9001 ISO 2015 Audit Checklist

This ISO 9001 audit checklist offers a thorough comparison between your existing quality management system and new ISO requirements, providing an invaluable opportunity for analysis. Optimizing quality management systems starts here.

Utilize this 9001 audit checklist for internal audits to streamline planning, guide the process, and document auditing activities and findings.

Clause 4 – Design and Development
ISO 9001’s Design and Development clause provides a process to be followed when creating products or services. It covers all activities related to designing, such as developing new offerings as well as improving existing ones.

Organizations should ensure they document and implement this process to comply with ISO 9001:2015 standards, including reviewing all changes during Design and Development to ensure they do not negatively affect product or service conformity.

Organizations must also learn from both their positive and negative experiences, both good and bad. This can be accomplished in various ways such as project debriefs, job close-outs, staff meetings, analysis of data and customer feedback. One effective strategy to do so would be formally documenting knowledge management systems or through informal methods like project debriefs or staff meetings.

Clause 5 – External Providers
People tend to express concern with clause 8.5.3 of 9001 iso 2015, which requires organisations to handle property belonging to customers or external providers with care. This could include materials, components, tools and equipment as well as intellectual property such as drawings and specifications belonging to such people or organisations.

Check that the organization has documented how it identifies, verifies, protects and safeguards customer and external provider property during handling and processing. Specifically, ensure that there is an established process for reporting when this property becomes lost, damaged or unsuitable for use and how these reports are resolved.

Verify the procedures for the evaluation, selection, monitoring and re-evaluation of external providers are documented and effective. This includes criteria used in these evaluations as well as actions taken from them – this might involve using risk analysis to set these criteria – this checklist also details how these activities are communicated to external providers as well as information retained – this checklist comes pre-populated for these activities so it’s easy to customize for your own processes and procedures.

Clause 6 – Process Monitoring
Monitoring all procedures is an invaluable practice that allows businesses to identify any that require updating, leading to improved performance and compliance with standards. Furthermore, monitoring can also serve to promote employee engagement with quality practices resulting in overall company success.

Companies should develop plans for inspecting/testing their product/service before providing it to customers, with documentation of these efforts, their implementation and monitoring processes.

Assuming these objectives have been met, examples of monitoring objectives could include: reduction of product defects, PPM’s (defect parts per million), scrap rates and rework; improvement of on-time delivery etc. Organizations use the ISO 9001 Audit Checklist to conduct internal audits against the requirements of ISO 9001 standard. Once complete, this checklist is then submitted to a certification body which conducts an on-site audit to validate that all documentation satisfies ISO standard requirements.

Clause 7 – Corrective Actions
This clause sets forth your arrangements for identifying and taking corrective actions for nonconforming products and services, including reacting to them; evaluating their need; implementing, monitoring, and reviewing their effectiveness/sustainability.

To meet this requirement, you should implement suitable and robust systems for recording internal communication (a subsequent clause will cover customer communication), documenting any improvement ideas that arise and implementing them as soon as possible. One way of accomplishing this would be creating a central repository where all procedures, forms, records etc can be stored allowing employees access and editing by employees with ease and where the latest version can be easily pulled down by using tools like Mango – helping keep everyone up to date!

Our ISO 9001 audit checklist offers a thorough internal audit procedure for your auditors to follow when conducting internal audits. Easily customize this template during purchasing to match the processes in place at your company before providing it to auditors and lead auditors to use during their audits.