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Steps to Implementing ISO 13485

Steps to Implementing ISO 13485

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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

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Steps to Implementing ISO 13485

Senior Management Commitment


Educate senior management in concepts Needs for new or the existing system Create a vision and roadmap for success

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Steps to Implementing ISO 13485

Senior Management Commitment, contd.


Identify your end goals: Regulatory requirements and certification Customer and business requirements Process Improvements New market penetration

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Identify an ISO Champion


Select an individual to lead your implementation effort Provide appropriate time and resources Establish an ISO Team

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Steps to Implementing ISO 13485

Identify an ISO Champion, contd.


If your firm lacks internal resources to manage an ISO 13485 implementation, third-party assistance is available
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

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Steps to Implementing ISO 13485

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?

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Steps to Implementing ISO 13485

Define Business Processes, contd.


Create quality plan for moving forward Set goals based on your gap analysis findings Utilize inputs from your implementation plan

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Steps to Implementing ISO 13485

Develop an Implementation Plan


Define timing and resources Document in a formalized plan Gain senior management approval

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Steps to Implementing ISO 13485

Typical Implementation Timelines


Timelines depend on company type, size and resources.
Number of Employees Under 100 100 250 250 or More Time Five to Nine Months Eight to 12 Months 12+ Months

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Steps to Implementing ISO 13485

Typical Implementation Plan

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Steps to Implementing ISO 13485

Quality Policy/Company Vision

Quality policy reflects essence of company Generated by senior management Apply to the needs of the company

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Steps to Implementing ISO 13485

Quality Policy, contd.

An effective quality policy should include commitments to the following:


Business processes for improvement Customers and suppliers Existing and new regulatory requirements

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Steps to Implementing ISO 13485

Example Quality Policy

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Example Quality Objectives, contd.


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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Understand Product Relations


A good, established QMS indicates good quality products Regulators link QMS to product approval ISO 13485 provides consistent processes

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Steps to Implementing ISO 13485

Product Relations, contd.


Maintain an effective quality system Addresses quality concerns Identifies issues and concerns with product quality Assures consistent methods and processes

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Develop Documentation
Quality manual
(why)

LEVEL 1 Policy Procedures


4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3 (and optional procedures)
Describes company policy relating to each 9001 / 13485 requirement

Procedures
(who, what, when, where)

LEVEL 2

Work instructions
(how)

Optional job instructions


Describes how tasks and specific activities are done

LEVEL 3

Forms, tags, labels, etc.

Other documents prompting recording of evidence of compliance to requirements


(see Control of Records: 4.2.4)

LEVEL 4

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Steps to Implementing ISO 13485

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)

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Chapter 4 Document Controls


Develop SOP/WI/Forms template Document Controls Managing Changes or Change Control Control of Quality Records Record Retention

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Other Procedures Needed


Adverse event reporting Advisory Notices and recalls Regulatory notification of changes Post market surveillance Maintenance of regulatory files

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

Conduct a Readiness Review


Preferably done by external party Should simulate an ISO Certification audit Ensure youre on the right track May be surprised: Cannot see the forest for the trees by being too close May be painful; dont make it personal

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Steps to Implementing ISO 13485

Utilize System to Respond to Findings


Generate Corrective Actions (CAs) from internal audit findings Generate CAs from the readiness review Dont make it personal Apply the standard to business processes Select important issues to correct

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

How to Avoid Mistakes


Obtain Top Management Commitment Dont underestimate amount of work Implement in phases dont bulk release all the procedures Ensure understanding by employees Monitor train coach

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Steps to Implementing ISO 13485

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

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Steps to Implementing ISO 13485

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
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Steps to Implementing ISO 13485

Thank you for your Attendance


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

Richard A. VINCINS Emergo Group VP Quality Assurance richard@emergogroup.com Office: 512.327.9997

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