Last time in Part 1 we talked about the former lives of Quality Manuals, now we will look to the future.
In the 2015 revision, there is no longer a requirement for a Quality Manual. Quality Manuals, Procedures, Work Instructions, Forms and Records are referred to as Documented information and it is left up to the organization to decide what documented information it needs to function and how it is presented. More on this in our next post.
Do I need a Quality Manual or are they ‘for the birds?’
Just like the manual that came with your refrigerator, your lawn mower,or your television, a quality manual could outline what is expected to be done and possibly who will do it or even how it will be done. Following the requirements is a must in order for an organization to receive ISO certification but nowhere in the Standard is it said those requirements must be documented anywhere in particular.
In addition, The International Standard is not intended as be all / end all road map for the organization, instead it is a checklist for auditors to determine if the organization complies with the requirements. This document: ISO 9001:2015 outlines the requirements an organization’s quality systems must satisfy and what documented information is required. The International Standard has not expressly listed itself as one of those requirements but instead leaves the determination of document requirements up to the individual organization. That is right – You get to say what is needed, not the auditor. Now the fun starts!
Before we explore the need for a Quality Manual there are a number of things we must consider (many of which will be covered in subsequent posts):
- If we are just starting this journey or have we been on the path for a while
- What we presently have for documentation
- Our organizational context
- Scope and boundaries
- Interested parties, their needs and expectations
- Our products
- Our threats and opportunities
- Size of the organization and types of activities
- Complexity of the processes and their interactions
- Competence of our people
- What we want to be when we grow up… This is known as Organizational Maturity.
Please keep this in mind – The auditor and consultant have an advantage. They may not know you or your processes but they do know the Standard; it is what they do for a living. Because they have been exposed to many different (and similar) work environments, they are able to enter your facility and within a short period understand your key processes – processes you may feel are unique and complex. The truth is there are only so many ways to ‘get the job done.’ Although your process may be unique to your organization, the experience of that auditor or consultant allows them to connect the dots and since they know that ‘the devil is in the detail,’ they are trained to look at the bigger picture.
Yes an auditor will look at Work Instructions, observe an operator performing the task, talk to others to determine if they know what is expected, look at training records and form an opinion of what is compliant and what is not.
Just a side note: The myth about an auditor needing to justify their existence by writing findings is just that. Their primary function is to determine compliance, not create more work for themselves. This is an important point to remember when we actually get to documenting information – the harder we make it for the auditor to verify compliance, the more likely we’ll have to ‘fight for our right to party.’
You have asked the question: “Do I need a Quality Manual?” I have to ask you back, “Do you?” The bottom line is, you need to decide, but I remind you of the paragraph above – How hard, or easy, do you want to make it for your auditor? If you already have a documented system and it is working for you, then it is a no brainer – keep it. If you are starting from scratch, you may want to check out my next post on Documented Information. In addition, for all you Old-Timers, who may feel cheated about not getting a ‘Magic Bullet,’ be patient, I will not let you down.
See you next time.