Quality and Medical Devices: ISO 13485:2003ISO 13485:2003 Quality Management System requirements for...

O3 Enterprise s.r.l.Medical Device

ISO 13485Quality Management Systems

Quality and Medical Devices:ISO 13485:2003

Quality Management System requirements for Medical Devices manufacturers

www.o3enterprise.com

O3 Enterprise

University of Trieste Spin-off Company, created in 2008

Company goals:

Offer open solutions to the health-care

Offer professional and innovative services to the community based on its open products


Open Approach

For O3 Enterprise “open” approach means:

Open Source

Open Standard

Open Interoperability

Independence



EN/ISO 13485:2012

Medical devices – Quality management systems – Requirements for regulatory purposes


What is a Quality Management System (QMS)?

Quality Management System (QMS) the organizational structure

responsibilities

procedures

processes

resources

Goalscomply with the company’s quality policy

meet the requirements of the customers

meet applicable regulatory requirements


Regulatory requirements for QMS – Medical devices (MDs)

US:

FDA – Title 21, Part 820

Quality System Regulation

Europe, Canada and other - international:

EN/ISO 13485:2003

Medical devices – Quality management systems – Requirements for regulatory purposes

ISO/TR 14969:2004

Medical devices – Quality management systems – Guidance on application of ISO 13485:2003


ISO 13485 ModelKey: Value-adding activities Information flow

Model of a process-based Quality Management System

ISO/TR 14969:2004 – Medical devices – Quality Management System – Guidance on application of ISO 13485


ISO 13485 ModelKey: Value-adding activities Information flow

Model of a process-based Quality Management System

ISO/TR 14969:2004 – Medical devices – Quality Management System – Guidance on application of ISO 13485

Chapter 4.

Ch.5.

Ch.8.

Ch.7.

Ch.6.


4. QMS and requirements for documentation

Quality Manual

The most important document, usually organised as the Standard

Scope of the QMS

– Organization● Quality policy● Quality Objectives

– Products

– Compliance ● Regulations and Standards

Documented procedures for QMS and for products



Other documents

Procedures

Work Instructions

Records

Form/template for developing documents or keeping record



Control of documents

Changes only with approval by the original approving function or another designated function

– Records shall be maintained

Communicate changes to everyone

– Changes in documents, procedures

Use only latest revision

– Available version is only the last version

– Old versions shall be saved

Records of changes, activities



Why Quality records?

Provide objective evidence of the achievements of quality requirements

Verify effective operation of the QMS

Comply with regulatory requirements

Provide for traceability of devices and components

Provide information for

– Corrective action

– Preventive action

– Non conformity

Provide information for continuous improvement


5. Management Responsibility

Duties of Top Management:

provide evidence of its commitment to the development and implementation of the QMS

mantain the QMS effectiveness

– Establish Quality Policy

– Quality Planning

– Management Representative

– Management Review


5. Management Responsibility

Management Review

Hold regularly with appropriate executive attendance

Define inputs including

– Status of QMS

– Status of preventive and corrective actions

– Result of Audits

– Customer feedback and complaints

– Processes performance and product conformity

Maintain records

– Conclusion on suitability of QMS

– Actions for improvement


6. Resource Management

The organization shall provide the resources needed

to implement the QMS

to mantain the QMS effectiveness

to meet regulatory and customer requirements

Types of resources:

Human Resources

Infrastructure

Work environment



Human resources

Personnel with appropriate background, education and experience

Determine required competence

– Job Descriptions

Training to ensure competence

– Test to evaluate the effectiveness

Maintain records

– Education, training, skills and experience



Infrastructure

Controlled conditions

– MDs meet their requirements

– MDs are free of contamination

Buildings and workspaces adequate

Process equipment (both HW and SW)

– Selected and designer to meet requirement

– Cleaned, maintained and adjusted

Maintain records



Work environment

Requirements for health, cleanliness and clothing of personnel

– Prevent personnel contamination

– Limitation on eating, drinking and smoking

Control environmental conditions

– Clean where necessary to meet specifications

– Prevent device or equipment contamination

Maintain records


7. Product Realization

Planning

Plan, develop and maintain processes needed for product realization

Use risk management methods

Pay attention to– Quality objectives– Requirements of the QMS and of the products

Maintain records

– Processes and products meet requirements



Customer-related processes

Define customer requirements

– Products, delivery, post-delivery activities

Ensure effective communication with customers

– Product information, pricing, contracts

– Feedback, complaints

– Advisory Notice

Information and training for safe and effective use of the MD

Maintain records



Design and Development

Plan and control the Design and Development of all MDs and their labeling in order to assure

Safety

Clinical utility

Effectiveness

Reliability

Meeting the requirements



Purchasing

Manage the supply of materials / products / services and outosourced products and services

– Evaluation of suppliers● Maintain record of approved suppliers

– Evaluation of purchasing● Conformity to requirements

– Verification of purchased product● Inspection of records

Manage records of purchasing process



Production and service provision

Processes must be performed under controlled conditions

– Following instructions

– Qualified and trained personnel

– Controlled environment

Control

– Attention to cleaning/sterilization processes



Production and service provision

Identification and traceability

– Unique serial number

– Labeling

– Batch number for consumables

– Status identification

Preservation of product


8. Measurement, Analysis and Improvement

Monitoring, measurement, analysis and improvement processes

Demonstrate conformity of products

Ensure conformity of QMS

Maintain the effectiveness of the QMS

Processes Results

Feedback

Goals



Feedback and Complaints

From all sources

– Employees

– Customers

Documented procedure

– Maintain record

Related to

– Quality

– Durability

– Reliability

– Safety

– Effectiveness

– Labeling

– Packaging

– Performance



Internal Audit

Conduct at planned intervals – At least once a year

Ensure – all aspects of the QMS are implemented and maintained – compliance with applicable regulatory standards

Identify areas for improvement

Auditor without direct responsibility for area

Maintain report – Report to Management Review– Non Conformity



Non Conformity – NC

Identify non conforming material/product/process– Prevent its unintended use

Detect and eliminate all causes of Non Conformity



How do you solve a NC?Review the NC

Determine the causes

Evaluate the need for action to ensure that NC do not recur– Correction

● Eliminate a detected NC– Corrective Action

● Eliminate the causes of a detected NC● Prevent recurrence of the problem

Determine and implement action(s) needed

Verify implementation

Maintain record– Track completion



Preventive ActionEliminate the causes of a potential NC

Prevent the occurrence of an NC – identify, analyze and eliminate potential quality problems– analyze information from

● Processes that affect product quality● Audit results● Quality records● Service reports● Customer complaints ● Adverse Event Reports



Case study

How can we do that?


JIRA – an issue tracking system

Proprietary issue tracking product, developed by Atlassian

– bug tracking

– issue tracking

– project management functions


Non Conformity

Issuetype: NonConformity

Types of NCs:

Audit – external audits

Customers

Internal – internal activities

Subtask:

Preventive action

Correction

Corrective Action

Priority of NCs:

Critical

Major

Minor


Customer satisfaction

Feedback:

Customer survey

Employee Survey

Complaints



Related to QualityReliabilitySafetyEffectivenessPerformance

AboutStaffCommunicationProductsServices



Analysis of data

Analysis of customer suggestions

Record maintaned on Jira Customers Project

Continuous Improvement

O3Enterprise s.r.l.Area Science Park, Padriciano 99, Trieste, 34149, Italy

Tel: +39-040-9890750

Email: [email protected]: www.o3enterprise.com

Medical Device

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Quality and Medical Devices: ISO 13485:2003ISO 13485:2003 Quality Management System requirements for...

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