ISO 9001 Program Checklist

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Overview

Use the ISO 9001 Program Checklist to follow and move forward to be audit ready. You can download a copy of this checklist at the end of this article.

Learn more about continuous ISO 9001 compliance with TrustOps for ISO 9001!

ISO 9001 Audit Checklist

ISO 9001 CHECKLIST
1 – SCOPE
☐ Identify the people, processes, and technology that support your business.

       ☐ Have you identified the relevant stakeholders needs for your product/service?

       ☐Have you identified the most relevant laws and regulations relevant to your product/service?

       ☐ Have you identified a critical physical location relevant for your product/service?

2 – STAGES
☐ Identify the people, processes, technology, stakeholder needs, applicable legislation, and location that support your business. Both stages are performed during an ISO 9001 audit

       ☐ Stage 1 if you were asked to demonstrate the design and execution of controls

       ☐ Stage 2 if you were asked to demonstrate operating effectiveness of controls over a period of time,

3 – GAP ANALYSIS
☐ Identify your current documentation posture

       ☐ Have you specified and properly documented the activities and procedures that make up your company’s control environment?

       ☐ Do you review documents on a regular basis to make sure they are up to date and accurate?

       ☐ Do you have your Quality Management System (QMS) policy documented?

☐ Identify your current control environment posture

       ☐ What is the organization’s governance structure?

       ☐ What is the tone and example of executive leadership and management?

       ☐ Have you designed and implemented hiring and exit procedures?

       ☐ How are personnel who are implementing or directing internal controls evaluated for competency?

       ☐ Are possible threats being identified?

       ☐ Have you put any mitigating plans in place?

       ☐ Do you have a protocol for dealing with incidents and a disaster recovery plan in place?

       ☐ What kind of management supervision and governance do you have in place to control the environment and reporting events, security problems, and fraud?

       ☐ Have you established a Management Review Committee to discuss QMS specific topics?

☐ Identify your current security environment posture

       ☐ Do you have access limited to positions that need it, with the appropriateness of the access being reviewed on a regular basis?

       ☐ Do you have policies in place for giving and taking away access from workers, customers, and other parties?

       ☐ Do you encrypt data while it’s in transit and while it’s at rest?

       ☐ Do you impose restrictions on administrative access to the technological stack?

☐ Identify your current risk mitigation environment posture

       ☐ Have you conducted vulnerability assessments or penetration testing on a regular basis to detect weaknesses in your environment?

       ☐ Do you have backup processes in place?

       ☐ Do you test your disaster recovery procedures on a yearly basis to guarantee that you can restart  operations in case of a calamity?

       ☐ Do you regularly check for intrusion attempts, system performance, and availability?

☐ Identify your current system changes and posture

       ☐ Are system modifications tested and authorized before they are implemented?

       ☐ Do you inform your employees about system changes?

       ☐ Are your controls being monitored on a regular basis?

       ☐ Have you enabled notification of settings changes?

       ☐ Is your technology up to date in terms of upgrades?

       ☐ Do you have a system in place for separating development and production tasks?

☐ Identify your current posture in a remote working environment.

       ☐ Is technology being used uniformly across all employee locations?

       ☐ Is time synchronization enabled on all employees workstations and software?

       ☐ Do you provide staff with regular security awareness training, address data privacy in common spaces, use secure connections while working from home, and raise awareness of phishing attempts?

       ☐ Do you use multifactor authentication to get into your company’s network and other systems?

       ☐ Have you deployed mobile device management to make sure that mobile devices are encrypted and authenticated?

4 – CONTROL IMPLEMENTATION
☐ Design the controls to address your gaps

☐ Implement controls to address your gaps

☐ Test the controls to ensure that they are operating effectively.

5 – STATEMENT OF APPLICABILITY (SOA)
☐ Document all your clause controls in an SOA

☐ Document all your Annex A controls in an SOA

☐ Document any non-applicability (i.e Physical Security)

6- INTERNAL AUDIT
☐ Identify an internal auditor

☐ Grant them access to TrustCloud.

7 – AUDIT READY
☐ Identify the auditor

☐ Initiate kickoff to set expectations

☐ Grant them access to TrustCloud.

8 – MAINTENANCE
☐ Maintain the program to show continuous compliance via TC integrations

☐ Perform surveillance audits every year

Download ISO 9001 Checklist (docx)

Download ISO 9001 Checklist (pdf)

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