What Was Old Is New Again
By Michael Haycock, Sr. BRC Consultant
Just about the time we get comfortable with what we’re doing – there is change.
Documentation as a requirement has been in place for the ISO 9001 standard for a long time. Back in 1987 and 1994 there were 20 requirements (if you were 9001) and most required a documented procedure and even if it wasn’t required – it was expected (you know…that unruly and pushy auditor). When ISO 9001:2000 came along there were only 6 requirements where documented procedures were specifically required. This carried over into ISO 9001:2008. Many of you maintained documented procedures for all requirements because you recognized the value of doing so OR you were “strongly urged” to do so by your external auditor (registrar). In the past, ISO 9001 always specified a “Quality Manual” (ISO 9001:2008 requirement – 4.2.2).
In all cases documents kept as evidence of required activities were called records. While there were cosmetic changes over the years, very little actual change in detail.
Now the big change – maybe…
ISO 9001:2015 no longer identifies procedures, records or even a Quality Manual. It does require us to “maintain” documentation, or “retain” documentation, or to have and control documented information.
To start with (the good news) is that while it is necessary to meet requirements, you are not required to use the structure or “specific terminology” of this standard. (Introduction, 0.1 General, about 3rd paragraph down). This is good because some of you have been calling your documentation procedures, work instructions, records, etc. for many years – and certainly may wish to continue doing so.
Let’s talk about what the requirements are and even if not specifically identified, what you may actually need. Where the standard indicates you need to “maintain” documentation this is equivalent to having procedures, work instructions or other controlled documents that create the expectation for the activities to be carried out. Where the standard indicates the need to “retain” documentation, this is equivalent to having records or documents that provide evidence that required activities have been carried out.
A little detail on application and usage of documentation.
A Quality Manual is not specifically identified or required. My opinion however, is that the Quality Manual is the means to link all requirements of the standard and the Quality Management System together. This “policy” manual details the requirements of the standard (because it is your policy to do so). Policy is the upper level of expectations when you are using the standard to identify the requirements to which you apply your system. This policy then provides the common link to the procedures (who, what, where, when, why) and the work instructions (how) you actually carry on the work of the organizations.
I have had a “mostly” gentle argument (with others) over the years that the Quality “policy” Manual may actually be a close mirror image of the standard – and if that is the case then why would it be necessary. In the past this was moot because you were required to have a manual (regardless of how constructed).
I still prefer this structure because most people in the organization never actually use, or have access to, the standard. As previously described the “manual” is a document that should allow anyone, regardless of their understanding of the standard, to access any part of the system needed for any reason. It only needs be created once, and if kept sufficiently generic would never have to be revised until the standard changed again.
The detail of these requirements, when kept in procedures or work instructions, are much simpler to change or control. Without the detail in the procedures and work instructions, this manual is a document that could be shared with customers, interested parties and throughout the organization. While it represents the system used by the organization, created properly it does not…and should not…compromise any sensitive information.
Procedures will still be necessary to detail the who, what, where, when and why. Much of what you already have may still be used. The manual (using the ISO 9001:2015 numbering) may be used extensively to link to your current procedures. After trying a number of different methods, I have found this to be most simple and effective. Where there are work instructions to support the procedures they may be referenced (identified as “maintain” documentation 4.4.2a).
Work instructions are mostly the “how”, and if used should be linked back to procedures. Documentation should be developed so the detail for information is only provided in one place. Less opportunity for conflicting information – more opportunity for simple control and change (managed the same as procedures.)
Records are documents that provide evidence supporting the activities actually carried out (identified as “retain” documented information or documentation – 4.4.2b).
There are a variety of word combinations used for documents and documentation.
Repeating, for clarity:
4.4.2a) Maintain – procedures, work instructions or other doc’s providing expectation
4.4.2b) Retain – records – documents providing evidence
The standard does not use the words “manual”, “procedures”, “records”, etc. Can you? Of course! The standard and more specifically the system to which it relates when applied to ”your” system – belongs to your organization. While you have to cover the requirements, you do not have to use their terminology or structure (ISO 9001:2015, Introduction, 0.1 General, pg vi). My preference is to use the standard terminology because I “teach” and “do” and want to avoid any confusion. You should do what will be most understood and will create the least confusion.
Just for clarity – you can always do more than is required. (You are then responsible for this, of course.) We have seen concern that because a Quality Manual wasn’t a specific requirement that it was something not allowed and could not be included. Absolutely not the case – the standard is the base and as long as that is in place, you can build anything else you wish. Again – what you build, you are responsible for.
The means by which you address these requirements is still up to you. Hard copy, electronic and any combination of these methods are possible. Processes are required to be identified but this should be in the detail and by the means most valuable to you including flow charts, process mapping or simple words.
There are definite and distinct changes to the ISO 9001:2015 standard. This does not prevent you from using the best tools and methods available to you – including what has worked for you in the past. We are always available to answer your questions.
A little something from the past…
In the rugged veldt of South Africa, the lion and antelope awaken from their night’s sleep. The lion knows it must run faster than the antelope or starve. The antelope knows it must run faster than the lion or be eaten. Regardless of whether you are the lion or the antelope, in the morning the one thing you know – you must be running. Seemed appropriate…