Do we need to update our Management System procedures when somebody leaves?
In our current society, people are always on the go, and businesses are not immune to employee turnover. Whether people move to another company or change positions within the same organization, the reality is that people don’t stay in one job forever.
The Dilemma of Procedure Reference on Process Maps and Quality Manuals
A reader asked, “I have the need to create a procedure as part of our ISO program and was wondering, should this procedure be listed on the process map either as a core process or as a supporting process? …
Document Control 101: How to comply with ISO and API without being trapped by your own words
Sometimes the interpretation of the ISO 9001 or API Q1 9th Edition/API Q2 requirements seem to force us to do things we won’t be able to do, or sustain for more than a few months— let alone days…
Numbering Schemes: Would a Document Register Help?
A reader recently asked us, “When generating a new form, procedure, or document, how do I know which number to use? How do I know which numbers are available? Let’s say I create a Receiving form…
Procedure vs. Work Practice
A reader recently asked, “What is the difference between a procedure and a work practice? For example, when a job is completed it is sent to Invoicing…
How to Write an ISO or API Compliant Quality Manual
How To Build A Perfect Quality Manual Quality Manual Series: Part 3 of 3 Ah, so you read my part 1, “The Abominable Quality Manual,” and part 2, “How Did We Get Here,” and now you are ready to learn how to build a perfect Quality Manual. Well, I have good news and bad news …
How did the Quality Manual Come to be a Mirror of the Standard?
How did this all start? Quality Manual Series: Part 2 of 3 Way back when, we used to have a Quality Manual with the following elements: A picture of our process map (to satisfy the sequence and interaction of the processes) …
The Abominable Quality Manual
Is a Quality Manual that simply regurgitates the standard useful for continual improvement? Quality Manual Series: Part 1 of 3 Have you ever seen a Quality Manual that did not look exactly like the ISO standard? Not lately, probably …
ISO Document Review: Do I HAVE to?
Deciding how to control your documents can be difficult. ISO 9001 requires you to maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between the requirements and the implementation lie grey areas and confusion. Let’s take a look at the difference between what is required and what …
Are You Sure the Procedures Your Organization is Using Represent Your Organization’s Processes? Using Process Mapping Concepts to Develop Accurate Procedures
To work properly, procedures have to match the company processes, and each organization must have their own set of processes which should be different than that of their neighbor. Even when companies build or perform similar activities, each of them has different culture and details that will make them unique and therefore they will have …
The History Behind MXI-CON-HOU-SOP-2-009-A
Back when the ISO 9001 standard came about over 20 years ago, emphasis was on documentation and unfortunately not much on the organization’s processes. Although the standard was well intended it caused many companies to produce a chart similar to the one below: Most organizations had the exact same chart on their manuals and whether …
Beginning the ISO 9001 Journey: The Quality Policy
Quality Policy The quality policy is meant to be a statement or a group of statements that reflects your organization’s culture. It does not necessarily have to repeat the sentences or paragraphs contained in the ISO 9001 standard nor include some words contained in the ISO standard, or much less be similar to another company’s …
