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Standard	Audit Type (select one per row)
ISO 9001	Initial Surveillance 1 Surveillance 2 Re-Certification N/A
ISO 14001	Initial Surveillance 1 Surveillance 2 Re-Certification N/A
	Initial Surveillance 1 Surveillance 2 Re-Certification N/A
	Initial Surveillance 1 Surveillance 2 Re-Certification N/A
	Initial Surveillance 1 Surveillance 2 Re-Certification N/A
	Initial Surveillance 1 Surveillance 2 Re-Certification N/A

Integrated System Element	Y / N
Integrated documentation set	YN
Management Reviews	YN
Internal audit	YN
Policy, Objectives	YN
Processes	YN
Corrective and preventive action	YN
Integrated management	YN

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ISO 14001

Environmental Management System

Environmental Factors

Higher sensitivity of receiving environment compared to typical location for the industry sector?

Yes No

Any additional / unusual environmental aspects or regulatory conditions?

Yes No

Risk of increased environmental impact, incidents, or accidents?

Yes No

Process Environment Complexity

Environmental complexity level

H (High) M (Medium) L (Low)

🍽️

ISO 22000:2018

Food Safety Management System

Please provide the following information. Write N/A for items that do not apply.

1) Whether certified relevant management systems

Y N

2) Number of CCPs

3) HACCP Plan reference

4) OPRP — attach file

5) Summary of internal audit and management review — attach file

6) Work flow chart — attach file

7) Manufacturing reports for typical product — attach file

Information about process lines

Exceptional circumstances? (remote location, pandemic, short seasonal production)

Please briefly describe the main processes

If there is an outsourced process, please list it

Relevant technical and legal requirements (licensing documents)

If it is an integrated management system, which system is it integrated with?

🛡️

ISO 22301:2019

Business Continuity Management

Complexity and Risk Level

Level	Complexity	Risk
H — Impossible of Recovery	Supplier chain · No. of processes · No. of servers	Reputation · Financial · Data · Legal · Customer service
M — Possible of Recovery
L — Non Effect

Continuity requirements for core business processes through BIA?

Please briefly describe the main processes

If there is an outsourced process, please list it

Relevant technical and legal requirements (licensing documents)

If it is an integrated management system, which system is it integrated with?

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ISO/IEC 27001:2022

Information Security Management

Business Complexity

Factor	Score	Points	Mark
Types of Business & Regulatory Requirements
Non-critical business sectors, non-regulated	1
Has customers in critical business sectors	2
Works in critical business sectors	3
Process and Tasks
Standard, repetitive tasks; few products/services	1
Standard but non-repetitive; high number of products/services	2
Complex processes; many business units in scope	3
Level of Establishment of the MS
ISMS well established / other MS in place	1
Some elements of other MS implemented, others not	2
No other MS; ISMS is new and not established	3
Business Complexity Total

IT Complexity

Factor	Score	Points	Mark
IT Infrastructure Complexity
Few / highly standardized IT platforms, servers, OS, databases	1
Several different IT platforms, servers, OS, databases	2
Many different IT platforms, servers, OS, databases	3
Dependency on Outsourcing & Suppliers (incl. Cloud)
Little or no dependency on outsourcing or critical suppliers	1
Some dependency for some business activities	2
High dependency for important business activities	3
Information System Development
None or very limited in-house development	1
Some in-house / outsourced development for some purposes	2
Extensive in-house / outsourced development	3
IT Complexity Total

Please briefly describe the major processes

Scope of outsourcing and third-party contractors within the ISMS scope

Relevant laws, regulations, contracts, and business requirements within ISMS scope

If it is an integrated management system, which system is it integrated with?

⚕️

ISO 13485:2016

Medical Devices Quality Management

Medical Device Risk Classification

Risk Level	GHTF Class	Complexity
High risk	D	Surgical
Medium-high risk	C	Treatment
Medium-low risk	B	Diagnosis
Low risk	A	Ancillary

1) Medical device license certificate — attach file

2) Product registration certificate — attach file

3) Interested parties document — attach file

Name of products

Technical characteristics of the product

Relevant technical and legal requirements (licensing documents)

If it is an integrated management system, which system is it integrated with?

Software validation

Function / User / Bio-compatibility test (if applicable)

🦺

ISO 45001:2018

Occupational Health & Safety

Key hazards and OH&S risks

Hazardous materials used in the processes

Legal obligations

Risk Factors

Rate of accidents higher than average for the business sector?

Yes No

Members of the public present on the organization's site (hospitals, schools, airports)?

Yes No

The organization is facing legal proceedings related to OH&S?

Yes No

Temporary large presence of many sub-contractors causing increased OH&S risks?

Yes No

Dangerous substances present in quantities exposing the plant to risk of major industrial accidents?

Yes No

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ISO/IEC 20000-1:2018

IT Service Management System

Your organization must have management controls over the following processes.

Process	Y / N
Service level management	Y N
Service reporting	Y N
Service availability management	Y N
Service continuity management	Y N
Budgeting and accounting	Y N
Capacity management	Y N
Information security management	Y N
Business relationship management	Y N
Supplier management	Y N
Incident management	Y N
Problem management	Y N
Configuration management	Y N
Change management	Y N
Release management	Y N

Please briefly describe the main processes

If there is an outsourced process, please list it

Relevant technical and legal requirements (licensing documents)

If it is an integrated management system, which system is it integrated with?

⚖️

ISO 37001

Anti-Bribery Management System

In which countries does the company operate?

Has an anti-bribery risk assessment been performed for all processes/activities?

Sensitive anti-bribery processes at headquarters and number of personnel involved?

Organization Category

Involvement in legal inquiries related to bribery in the last 5 years?

Has the organization been convicted of bribery in the last 5 years?

Has the organization been involved in any legal proceedings related to bribery in the last 5 years?

Does the organization receive compensation from public entities greater than 30% of its turnover?

Relevant technical and legal requirements (licensing documents)

If it is an integrated management system, which system is it integrated with?