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

13485

• 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)

Other documents prompting recording of

evidence of compliance to requirements(see Control of Records: 4.2.4)

Optional job instructionsDescribes how tasks and

specific activities are done

Work instructions (how)

Procedures(who, what, when, where)



Draft Operating Procedures

•Update or generate the Level 2 standard operating procedures (SOP)

•Update or generate Work Instructions (WIs) Level 3 as needed

•Create the associated forms (ref in procedures) as needed for Level 4

•Forms become the Quality Records (objective evidence or proof)



Implementation Process

• Follow the ISO Standard

– Chapter 4 -> 5 -> 6 -> 7 -> 8 -> others

– Or Chapter 4 -> 5 -> 6 -> 8 -> 7 -> others

– Prioritize development as needed

– Utilize a checklist to gauge process

• Roll out in phases, implement, then train

• Start generating quality records ASAP

• Need to show evidence of utilization

• Have periodic (weekly) review meetings



Chapter 4 – Document Controls

• Develop SOP/WI/Forms template

• Document Controls

• Managing Changes or Change Control

• Control of Quality Records

• Record Retention



Chapter 5 – Management Controls

• Quality Policy

• Quality Objectives

• Quality Planning

• Start the Quality Manual (more later)

• Responsibility definitions (org chart)

• Management Representative (and

designate)

• Management Review meetings



Chapter 6 – Resource Management

• Training Program

• Job descriptions (org chart)

• Infrastructure

– Equipment and facilities

– Preventive maintenance

• Work environment

– Controlled environments – clean

rooms

– Cleaning and cleanliness



Chapter 7 – Product Realization

• Customer ordering

• Supplier Qualification and Purchasing

• Manufacturing controls

• Identification and Traceability

• Distribution and handling

• Servicing and Installation

• Calibration of Measuring Equipment



Chapter 8 – Improvement

• Customer Feedback

• Customer complaint handling (returns)

• Post market activities (next slide)

• Internal Audits

• Control of Non-Conforming product

• Corrective and Preventive Actions



Other Procedures Needed

• Adverse event reporting

• Advisory Notices and recalls

• Regulatory notification of changes

• Post market surveillance

• Maintenance of regulatory files



Develop Quality Manual

•Fill in during implementation or complete at the end (review

processes)

•This is “cliff notes” to the QMS

•Summary of your QMS and company

•Defines the scope and exclusions

•Make reference to the SOPs/Level 2 docs



Create One Quality System

• Depending on the system scope

– ISO 9001 versus ISO 13485

– ISO 13485 versus FDA QS Regulations

– ISO 13485 versus country GMPs

• Address other regulatory & quality system

components in different procedures

• Include the scope in management review

• Define the scope in the Quality Manual



Make It Personal With Employees

•Discuss one-on-one with champion

•Make sure the standard is understood

•Evaluate effect on existing processes

•Establish a due date for the procedure(s)

•Review implementation on set basis



Review the Implementation Plan

• Utilize different metrics for review

– Number of procedures required and done

– Target times being met to plan

– Training effectiveness and completion

• Update through frequent meetings

• Champion drives with “ISO Team”

• Periodic updates to management



Implement the Quality System

• Complete and generate quality records

• Hold at least one or two Management Review

meetings

• Complete a full cycle of Internal Audits

• Educate employees throughout

• Update and change documents as needed



Conduct a “Readiness” Review

• Preferably done by external party

• Should simulate an ISO Certification audit

• Ensure you’re on the right track

• May be surprised: “Cannot see the forest for

the trees” by being too close

• May be painful; don’t make it personal



Utilize System to Respond to Findings

• Generate Corrective Actions (CAs) from internal audit

findings

• Generate CAs from the readiness review

• Don’t make it personal

• Apply the standard to business processes

• Select important issues to correct



Certification Audit Time

• Stage 1 is performed ~30 days before the Stage 2 audit

– Stage 1 is sometimes desk audit – only procedures

– Stage 1 is sometimes onsite – “kick the tires”

• Certification hinges around Stage 2 audit

• Partner with your Notified Body/Registrar

• Learn from the experience

• Get employees involved



How to Avoid Mistakes• Obtain Top Management Commitment

• Don’t underestimate amount of work

• Implement in phases – don’t “bulk” release all the

procedures

• Ensure understanding by employees

• Monitor … train … coach



Tips for Successful Implementation

• Keep procedure simples – K.I.S.S.

• Allow flexibility and course correction

• Implement using practical sense

• Identify good business practices

• Monitor procedures and processes for

compliance and meeting objectives

• Periodic review meetings with team



Conclusion – Take Away Info

• Management must take charge

• Develop an Implementation Plan

• Educate the employees

• Develop the procedures

• Review the process frequently

• End objective may be certification



Thank you for your Attendance

Richard A. VINCINS

Emergo Group

VP Quality Assurance

[email protected]

Office: 512.327.9997

Additional Resources

International Standards Organization website: http://www.iso.org/iso/home.html

Emergo Group ISO 13485 implementation support:

http://www.emergogroup.com/services/worldwide/iso-13485-consulting

Emergo Group ISO 13485 training service: http://www.emergogroup.com/services/worldwide/iso13485-training

Emergo Group ISO 13485 audit service: http://www.emergogroup.com/services/worldwide/iso-13485-auditor

Documents

Iso 13485 Webinar Slides