Medical Devices - ISO5 2016 - Seminar on Medical Devices - ISO 13485

Overview:
A detailed look at each section of the standard.
Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.
What must a documentation system look and feel like to ensure compliance?
These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times.
How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.
Your suppliers must be chosen carefully. Ensure that each vendor is vetted and reviewed at least annually. The product you are making cannot be at or maintain any level of quality unless the supply chain is acceptable and consistent.
A true and complete internal audit is key to ongoing certification. The system must be looked at entirely each year, and by independent parties to validate that each section of the standard is being met, and is consistently documented to be functional. Who should audit which section, what type of documentation must be kept; this will be reviewed and explained.
Management plays a key role with any certification. Their support is needed to implement and maintain the system for certification. Their roles should be clear, and they must be involved in the annual review to ensure that the system overview is known and communicated to all. These way ongoing changes, both good and bad, are feed back into the system to keep it live and continually improving as a whole.
Why should you attend:
Are you prepared, do you have a trained staff, what do are you not aware of?
Does your staff know what to do when they are approached by an auditor?
What documentation must be completed, up-to-date, and available to avoid major and minor findings?
What issues are auditors looking for, as well as in the new updated standard?
Areas Covered in the Session:
? An overview of the standard and the different areas needed to create, maintain, and sustain a proper documentation system to ensure certification.
? Know what to look for and where to prepare to enable one's organization and personnel to assist in an audit for certification.
? Clean rooms
? Supplier demands
? Quality from when materials are received, until after the devices leaves the facility.
? Annual upkeep
? Management representation and participation.
Who Will Benefit:
? Quality Managers
? EH&S Reps
? Quality Control
? QCQA
? CEOs
? Sales
? Buyers
? Vendors
? etc
Agenda:
Day 1 Schedule:
Lecture 1:
? Foundation of this standard (Clauses 0-3)
? Scope & normative references
Lecture 2:
? Scope & normative references - cont.
? Definitions
? Quality Manual System (Clause 4)
Lecture 3:
? Quality Manual System cont.
? Management Responsibility (Clause 5)
Lecture 4:
? Management Responsibility cont.
? Resource Management (Clause 6)
Day 2 Schedule:
Lecture 1:
? Recap
? Resource Management cont.
Lecture 2:
? Product realization (Clause 7)
? Measurement, Analysis... (Clause 8)
Lecture 3:
? Measurement, Analysis... cont.
? Annex A & B
? Recap
Lecture 4:
? Implementation
? Internal Audits
? Interviews
? Documentation
Speaker:
Jason Teliszczak
CEO/Founder, JT Environmental Consulting
Mr. Jason Teliszczak is an entrepreneur with a passion for ensuring quality through proper processes and strengthening any organization to better their outputs. After earning a B.S. in Environmental academia and to ensure his vision would not be put to waste, he built his own successful consulting firm, JT Environmental Consulting, and has quickly become an expert within the Quality, Safety, Security and Environmental industries. With more than a decade of consulting experience, Mr. Teliszczak assists his clients in setting targets and achieving goals.
Organizations throughout the world, from fortune 500 corporations within the US to companies and non-for-profits with under 25 employees, utilize Mr. Teliszczak's expertise & knowledge to perform compliance audits, internal audits, and to become certified to many different standards.
Mr. Teliszczak continues to streamline growth within the industry through working closely with Registrars, and by updating, incorporating and strengthening new standards. Mr. Teliszczak currently sits on numerous committees within organizations to develop standards for auditing, quality, safety, and security.
Mr. Teliszczak continues to stay focused on the ever changing industry by holding many various and pertinent certifications.
Location: Washington, DC Date: October 6th & 7th, 2016 Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport
Address: 2899 Jefferson Davis Highway Arlington, VA 22202 USA
Register now and save $200.
Price: $1,295.00 (Seminar Fee for One Delegate)
Until September 10, Early Bird Price: $1,295.00 from September 11 to October 4, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register now and save $200. (Early Bird)
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