ISOcert Solutions, LLC

Follow our ‘1-2-3’ Implementation Guide: Here’s how

Step 1: Assign responsibilities, goals of your project


Determine who will lead your certification project and have sign-off authority. Who else in the organization – from production, sales, finance, or engineering – needs to contribute? Determine authorities, reporting, procedures, documents and training you will need to complete your implementation.

At the conclusion of Step 1 you will have approved ‘Level 1’ Documents for your Quality Policy, Quality Objectives and Quality Manual. You will also identify the basic processes and interactions (the ‘Scope’) of your business activities that must be documented and require your ability (during certification audit) to demonstrate these processes are followed.

Step 2: Build your Level 2 (processes), Level 3 (who, what, where, when) and Level 4 (records)


Personnel assigned (during Step 1) the task of identifying your processes, gathering and reporting on those processes, edit the supplied materials and submit drafts of the 9 critical processes based procedures of a quality management system. These include but are not limited to, Sales, Purchasing, Document Control, Production, Internal Audit, Risk Management and the data collection necessary to meet the Metrics stated in your Quality Policy / Objectives.

Using QWorks® fully customizable document, form and log templates – complete your Quality System fast and easily.

Step 3: Conduct Your Internal Audit(s), conduct Management Review and schedule Certification Audit


During Step 3 your Team will conduct a complete internal audit of your company demonstrating your successful implementation of your quality system. You and your Team will analyze and report on the data collected at a Management Review. After conducting your internal audit, Process and Procedure discrepancies will be identified and corrected -- and then you are ready for a successful Certification Audit.

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ISOcert® Solutions, LLC

ISOcert® Solutions is the leader in customizable ISO9001:2015 and AS9100D and ISO13485:2016 documentation solutions for small to medium manufacturers. With over 140 successful certified systems to date, we'll help you get your certification.

ISOcert®, QWorks® and QExpert® are registered trademarks of ISOcert® Solutions, LLC.

Phone: (707) 570-5669