Indian Certification for Medical Devices (ICMED) Scheme- - - PowerPoint PPT Presentation

QUALI LITY Y

COUNCIL

OF IN INDIA

Indian Certification for Medical Devices (ICMED) Scheme- Provisional Approval of CBs

Key stakeholders ....

Association of Indian Manufacturers of Medical Devices NATIONAL ACCREDITATION BODY

National Accreditation Board for Certification Bodies (NABCB) Quality Council

• f India

Certification Bodies Users Manufacturers of Medical Devices Regulators

Governing Structure

3

Steering Committee

• Advisory committee

which comprises of key stakeholders

• Overall structure

formulation, modification and its supervision

• Adapts measures to

enhance scheme’s acceptability and promotion

Technical Committee

• Comprises of

personnel with technical expertise

• Identifies, defines and

develops criteria w.r.t technical implementation

• Resolves technical

issues pertaining to scheme’s requirements

Certification Committee

• Develops, maintains

and revamps the scheme documents

• Develops, maintains

and revamps as appropriate the requirements for CBs; usage of certification mark as certified entities

Why Provisional Approval is needed-

4

CB needs to have a brief period of understanding the Scheme and the accreditation to needs to have couple of cases done before they grant certification.

Scheme has been Launched with Two Levels of Certification

• ICMED 9000 Certification
• which is ISO 9001 plus Additional requirements
• ICMED 13485
• which is ISO 13485 plus Additional Requirements
• ICMED 13485 Plus
• Under development

Eligibility Requirements

6

ICMED 9000

• Hold NABCB Accreditation for

QMS certification as per ISO 17021-1:2015

• IAF scope 19 covering NACE

(Rev 1.1) DL 33.1

• Shall have undergone a witness

for scope in last 3 years

ICMED 13485

• Hold NABCB Accreditation for

ISO 13485 certification

• Accredited for scope DL 33.1 for

QMS as per ISO 17021:2015

• Shall have undergone a witness

for the first audit for ISO 13485

CB shall be a Legal entity/ Governmental Certification body

Application for PA - Documents to be attached

7

Organization Registration Certificate & Memorandum / Articles of Association (copy only) Master List of Documents relating to ICMED (with issue and/or revision status) Quality Manual in accordance with ISO/IEC 17021(ICMED Related) Documentation relating to ICMED (Procedures, Competence Criteria, Formats, Checklists etc.) Branch Office(s) to be covered under approval List of Managerial Personnel & Auditors Application Fee - Amount, Cheque / DD No., Date etc. Other Documents as appropriate to Scheme

Approval Process of Certification Body

CB must obtain NABCB Accreditation within One Year of Provisional Approval Decision by QCI on Provisional Approval of CB Submission of Report on both Review of Document and Office Assessment to QCI Onsite Office Assessment by Assessment Team Document Assessment by Assessment Team Submission of Application and Associated Documents by the applicant CB

Closure of NCs (if any) Closure of NCs (if any) One Year

Approval Process of CBs for ICMED Certification

Witness Assessment by QCI to Confirm CB’s Competence

Formation of Assessment Team

• One Assessor for ISO

17021

• One Technical Expert

Closure of NCs (if any)

Provisional Approval Criteria – CORE Elements (Indicative)

9

Legal Entity Liability & Financing Impartiality Competent Resources Publicly available information Use of certification mark

Competence- Auditors

Experience in Manufacturing, Research & QA in Medical Device Education CBs Auditors Required Qualifications Graduate in Bio Technology, Electrical Engineering, Electronics Engineering, Chemical Engineering, Bio Medical Engineering, Mechanical Engineering, 2 Years Graduate in Science 3 Years Diploma in Engineering or Pharmacy 4 Years

Audit Experience

Specific Skill Set Training Undergone Certification Scope

ICMED 9000 Training on ICMED 9000 requirements Review of Documentation Risk Management Of Medical Devices Implementation Audit Audit Reporting

___________________________

Two Audits (at least 10 mandays ) for accredited QMS programme

Specific Skill Set Training Undergone Certification Scope

ICMED 13485 Training on ICMED 13485 requirements Two Audits (at least 10 mandays ) for Accredited ISO 13485 Programme

Lead Auditor Experience Requirements

Experience Requirement Certification Scope ICMED 9000 For ICMED 9000 Auditor Performed as an audit team leader for 3 ISO 9001 Audits Experience Requirement Certification Scope ICMED 13485 For ICMED 13485 Auditor Performed as an audit team leader for 3 ISO 13485 Audits

Publicly Available Information of Certification Body

Certification Processes Granting Maintaining Extending Renewing Reducing Suspending Withdrawing Certification Geographical Area of Operations

• Website

Certification Body

• Scheme

Information on Scheme Details Applications Registered Certifications Granted Suspended or Withdrawn Validity of a given Certification

• Legal , Commercial, Ownership or Organisational Status

Documentation

• The Organisation , Top Management and key Personnel

Human Resources

• Main Policies

Clauses

• Resource and Premises

Infrastructure

• Scope of Approval

Content Specifications

• Other such matters

Miscellaneous

Seeking information from a CB post approval – SIGNIFICANT Changes

Suspension / Withdrawal of Provisional Approval

Non Compliance w.r.t scheme’s requirements Suspension of NABCB accreditation for ISO 17021

Fee Structure ( under revision process)

• Rs. 10,000/-

Application Fee

• Rs. 20,000/- per Man-day

Man-day Charges

• On actuals

Travel / Stay Expenses

• To be duly Communicated at QCI’s

discretion with due notice to CB Changes on Fee

Ongoing Schemes in PAD Division

17

IndGAP IndGHP & IndHACCP RMCPCS BSCS TCHP VCSMPP STAR

Thank You

C S Sharma Deputy Director Project Analysis & Documentation Division (PADD) Quality Council of India

p: +91 11 23379321 / 9621 a: Indian Council for Child Welfare, 2nd Floor, New Delhi - 2, India w: www.qcin.org m: csharma@qcin.org

QUALI LITY Y

COUNCIL

OF IN INDIA

Approach to Indian Certification of Medical Devices (ICMED) Certification

• - Certification Process --

Webinar on 21 May 2020

Mrutunjay Jena Director, NABCB/QCI

Agenda

• Type of ICMED Certification
• Certification Criteria

− Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device

• Registration Process

− Application − Information for Applicants − Information to CB before office assessment

• Audit Process

− Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate

• Maintaining Certification

− Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure − ICMED Symbol

Contents….

20

Type of Certification Schemes

• ICMED 9000

 which is based on ISO 9001:2015 + Additional requirements (29)

• ICMED 13485

 which is based

• n

ISO 13485:2016 + (MDR 2017 + Additional Requirements)=270

• ICMED 13485 Plus

 Which is ICMED 13485 + Product specifications (As per ISO/IEC/BIS/NHSRC etc)

Scheme Applicability: For Manufacturers of MDs

MD Manufacturers

Category of Medical Devices % of Minimum Local Content

Medical Disposables and Consumables 50% Medical Electronics, Hospital Equipment, Surgical Instruments 25% Implants 40% Diagnostic Reagents / IVD 25% As defined in Guidelines by DOP on Make in India PPO:2017, subject to revision

22

ICMED Scheme

ICMED 9000

− ISO 9001:2015 − Labelling requirement list – ICMED − Essential requirements for safety

• f Medical Device

− ICMED 9000_Issue2_19012019.pdf − QCI AIMED ICMED 13485 R3 11 03 2019.pdf

ICMED 13485

− ISO 13485:2016 − MDR 2017 − Installation, Maintenance, Repair, Service and Rework procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety

• f Medical Device

23

Agenda

• Type of ICMED Certification
• Certification Criteria

− Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device

• Registration Process

− Application − Information for Applicants − Information to CB before office assessment

• Audit Process

− Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate

• Maintaining Certification

− Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure − ICMED Symbol

Contents….

24

Information for Applicants

Following Information from CB has to be publically available – a) Certification process for granting, maintaining, extending renewing, reducing, suspending or withdrawing the certificate and the geographical area of operation of CB. b) Application form c) Reference to the certification criteria d) Detailed procedure of certification under scheme e) List of documents required along application f) Fees for application till continuous maintenance of certificate and the policy for Fee. g) Information regarding rights, duties of applicants and certified clients and procedure of complaints/ Appeals

Application for Certification

• Application form – prescribed by CB

applicant indicate type of certification  Details of manufacturing facility – no of sites, activities to be audited, list of MD in scope  Each and every Mfg facility shall be audited

• List of documents – As per the applied criteria for document

review.

• Only complete applications supported with required documents

shall be accepted.

Registration of Application

• Response to queries from applicant within 7 days.
• Applicant has to furnish all relevant information on the prescribed form -

— if approved earlier for the same scheme with other CB. The CB now may verify and evaluate the previous reports. — if any judicial proceedings are going which need to be verified.

• Certification is granted only against the current relevant certification

criteria.

• Application review status to be informed to applicant within 7 days.
• Only complete application has to be accepted and registered with unique ID

number.

Rejection of Application

• Initial Evaluation is not carried out within 3 months of registration of application
• entire certification process is not completed within 6 months of registration of

application.

• applicant shows no progress towards completion of corrective actions within 3

months of Initial Evaluation and 6 months of Registration of application.

• Misuse of certification under the Scheme
• Evidence of any malpractice

Request for grant of certification from applicant whose application rejected as above and /or certificate expired may be processed like a fresh application.

• Voluntary withdrawal of application
• The application fee if already charged is not refundable.

28

Registration contd…..

• In case of declaration about any proceedings or suspension etc, the

client application will not be entertained for a period of one year from the date of conviction, suspension, withdrawal or deregistration etc

• In the certification of any level under the scheme suspended /

cancelled by any approved CB, the application will not be accepted till suspension is revoked or one year from the date of action, however other facilities will not be affected under the same legal entity.

• In case ISO 9001/ 13485 certification is cancelled by any CB, after

checking the antecedents carefully, the certification activity may be carried out considering the facility is new.

• The ISO certification by CB other than IAF MLA signatory accredited

will not be accepted.

Registration contd…

• Where facility is certified by NABCB accredited CB, audit for

scheme criteria will be carried out only.

Agenda

• Type of ICMED Certification
• Certification Criteria

− Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device

• Registration Process

− Application − Information for Applicants − Information to CB before office assessment

• Audit Process

− Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate

• Maintaining Certification

− Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure − ICMED Symbol

Contents….

31

Audit Time Duration

• Stage 1 (20% ) + Stage 2 (80 %)
• ICMED 9000 – As per IAF MD 5
• ICMED 13485 – As per IAF MD 9
• Time duration shall be calculated for each manufacturing facility

and shall be audited individually.

• Min. 1 man-day (8 hrs) for each audit site
• Document Review, audit preparation and report preparation

time shall be additional at least one man-day.

Audit Time Duration

Certification activity Certification activity ICMED 9000 Certification activity ICMED 13485 Certification Audit/ Surveillance/ Recertification As per IAF MD 5 Plus 1 man day on Site As per IAF MD 9 Plus 1 man day on Site

33

Preliminary Information Provided to the CB

Relevant to the manufacturing facility for Document Review The documents shall include the following – QM, Procedures, Quality Plan, SOPs , WI, Forms and formats

Audit Team –

• Audit team having appropriate competence (Knowledge & skill)
• Certification and Surveillance audits will require – auditor/s +

Technical Expert ( if Auditor is not qualified for MD sector)

Audit it Plan lan –

• Audit has to be conducted while the plant is operational.
• The audit can be conducted in parts between the team members.
• All activities as per scope such as design, manufacture etc shall be

audited irrespective of the location

• HO shall be audited if controlling multiple facilities /activities.

Certification Audit

Stage 1

• at client’s premises
• as per CB’s guidelines ( ref IAF MD 2-Transfer)
• to ensure the status of over all preparedness and understanding

related to the standard and also adequacy of system.

• to collect the information regarding scope of system
• to review the allocation of resources for Stage 2 audit
• Evaluate IA/MRM, if conducted

Certification Audit contd…

Stage 2 Audit – Shall be conducted on site to verify –

• compliance to the criteria
• competence of people for different activities being held

Organization’s Requirements- At least one person at manufacturing and QA site who is at supervisory position and whole time employee having qualification

Qualification & Experience of Supervisory Position (Prod/QA)

Experience in Manufacturing, Research & QA in Medical Device Education Production/QA Person Required Qualifications Graduate Engineering/ Pharmacy 1.5 Years Graduate in Science 3 Years Diploma in Engineering or Pharmacy 4 Years

Safety During Audits

• MD manufacturing may involve risks linked to work environment.

To identify and analyse the risk and accordingly to provide prevention and protection is responsibility of Mfr.

• Auditors must have PPE which may be required while auditing

different activities at manufacturing site.

Non-Conformities

• Need to be reported in writing with evidence to the client for

taking necessary action in stipulated time (1 or 3 months).

• Shall be classified as Major and Minor according to the severity

and also as per CBs guidelines.

• In case of Non conformities - root cause analysis and inform the

same along with CAPA.

• Need to be closed before initial certification.

Audit Report

• CB shall send the Audit Report within 7 working days after audit
• Audit report for stage 1 and 2 shall clearly provide evidence and

conclusions about the fulfillment of audit objective of the Criteria in the CBs report format as per their guidance document.

• The decision in respect of granting certificate has to be based on proper

evaluation and review.

• The audit Report shall cover at least –

−Name, address of the client −Scope of certification and Processes excluded by the scope of certification, if any −Name of Audit team −Date and time of audit −Audit criteria −Structure of audited Mfg facility −Report on auditing covering“ Additional Requirements” with evidence of competence. −Findings

Certification Decision

• Certification decision shall be the sole responsibility of CB taken by

the internal person who is competent and evaluated based on the requirement in Annex B of MD9

• has not been involved in the process of Audit of that organisation.
• Impartiality and absence of any COI shall be ensured before

entrusting the task of certification decision making

Conditions for Granting a Certificate –

When following conditions are met -

• Audit Report with suitable recommendations is available
• NCs if raised are closed
• No other issue open impacting grant of certification

There shall be no conditional grant for certification.

Certificate

• The manufacturer may achieve one of the following Certificates –

Certificate Object Extension

Certificate Number

Single mfg facility All processes carried out

• One Certificate

Mutisite mfg facility

Group of mfg facilities sharing common facility / process

Group of Mfg facilities One certificate with annexure listing all mfg facilities Company Entire Company

All Manufacturing facilities One certificate with annexure listing all

Certification Documentation

The Certificate shall include the following information – −Certificate No. −Certification scheme name −Reference to Certification Criteria −Mfr Name with locations −Certified Mfg facility address −Scope of Certification −Scheme logo −Logo/mark of the CB −Accreditation symbol −Date of Certification −Expiry date −Signature of CB’s authorized representative

• In case of company or multisite facility, the CB shall annex to the certificate

the list of the certified manufacturing facilities.

Agenda

• Type of ICMED Certification
• Certification Criteria

− Installation, Repair, Service and maintenance procedure − Labelling requirement list – ICMED − Labelling requirements – MDR − Environment requirements from MDR Annex A − Essential requirements for safety of Medical Device

• Registration Process

− Application − Information for Applicants − Information to CB before office assessment

• Audit Process

− Stage-1 − Stage-2 − Audit Time duration − Audit Report − Certification Decision − Certificate

• Maintaining Certification

− Validity − Surveillance − Re-certification − Suspension − Withdrawal − Complaint and Appeal − Fee Structure − ICMED Symbol

Contents….

43

Validity of Certification

The certification shall be valid for 3 years from date of issue.

44

Surveillance Audits

• 1st Surveillance audit within 12 months from certification
• 2nd unannounced between 9 to 12 months after 1st one
• shall be carried out on site as mentioned in the criteria
• The audit man-days also as described earlier IAF MD 5 / MD 9

Renewal of Certification

• After the expiry of validity period that is 3 years normally.
• The notice by CB has to be sent prior to 4 months of expiry
• The organisation has to apply in the prescribed form of CB along with fee at least 3

months before expiry of certificate.

• The objective of this audit will be a combination of SA + stage 2 audit if there is no

change in product, process etc which will require revised assessment.

• CB shall review the performance of the organisation during entire certification

cycle, prior to a decision on renewal of certificate.

• The review shall be conducted by a competent person essentially has to be

based on the following –

a) SAs and RA reports b) Closure of NCs if raised c) Any suspension during previous validity period – status now d) Complaints if any received and their response – satisfactory e) Adverse information from stake holders / regulators – resolved?

Renewal of Certification contd….

• When performance of organisation found unsatisfactory the CB will

withhold the renewal giving time for effective CA.

• The CB shall not renew certificate with conditions for verifying compliance

subsequently.

• The verification and decision making have to be completed within that 3

months of expiry period

• The corrective action shall be verified on site if not then justification for off

site review has to be recorded.

• In case the manufacturing unit does not complete satisfactory actions

within these 3 months, the certificate shall stand expired from the date of expiry of previous validity

Change of Location/ Name/Ownership

• Organisation will inform CB if any change in location of the plant/

Manufacturing unit happens.

• On receipt of such information the CB will issue instructions to the
• rganisation for suspension of the certificate with immediate effect.
• An on-site audit will be required at new site like an initial one
• On satisfactory audit CB shall transfer Certificate to the new location

endorsing the change of premises in certificate.

• In case of change in ownership, organisation shall provide

necessary documentary evidence, acceptance of CB’s terms by new management and payment of fees. These changes do not require any on site visit.

• In the event of change in Name, the manufacturer shall inform CB

with all supported documents and on satisfaction CB can endorse the Certificate in new name

Suspension

The CB shall issue instructions to the Certified Organisation for suspension of certification when –

• Major NCs not closed within stipulated time;
• Repeated Major NCs raised in consecutive SA;
• Failure to organise SA within specified time frame;
• Non payment of dues;
• Major changes in legal status, ownership, name etc without

prior information to CB;

• Any intentional misuse of logo of scheme is detected;
• any willful false declaration in the application or otherwise is

detected;

• excessive or serious complaints against the management

system are received and found to be valid;

Suspension contd….

• Certified Organisation voluntarily requests a suspension in writing

with quoting reasons but

• not allowed to revoke of its own
• CB shall issue notice at least one week before suspension
• During suspension client can not make misleading claims
• CB can revoke suspension when corrective actions done by
• rganisation & verified by CB

Withdrawal

• CB will withdraw the certificate when –
• Organisation contravenes the terms and conditions of certification &

provisions of the ICMED Scheme.

• The corrective actions taken by organisation are not ensuring

compliance.

• The proposed plan for corrective actions will take longer time beyond 6

months for implementation.

• CB shall also withdraw certificate at the request of organisation, if the
• perations can no longer be carried out due to unavoidable

circumstances, natural calamities, lock out declared or closure of business operations etc.

Complaints and Appeals

• CB shall have a documented procedure for handling complaints

and appeals and need to be made available to the public on CB’s website.

• Procedure for complaints handling shall include complaints from all

stake holders, certified organisations and their customers.

• Upon receipt of complaint/ appeal, CB will acknowledge the same

and shall verify whether it relates to certification activity, if so, CB has to address the same.

• CB shall gather and verify all possible relevant information to

progress to a decision.

• The process step shall include the activities of root cause analysis,

correction and corrective action.

• If the complaint relates to a certified organisation then the

examination and evaluation

• f

complaint shall take into consideration the effectiveness and implementation

• f

their system.

• CB’s process shall document the required action by CB as well as

certified organisation. Some of these actions may be the part of CB’s legal enforceable contract with the client.

Complaints and appeals contd..

• The CB shall record and track such complaints and appeals and

the actions being undertaken to resolve them.

• The decision resolving the Complaint or Appeal shall be made,

reviewed and approved by person(s) not involved in the certification activities related to the complaint /appeal.

• Persons involved in consultancy or been employed by the
• rganisation shall not be used by CB to review or to approve the

resolution of complaint /appeals before 2 yrs after the end of contract.

• Wherever possible CB shall give formal notice of the outcome

and end of the complaint process to the complainant

• In case of appeals CB shall ensure that individual(s)/ committee

involved in appeal and its resolution decisions should not be in the position in CB to influence the decision.

Complaints and Appeals contd….

• The CB procedure shall have provision for giving a written

statement to the appellant about the findings and also to give him

• pportunity to formally present his case.
• Based on presentation made the individual or committee

appointed for hearing shall take a final decision and formal notice

• f outcome and the end of appeal process shall be given to

appellant.

• The CB then formally put a notice for the end of the process of

appeal to the appellant

• The CB shall take any subsequent action needed to resolve the

complaint or appeal

Fee Structure

• The CB’s fee structure shall be provided on request.
• The fee structure shall provide break up of costs.
• A fee to be charged to the organisation for various activities of the

scheme without any discrimination between manufacturing facilities, geographical locations, size of the manufacturing facility

• CB shall notify and obtain consent to its fee structure from the

client prior to grant of certification. As and when fee undergoes a change all clients and applicants certified under this scheme shall be communicated for their acceptance

Logo of Scheme

57

FOR ICMED 9000 and ICMED 13485 TUV SUD South Asia

6

Approved CBs

Approved Certification Bodies pan India

Cur Curren ent S t Sta tatus tus - ICM ICMED ED

TUV Rheinland (India) Pvt. Ltd. TUV Intercert SAAR India Pvt. Ltd. International Certification Services Pvt. Ltd. BSI Group India Pvt. Ltd. Intertek India Pvt. Ltd.

58

Thank you

Mrutunjay Jena Director, NABCB/QCI

dirnabcb@qcin.org

Quality Council of India

2nd Floor, Inst. of Engineers Bldg., 2, Bahadur Shah Zafar Marg, New Delhi – 110002 | Ph: +91-11-2337 9321

58

QUALI LITY Y

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OF IN INDIA

Indian Certification for Medical Devices (ICMED) Scheme- Overview of additional features required by the scheme

Definitions – The changes

All the definitions are basically from 9000 and 13485 as may be applicable Some of the definitions are unique to ICMED scheme and there are some taken from Indian MDR 2007 Wherever applicable it is also to be understood that the QMS requirements specified are in addition and complementary to the technical requirements given Indian MDR 2007. The definition of manufacturer based on the category of medical device and labelling are the key changes in definitions

60

Definitions

Category of medical device % of minimum local content Medical disposables and consumables 50% Medical electronics, Hospital equipment, Surgical instruments 25% Implants 40% Diagnostic Reagents/IVD 25%

6 1

As defined in DOP guidelines on Make in India PPO

Labelling

• Compliance to national/state/scientific recommendations mandatory
• Shelf life and expiry date mandatory
• Labelling checklist is a part of ICMED scheme and clearly outlines markings on Unit pack and Secondary pack

62

Additional features on ICMED 9000 scheme

General requirements

• Manufacturer to have established and documented system for implementation and maintenance of a QMS
• Identification of indicators to measure frequency of measurement to be documented

Control of records

• Address, theft of records/ conducting investigation for missing records
• Records of compliance to regulatory requirements
• Certificates issued by regulator for running the manufacturing site
• Records of all sale installation and product commissioning

63

Additional requirements – Cont’d

Infrastructure

• Verification of energy storage and transmission equipment
• Validity of national/state approvals for installation
• Verification of functionality of fire prevention and fighting measures

Specific area requirements

• Identification of sections to store conforming and non conforming products
• Verification that there is no mix up

Waste management and disposal

• Verification of regulatory compliance and records of appropriate authority having inspected the system
• Ensuring the system does not endanger the quality/conformity of product
• Verification of training to personnel to follow WMnD

64

Additional requirements – Cont’d

Cleanliness of the facility

• Procedure for fumigation, disinfection required
• Availability of reagents and chemicals verified

Traceability

• Traceability to be ensured to the extent defined based on product type and category

Labelling

• Compliance to regulatory guidelines
• Verification of precautionary material, expiry date, shelf life
• Information on packaging and storing
• Procedure to ensure all docs and instructions accompany the product required for installation and use
• Attaching labelling tags for intended use as maybe required

65

Additional requirements – Cont’d

Cleaning and sterilization

• Defined and documented policy/process required
• Guidelines with product where cleaning, sterilization required before use
• Procedure to prevent contamination
• Ensuring suitability of all components with reference to sterility

Installation Procedure

• Verification of protocol with reference to briefing customer and inspection at site
• Adequacy of documentation for installation
• Verification about warranty/guarantee/shelf life in the documentation supply

Non conformity after dispatch

• Transit damage to be brought to notice of manufacturer and customer - procedure required

66

Additional requirements – Cont’d

Product safety, reliability and credibility

• Appropriate permissions from regulators before any clinical trials where required
• Not required for evaluation and investigation

67

Overview of additional requirements of ICMED 13485 scheme

General requirements

• Requirement for established documented system for implementation and maintenance of QMS
• Shall be appropriate to the needs of the organisation
• Shall identify all processes, sequences, interactions and results
• Responsibilities of individuals for all processes
• Components of all processes like manufacturing, storing, pre market authorisation, sale, installation, maintenance, repair, disposal
• Criteria to monitor, measure the compliance and effectiveness of all processes
• Measuring adequacy of inputs
• System to track delays in completion of any process
• System to measure correctness of the processes and its sub parts
• Verification and validation of software used for product

68

Overview ICMED 13485 – Cont’d

Documentation Mandatory documents

• Quality manual
• Quality policy and objectives
• Document to ensure effectiveness of planning, implementation and control of all operations
• Product specifications in detail
• Procedure to approve, review and improve QMS
• Documents showing compliance to applicable regulations
• Process to update records, prevent use of obsolete records
• Justification of exclusions from scope

69

Overview ICMED 13485 – Cont’d

Control of records

• Requirement for a robust record management system
• Identify personnel for record maintenance
• Ensuring safe conditions for preservation
• Procedure to access, issue and obtain copy of records
• Procedure to address theft/investigating missing records
• Record management policy to support quality policy

Mandatory records 1. Product conformity – Batch/sample testing record 2. Audit management review, corrective and preventive action (Custodian to be identified) 3. Records of regulatory compliance 4. Records of change ( Mfr infrastructure and training)

70

Overview ICMED 13485 – Cont’d

• Safety management records
• Adverse incident record
• Verification, validation and calibration
• Customer feedback and complaint
• Components used for verification of product quality
• Sale, installation and product commissioning
• Software and risk review

71

Overview ICMED 13485 – Cont’d

Management responsibility

• Evidence of managements resolution to develop, implement and improve QMS
• Evidence of communication within the organisation about customer/regulatory requirement
• Defined procedure to update QMS regulatory requirement, product safety guideline
• Evidence of management effort to promote quality and safety
• Evidence of communication of QP and objectives
• Conducting management review, providing resources

Customer focus

• Top management to establish procedure to identify customer requirement and measure its capability to meet + regulatory requirement

72

Overview ICMED 13485 – Cont’d

Quality policy and objectives

• Availability of quality policy and objectives
• Define periodicity of measuring objectives
• Quality management system planning
• Identify indicators to measure performance in all divisions of the organisation
• Define data collection for performance measurement

Responsibility/authority/management review

• Define roles and responsibilities for every member
• Identify individuals for all processes + management representative
• Define communication system within the organisation
• Management review to be done at planned intervals – record to be maintained

73

Overview ICMED 13485 – Cont’d

• Review input shall have feedbacks and reports on performance
• Monitoring and measuring of performance
• Compliance with reference to regulations
• Evidence of management effort to promote quality

Resource management

• Availability of chemicals, reagents for cleaning and fumigation + procedure for their use
• Compliance to qualification, competence as per statutory requirement
• Verifying adequacy of human resources
• Evidence of skills, training, experience for each category
• Procedure for selection, induction, training, performance monitoring and appraisal
• Defined policy for ensuring awareness after training and also to determine the necessary competence

74

Overview ICMED 13485 – Cont’d

• Identify training required for special tasks
• Training calendar, monitoring effectiveness after training
• Verifying awareness of personnel with reference to their duties and responsibilities
• Procedure to take appropriate action for negligence of duty when it affects product quality
• Procedure to address personnel grievances
• Schedule for screening of health for employees in sensitive areas
• Procedure to report adverse affects and provide adequate compensation

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Overview ICMED 13485 – Cont’d

Infrastructure

• Ensuring appropriate infrastructure with reference to building, fencing environmental conditioning, power, fire
• Validity of equipment's for the above and conformance to regulations
• Adequate space to prevent mix up at all stages
• Products of biological origin to be segregated physically and environmentally

Work environment and contamination control

• Ensuring proper environment with monitoring and control mechanisms
• Preventing pollution, dust, dirt etc
• Documented requirements as per schedule 5 of MDR 2007
• Document for health cleanliness and clothing where required
• Procedures for cleaning, preventing cross contamination
• Protecting equipment from contamination

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Overview ICMED 13485 – Cont’d

• Disinfection of personnel items and clothing
• Prevention of smoking, eating, drinking, chewing or keeping food and drink in production laboratory and storage (MDR requirement)
• Documented code for washing and PPE’s
• Waste management regulations to be complied
• Personnel to be trained
• Ensure the system is safe and do not endanger personnel or product
• Ensuring quality of water and air as appropriate
• Specify lighting requirements
• Records for all the above required
• Preventive maintenance protocols, identity of responsible personnel, documenting delays and lapses, conduction of major repairs action

taken to be documented

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Overview ICMED 13485 – Cont’d

• Product realisation
• Identifying system for inputs required, specific resources
• Integration of QMS objectives
• Documenting verification, validation, monitoring inspection and test.
• Maintaining production schedule.
• Identifying risks to product quality and managing
• Records of product realisation and acceptance.
• Evidence of product verification, validation ,rejection ,criteria
• Identifying and meeting customer and regulatory requirements.
• Providing information to the customer about scope limitations of product.
• Reassessing product specifications when requirements change.

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Overview ICMED 13485 – Cont’d

• Communication
• Adequacy and effectiveness of communication – within the organisation with regulator, with customer verified.
• Customer feedback complaints – records
• Verification of adequacy of communication with reference to product parameters, packing, storing, usage, etc.
• Communication to customer about scope, limitations and jurisdiction of any legal dispute.

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Overview ICMED 13485 – Cont’d

• Design and Development
• Incorporation of product quality and safety in manufacturing plan.
• Complete design dossier including all stages of design specified
• Identifying various phases of manufacture.
• Awareness and competence of personnel involved in design.
• Verification and Validation of
• 1. Quality parameters
• 2. Software used for Manufacturers
• 3. Measuring Instruments.
• Ensuring design to meet applicable regulations

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Overview ICMED 13485 – Cont’d

• Traceability
• Defined policy for traceability for all input components
• System to appropriate action when traceability is compromised, where applicable by regulation identify maintaining UID of the product.
• Labelling as per regulatory guidelines, Chapter 6 Rule 44 (Indian MDR 2017)
• Cleaning and sterilization
• Documented criteria for cleaning and sterilization of products and guidelines to be sent with the product.

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Overview ICMED 13485 – Cont’d

• Design and Development outputs
• Monitoring and testing accuracy in design during various phases.
• Validation of design as per approved procedure
• Evidence of permission for any clinical trials as may be required.
• Policy for communication of changes and ensuring incorporation in all documents.
• Operational life cycle management
• Ensuring consistency in product characteristics, installation procedures
• Maintain after sale documents
• Addressing non-conformity after dispatch.

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Overview ICMED 13485 – Cont’d

• Purchasing
• System to select and evaluate suppliers
• Providing all information relevant prior to order placement.
• Components selected using predefined criteria
• Ensuring suitability of components influencing sterility.
• Production and service provision
• Manufacturing plan to incorporate quality and safety
• Defining controls at various stages.
• Ensuring proper instrumentation.
• Checking of quality and specification of components used.
• Maintaining records of sale installation and product commissioning.
• Documentation of validation of production process, equipment qualification and personnel.

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Overview ICMED 13485 – Cont’d

• Customer property
• To be conserved against undue damages and defined in installation policy
• Preservation of product
• Ensuring proper preservation, packing, prevention of contamination, ensuring segregation of products where products of biological
• rigin are made or used.
• Records of all calibration to be maintained
• Measurement analysis and improvement
• Procedures to monitor and measure the performance of the QMS and product
• Evidence of analysing feedback

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Overview ICMED 13485 – Cont’d

• Complaint handling
• Informing customer about jurisdiction for disputes
• Reporting to regulatory authorities
• Policy to bring to notice appropriate authority/Public any adverse event, potentially adverse event due to manufacturing fault
• Internal Audit
• Planning sufficient internal audits to ensure effectiveness
• Audit done by trained auditors with required competence and independent of the area of their activity.
• Evidence of the action taken on recommendations
• Evidence of internal and external audits

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Overview ICMED 13485 – Cont’d

• Monitoring and measurement of process/product
• Monitor process when planned results are not achieved to initiate correction and corrective action.
• Ensuring monitoring and testing of all processes effecting product quality
• Define verification and validation of all quality parameters
• Define rejection criteria
• Records of product conformity
• Records of components to be maintained.
• Control of non-conforming products
• Procedure to define responsibilities and authorities.
• Ensuring proper records of such products to avoid reuse.
• All records which indicate failure to be maintained.
• Systems to handle unintended acceptance or use of non-conforming products
• Procedures to recall if products already in the market to initiate repair and replacement

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Overview ICMED 13485 – Cont’d

• Segregation of products coming for rework
• Informing regulatory authority where required
• Analysis of data
• System to analyse and evaluate data to demonstrate suitability adequacy and effectiveness of QMS
• Analyse feedback market trends feedback from supplier audit service reports etc.
• Use statistical techniques to analyse.
• Corrective action
• Ensure procedures for incorporating continuous quality improvement
• System to initiate action to rectify the failures and prevent its recurrence
• System to initiate investigation to a non-conformity.
• Records need to be kept for all preventive and corrective action

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Annexures of ICMED 13485

There are two annexures providing information on labelling and installation and servicing. There is a label checklist provided which gives the mandatory markings to be done on the product. These are :- 1. Name and address of the manufacturer 2. Name and trade name of the device 3. Lot/Batch number 4. Expiry date 5. Indication for single use (if applicable) 6. The word ‘STERILE’ for sterile devices 7. Caution to user in case sterile pack is received damaged 8. Maximum retailed price

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Labelling

Where there is space constraint on the unit pack the following information is mandatorily applied on the secondary pack, unit pack to carry the caution symbol.

• Device description
• Manufacturers license number
• Date of manufacture
• Storage/handling instruction
• Operating instruction where applicable
• Method of sterilization where applicable
• Warning precautions and symbols
• Contact detail of the customer care

For all symbols refer to ISO 15223

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Annexure 3 Installation, maintenance

This annexure deals in detail the requirements on various activities related to installation, maintenance, servicing etc The salient features are:-

• Having a procedure
• Mentioning a time period to the customer for the activity
• Acceptance criteria for verification
• Briefing to the customer
• Inspection of the site of installation
• Details of transportation
• Unique identification of the project to be maintained throughout

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Annexure 3 installation, maintenance

• Whenever installation involves customer property, taking due responsibility to safeguard against any damages, this is to be defined in

the installation policy

• Instructions for installation, shelf life to be communicated to customer
• Defined policy for financial responsibility for any transit damage
• Ensuring infrastructure – energy – man power before commissioning
• Ensuring regulatory compliance where applicable before installation
• Maintaining all records of installation

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Servicing and maintenance after dispatch

• Maintenance manual, IFU manual shall be available for every category of product
• Non conformity during transit to be brought to the notice of manufacturer and customer – shall have a laid down procedure
• Servicing records to be documented
• The unique identification or batch number shall be mentioned in all maintenance, service related activities

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Non conformity after dispatch/during warranty

• Procedure required for return and repair of such products
• Segregation of such products after received
• Identifying non conformities
• Initiate procedures to prevent recurrence
• Effects and impacts if detected to be documented
• If no investigation is performed, justification to be provided and documented
• Any adverse effect if predicted due to repair or rework – to be documented and authorised

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Service/Rework/Repair/Post Guarantee/Warranty period

• AMC or CMC based on product type and customer need to be done
• Manufacturer has to provide spare parts and service support during the shelf life of the product
• Renew warranty periods after satisfactory rework or repair Is done

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Thank You

M G Sathyendra Technical Expert - NABCB Quality Council of India

p: +91 98808 47562 a: Indian Council for Child Welfare, 2nd Floor, New Delhi - 2, India w: www.qcin.org