Awareness Training Session
About Us
• Certvalue is a global organization specializing in ISO 9001,ISO
14001,OHSAS 18001/ ISO45001, ISO 27001, ISO 22000 and ISO
20000 , other International Standards Consulting and Certification.
• Our ISO Consulting solutions are suitable for organizations of all size
and nature irrespective of their location, no. of employees, turnover,
nature of business etc. We provide 100% customized ISO consulting
solutions to your ISO certification requirements. We posses capacity to
deliver our services in India, Middle East, UAE, Saudi Arabia, Oman,
Qatar, Kuwait, Yemen, Bahrain, Jordon, Africa, Southeast Asia,
Malaysia, Thailand and Indonesia.
Our Key Strengths
What: International Organization for Standardization (ISO) is an independent,
non-governmental international organization with a membership of 162 national
INTRODUCTIO standards bodies.
Where: Geneva, Switzerland.
N When: On 23 February 1947 .
Why: To facilitate the international coordination and unification of industrial
standards, so far ISO has published 21000+ International Standards covering
almost all types of industries.
Hierarchy of certification
International
IAF Accreditation
Forum
Accreditation
Bodies AB
CB Certification
Bodies
Client You
How do we get certified?
Step 1 Step 2 Step 3 Step 4 Step 5
Management Consultant Department Heads Internal Audit & MRM External Audit
• Conduct Gap Analysis • Document department • Conduct Internal Audit
• Create action group to and produce report. processes and present Audit Report • Stage 1: Document
• Create documentation • Records for necessary • Root Cause Analysis and
work towards Corrective Actions for all Review
certification – Standard activities • Stage 2: Onsite Audit/
management system • Make corrections to the Non-Conformances
• Identify appropriate • Verify closure of all Non- Remote audit
standard. manual, management system as per gap • Recommendation
system Procedures conformances
• Identify consultant. analysis. • Present information to based on Audit Findings
• Conduct trainings on
• Identify certification Management via
MS Awareness and Management Review
body. Internal Auditing Meeting
ISO 13485:2018
(QUALITY MANAGEMENT SYSTEM
FOR MEDICAL DEVICES)
About ISO 13485:2016
• ISO 13485:2016 specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices and related
services that consistently meet customer and applicable regulatory requirements. Such
organizations can be involved in one or more stages of the life-cycle, including:
• Design and development
• Production
• Storage
• Distribution
• Installation
• Servicing of a medical device and design and development or provision of associated
activities (e.g. technical support).
What is Quality Management system
• Quality – Quality is the value perceived by the customer
• Management System – A collection of business processes, policies and
procedures on consistently meeting customer requirements and
enhancing the satisfaction of all the stake holders
Who is ISO 13485:2016 for?
• ISO 13485 is designed to be used by
organizations involved in the design,
production, installation and services.
• It can also be used by internal and external
parties, such as certification bodies, to help
them with their auditing processes.
• It helps an organization an organization design
a QMS that established and maintains the
effectiveness of its processes.
Benefits of Implementing ISO 13485:2016
• Demonstrate compliance with regulatory and legal requirements.
• Ensure the establishment of QMS practices that consistently yield safe
and effective medical devices.
• Manage risk effectively.
• Improve processes and efficiencies as necessary.
• Gain a competitive advantage.
• National and international recognition
Risked based Thinking
• Risk-based thinking ensures the risks are identified, considered and
controlled throughout the design and use of the
quality management system.
• Risk is the probability of occurrence of an undesirable outcome.
Main FOCUS of ISO13485:2016
Manufacturing-focused risk is the impact
Design-focused risk was all about what
might happen to the patient Main focus of risk elements on our ability to deliver
the product
Design-focused Manufacturing-
risk focused risk
With design risk, you assume the product was With manufacturing risk, you assume it was
manufactured correctly designed correctly
“The fundamentals of RISK-BASED THINKING is that you must factor in the risk of each decision on the manufacturing
process and/or the patient.”
Clauses of ISO 13485:2016
1. Scope
Non- auditable Clauses
2. Normative references
3. Terms and definitions
4. Quality Management System
5. Management responsibility
6. Resource management Auditable Clauses
7. Product Realization
8. Measurement, analysis and
Improvement
Why is ISO13485:2016 needed?
As the international standard for Quality Management
Systems in the medical device industry, ISO 13485 has
already been tested and proven.
Companies that have achieved certification can show proof
to potential clients that they comply with best practices, and
with regulatory requirements.
And, along the way, your company will naturally enjoy
better control over its processes, and continual
improvement
Impacts
Company incidents
• Financial losses and costs
• Devaluation of the medical product
• Degradation of the organisation and their product
• Reputation and brand damage leading to loss of
customer, market, business partner or owners’
confidence and lost business
• Fear, uncertainty and doubt
Responsibilities
Communicating the importance of meeting customer and regulatory requirements.
Establishing the Quality Policy.
Establish the objectives. (SMART- Specific, Measurable, Achievable, Realistic and
Time bound)
The objectives also provide a clear measure of whether the system is effective.
Ex- To decrease the rate of defective product shipped to customers by 1% in the next
12 months.
Conduct the management reviews.
Comply with security and privacy laws of the standard, NDA (Non Disclosure
Agreements) and contracts
Comply with company policies and procedures.
Benefits Improve processes and
procedures
Continuous Improvement customer satisfaction
Get More Business from
New & Existing Customers
Reduce risk of customer
dissatisfaction
ISO 13485
Make better decisions,
based on evidence
Guarantees
quality services
and products
Who is RESPONSIBLE ?
• Management committee
• MR – management Representative
• All the respective Departments
• Audit Committee
•
Last but not least, you!
