Advanced Audit Planning

Audit Planning and Review Form (Yearly/Recert/Transfer)

Please complete the following questions, as applicable for each facility in the scope of certification for the upcoming Audits

Company Name(Required)

Name(Required)

First Last

Date Completed:

Standards: List

Phone(Required)

Email(Required)

Type of Audit? (Yearly/Recert/Transfer/Special):

Yearly/Recert/Transfer Audit Planning Questions: Note: Response(Q 3-17): YES/NO/N.A? ( If response to any questions is “YES”, please provide detail information/attachments as appliable) (ISO 9001, ISO 13485, ISO 14001, ISO 45001, ISO 27001, ISO 20000, ESD S20:20, ISO 50001, HACCP,AS 9100...)

1) What is your current total number of employees Full-time, Part-time, Seasonal, Temporary, Contractors included)?

2) What is your current number and hours of shift/s ?

3) Are there any changes to your contact information, address, number of sites, etc.?

4) Are there any major changes to your organization and/or management system and processes (key managerial, decision making, or technical staff)?

5) Are there any changes to legal, commercial, organizational status or ownership?

6) Are there any changes to current certification scope, statutory, regulatory, and/or contractual requirements?

7) Please provide copy of updated product list and regulatory compliance evidence/list such as FDA, EPA, OSHA, DOD, FCC etc., and the related certificates/Permits as applicable

8) Are there any changes to design requirements, if appliable?

9) Are there any changes to the outsourcing of any activities in the scope of the management system?

10) Are there any changes to your process documentation since your last audit? If so, please send updated copy

11) Is there any expansion of facility such as adding new space or building, etc.?

12) Are there any changes of company infrastructure that could affect the quality management system such as upgraded process equipment, IT, or major remodeling, etc.?

13) Is NDA required for your company? If so, please attach.

14) Are there any changes to design requirements, if appliable?

15) Are there any changes to the scope of operations under the certified management system extension/reduction)?

16) Please provide your current Accounts Payable name, contact information and email.

17. Additional Questions for the specific certification standards for the company’s coming audit as applicable: 17-1 - ISO 13485 (Medical Device):

a) Are there have been any changes to the medical list? (Please send the updated medical list). (Required)

b) Are there have been any Medical Device recalls? (Required)

c) Are there have been any citations by any Regulatory Body? (Required)

d) Are there any Advisory notices issued for any of medical Device Products? (Required)

e) Are there have been any new product approvals by any Regulatory Agency? (Required)

17-2 - ISO 14001 (EMS):

a) Are there have been any changes to the Environmental Regulations list? (Required)

b) Are there have been any changes in the Permit requirements?(Required)

c) Are there have been any citations by any Regulatory Body? (Required)

d) Are there any new processes/products/equipments that may effect on Environment? (Required)

17-3 - ISO 45001(OH&SMS):

a) Are there have been any changes to Occupation Health and Safety Regulations list? (Required)

b) Are there have been any changes in the Permit requirements? (Required)

c) Are there have been any citations by any Regulatory Body? (Required)

d) Are there any new processes/products/equipments that may have effect on the Occupation Health and Safety? (Required)

17.4 - ISO 27001/ISO 20000 (Information and Cyber Security):

a) Are there have been any changes to Regulations list? (Required)

b) Are there have been any changes in Permit/License requirements? (Required)

c) Are there any breaches of information security? (Required)

d) Are there have been any citations by any regulatory body? (Required)

e) Are there any new processes/products/equipments that may have effect on Data Integrity and/or Data Security? (Required)

17-5 - ISO 22000 (Food Safety Management System):

a) Are there have been any changes to Regulations list? (Required)

b) Are there have been any changes in Permit/License/approval requirements? (Required)

c) Are there have been any issues of Food Safety, Recall etc.? (Required)

d) Are there have been any citations by any regulatory body? (Required)

17-6 - ESD S20:20 (Electro Static Discharge Control Program):

a) Are there have been any changes to Regulations list? (Required)

b) Are there have been any changes in Permit/License/approval requirements? (Required)

c) Are there have been any issues related to ESD? (Required)

d) Are there have been any citations by any regulatory body? (Required)

17-7 - ISO 50001 (Energy Management System):

a) Are there have been any changes to the Energy Regulations list? (Required)

b) Are there have been any changes in the Permit requirements? (Required)

c) Are there have been any citations by any Regulatory Body? (Required)

d) Are there any new processes/products/equipments that may effect on Energy? (Required)

17-8 - HACCP (Food Safety Management System):

a) Are there have been any changes to Regulations list? (Required)

b) Are there have been any changes in Permit/License/approval requirements? (Required)

c) Are there have been any issues of Food Safety, Recall etc.? (Required)

d) Are there have been any citations by any regulatory body? (Required)

**Please make a note that the Internal Audit and Management Review will be audited during every audit.

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