The Q1 Spec has about 30 sections called “clauses” with hundreds of individual requirements. Lot’s of things you need to do to avoid audit findings and get certified, right? Actually, it’s really not that daunting. The vast majority of API findings are in only 9 clauses. In our upcoming free webinars we’ll cover the most

API published the Q1 9th Edition 2nd Addendum in June with an effective date of June 2019. But that doesn’t mean you can forget about it until next year.  Beginning immediately auditors are looking for compliance with these new requirements. Don’t wait until you get a finding before you implement these changes to your QMS. The

Calibration Audit Video This video (click on "Calibration Audit Video" above) is from our API Spec Q1 online course. It is one of the lessons on what an auditor looks for. There are several similar lessons on common Q1 audit finding areas. You can find out more information about the course on our website under

Design and Development Potential Audit Issue: When Design Contains Sensitive/Confidential Proprietary Intellectual Property Owned by the Customer API Specification Q1 9th Edition paragraph 5.4 has 7 sections, each of which require you to maintain records. I won’t go into all the details of those records requirements here. You can refer to the Spec if you

API Specification Q1 Addendum 2 has just been published with a 1 year implementation deadline of June 2019 for Monogram Licensees and Q1 certified organizations. When you think of the word “addendum” you probably think of something insignificant added at the end of a document. Probably no big deal, right? Well, this addendum is a