ISO 13485.2016 Training (Sample)

• ISO 13485:2016 / ISO 9001:2015 Standards Comparison

• Major Differences between ISO 13485:2016 & ISO 9001:2015

• ISO 13485:2016 Critical Terminology

• ISO 13485:2016 – by Clause / Elements

Copyright©2016, QMS Consulting LLC

Copyright 2016, QMS Consulting LLC

• High Level Structure (HLS) remains at 8 clauses

• Primary focus on safety / performance of medical devices in conformance with customer and regulatory requirements

• Applicable to manufacturers and servicers in one or more stages of the medical device life-cycle

• Term “Risk” pertains to safety or performance requirements of device or meeting applicable regulatory requirements

• Standard still requires Documented Procedures, Quality Manual, and role of Management Representative

•High Level Structure (HLS) increased to 10 clauses •Primary focus on customer satisfaction and continual improvement in consideration of the QMS as a risk-based business model •Applicable to wide range of manufacturers and servicers •Term “Risk” pertains to effect of uncertainty, positive or negative, on organization’s QMS •Standard no longer requires Documented Procedures, Quality Manual; nor requirement for a Management Representative

ISO 13485:2016 ISO 9001:2015

Changes -Planned & Controlled


Use a Risk-Based approach to control processes of QMS, in accordance with requirements of ISO 13485:2016 and applicable regulatory requirements

Establish -

Document – roles of organization (manufacturer, distributor, etc.)

Determine -

-processes necessary for QMS

-criteria & methods needed t o ensure operation & control of processes

- availability of resources to support operation & monitoring of processes

Implement – actions needed to achieve planned results , including:

-control outsourced processes affecting product conformity to requirements via written agreement (proportionate to risk involved & ability of external party)

-validation of computer software application used in the QMS (retain records)

-

Maintain – effectiveness of processes & QMS by:

-monitoring, measuring, & analyzing processes

- maintain records demonstrating conformance to ISO 13485:2016 and applicable regulatory requirements

QMS Objectives Planned &

Communicated

Customer & Regulatory

Requirements

Management Commitment (Top Mgmt & Mgmt Rep)


*Follow-up Actions from previous Management Reviews

*Applicable New or Revised Regulatory Requirements

*Changes that could affect the QMS

*Complaint Handling

*Reporting to Regulatory Authorities

*Audits

*Monitoring & Measurement of Processes

*Monitoring & Measurement of Product

*Corrective Action

*Preventive Action

*Recommendations for Improvement

Inputs

*Improvement needed to maintain suitability, adequacy, & effectiveness of QMS / Processes

*Improvement of Product Related to Customer Requirements

*Changes Needed to Respond to Applicable New / Revised Regulatory Requirements

*Resource Needs

Outputs



Validation of Computer Software

• validate software applications prior to initial use & after changes to software or application

• specific approach & activities for V&V proportionate to risk associated with software use

• consider effect on ability of product to conform to specifications

Identification & Traceability

• maintain ID of product status thru production, storage, installation, & servicing

• ensure only product passing required inspections / tests or released under authorized concession is dispatched, used, or installed

• if regulatory requirements apply – document system to assign unique device identification number

• ensure returned devices are ID’d & distinguished from conforming product

• traceability in accordance w- applicable regulatory req’s

Preservation of Product

• Protect product from alteration, contamination, or damage when exposed to expected conditions & hazards during processing, storage, handling, & distribution

• Design & construct suitable packaging and shipping containers

• Document req’s for special conditions needed if packaging alone cannot provide preservation

Document procedures for validation of application of computer software used in

Production and Service Provision

Document procedures for preserving product conformity

to requirements

•take action, appropriate to

effects or potential effects of NC

•Issue advisory

notices in accordance with applicable regulatory req’s

•take action to eliminate NC

•preclude original

intended use / application

•authorize use,

release, or accept under concession

Before Delivery

After Delivery


Documented procedure to define controls & related responsibilities / authorities for identification,

documentation, segregation, evaluation, & disposition of NC product.

Records of nature of NC’s and any subsequent action, including investigation and notification of

any investigation & rationale for decisions must be maintained

Documented procedures – must undergo same review / approval as

original

Rework – must consider potential adverse effect of rework on

product

Completion of rework – must verify product / ensure meets acceptance criteria & regulatory requirements


Rework

Maintain records of

Rework

Feedback

(determine if organization met customer requirements)

Complaint Handling

(investigate cause /

determine action)

Reporting to Regulatory Authorities

(If adverse event or advisory notice

warranted

Analysis of Data

(demonstrate suitability,

adequacy, & effectiveness of

QMS)


If Regulatory Requirements stipulate

Feedback Gathered

Feedback Procedures

•organization must obtain specific experience from Post-Production activities

•review of experience must form part of Feedback process

•potential input to Risk Management

•applicable to monitoring & maintaining product requirements, realization, or improvement

•documented methods for obtaining & using info

•provisions to gather data from Production & Post-Production


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ISO 13485.2016 Training (Sample)

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