TOP Management – Practices for supporting and improving quality management systems for manufacturers of medical devices (ISO 13485)

This online course will provide top management of organizations with the necessary knowledge and skills to use the full capabilities of the quality management system for medical device manufacturers that meets the requirements of ISO 13485:2016, which allows them to manage the quality of manufactured medical devices efficiently and effectively.

The course also contains an array of practical instruments that will help your management system work like a charm and continuously improve the management system, processes, products and services, increase competitiveness and customer loyalty.

Duration

42 hours

Language

English/Ukrainian/Russian

Format

100% online

Objectives

• Successfully implement a systematic approach to the enterprise’s business processes

• Apply effective business-planning instruments

• Accurately identify processes, measure their performance, and manage them efficiently

• Effectively allocate responsibilities and authorities

• Correctly formulate the policy and strategy of your business

• Develop risk-based thinking

• Develop objectives at the strategic, tactical, and operational level

• Build a stable team, determine and maintain competence of each employee, build a motivation system at your company

• Carry out regular reviews of your management system

• Get the maximum benefit from the implementation of the “improvement” principle

Target audience

• Successful managers and leaders who wish to achieve maximum results

• Managers of all levels – to develop their own leadership and managerial abilities, as well as to develop their own team and business

• Specialists who plan to take up managerial posts – to gain self-confidence and deep understanding of the specifics of future work

• Quality directors and managers

Document on completion

Top manager qualification certificate, specialization «Best business management practices in accordance with the requirements of the international standard ISO 13485:2016», listed in the SIC international register

 

Evaluation scale

60.0-100.0 

0.0-59.9

Complies

Does not comply

Thematic plan

The course program includes two modules.

The program is designed for 42 hours, including time for studying theoretical material and taking tests.

After completion of each module, the listener is being tested.

Objectives

Module 1 The practice of implementing, maintaining and improving the quality management system for medical device manufacturers in accordance with the requirements of ISO 13485:2016

Number of hours

1.1

1.2

Introduction

Scope

1

0.5

1.3

Terms and definitions

1,5

1.4

Quality management system

1,5

1.5

Management commitment

2

1.6

Resource management

2.5

1.7

Product realization

6

1.8

Measurement, analysis and improvement

3

 

Testing

1

Module 2 Tools and approaches for the development and continuous improvement of the business management system

Number of hours

1.1 Understanding the organization and its context. Auxiliary tools 3
1.2 Understanding the needs and expectations of stakeholders 1
1.3 FSMS scope and processes 0,5
1.4 Leadership in business 2
1.5 Policy and strategy 1
1.6 Functions, responsibilities, and authorities 1
1.7 Actions to treat risks and implement opportunities 2
1.8 FSMS objectives 1
1.9 Planning changes 1
1.10 Resources. Efficient use 1,5
1.11 Documentation 1
1.12 Operational planning and control over current activities 1
1.13 Internal audits 1
1.14 Management systems analysis 2
1.15 Nonconformities and corrective actions 1
1.16 Improvement 2
  Testing 1
Detailed content of the program Module 1 The practice of implementing, maintaining and improving the quality management system for medical device manufacturers in accordance with the requirements of ISO 13485:2016

1.1

Introduction:

–       General provisions:

–       Concept

–       Process approach

–       Relationship with ISO 9001

1.2

–       Scope

1.3

–       Terms and definitions

1.4

Quality management system:

–       General provisions

–       Documentation requirements:

–       A) Control of documents

–       B) Control of records

1.5

 

Management responsibility:

–       Management commitment

–       Customer focus

–       Quality policy

–       Planning. Quality objectives

–       Responsibility and authority

–       Management review

1.6

Resource management:

–       Provision of resources

–       Human resources

–       Infrastructure

–       Work environment

–       Contamination control

1.7

Product realization:

–       Planning of product realization

–       Customer-related processes

–       Determining and reviewing product requirements

–       Design and development

–       Purchasing

–       Production and service provision

–       Control of monitoring and measuring equipment

1.8

Measurement, analysis and improvement:

–       Monitoring and measurement

–       Internal audit

–       Monitoring and measurement of processes and products

–       Control of nonconforming product

–       Analysis of data

–       Improvement

–       Corrective and preventive action

Detailed content of the program Module 2 Tools and approaches for the development and continuous improvement of a business management system
1.1

Understanding the organization and its context. Auxiliary tools:

–       SWOT-analysis:  strengths, weaknesses, opportunities, threats

–       SWOT-matrix

–       PEST-analysis:

–       The PEST-analysis main stages

1.2

Understanding the needs and expectations of stakeholders:

–       Interested parties: types, categories, processing of needs and expectations

1.3

FSMS scope and processes:

–       Defining the scope

–       Process identification

–       Responsibilities and authorities

–       Actions for effectiveness and efficiency

1.4

Leadership in business:

–       Leadership in management systems

–       Leader and his qualities

1.5

 

Policy and strategy:

–       The role of FSMS Policy

–       Strategy formulation model

1.6

Functions, responsibilities, and authorities:

–       Distribution of roles, process-based approach

–       Responsibility matrix

1.7

Actions to treat risks and implement opportunities:

–       The impact of risks and opportunities on the organization’s activities

–       Management levels

–       Identifying critical points

–       Documentation

1.8

FSMS objectives:

–       Developing objectives at the strategic, tactical, and operational level

–       SMART Technology

1.9 Planning changes
1.10

Resources. Efficient use:

–       Resources needed to effectively manage the organization

–       Knowledge base

–       Competence and continuous development of personnel

–       Ensuring awareness and effective communication

1.11 Documentation and the principles of its development
1.12

Operational planning and control over current activities:

–       Operational control methods

–       Factors

–       Outsourced process

1.13

Internal audits:

–       Purpose and frequency of internal audits

1.14 Management systems analysis: suitability, adequacy, effectiveness
1.15

Nonconformities and corrective actions:

–       Root cause analysis

–       Problem Statement: The «5 Whys» Principle

1.16

Improvement:

–       The «Improvement» principle: advantages of use

–       Setting objectives

–       Education and training of personnel

–       Improvement projects analysis

–       Development and implementation of improvements