Iso 13485 Webinar Slides

ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com

Steps to Implementing ISO 13485

Presentation Objectives

• Initiating the steps of an ISO 13485 implementation project

• Establishing your QMS criteria

• Determining training requirements

• Defining your business processes

• Implementing your quality system

• Generating records

• Conducting Readiness Reviews

Senior Management Commitment

• Educate senior management in concepts

• Needs for new or the existing system

• Create a vision and roadmap for success

Senior Management Commitment, cont’d.

Identify your end goals:

•Regulatory requirements and certification

•Customer and business requirements

•Process Improvements

•New market penetration

Define Your QMS Criteria – Why Choose

ISO 13485?

• ISO 13485: a quality management system

designed specifically for medical device

manufacturers

• Used for regulatory purposes

– Depends on market needs

– Depends on classification of the device

• Recognized around the world

• One day may truly be international

Identify an ISO Champion

• Select an individual to lead your implementation effort

• Provide appropriate time and resources

• Establish an “ISO Team”

Identify an ISO Champion, cont’d.

•Select an appropriate third-party consulting company

•Your selected consultant must be a strong implementation partner

•Your consultant should demonstrate good synergy with your ISO team

If your firm lacks internal resources to manage an ISO 13485

implementation, third-party assistance is available

Define Business Processes

Conduct gap analysis

•What does your current quality system look like?

•How are your key business systems handled?

•How much documentation do you have in place?

Define Business Processes, cont’d.

• Create quality plan for moving forward

• Set goals based on your gap analysis findings

• Utilize inputs from your implementation plan

Develop an Implementation Plan

• Define timing and resources

• Document in a formalized plan

• Gain senior management approval

Typical Implementation Timelines

Timelines depend on company type, size and resources.

Number of Employees Time

• Under 100 • Five to Nine Months

• 100 – 250 • Eight to 12 Months

• 250 or More • 12+ Months

Typical Implementation Plan

Quality Policy/Company Vision

• Quality policy reflects essence of

company

• Generated by senior management

• Apply to the needs of the company

Quality Policy, cont’d.

An effective quality policy should include commitments to the

following:

• Business processes for improvement

• Customers and suppliers

• Existing and new regulatory requirements

Example Quality Policy

Establish Quality Objectives

• Related to the Quality Policy

• Established by senior management

• Realistic and measurable goals

• Make them visible to the entire company

• Define periods for review of objectives

• Make improvements each year; not static

Example Quality Objectives, cont’d.

Quality objectives for January 1, 2012 to December 31, 2012:

•Complete a 96% on-time delivery of finished goods to customers

•Attain compliance rate of less than 1% versus finished goods sold per month

•In-process rejection rates must be less than 1% throughout the manufacturing process

•Obtain ISO 13485:2003 certification by November 2012

•Launch next-generation product line according to released development plan by

August 2012

Relation to EU Medical Device Directive

• ISO 13485 bears similarities to EU Directives:

– Medical Device Directive 93/42/EEC

– In Vitro Diagnostic Directive 98/79/EC

– Active Implantable Directive 90/385/EEC

• Medical Device Directives require a specific quality system to be

implemented – not ISO 13485

• ISO 13485 is de facto standard

• Includes additional information – “other”

Relation to FDA QSR 21 CFR 820

• Similar to ISO 13845

– Different structure and format

– Some wording is similar

• Most elements are the same

• GMPs have been around for years

• FDA performs QSIT inspection currently on a

“surprise” basis

Relation to Canada Medical Regulations• Audit to SOR 98-282 Regulation

• Class II, III, & IV medical devices must conform to ISO

• Conducted by registrar performing CMDCAS

– Canadian Medical Device Conformity Assessment

System

– Performed by a Registrar, not Notified Body

• Separate certification than “ISO 13845”

• Slight variations that must be addressed

Relation to Japan MHLW Ordinances• Conformance with Ordinance #169

• Is not the same but similar

• Based on device class

– Some Class II can be audited by Certified Bodies

– Class III/IV performed by PMDA

• It is NOT ISO 13485 certification, similar

• Slight variations that must be addressed

Relation to Rest of World (ROW)

• Some countries will accept ISO 13485

• Really based on customer needs

• Some countries expect a GMP compliance

• ISO 13485 system will generally be closely related to GMP for compliance

• Depends on regulatory requirements

Understand Product Relations

• A good, established QMS indicates good quality products

• Regulators link QMS to product approval

• ISO 13485 provides consistent processes

Product Relations, cont’d.

Maintain an effective quality system

– Addresses quality concerns

– Identifies issues and concerns with

product quality

– Assures consistent methods and

processes

ISO 13485 Related to Customer

Requirements

• Understand customer requirements

• Understand why implementing ISO 13485

– Customer request or market request

– Regulatory requirement

– Generally both; provides confidence

• Implements a method for customer feedback or complaints

• Measure product performance

Review Process Interactions

• Output from gap analysis and implementation plan

• Lay out your different key processes

• Understand interactions and workflow

• Helps to organize implementation

• Key component of the quality system

– Becomes part of SOP or Quality Manual

Educate Employees

• Train all employees on what ISO 13485 means to the company

• Train employees on what ISO 13485 means to them

• Need awareness from everyone

• Also serves as communication of project

• Train champion(s) one-on-one/group

Communicate Key Principles

• Establish the following for staff training

– Quality policy

– Quality objectives

– Process interactions

• Explain and show benefits of ISO 13485

• Communicate regulatory requirements

• Make these visible and understood

Select a Notified Body or Registrar

• This will be a partnership between you and your NB/Registrar

• Ensure they can meet scope of your current and future QMS criteria

(CA, JP, EU)

• Cost depends on the number of your employees

• Obtain quotations from a few NBs/Registrars

• Decide on a certification date

Develop Documentation

Forms, tags,

labels, etc.

Quality manual(why)

PolicyLEVEL 1

Describes company policy relating

to each 9001 / 13485 requirement

LEVEL 2

LEVEL 3

LEVEL 4

Procedures4.2.3, 4.2.4, 8.2.2,

8.3, 8.5.2, and 8.5.3

(and optional procedures)

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