3. 3. International standard ISO 9001 quality management system
And what is the quality management system for ISO 13485 medical device manufacturing?
The ISO 9001 quality management system acquired by SMP GmbH of Germany is aimed at the most popular quality management system in international standards, and the quality of products and services is consistently provided and customer satisfaction. It is a requirement and its standard that can lead to improvement of.
○ The quality management system is based on the "7 principles" [i] .
-Customer focus
: Quality management meets and exceeds customer requirements
-leadership
: Each leader at all levels aligns objectives and directions so that people in the organization can participate to achieve quality goals
-Active participation of people
: It is important for an organization that all people have the skills, empowerment, and involvement to provide value, and enhance the ability of the organization to create value.
-Process approach
: To make quality activities function as a consistent system, management can maintain consistent predictions and results of mutually influential processes to maintain efficiency and effectiveness.
-Improvement
: The quality management system aims to improve (turn PDCA), and the organization keeps focusing on improvement with sustainability.
-Decision-making based on objective facts
: Decisions based on objective data, information analysis and assessment increase the likelihood of maximizing results
-Relationship management
: Organizations must manage stakeholders for sustainable success
In this way, the quality management system is based on the principle of building and operating a system in which the quality of products and services is determined by "people" and "people", and asks the importance of management up to decision making. increase.
On the other hand, companies that manufacture medical devices are ISO 9000 series industry standards, and comply with the ISO 13485 quality management system for medical device manufacturing that specializes in manufacturing medical devices, and are certified by a third-party certification body (Notified Body). ), Or QMS by PMDA, etc. in accordance with the ministry ordinance (QMS ministry ordinance) [ii] regarding the standards for manufacturing control and quality control of medical devices and in-vitro diagnostic drugs established by the Ministry of Health, Labor and Welfare. You must comply with the quality management system for medical device manufacturing, such as undergoing a conformity survey (Ministry Ordinance survey) [iii].
ISO 13485 aims to build and sustainably operate a quality management system for medical device manufacturing, as well as regulatory requirements for medical device manufacturing.
We, SMP GmbH and SMP Laboratories Japan Co., Ltd., are not so-called Notified Body. As an Independent Testing Laboratory for medical device certification, we provide testing and protocol creation support, but we do not provide testing or support just for "certification acquisition only".
From the standpoint of the end user of medical equipment and devices, tests based on any "risk assessment" are conducted on patients and their families who are used for treatment and surgery using those devices, as well as in society. Always face the Philosophy and Management Principles of the organization and the individuals engaged in it, such as whether the examination was conducted on an objective basis as an independent testing laboratory. We are working on it.
The configuration and requirements of the ISO 9001 quality management system are as follows ⅶ.
-preface
1 Scope of application
2 Cited standard
3 Terms and definitions
4 Organizational status 1)
4.1 Understanding the organization and its situation
4.2 Understanding the needs and expectations of stakeholders
4.3 Determining the scope of application of the quality management system
4.4 Quality management system and its process
5 Leadership 2)
5.1 Leadership and Commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Formulation of quality policy
5.2.2 Communication of quality policy
5.3 Organizational Roles, Responsibilities and Authority
6 plans
6.1 Risk and Opportunity Initiatives
6.2 Formulation of quality goals and plans to achieve them
6.3 Change plan
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Process operation environment
7.1.5 Resources for monitoring and measurement
7.1.6 Organizational knowledge
7.2 Competence
7.3 Recognition
7.4 Communication 3)
7.5 Documented information 4)
7.5.1 General
7.5.2 Create and update
7.5.3 Management of documented information
8 operation
8.1 Operational planning and management
8.2 Product and service requirements
8.2.1 Communication with customers 5)
8.2.2 Clarification of requirements related to products and services
8.2.3 Review of requirements related to products and services
8.2.4 Changes to product and service requirements
8.3 Product and service design and development
8.3.1 General
8.3.2 Design and development planning
8.3.3 Input to design and development
8.3.4 Design and development management
8.3.5 Output from design and development
8.3.6 Design / development changes
8.4 Management of externally provided processes, products and services 6)
8.4.1 General
8.4.2 Management method and degree
8.4.3 Information for external providers
8.5 Manufacturing and service provision
8.5.1 Management of manufacturing and service provision 7)
8.5.2 Identification and traceability
8.5.3 Property of Customer or External Provider
8.5.4 Save
8.5.5 Activities after delivery
8.5.6 Change management
8.6 Product and service releases
8.7 Management of non-conforming output
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
9.3.1 General
9.3.2 Input to management review
9.3.3 Output from management review
10 improvements
10.1 General
10.2 Nonconformity and corrective action
10.3 Continuous improvement
Annex A (Reference) Clarification of new structures, terms and concepts
Annex B (Reference) Other standards for quality management and quality management systems created by ISO / TC 176
The order of the actual regulations also touches on the definition of terms from the preface and the outline of the quality management system, and as the text to realize it, in Chapter 4 Organizational Situation 1) , the current status to build the quality management system It requires an understanding of the organizational situation, the needs and expectations of stakeholders, and the associated internal and external issues to be organized and documented.
It also describes the process approach within the organization that builds a quality management system and maintains it for improvement. The process approach means planning (Plan) → execution (Do) → evaluation (Check) → improvement (Act), and efficient and effective operation and keeping of its records are required. PDCA is generally widely known as a method for continuous improvement of quality management. We will follow the four stages of P → D → C → A in sequence, and once we make a round, we will connect to the next cycle and draw a spiral to improve sustainable quality control seamlessly.
It is clarified in Chapter 5 Leadership 2) who is responsible for implementing quality management using the PDCA cycle. First, businesses and managers are accountable for the effectiveness of quality management systems and the goals and directions of the organization. In order to ensure the construction and operation of a quality management system led by business operators and managers, it is necessary to appoint leaders (managers) and prepare an environment for them to demonstrate leadership and support them. ..
It is the responsibility and responsibility of leaders appointed to comply with relevant laws and regulations and to provide products and services that meet customer demands or provide satisfaction that exceeds customer expectations. Permission is granted. Businesses and business owners must continue to support for that.
There are requirements for communication 3) in Chapter 7, Section 4 of Support. Supports the 2008 version of internal communication. Section 5 states documented information4) , but it does not necessarily require the creation of a manual, but it is a document for what is considered to be a document necessary for quality management within the organization.
The appointed leader prepares the documents that the quality management system considers necessary to meet the customer's demands in its responsibility and authority, goes through the cycle of improvement represented by PDCA, and records the results.
In addition, we will report the situation to top management such as businesses and managers, and make decisions while comparing it with the goals and directions of the organization. Leaders are also required to share the information needed for quality management systems with teams and group members.
Chapter 8 Operation Section 1 The first item of product and service requirements describes communication with customers5). This is external communication. Following the second, third, and fourth steps, communication is indispensable to meet customer requirements, and in order to do so, the requirements must be clarified, and the requirements are brought back to the organization and expected. You have to add or scrutinize.
Section 4 Management of processes, products and services provided from outside 6) Similarly, communicate with outsourcers such as outsourcers and suppliers of raw materials in order to meet the requirements of the quality management system. It is required to have to.
In addition, there is a description in Section 5 Manufacturing and Service Provision 1st Manufacturing and Service Provision Management 7) that g) Take measures to prevent human error.
In this way, in building a quality management system, not only improving specialized skills (Technical Skills), but also building a mechanism for non-technical skills (Non-Technical Skills) and improving it. There are many things that need to be done.
"To Err is Human" is a slogan for building medical safety in the medical field.
"People" make mistakes. People make mistakes unintentionally. However, even if the person who made the mistake is urged to reflect and bear the crime, the lessons learned from the mistake will not be utilized and the quality of medical care will not be improved. This includes not only mistakes in actions, but also communication failures, situational awareness and decision-making mistakes, and team collaboration.
In order to improve the quality of medical products and general consumer goods and services, we will build a system to manage and support "people" and improve it in customers, society, and medical care. If so, it can be said that it is possible to provide products and services that exceed the demands and expectations of patients and their families.
Rather than aiming to acquire ISO, which is an international standard, by building a mechanism to introduce and improve the quality management system required within the organization, people, technology and organization will grow and high quality. Will continue to provide.
[i] International Organization for Standardization; Quality management principles. ISO. 2015, p1.
[ii] December 17, 2004 Ministry of Health, Labor and Welfare Ordinance No. 169; Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In Vitro Diagnostic Drugs, https://www.mhlw.go.jp/web/t_doc ? dataId = 81aa6618 & dataType = 0 & pageNo = 1
[iii] “QMS Conformity Survey Business”. Pharmaceuticals and Medical Devices Agency. Https://www.pmda.go.jp/review-services/gmp-qms-gctp/qms/0003.html