1. Based on the ISO 9001:2008 process model
2. Meets the quality system requirements of various
3. Has not been adopted by the FDA, but can easily
meets the FDA QSR requirements
4. Was written as a tool for maintaining the
effectiveness of processes
5. Risk management is a very key element
ISO 9001:2008 process model
Continual Improvement of the
Quality Management System
Process controls (including environmental
Special processes (relevant product and service
oriented technical standards )
Quality Management System
Process Approach- Establish a QMS which identifies
and manages processes
Regulatory requirements- Greater emphasis on
understanding and controlling processes and Combines
process and compliance auditing
Outsourcing- Responsible for controlling outsourced
activities and processes
Objectives- Quality Policy should be a framework of
objectives and All objectives must be measurable
Documentation- All required procedures must be
implemented and maintained
Commitment to the QMS by Top Management
Ensure there are available resources to support
the QMS, and conduct management reviews
Ensure that regulatory and customer
requirements are determined and met
Objectives must have top management support
Periodic review and control
Adequate resources for an effective QMS that is
capable of meeting customer and regulatory
Management of work environment to ensure
there is no adverse impact on product quality
Risk management- Greater emphasis on documented
Customer and regulatory requirements- Proactive
Design and Development:
Design outputs to be verified as suitable for manufacturing
Safety according to intended use
Design Reviews and formal verification
Validation to be completed before delivery or clinical evaluation
Product Realization (Cont.(
Purchasing- Qualification and re-evaluation
Production- Sterilization processes must be
validated and records maintained (traceable to each
Process Validation- Process validation and
verification (keeping with the QSR requirements of
Product Identification and Traceability - Required
throughout product realization
Monitoring & Measurement of processes
Monitoring and measurement of product
Control of Non-conforming product
Analysis of data
Corrective and Preventive actions
7.1 Control realization planning
Product quality objectives and requirements.
Product realization needs and requirements.
Product realization risk management
Product realization record keeping
Realization Requirements (Cont.(
7.2 Control customer processes
Requirements that customers want you to meet.
Requirements that are dictated by the product's use.
Requirements that are imposed by external
Requirements that your organization wants to meet.
Review customers' product requirements.
Communicate with your customers
7.3 Control product design and development
Plan design and development (Stages, Controls, CM)
Define design and development inputs (Intended
Use, Spec, RM, DRs).
Generate design and development outputs.
Carry out design and development reviews.
Perform design and development verifications.
Conduct design and development validations.
Manage design and development changes.
7.4 Control your purchasing function
Control purchasing process
Document product purchases.
Verify purchased products.
7.5 Manage production and service provision
Control production and service provision.
Validate production and service provision.
Identify and track your products.
Protect property supplied by customers.
Preserve your products and components.
7.6 Control monitoring devices
Identify monitoring and measuring needs.
Select monitoring and measuring devices.
Develop monitoring and measuring procedures.
Calibrate your monitoring and measuring devices.
Safeguard your monitoring and measuring devices.
Validate your monitoring and measuring software.
Use your monitoring and measuring devices.
Detailed Gap Analysis
Detailed Work Plan
Procedures and Records
Comments from SII and corrective actions
Comprehensive internal audits
External audit and certification