DEVICE REGULATIONS: WHAT QUALITY SYSTEM WOULD BE REQUIRED

Lauranda Breytenbach

24 July 2015

SAMED GENERAL MEMBER’s MEETING

DRAFT REGULATIONS (JULY 2015)

6. LICENCE TO MANUFACTURE, IMPORT, EXPORT OR ACT AS A DISTRIBUTOR OR

WHOLESALER OF MEDICAL DEVICES OR IVDs

(1) c must as part of the application . . .

iii evidence of accreditation certification to a Quality Management System

for medical devices and IVDs as determined by the Council,

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

• ISO 9001: Quality Management Systems – Requirements

• General application

• For about any industry

• ISO 13485: Medical Devices – Quality Systems Regulations –

Requirements for Regulatory Purposes

• Medical Devices

• Requirements for Regulatory Purposes

DIFFERENCES

ISO 9001 (2008)

• Customer satisfaction

• Continuous improvement

ISO 13485 (2003)

• Regulatory Requirements

• Customer fulfilment

• Maintaining effectiveness

BUT

• Council will determine . . .

WHY IS ISO 13485 REQUIRED?

• Regulations “assume” some requirements are addressed in the standard.

• ISO 13485 vs 21 CFR 820

• Application (§1.2 from ISO 13485)

• Specific to organizations providing medical devices, regardless of the type and size of

the organization.

• Design and Development can be excluded, IF regulatory requirements permits.

• Requirements may be not applicable due to the nature of the medical device.

• Requirements are appropriate, unless the justification otherwise is documented

WHAT IS THE REQUIREMENTS OF ISO 13485?

• Quality Management System (4)

• Management Responsibility (5)

• Resource Requirements (6)

• Product Realization (7)

• Measurement, Analyses, Improvement (8)

SECTION 4: QUALITY MANAGEMENT SYSTEM

• Provides the sequence and interaction

of the processes

• Hence, establishes a framework

incorporating the regulatory

requirements

• Basic idea:

• Say what you are going to do

• Do what you said

• “If it is not documented, it is not done!”

Plan

• Define the process: Manuals, procedures, work instructions, protocols etc.

• Why, What, When, Where, Who, How, and Acceptance Criteria

Do

• Implement the process as described

• Do not deviate without justification

Proof

• Prove that you have implemented the procedure as described

• Records!!!

STROKE OF GENIUS

SECTION 5: MANAGEMENT RESPONSIBILITY

• Top Management is overall responsible for the Quality System

• Without management commitment, any quality system is futile

• Top Management determines the quality philosophy (policy) and strategy to achieve it

(objectives)

• They appoint a Management Representative that irrespective of other duties, has the

authority and responsibility to implement, maintain and report on the quality system.

• Top Management is also required to review the quality system for suitability, adequacy

and effectiveness.

• No excuse for not knowing

SECTION 6: RESOURCE MANAGEMENT

Human Resources

• Competency

• Maintaining Competence

Infrastructure

• Get the right tools for the job

• Maintenance

Work Environment

• To achieve conformity to product requirements

TRAINING

• The regulatory field is continuously evolving

• YOU NEED TO STAY ON TOP OF THE GAME

• Training is one of the means of keeping up to date with latest developments

• Training ensure that your understanding of changes is sound

• Can be used as an effective measuring tool.

• Idea: Know before the auditor tells you

SECTION 7: PRODUCT REALIZATION

Effective management of products

• Ensuring safety and effectiveness

• Through a reliable process

• That minimalize errors

• That meets internal controls and

regulatory requirements.

Basically – ensuring that the devices that are

placed on the market replicate the devices

in the technical file.

PRODUCT REALIZATION OVERVIEW

As applicable:

• Planning

• Customer Requirements

• Identify

• Evaluate

• Correct

• Commit

• Design

• Design Planning

• Design Input

• Design Output

• Design Verification

• Design Validation

• Design Review

• Design Changes

PRODUCT REALIZATION OVERVIEW

• Purchasing

• Supplier Control

• Purchasing requirements

• Verification (Acceptance Activities)

• Production and Service Provision

• General

• Cleanliness, Installation, Servicing,

Sterilization

• Process Validations

• Wherever the output cannot be verified

• Production and Service Provision

• Identification and Traceability

• Customer Property

• Preservation of product

• Control of monitoring and measuring

devices

• Calibration / Verification / Validation

SECTION 8: MONITOR, ANALYSIS AND IMPROVEMENT

• In the simplest form – to monitor the

process and correct nonconformances

when they occur.

• Reactive

• False sense of security

• This is only the first step

SECTION 8: MONITOR, ANALYSIS AND IMPROVEMENT

Data Collection

Processes, products, audits, post

market activities, validations,

calibrations

Analysis

Well performing processes

Systemic problems

Processes that can do better

Improvement

Corrective Action

Preventive Action

Justification for change

EFFECTIVE MONITORING, MEASUREMENT AND ANALYSES

• Early identification of systemic issues

• Preventing expensive mistakes

• Cost savings

• Maintains an effective quality system

BENEFITS OF AN EFFECTIVE ISO 13485

• Assists in producing safe and effective devices

• Reduce costs

• Fewer nonconformances

• No Sales = No profits

• Reduce liability

• International harmonization

• Minor alterations to meet the regulatory requirements of most major markets

PROCESS OF OBTAINING ISO 13485

• Implement ISO 13485 (6 months to 2 years)

• You need at least 6 months records to prove implementation

• Engage a certification body

• Stage 1 audit – verify procedures

• Stage 2 audit – measures implementation

• Certificate is valid for 3 to 5 years

TIPS

• Choose a Conformity Assessment Body wisely

• Make or break your business

• Can simplify your transitions into new markets

• Don’t become attached to your procedures

• Even if it is a piece of art, it is useless if it don’t meet requirements in full

• Objective Evidence

• Knowledge is power

• Document, Document, Document

• If it is not documented, it is not done

• What has been documented, is what have happened.

THE END

• Questions?