A Woman's Approach to ISO 9001 - Documentation

A Woman’s Approach to ISO 9001 - Documentation

?It’s hard to believe, but next year will mark my 30th year working with the ISO 9001 requirements. I can barely say it let alone believe it!

I probably would not have believed you if you told me I would make this a career. But little by little, job by job and company by company, I became increasingly convinced that I enjoyed my work and was good at it.

And that counts for a lot. I want to delve into why I enjoy it and am successful at it because a lot of my success had to do with what I learned from mentors along the way that affected my attitude and approach to implementing and maintaining quality management systems. For me, it’s about helping things to work right and witnessing improvement.

I believe women have a distinct approach to ISO 9001 and quality in general. I say this because I have been a witness to it, and I now feel compelled to share some of what I have experienced throughout the years of my involvement. As I evolved, each layer of learning became part of my toolbox that I could share with the organizations I was involved with.

I hope you will understand the ISO requirements better and genuinely understand the power of such a simple but succinct document. Is it perfect? Not! It needed improvement the moment it was last published. The ISO requirements are in a state of continual improvement.

It’s important to understand that ISO 9001 is a global standard and the most popular of all the standards published by ISO. You should also know that many countries worldwide must agree on the standard each time it is revised. The countries who use it must come to a consensus, and each country has unique concerns. It’s very political, and it’s not an easy task to get everyone to agree. Arguments ensue, and the process takes months and months.

Over one million companies and organizations in over 170 countries are certified to ISO?9001. Why? Because it is highly adaptable and can be used by any organization, regardless of size or type of business.

Here's my simple, earthy approach. A quality management system (QMS) is not a thing. A QMS is an organic, changing force. Why? Because the first ingredient is people. A QMS is a combination of people, processes, and tools that you decide to use to get the job done. The processes tell the story of how things should be accomplished. The systems and tools you choose to use will support the effort. The people in and outside of the system make the whole thing work. And when things don’t work right, the first place to look is with the people. Remember that thing called human error?

A QMS doesn’t land on your doorstep from the Amazon Prime truck. It’s not something you install that comes out of a box. Although some consultants would like you to believe that so they can sell you their “ISO in a Box!” A QMS is something you build with people.

I chose to start these discussions about ISO 9001 with the topic of Documentation because, throughout my career, it seems to be one of the most significant stumbling blocks for organizations implementing or maintaining a QMS.

Regarding documentation, I am a minimalist, and those of you who know me or have worked with me know that I consistently say, “You’ve got too many documents!” But let me tell you why.

Documenting something becomes auditable in your Internal, Surveillance, Certification, and Re-Certification audits. That means the documentation must be accurate to the work being done. If it isn’t and gets audited, there could be a non-conformance. Monitoring, maintaining, and reviewing process documentation regularly is vital but often challenging.

This can become an added burden if you have a lot of process documentation in your department, are shorthanded, or are just plain busy. Which is always, right? ?Maintaining documents can be an added burden if a new system is implemented. And that new system may also mean that your present documentation will now be inaccurate. That means new documentation is necessary. When does this stop?

Back in the day, an old saying went like this: “Do what you say, say what you do.” You may have heard it. Look at the words; it says nothing about writing. But everyone, and I do mean everyone, seemed to interpret that to mean they needed to document everything they did! I was there, and I am not sure how that caught on, but everyone was furiously writing every little thing, afraid of missing anything! The result was tons of binders of printed procedures distributed all over the place. A nightmare to revise. That is so old school, so 80s! Thank goodness computers came along.

I am here in 2022 to tell you it does not mean that. In modern times, yes, we are in the 21st century; it just means that you should be able to articulate what you do during a conversation with an auditor. It’s called the show and tell show. I do this; let me show you how I do it. Simple! You just demonstrated competence.

Here’s what you need to know. A QMS built on the ISO 9001 requirements is not meant to be a monstrous catalog of documents. This may come as a shock to some. You should not be building a “system of documents.” Instead, you should “document the system” wherever you believe it is necessary.

And remember that the word “necessary” means different things to different people. So, deciding what “necessary” means to your organization at the beginning of your implementation would help avoid the common and dreaded mistake of over-documenting.

So how do you decide what is necessary? Here’s where the level of competency of the people doing the work comes into play. When sophisticated systems are being utilized to process work, and everyone is highly skilled and trained, you may not need as much documentation.

Suppose you have production activities in your organization. In that case, you’ll need more detailed work instructions or videos for the workers to demonstrate how things should be done and how finished products should look. Whatever method, ensure the proper training. The key is demonstrating competency, showing that you’re getting the desired results, and explaining the process during an audit. And remember that on-the-job training (OJT) can count for a lot. Just keep good training records.

Don’t fall victim to a documentation obsession that redirects your priorities. That is one of the fastest ways for employees to get a bad taste for the QMS. And it comes right at the beginning of the implementation, which is not an excellent way to get started. If the masses grumble in the beginning, you’ll impede your ability to show them the value of the QMS. The phrase “ISO sucks” comes to mind! And no doubt, they feel pressured to document their entire lives and already have a job that keeps them busy.

Your job is to run the business, not a bunch of documents. Strike a balance between the ISO documentation requirements and the fundamental business of running the company. Make sure people are adequately trained and that they can demonstrate competence on the job.

Whenever there is a question or doubt in anyone’s mind, I always refer to the ISO 9001 requirements. The requirements for documentation in Section 7.5 Documented information start by stating:

??“The organization’s quality management system shall include:

a)??documented information required by this International Standard.

?Okay, easy. But let’s stop right there. And let me preface that statement.

The ISO 9001:2015 requirements for documents are very relaxed compared to previous revisions. The first ISO 9001 standard was published in 1987, with revisions in 1994, 2000, and 2008. The 1987 and 1994 revisions required twenty documents plus a Quality Manual. The 2000 and 2008 revisions required six documents plus a Quality Manual.

By 2015, there had not been a comprehensive revision to the standard since the 2000 version. The 2008 version was merely a minor cleanup of the 2000 version, and there was a good reason for that. During the economic downturn of 2008-2009, many companies were either going belly up, laying off vast amounts of workers, or suffering terrible losses.

At that time, a global decision was made?only to make minor changes. It was felt that changes that required too much work on the part of certified companies during a time of economic stress would cause the companies to give up their certification rather than comply. Not a good thing!

So what documents are required to comply with the 2015 version?

You may be surprised to learn that the number is very few. You’ll need to document your Scope, Interaction of Processes, Quality Policy, and Quality Objectives. Why are there so few required documents? Because ISO 9001: 2015 was meant to reflect how work is accomplished in a modern organization where things are less manual and more automated. Systems are doing the work. Remember, the way we do work changed radically from 2000 to 2015. So, it makes sense that the newest revision would also reflect that. And I am confident that the next revision will be even better.

There are no requirements for a Quality Manual, although companies new to ISO may choose to publish one. But trust me, no one reads it! The six procedures required in the 2008 version are also no longer needed. Once again, organizations just starting with ISO 9001 may choose to create documents for Corrective Action, Internal Audit, and Document Control if that makes them comfortable. But suppose you have an automated system for your QMS. In that case, you could rely on the system’s dictates and the ISO 9001 requirements and remain in compliance if you work your automated system properly. Just a thought.

The next requirement in the ISO 9001 standard states:

“The organization’s quality management system shall include:

b)??documented information determined by the organization as being necessary for the effectiveness of the quality management system.

That’s where the “necessary” part comes into play.

There are a few NOTES that read:

The extent of documented information for a quality management system can differ from one organization to another due to:

·?????the size of organization and its type of activities, processes, products, and services;

·?????the complexity of processes and their interactions;

·?????the competence of persons.

It should be noted here that NOTES in the ISO 9001 standard are not auditable. They are there to be helpful. The other part of the Documented Information section outlines how documents are created and updated and how they are controlled. I’ll save that for another discussion.

So that’s it! Those are the requirements for documentation and my philosophy on how it can be easy. Honestly, it would help if you spent time working on fun stuff like continuous improvement efforts, improving results, and building a Culture of Quality, not babysitting documents! In doing so, you will feel like you are getting more benefits from ISO 9001.

I hope this discussion was interesting and helpful, and most of all, it helps you realize that ISO 9001:2015 can be as easy as we want to make it. The choice is always yours. If you have any questions or concerns regarding anything to do with a QMS based on ISO 9001:2015, you can contact me!

Next up: A Woman’s Approach to ISO 9001 – Management Review