related) of the business. Monechoulie NITIBHON
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ISO/IEC 90003:2004 Software engineering -- Guidelines for the application of ISO 9001 : 2000 to computer software (5/5) ISO/IEC 90003:2004 identifies the issues which should be addressed and is independent of the technology, life cycle models, development processes, sequence of activities and organizational structure used by an organization.
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ISO/IEC 90003:2004 Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software (5/5) Additional guidance and frequent references to the ISO/IEC JTC 1/SC 7 software engineering standards are provided to assist in the application of ISO 9001:2000: in particular ISO/IEC 12207, ISO/IEC TR 9126, ISO/IEC 14598, ISO/IEC 15939 and ISO/IEC TR 15504. Monechoulie NITIBHON
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ISO 14971:2000 Medical devices -- Application of risk management to medical devices No abstract available
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ISO 14971:2000/Amd 1:2003 Rationale for requirements No abstract available
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ISO 15223:2000 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied No abstract available Monechoulie NITIBHON
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ISO 15223:2000/Amd 1:2002
No abstract available
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ISO 15223:2000/Amd 2:2004 No abstract available
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ISO 15225:2000 Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange No abstract available Monechoulie NITIBHON
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ISO 15225:2000/Amd 1:2004
No abstract available
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ISO/TR 16142:1999 Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
No abstract available Monechoulie NITIBHON
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ISO/TS 20225:2001 Global medical device nomenclature for the purpose of regulatory data exchange No abstract available Monechoulie NITIBHON
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ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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ISO14001:2004 Environmental management systems - Requirements with guidance for use ISO 14004:2004 Environmental management systems -- General guidelines on principles, systems and support Monechoulie NITIBHON
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BS 8800:2004. Occupational health and safety management systems. Guide
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ISO/FDIS 14004 : 2004 Environmental management systems - General guidelines on principles, systems and supporting techniques
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ISO/FDIS 14001:2004 ISO/FDIS 14001:2004 Environmental management systems -- Requirements with guidance for use. ISO/FDIS 14004:2004 Environmental management systems General guidelines on principles, systems and supporting techniques Monechoulie NITIBHON
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FDA is planning to develop a quality management system for the regulatory processes associated with product quality regulation. The scope of this effort is still under consideration. Monechoulie NITIBHON
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Further Steps The steering committee expects to finish an overall plan for the initiative within the next four months. Work groups will continue to develop their projects.
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Topics that require further work by the steering committee include the definition of "quality" for pharmaceutical products, risk assessment, the role of the CMC review function, and the current regulatory structure for quality management systems. Monechoulie NITIBHON
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As was stated in the August announcement, the existing regulations appear to provide the flexibility to accommodate this initiative, but, FDA will consider various options for enhancing the use of quality systems approaches in FDA regulation of drug quality. Monechoulie NITIBHON
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Criteria for evaluating the success of each working group, and for the initiative as a whole, are being developed.
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The Future Pharmaceuticals will have an increasingly prominent role in the health care of the future. The health of our citizens depends on the availability of safe, effective and affordable medicines.
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The Future In the future, pharmaceutical manufacturing will need to employ innovation, cutting edge scientific and engineering knowledge, and the best principles of quality management to respond to the challenges of new discoveries and ways of doing business such as individualized therapies or genetically tailored treatments. Monechoulie NITIBHON
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Regulation of the future will also need to meet these challenges, by incorporating new scientific information into regulatory standards and policies. Both industry and regulatory practices will need to be informed by the best techniques of risk assessment and management. "Pharmaceutical cGMPs for the 21st Century" is intended to jump-start progress into this future.
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Pharmaceutical manufacturing is evolving from an art form to one that is now science and engineering based. Effectively using this knowledge in regulatory decisions in establishing specifications and evaluating manufacturing processes can substantially improve the efficiency of both manufacturing and regulatory processes.
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This initiative is designed to do just that through an integrated systems approach to product quality regulation founded on sound science and engineering principles for assessing and mitigating risks of poor product and process quality in the context of the intended use of pharmaceutical products. In this regard, the desired future state of pharmaceutical manufacturing may be characterized as: Monechoulie NITIBHON
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Product quality and performance achieved and assured by design of effective and efficient manufacturing processes
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Product specifications based on mechanistic understanding of how formulation and process factors impact product performance
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Continuous "real time" assurance of quality
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Risk based regulatory scrutiny that relates to the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and the capability of process control strategies to prevent or mitigate risk of producing a poor quality product
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Regulatory policies and procedures tailored to recognize the level of scientific knowledge supporting product applications, process validation, and process capability
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Comments Comments in the initiative may be submitted to Docket number 03N-0059. However, comments on either of the two draft guidances should be submitted to the respective dockets. Electronic Management Comment Pharmaceutical Current Good Manufacturing Practices for the 21 st Century: A Risk- Based Approach Monechoulie NITIBHON
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THANK YOU FOR YOUR ATTENTION Monechoulie NITIBHON
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