Quality Standards for Medical Devices Industrymedicaldevices.oie.go.th/box/Article/2672/Power...

Quality Standards for Medical Devices Industry

มาตรฐานเบองตนส าหรบการเขาสอตสาหกรรมวสดอปกรณทางการแพทย

By Nonglak Tantikunwatthana

2 ISO 13485 Internal Audit Training Course

Medical device definition

Medical device

Any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

investigation, replacement, modification, or support of the anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information for medical purposes by means of in-vitro examination of specimens derived from the human body,

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Types of Medical Devices

• Active Implantable Medical Devices

such as Pacemakers

• Implantable Medical Devices

such as hip / knee replacements, ocular lenses or teeth

• Active Medical Devices

such as X-ray units, monitors, defibrillators and pumps

• Non-Active Medical Devices

such as syringes, catheters, contact lens and swabs

• In-Vitro Diagnostic Diagnostic Medical Devices

Testing of typically blood, urine, faeces and other body fluids outside the body for any number of potential diseases, but primarily cancers, HIV, Avian flu, diabetes and others, such as pregnancy testing. This includes sampling swabs.

• For all devices, need to identify INTENDED USE

Medical Device Standards

► ISO 9001 Quality Management Systems (QMS)

► ISO 13485 Medical Devices - QMS

► ISO 19011 Guidelines for auditing Management Systems

Quality Management Systems

► IEC 60601 Medical Electrical Equipment

► ISO 80601 Medical Electrical Equipment

► ISO 80001 Risk Management

► IEC 62304 Medical Device Software

Electronics

► ISO 11135 Ethylene Oxide

► ISO 11137 Radiation

► ISO 17665 Moist Heat

► ISO 14160 Liquid Chemicals

► ISO 11138 Biological Indicators

► ISO 11140 Chemical Indicators

► ISO 11737 Estimation of Bio-burden and Microbiological Monitoring

► ISO 10993 Biological evaluation of medical devices

► ISO 10993-7 Ethylene Oxide Residuals

Sterilisation

► ISO 14644-1/2/4 Cleanroom and Associated Controlled Environments

Controlled environments / Cleanrooms

► ISO 11607 Packaging

► ISO 15223 Symbols used on labels

► ISO 17664 Information supplied by the manufacturer with medical devices

Packaging and Labelling

► ISO 14971 Application of Risk Management to Medical Devices

Risk Analysis

Requirements of ISO 13485: 2003 Medical Device – Quality Management System and

Requirements of GMP for Medical Devices

Objectives of ISO 13485

• Facilitate harmonised Medical Device Regulatory Requirements for the QMS

• Includes Particular Requirements for various types of device

• All sizes and types of Medical Device can be covered

• Excludes some requirements of ISO 9001 that are not appropriate as Regulatory Requirements

• Justifications need to be justified in the QM

• Due to the exclusions, companies whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS conforms to all relevant requirements of ISO 9001

ISO 13485

► The EN ISO 13485:2012 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that meet customer requirements and meet the legislative requirements regarding medical devices and related services.

► The primary objective of this International Standard is to maximize the probability that organizations working in medical devices field meet the legal requirements related to quality management at a global level, and thus provide safe and effective medical devices that meet the customer's requirements

Differences between ISO 9001 and ISO 13485

ISO 13485:2003/EN2012

► Quality Manual

► 26 Documented procedures

► 35 Records

(where relevant)

ISO 9001:2008

► Quality Manual

► 6 Documented procedures

► 19 Records

(where relevant)

The main differences between these two standards are:

• ISO 9000:2008 requires the organisation to continually improve in 8.5.1, where as, the continual improvement references throughout ISO 13485:2003 is replaced by ensuring the continued maintenance, suitability and effectiveness of the quality system.

• ISO 9001:2008 refers to customer satisfaction in 8.2.1, where as ISO 13485:2003 refers to meeting customer requirements / perceptions.

• when documented procedures are required this means they are also implemented and maintained in ISO 13485

In ISO 13485, there are a number of particular requirements, which may be relevant:

- Cleanliness

- Sterilization (Records of process used and validated process)

- Installation

- Servicing

- Names of personnel carrying out inspection and testing plus full traceability to the patient for Active Implantable and Implantable Medical Devices

- Advisory Notices & Recall

- Post Market Surveillance

- Risk Management recommended to be carried out to ISO 14971

ISO 13485:2003 CONTENTS

1 SCOPE 1.1 General 1.2 Application

2 NORMATIVE REFERENCES

3 TERMS AND DEFINITIONS

4 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 4.2 Documentation requirements

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

ISO 13485:2003 CONTENTS

6 RESOURCE MANAGEMENT 6.1 Provision of resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment

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

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of data 8.5 Improvement

PROCESS APPROACH

► The standard promotes the adoption of a process-based approach, to

improve the performance of processes and increase customer

satisfaction.

► Activity, which uses resources and that is managed to allow the

transformation of input elements in the output elements can be

considered as a process

Process

Activities +

Resources

Input Output

Controls

Product

PROCESS APPROACH

C U S T O M E R

Management responsibility

Resource management

Measurement, analysis, improvement

Product Product realisation

Quality Management System Improvement

R e q u i r e m e n t s

P e r c e p t i o n s

Output

Risk Management

R E G U L A T O R Y

PROCESS APPROACH

APPLICATION

► Some requirements of ISO 13485 for the realization of the product can

be legally omitted in one of two ways: they can be "excluded" or maybe

"not applicable."

IMPORTANT NOTE that any exclusion or non-applicability must be

described in detail and justified in the organization's quality manual.

► The requirements that can be excluded are relevant parts of section 7

and clause 8.2.4.2

4.1 General Requirements

(Requirements of GMP for Medical Devices; 2)

► "The organization shall establish, document, implement and maintain a

quality management system and maintain its effectiveness in accordance with the requirements of this International Standard“

► The organization can maintain the effectiveness of its QMS through a series of activities such as:

Internal Audits;

Management review;

Corrective and preventive actions;

Independent external evaluations

4.2 Documentation requirements

► 4.2.1. General:

• Include any other documentation specified by national or regional

regulations

• Establish and maintain documentation on each type / model of medical

device including product specifications and quality system requirements

4.2.2 Quality Manual

► The Quality Manual is the identity card of the organization and the key to understanding its management system.

► It must present the company and its activities, and most importantly, describe the processes of the management system and their interactions.

► The MQ is to highlight the structure of the documentation used in the quality management system.

► The Quality Manual shall include:

a) the scope of the quality management system, including details of and

justification for any exclusions and/or non-application;

b) the documented procedures established for the quality management

system, or references to them;

c) a description of the interactions between the processes of the quality

management system.

► The documented procedures should be written in a simple and understandable way.

► They should also indicate the methods to be used and the criteria to be satisfied.

► These procedures define the activities and describe:

What needs to be done and by whom;

When, where and how it should be done;

What materials, equipment and documents are to be used;

As an activity must be monitored and measured;

What records are required

4.2.3 Control of documents

► Define the retention period for at least one copy of obsolete documents for the lifetime of the Medical Device or based on relevant Regulatory requirements

4.2.4 Control of records

► Records are to be retained for at least the LIFE TIME of the device but not less than 2 years from Product Release Date

► Required by GMP to retain the quality records for product SHELF LIFE + 1 year but not less than 2 years from Manufactured Date

5. Management responsibility

► 5.1 Management Commitment

Top Management shall provide evidence of its commitment to the development and implementation of its quality management system and maintaining its effectiveness.

► 5.2 Customer Focus

► 5.3 Quality Policy (Requirements of GMP for Medical Devices; 4)

► 5.4 Planning

5.4.1 Quality Objective (Requirements of GMP for Medical Devices; 5)

5.4.2 QMS Planning

► 5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority (Requirements of GMP for Medical Devices; 6)

Need to establish the interrelationship of all personnel who manage, perform and assess work affecting quality – independence and authority to be provided

5.5.2 Management Representative (Requirements of GMP for Medical Devices; 7)

► 5.6 Management Review

Input shall include a review of new or revised regulatory requirements

The output from the review shall include any decisions or actions related to the maintenance of the effectiveness of the quality management system and its processes .

6. Resource Management

► 6.1 Provision of resources

The organization shall determine and provide the resources needed to:

a) implement the QMS and maintain its effectiveness

b) meet regulatory and customer requirements

► 6.2 Human Resource (Requirements of GMP for Medical Devices; 8)

6.2.1General

6.2.2 Competence, awareness and training

National or regional regulations may require documented procedures for identifying training needs

QUALITY

► 6.3 Infrastructure (Requirements of GMP for Medical Devices; 9)

Documented requirements for maintenance activities that might affect product quality

Maintenance records need to be kept

QUALITY

► 6.4 Work environment (Requirements of GMP for Medical Devices; 10)

Documented requirements for health, cleanliness and clothing of personnel if contact could affect the quality of product

Need to establish documented procedures to monitor and control environmental conditions that affect product quality

Temporary workers are appropriately trained or supervised by a trained person

Special arrangements shall be established and documented for the handling contaminated product in order to prevent contamination to other product, the work environment or personnel

7. Product Realization

► 7.1 Planning of product realization (Requirements of GMP for Medical Devices; 11)

Risk management activities to be documented and recorded

Note: the output element from the risk management activities can influence decisions and activities outside the area of product realization

► 7.2 Customer related processes (Requirements of GMP for Medical Devices; 12)

Customer specified product requirements are defined and documented

Effective communication of advisory notices

► 7.3 Design and development (Requirements of GMP for Medical Devices; 13)

Documented procedures for design and development

Planning to include Design transfer activities

Design input to include functional, performance and safety requirements, as well as results from risk management activities

Design input shall be reviewed for adequacy and approved

Design review can include specialist personnel

Design validation to include clinical evaluation if required by regulations

► 7.4 Purchasing (Requirements of GMP for Medical Devices; 14)

Documented procedures for purchasing

Purchasing and verification records to be maintained for traceability

► 7.5 Production and service provision (Requirements of GMP for Medical Devices; 15)

Need for documented procedures, requirements, work instructions, reference materials and reference measurement procedures as necessary

Defined operations for labeling and packaging

Batch records to show quantity manufactured and approved for distribution

Documented requirements and records for:

a) sterile medical devices

b) cleanliness of product and contamination control

c) installation activities

d) servicing activities

► 7.5.1.2.1 Cleanliness of product and contamination control (Requirements of GMP for Medical Devices; 16)

Documented requirements for cleaning

- cleaning before use or sterilization

- removal of process agents

- requirements to maintain cleanliness

► 7.5.1.2.2 Installation activities (Requirements of GMP for Medical Devices; 16)

Documented requirements for installation

Acceptance criteria to be established for the installation

Documented requirements for installation and verification to be provided if carried out by a third party

Records of installation and verification to be maintained

► 7.5.1.2.3 Servicing activities (Requirements of GMP for Medical Devices; 16)

Need for documented procedures, requirements, work instructions, reference materials and reference measurement procedures

Records of servicing to be maintained

Servicing can include repair and maintenance

► 7.5.1.3 Sterile Medical Devices

Maintain records of the process parameters for the sterilisation process

Records shall be traceable to each batch

► 7.5.2 Validation of processes for production and service provision (Requirements of GMP for Medical Devices; 17)

Documented procedures for validation of the application of the computer software. Software applications to be validated prior to initial use

Documented procedures and records for the validation of the sterilisation process

► 7.5.3 Identification and traceability (Requirements of GMP for Medical Devices; 18)

Documented procedures for returned product to ensure that they are identified and distinguished from normal production

Documented procedures for traceability to assist the control of non conforming product and issue of advisory notices

For implantable medical devices:

a) Records of components, materials used and environmental conditions

b) Distribution records to be maintained to ensure traceability

c) Recording the name and address of the end user

Clear status of identification at all stages of manufacture

► 7.5.4 Customer Property (Requirements of GMP for Medical Devices; 19)

► 7.5.5 Preservation of product (Requirements of GMP for Medical Devices; 20)

Preservation during internal processing and delivery to the intended destination

Documented procedures to control the limited shelf life of product or requiring special storage conditions

► 7.6 Control of monitoring and measuring devices (Requirements of GMP for Medical Devices; 21)

Documented procedures to ensure consistent monitoring and measurement requirements

8. Measurement, analysis and improvement

► 8.1 General

Need to implement the monitoring, measurement, analysis and improvement processes to maintain the effectiveness of the Quality Management System

Possibility of documented procedures for application of statistical techniques

► 8.2.1 Feedback

Documented procedure for a feedback system to provide early warning of quality problems and input into CAPA processes

Post market surveillance

► 8.2.2 Internal Audit (Requirements of GMP for Medical Devices; 23)

► 8.2.3 Monitoring and Measurement of Processes

► 8.2.4 Monitoring and measurement of product (Requirements of GMP for Medical Devices; 22)

Product characteristics to be monitored through planned arrangements and documented procedures.

► 8.2.4.2 For implantable Medical Devices

Records of personnel performing inspection and testing to be maintained

► 8.3 Non conforming product (Requirements of GMP for Medical Devices; 24)

Product can only be released under concession if regulatory requirements are met and the authorizing person is identified and recorded.

Rework instructions need to be approved

Any adverse effect of rework to be assessed and documented

► 8.4 Analysis of data

Documented procedures to analyze data on the suitability and effectiveness of the Quality Management System.

Records of customer feedback, product conformity, trends and suppliers to be maintained.

► 8.5 Improvement

Identify and implement changes to maintain the suitability and effectiveness of the Quality Management System.

Documented procedures for the issue of advisory notices

Record customer complaints. If the complaint is not followed by any CAPA, the reason must be recorded.

Documented procedures to notify the regulatory authorities of any adverse event, if required by regulations

► 8.5.2 Corrective Action (Requirements of GMP for Medical Devices; 25)

Corrective Action must be reviewed for its effectiveness

► 8.5.3 Preventive Action

Preventive Action must be reviewed for its effectiveness

12 Steps for Transferring to be Medical Devices Manufacturer

1) Gap analysis both documentation and onsite.

2) Provide training about Medical devices – Quality standards

a) ISO 13485 requirements and internal audit,

b) GMP for Medical devices requirements and internal audit,

c) ISO 14971

3) Prepare Quality manual, mandatory procedures

and other necessary documents according to

the concerned quality standards.

4) Perform risk assessment for the medical devices and prepare the risk management files.

5) Clean room is required? If yes, provide training about cleanroom validation, monitoring and routine control.

6) Build up the clean room then perform validation.

7) Sterilization is required for the products? If yes, Provide training about sterilization process validation and routine control.

8) Perform sterilization process validation.

9) Is there any process required validation? If yes, provide training about process validation, monitoring and routine control.

10) Then perform process validation.

11) Arrange internal audit according to ISO 13485 and GMP for Medical devices requirements.

12) Arrange Management review meeting according to ISO 13485 and GMP for Medical devices requirements.

Ready to be certified GMP – Medical Device by Thai FDA and certified ISO 13485 by Certified body!!!

Email : Sale.support@th.bureauveritas.com

www.bureauveritas.co.th

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