ISO 13485: Key Points to be Considered

1. This standard is the QMS involved in life cycle of medical devices including –
a. Design
b. Development
c. Production
d. Storage & Distribution
e. Installation
f. Servicing and
g. Final decommissioning and disposal, and
h. Design & Development, or
i. Provision of associated activities like technical support, etc.
2. This can also be used by suppliers or external parties providing product to the organization, and
can choose voluntarily or enter a contract to conform to this standard
3. This Standard assumes that the organization –
a. identifies its role(s) under applicable regulatory requirements;
b. identifies the regulatory requirements that apply to its activities under these roles;
c. incorporates these applicable regulatory requirements within its quality management
system.
4. This International Standard does not include requirements specific to other management
systems, such as –
a. environmental management
b. occupational health
c. safety management, or
d. financial management
5. Requirements specified as applicable to medical devices shall equally apply to the associated
services as supplied by the organization
6. For any clause that is determined to be not applicable, the organization should record the
justification as describe in clause 4.2.2 of IS/ISO 13485:2016
7. Normative Reference:
a. ISO 9000:2015, QMS - Fundamentals & Vocabulary
8. Terms & Definitions:
For 13485, terms & definitions in ISO 900:2015 & the following apply –
a. Advisory notice: notice issued by the Organization, after delivery of the product, to
provide supplementary information or to advise on action to be taken in:
i. use of a medical device,
ii. modification of a medical device,
iii. return of the medical device to the organization that supplied it, or
iv. destruction of a medical device
b. Authorized representative
c. Clinical Evaluation: to verify clinical safety & performance of device as intended by the
manufacturer
d. Complaint: written, electronic, & oral communication against identity, quality, durability,
reliability, usability, safety, or performance
e. Distributor
i. Person involved in storage & transport on behalf of manufacturer are not
considered under this definition
 f. Importer
g. Labelling: information related to identification, technical description, intended purpose,
or proper use of medical device, excluding shipping documents
h. Life Cycle: conception to final decommissioning & disposal of product
i. Manufacturer
j. Medical device
i. Included aids for the disabled, which are not considered Medical devices in
some jurisdictions.
k. Medical device family: same basic design & performance characteristics related to
safety, intended use, & function
l. Performance Evaluation: assessment & analysis to achieve intended use
m. Post Market Surveillance
n. Product: (includes)
i. Services
ii. Software
iii. Hardware
iv. Processed Materials (e.g. Lubricants, etc)
o. Purchased Product: product provided by a party organization’s QMS
p. Risk: probability of occurrence of harm & the severity of that harm
q. Risk Management: policies, procedures, practices to analyse, evaluate, control, &
monitor risk
r. Sterile Barrier System: minimum packing that prevents ingress of microorganisms
s. Sterile Medical Device
9. QMS: General Requirements
a. Document QMS
b. Document roles undertaken by the Organization (can include manufacturer, authorized
representative, importer, or distributor)
c. Determine processes needed for QMS and application the processes as per roles
undertaken by the organization
d. Risk based approach to control processes
e. Document procedures for the validation of computer software used in QMS
f. Establish and maintain records in conformance to IS and compliant to applicable
regulatory requirements
g. Documented statements of QUALITY POLICY and QUALITY OBJECTIVES
h. QUALITY MANUAL: includes any details of and justifications for any exclusions or non-
application
i. Documents, including records, to ensure effective planning, operation, and control of its
processes
j. MEDICAL DEVICE FILE: (like a product manual)
k. Control of Documents
l. Control of Records
m. Customer Focus: Management shall ensure customer and applicable regulatory
requirements are determined and met
n. Definition of Responsibilities & Authority
o. Appointment of Management Representative to ensure documentation of processes
and promotion of awareness of applicable regulatory requirements and QMS
throughout the organization
p. Ensure appropriate communication processes and effectiveness of the QMS
q. Documentation of procedures to control Design and Development changes