ISO 13485:2016 (E)

(Medical Device)
ISO is the International Organization for Standardizations.
What is Medical Devices? –Quality management Systems Requirement s For Regulatory purposes.

 Documentation Requirements (ISO 13485:2016 Clause No 4.2.):Documentation has been

completed as per requirements of the ISO 13485:2016 standard as per ISO 13485:2016
Clause No 4.2.
The documented system includes:

 Quality Policy (ISO 13485:2016 Clause5.3):A Quality Policy is typically a brief

statement that aligns with an organization's purpose, mission, and strategic
direction.The Top Management has established the Quality Policy to provide
framework for the development and implementation of quality management system.
The policy states Medicare Hygiene Limited’s commitment to regulatory compliance
and meeting customers’ requirements.The Quality policy will be displayed at various
locations of company which offers to serve as a frequent reminder of various elements
of Quality policy to all persons who works for the organization.
 Quality Objectives (ISO 13485:2016 Clause 5.4.1): Quality Objectives are specific
business goals for the value and performance of products or services.
 Quality Manual (ISO 13485:2016 Clause 4.2.2): A Quality Manual is a document
that was first required by the ISO 13485:2016 standard for Quality Management
Systems.The quality manual allows to understand the functioning of a company and
its environment and to communicate its objectives. It is often presented to auditors
and new employees.
 Device master file (ISO 13485:2016 Clause 4.2.2) /Technical file:
The contents of Device Master File are as follows:
 Executive Summary
 Device description and Product specification, Including variants and
accessories
 including instructions for all manufacturing processes& Flow chart
 ,Intended use,drawings, and All specifications including variants and labeling and
packaging requirements
 Essential Principle Check list
 Risk Analysis and Control Summary
 Product Verification and Validation
 Standard Operating Procedures(SOP):A standard operating procedure is a set of
written instructions that describes the step-by-step process that must be taken to
properly perform a routine activity.
 Formats& BMR & IPQC:A good record maintained enables personnel to keep the
record of information that actually happed during the manufacturing operation in
company. These records help to maintain the audit trial for subsequent investigations
and tracking of the product batch.
 Design &Development File(ISO 13485:2016 Clause 7.3): The purpose of this
procedure is to provide guideline for the design and development activities from
design planning phase to design transfer for commercialization along with the control
and verifying the change in basic design of the existing product and developing new
product and validate the requirements.The stages involved in the design and
development of any product are as follows:

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 ISO 13485:2016 (E)
(Medical Device)
 Design and development planning
 Design and development Inputs
 Design and development outputs
 Design and development Review
 Design and development verification
 Design and development validation
 Design transfer
 Control of design and development changes
 Method of Analysis & Specification.
 Approved Vendor List
 Plant Master File :
 Validation Master Plan
 Certificate of Analysis (COA) & Protocol

 Control of Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :
 Purpose: The primary purpose of document control is to ensure that only current
documents and not documents that have been superseded are used to perform work
and that obsolete versions are removed. The latest current revision and revised
documents are in use at appropriate location throughout the organization.
 What is Master Copy?: The original set of documents which shall be retained at
Documentation of Quality Assurance Department and shall always possess the stamp
‘MASTER COPY’ in Green Colour at front side of every page.
 What is Control Copy?: The Photo copy of master copy of document is taken and
then stamped for “Controlled Copy” in blue colour at right bottom corner side and
control copy retained by the MR.
 What is Obsolete Document? : on change of any Document ,in full or in part, pages of
previous hard copy version with MR would become obsolete & shall be destroyed one
copy of obsolete document s may be maintained with concerned MR marked
“obsolete ‘ on all pages in obsolete document file.

 Documents must be Legible, Concise, Traceable, Enduring, Accessible, Clear ,Timely

Complete
 The filled formats/Records should be legible and filed in the respective files or simply
registered in registers / books. The records are maintained in box file, flat file,
computer, register books etc.
 The Formats /records should be stored in such a way that are easily accessible and
traceable.
 The records are also maintained in the computer .In such cases the files for such data
is operated by authorised person only to avoid damage of records and access of data
by unauthorised person. The backup of computer data is taken by user department to
protect such records from loss or damage, periodically (as and when changes are
done in present file). Also, passwords are used wherever necessary and identified by
concerned authorised person to establish control.
 The records are stored and placed in fire proof almirahs.
 Cabinets containing records are clearly labelled.

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 ISO 13485:2016 (E)
(Medical Device)
 We have defined the period for which at least one copy of obsolete controlled
documents shall be retained, 10 years in case of CE certified products, or one year
after the expiry date for products or retention period of any resulting records,
whichever is longest.

 MR/QA - (ISO 13485:2016 Clause 5):

 Followed Total QUALITY MANAGEMENT SYSTEM (ISO 13485:2016 Clause No 4 )
 Followed Documentation Requirements (ISO 13485:2016 Clause No 4.2.) & Control of
Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :
 Management Commitment - ISO 13485:2016 Clause 5.1
 Quality Objectives - ISO 13485:2016 Clause 5.4.1
 Quality Management System Planning - ISO 13485:2016 Clause 5.4.2
 Responsibility and Authority (ISO 13485:2016 Clause 5.5,5.5.1)
 Management review (ISO 13485:2016 Clause 5.6): The purpose of the review is to
ensure the effectiveness, adequacy and continued suitability of the quality system to
meet the requirements of the ISO 13485:2016 and Fifth Schedule of MDR 2017
requirements, suitability of Quality Policy and objectives.Management review
meetings to review the quality management system once in six months and more
frequently if needed.
 Review input : complaint handling, reporting to regulatory
authorities,audits, monitoring and measurement of processes,
monitoring and measurement of product,corrective action, preventive
action; follow-up actions from previous management reviews, changes
that could affect the quality management system, recommendations for
improvement, applicable new or revised regulatory requirements.
 Review output : improvement of product related to customer
requirements; changes needed to respond to applicable new or revised
regulatory requirements; resource needs
 Internal Communication (ISO 13485:2016 Clause 5.5.3) : on-job training reviews, and
meetings.General briefing displayed on Notice Board, Internal Audit Results, Memos to
employees, E-mail, phone, What’s App, Suggestions for improvement, use of corrective and
preventive action processes to report nonconformity communication with contractors (via
phone or mail) and other visitors to the workplace.
 Internal audit (ISO 13485:2016 Clause 8.2.4 ) : internal audits at least twice a year to
determine whether the quality management system, Auditors shall not audit their
own work/ department. Audit program shall be planned, taking into consideration
the status and importance of the processes and area to be audited, as well as the
results of previous audits.
 Control of monitoring and measuring equipment – (ISO 13485:2016 Clause 7.6) :
calibrated or verified or both at specified intervals, and prior to use, against
measurement standards traceable to national or international standards wherever

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(Medical Device)
available; where no such standards exist, the basis used for calibration or
verification shall be recorded;protected from damage and deterioration during
handling, maintenance and storage.
 Monitoring and measurement. (ISO 13485:2016 Clause 8.2) :
 Analysis Customer Feedback (ISO 13485:2016 Clause 8.2.1) information relating to
customer satisfaction and regulatory requirements. Procedure for a feedback system to
provide early warning of quality problems.The feedback process will include provision to
gather data from production as well as from post-production activities.
 Complaint handling (ISO 13485:2016 Clause 8.2.2) : Procedure for Handling of
complaints,handling of complaint-related product;determining the need to initiate
corrections or corrective actions.Process has also been established to ensure
communication with external parties, if the root cause of any complaint is found to
be due to external party (s).Any correction or corrective Action resulting from
complaint handling process shall be documented.
 Reporting to Regulatory Authorities: (ISO 13485:2016 Clause 8.2.3) : Records for
reporting to regulatory authorities are maintained.In case of any adverse events, the
organization will issue Advisory notice to end-user through distributor in
case:Reference Procedure for Advisory Notice.Procedure for Product Recall.
 Monitoring and measurement of processes (ISO 13485:2016 Clause 8.2.5) :
Procedure for Monitoring and measurement of processes and Analysis of Data,
Procedure for Corrective and Preventive Action
 Monitoring and measurement of product (ISO 13485:2016 Clause 8.2.6)
 Control of nonconforming product (ISO 13485:2016 Clause8.3) : The evaluation of
Non-conformity includes determination of need for investigation and notification of
person or external party responsible for non-conformity.Records of the nature of
the nonconformities and any subsequent action taken, including the evaluation, any
investigation and the rationale for decisions are maintained.
Action in response to nonconforming product detected before delivery - & Action in
response to nonconforming product detected before delivery (ISO 13485:2016
Clause 8.3.2 & 8.3.3) : rework in accordance with documented procedures that
takes into account the potential adverse effect of the rework on the product. These
procedures shall undergo the same review and approval as the original procedure.
After the completion of rework, product shall be verified to ensure that it meets
applicable acceptance

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 ISO 13485:2016 (E)
(Medical Device)
 Rework(ISO 13485:2016 Clause 8.3.4)
 Analysis of data - ISO 13485:2016 Clause 8.4 : feedback;conformity to product
requirements;characteristics and trends of processes and products including
opportunities for improvement; andSuppliers, Audits
 Improvement. (ISO 13485:2016 Clause 8.5)
 Corrective action (ISO 13485:2016 Clause 8.5.2) : reviewing nonconformities
(including customer complaints);determining the causes of
nonconformities;evaluating the need for action to ensure that nonconformities do
not recur; planning and documenting action needed and implementing such action,
including, as appropriate, updating documentation;Verifying the corrective action
does not adversely affect the ability to meet applicable regulatory requirements or
safety performance of medical device.Reviewing the corrective action taken and its
effectiveness.
 Preventive action – (ISO 13485:2016 Clause 8.5.3): determining potential
nonconformities and their causes,evaluating the need for action to prevent
occurrence of nonconformities,planning and documenting action needed and
implementing such action, including, as appropriate, updating
documentation;Verifying the preventive action does not adversely affect the ability
to meet applicable regulatory requirement or safety and performance of the medical
device.Monitor and review any preventive action taken and its
effectiveness.Records of preventive actions are maintained.

 Product realization (ISO 13485:2016 Clause No -7):Product realization for medical devices
is defined in ISO 13485:2016 as a mandatory requirement for a quality management system
(QMS).
Production planning is important because it creates an efficient process for production
according to customer and organizational needs.
Functions of production management:
 Design and development of production process
 Production plan cum inventory plan
 ensure good practice is achieved at all times
 Followed Standard Operating Procedure
 Clearance and Cleaning of Lines and Production area
 provide role clarification for all members of staff
 provide staff training( ISO 13485:2016 Clause 6.2)

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(Medical Device)
 facilitate communication and team work
 Allocating Instrument deification numbers
 Cleanliness of product and contamination control ( ISO 13485:2016
Clause 7.5.2) :cleanliness of the product and avoid the cross contamination.
Procedure for Work Environment & its controlling environment.
 Area Cleaning as well as machine cleaning Procedure for Processing Areas
 Validation of processes for production and service provision Analysis of Rejection
(ISO 13485:2016 Clause 7.5.6)
 Particular requirements for validation of processes for sterilization
and sterile barrier system (ISO 13485:2016 Clause 7.5.7) : records of
validation of each sterilization process
 Analysis of targeted work
 Batch monitoring and BMR
 In-Process Checking

Identification & traceability (ISO 13485:2016 Clause7.5.8 & 7.5.9 ) implemented

the system to trace materials, components, and finished products,
nonconforming products, returned products, machines and equipment’s by
unique identification. Identification of product status should be maintained
throughout the production and storage activities to ensure that only product
that has passed the required inspection and tests or released.
Traceability :Procedure for Identification and Traceability
 Proper Allocation of man power
 Check on production yields and reconciliation at various stages of manufacturing
 To monitor outputs and to validate the performance of manufacturing process
 To achieve Quality objective (ISO 13485:2016 Clause5.4.1)
 Rework(ISO 13485:2016 Clause 8.3.4)
 Particular requirements for validation of processes for sterilization and sterile
barrier system (ISO 13485:2016 Clause 7.5.2.2 )
 Customer Property (ISO 13485:2016 Clause7.5.10) :customer property like
artwork, drawings, product specification etc. documented procedure to identify,
protect and safeguard the customer property received by it.
 Control of monitoring and measuring devices (ISO 13485:2016 Clause 7.6)
 Control of nonconforming product (ISO 13485:2016 Clause 8.3)
 Preservation of product (ISO 13485:2016 Clause 7.5.11) : The procedure
includes requirements to be taken care of the following for medical devices: -
 Identification
 Handling
 Packaging
 Storage
 Protection.
 Distribution

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 ISO 13485:2016 (E)
(Medical Device)
 Followed Documentation Requirements (ISO 13485:2016 Clause No
4.2.) & Control of Document & Record (as pre ISO 13485:2016 Clause
No 4.2.4 & 4.25) :

 Resource management (ISO 13485:2016 Clause -6):

 Human resources ( ISO 13485:2016 Clause 6.2)
 Recruitment & Selection of Admin & support staff / Technical staff
 Induction Training – New Joiner
 Training Need identification
 Followed Standard Operating Procedure
 Training Impart & effectiveness evaluation
 To achieve Quality objective (ISO 13485:2016 Clause5.4.1)
 Job responsibility & authority.
 Performance Analysis :
 There are three steps in performance analysis.
 Data collection
 Data transformation
 Data visualization
 Infrastructure (ISO 13485:2016 Clause 6.3): The organization is required
to document any facility that they need to meet conformity to product
requirements, to help prevent any mistakes and to create an environment
that allows for proper handling of all products. According to the standard
infrastructure is any building, workspace and utilities, equipment, and
supporting services that guide in transportation, communication, or
information systems.

 Work environment and contamination control(ISO 13485:2016

Clause6.4):document requirements for health, cleanliness and clothing of
personnel if contact between such personnel and the product or work
environment could affect medical device safety or performance;sterile
medical devices, the organization shall document requirements for control of
contamination with microorganisms or particulate matter and maintain the
required cleanliness during assembly or packaging processes.Documents
outlining the work environment requirements, such as humidity,
temperature and lighting, if the work environment could adversely affect the
product quality.
Ensure Health & Safety of Employee

 Followed Documentation Requirements (ISO 13485:2016 Clause No

4.2.) & Control of Document & Record (as pre ISO 13485:2016 Clause
No 4.2.4 & 4.25) :

 Purchasing (ISO 13485:2016 Clause 7.4, 7.4.1, 7.4.2):

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 ISO 13485:2016 (E)
(Medical Device)
 New Vendor / Supplier Selection & approval& Contract Agreement
 Vendor evaluation & Rating
 Purchasing & monitoring
 Verification of Purchased Product
 Supplier Performance Evaluation & selection
 Logistics Management
 Follow Purchasing process
 To achieve Quality objective (ISO 13485:2016 Clause 5.4.1)
 Followed Documentation Requirements (ISO 13485:2016 Clause No 4.2.) &
Control of Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :

 Incoming RM/PM (ISO 13485:2016 Clause 7.4)

 Receipt of Materials
 Verification of Purchased Product (ISO 13485:2016 Clause 7.4.3)
 Storage & Stock Updating
 Material issue to requesting department & Stock Updating
 Identification & traceability& Followed FIFO System (ISO 13485:2016 Clause 7.5.8 &
7.5.9 )
 Preservation of Product (ISO 13485:2016 Clause 7.5.11) : The procedure includes
requirements to be taken care of the following for medical devices: -
 Identification
 Handling
 Packaging
 Storage
 Protection.
 Cleanliness of product and contamination control (ISO 13485:2016 Clause 7.5.2)
 To achieve Quality objective (ISO 13485:2016 Clause5.4.1)
 Followed Documentation Requirements (ISO 13485:2016 Clause No 4.2.) &
Control of Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :
 Ware house:
 Verification of Product (ISO 13485:2016 Clause 7.4.3)
 Storage & Stock Updating
 Identification & traceability & Followed FIFO System (ISO 13485:2016 Clause 7.5.8
& 7.5.9 )
 Preservation of Product (ISO 13485:2016 Clause 7.5.11) : The procedure includes
requirements to be taken care of the following for medical devices: -
 Identification
 Handling
 Packaging
 Storage
 Protection.

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 ISO 13485:2016 (E)
(Medical Device)
 Cleanliness of product and contamination control (ISO 13485:2016 Clause 7.5.2)
 To achieve Quality objective (ISO 13485:2016 Clause5.4.1)
 Followed Documentation Requirements (ISO 13485:2016 Clause No 4.2.) & Control
of Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :

 Sales & Marketing

 Monitoring and measurement. (ISO 13485:2016 Clause 8.2)
 Enquiry
 Order review & Confirmation
 Finalization of customer order
 Handover to dispatch department
 User Training (post-sales)
 Send Customer/user feedback form (ISO 13485:2016 Clause 8.2.1)
 Collect & analyze the customer/user feedback
 Followed Documentation Requirements (ISO 13485:2016 Clause No 4.2.) &
Control of Document & Record (as pre ISO 13485:2016 Clause No 4.2.4 & 4.25) :
 To achieve Quality objective (ISO 13485:2016 Clause5.4.1 )

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