iso 13458:2016 certification medical device QMS

ONLINE-APPLICATION

Name of Company *

Number of Site *

Fill Detail of Sites *

Employees Status

No of Employees Full Time Different job :
No of Employees performing same type of Job:
No of Part time Employees:
No of Temporary Workers:
No of Unskilled workers:

( * If number of sites is more than one,then first site would be considered as the main site )

Standards *

Name of Concerned Person *

Position / Designation *

Mobile No. *

Website

E-mail *

Phone Number

Legal Status Of Company *

Legal & Statutory Requirement

Registration

Outsourced Process

Is it Integrated Management System

YesNo
In Case Yes, Do you Have the Integrated Documents YesNo
( If the answer is yes, please specify)

Scope Of Certification *

Key Process Involved

Accreditation Required *

Hazard’s Identified?	YesNo
Detail any critical occupational health & safety risks identified?

*ADDITIONAL INFORMATION
Potential hazards and other factors	Range indicators for determining scores	Score
Dangerous Goods	1. There are some dangerous goods (but not licensable quantities). 2. There are licensable quantities of dangerous goods.	YesNo YesNo
Vehicle/pedestrian interaction (including fork-lifts)	1. There is vehicle traffic that has the potential to interact with employees or other persons but this interaction is very limited due to the low numbers of vehicles involved and limited potential pedestrian impact. 2. There are a number of forklifts or other vehicle movements around employee work areas, and/or pedestrians are able to enter vehicle work zones.	YesNo YesNo
Powered plant (including building plant rooms)	1. Powered plant is used occasionally 2. Powered plant is used regularly or daily	YesNo YesNo
Other plant (including scaffolding) or mechanical hazards	1. Other plant is used occasionally 2. Other plant is used regularly or daily	YesNo YesNo
Manual handling (includes Occupational Overuse Syndrome)	1.There is handling, storage, transport or use of hazardous substances 2.There is handling, storage, transport or use of hazardous substances on a daily basis by a number of persons	YesNo YesNo
Atmospheric contaminants other than hazardous substances (excludes confined spaces)	1. There has been or could be the need to test atmospheric contaminants to confirm they are below hazardous levels 2. There are known airborne contaminants in the atmosphere requiring breathing apparatus to be worn on a regular basis (may be in limited parts of the worksite).	YesNo YesNo
Use of ionising or non-ionising Radiation	1. There are low radiation sources 2. There are high radiation sources	YesNo YesNo
Confined Space	1. There is a confined space requiring entry 2.There are a variety of confined spaces requiring entry and/or a number of teams operating in confined spaces.	YesNo YesNo
Slips, trips and falls	1. There are slip, trip or fall hazards 2. There are a range of activities that expose people to slip, trip and fall hazards	YesNo YesNo
Noise	1. There are nuisance noise levels that do not exceed the maximum legislated noise level 2. There are noise levels that exceed the maximum legislated noise level	YesNo YesNo
Thermal environment	Score = 0 or 5 5: There is exposure to extreme thermal discomfort
Below ground work environment	1. There is occasional below ground work 2. There is regular or daily below ground work	YesNo YesNo
Storage and/or use of explosives	1. There are explosives on site 2. There are explosives being used	YesNo YesNo
Electrical hazards	1:Use of electrical equipment 2:Occasional need for personnel to work on electrical equipment 3: Regular or daily need for personnel to work on electrical equipment	YesNo YesNo YesNo
Pressurised environment	There is work in a pressurized environment	YesNo
Threats of bullying, violence or occupational assault	1.Exposure to internal bullying or violence 2.: Exposure to external bullying or violence 12: Both conditions apply	YesNo YesNo

Do you have confidentiality information that would be excluded during onsite audit	YesNo
Additional Information Required (Tick one in each box) Critical business sectors are sector that may affect critical public services that will cause risk to health, security, economy, image and governmental ability to function that may have a very large negative impact to country
* Business and organization Complexity
The number of employees department wise
Number of user
Number of Sites
Number of server
Number of WS+PC+Laptop
Number of Application Development and Maintenance staff
Types of Business and regulatory Requirement	1. Organisation work in non critical business sector and non regulated sector 2. Organisation has customer in critical business sector. 3. Organisation works in critical business sector.
Process and Task	1. Standard Process with standard and repetitive task i.e lots of persons doing work under the organization’s control carrying out the same tasks, few product or services 2. Standard but not repetitive process with high number of products or services 3. Complex Process, High number of products and services, many business units included in scope of certification
Level of establishment of the Management System	1. ISMS is already well established and/or other management system are in place. 2. Some elements of other Management system are implemented, others not specific risk applies 3. No other Management system implemented at all, ISMS is new and not established.
Any Industry specific standards applicable, If yes, please provide details	YesNo
Any specific Legal / Regulatory / Statutory Act / Standard applicable. If yes, please provide details	YesNo
IT Environment Complexity
IT Infrastructure Complexity	1. Few or highly standardized IT platforms, servers, operating system, database, networks etc 2. Several different IT platforms, servers, operating system, database, networks etc 3. Many different IT platforms, servers, operating system, database, networks etc
Dependency on outsourcing and suppliers including cloud services	1. Little or no dependency on outsourcing 2. Some dependency on outsourcing or suppliers, related to some but not all important business activities. 3. High dependencies on outsourcing or supplier, large impact on important business activities.
Information System Development	1. Non or very limited in house system/application development 2. Some in house or outsourced system/application development for some important business purpose. 3. Extension in house or outsourced system/application development for important business purpose.
Risk Treatment Plan	Yes No
Statement of Applicability w.r.t. ISO 27001	YesNo
Procedures required by the Standard	YesNo
Records required by the Standard	YesNo
ISMS MRM	YesNo
Internal Audit Program	YesNo
No. of Customer/Projects covered under the scope	YesNo
Any service(s) outsourced	YesNo
Any other information Client would like to provide and which is not covered above:

Certification Programme Requested *

Do you have a specific Programme/Timescale for achieving Registration

Yes No

Is Consultants Involved ?

Yes No

( IF yes please specify,which one )

Combined Audit

In the case of several certification programmes, would you like the audits to be Combined or carried out separately? Yes No

( If the answer is yes, please specify which combination : )

Is Already ISO Certified

Additional Information

Declaration*

I hereby declare that the information provided above is true to the best of my knowledge and belief

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