iso 13485 webinar slides
TRANSCRIPT
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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, cont’d.
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, 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
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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, cont’d.
• 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 Time
• Under 100 • Five to Nine Months
• 100 – 250 • Eight to 12 Months
• 250 or More • 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, cont’d.
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, 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
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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, cont’d.
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
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)
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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 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
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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
• Don’t 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
• Don’t underestimate amount of work
• Implement in phases – don’t “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
Richard A. VINCINS
Emergo Group
VP Quality Assurance
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