Records, Retained Documented Information, and ISO 9001:2015

ISO 9001:2015 does a lot of things right, but using clear language is not one of them. One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That’s right, they took one word and turned it into three. And the three words are not nearly as intuitive as the one word they replaced. Regardless of what you call them, records are the proof of something happening. They are historical, referring to past events. As such, they are not revised. Records might be “corrected” in some cases, but they are never revised. Only documents are revised. (We’ll address documents and their status in ISO 9001:2015 in a future article.) The primary control of records is that of housekeeping: knowing where they are stored, who is responsible, how long they’re kept, etc.

Here is a summary of records requirements in ISO 9001:2015:  

·         24 records are required in ISO 9001:2015. This is compared to 21 records required in ISO 9001:2008. Some of the 24 records required by ISO 9001:2015 are actually repeat requirements.

·         20% of all the record requirements come from section 8.3, Design and development of products and services. That amounts to 5 records, which is the same number required by ISO 9001:2008.

·         A completely new record that is required in 9001:2015 is retained information on changes: review of changes, persons authorizing the change, and necessary actions arising from change (section 8.5.6)

·         ISO 9001 continues its redundant ways. ISO 9001:2015 requires records of evidence of processes being carried out effectively TWICE, once in section 4.4.2 and again in section 8.1.e.1.

·         More redundancy: ISO 9001:2015 requires records that demonstrate conformity of products & services processes TWICE, once in section 8.1.e.2 and again in section 8.6.

·         5 of the records in ISO 9001:2015 have qualifiers. They are “to the extent necessary” and “as applicable.”

·         One item listed as “retained documented information” (i.e., record) is actually a document. That is design outputs. Design outputs are living information such as specifications, engineering drawings, recipes, formulas, and bills of material. Since they are living, they are subject to revision, meaning they are documents.

·         A handful of requirements would be virtually impossible to have evidence of without records, and yet records are not required by ISO 9001:2015. These include context of the organization (4.1), interested parties (4.2), planning of changes (6.3), and customer feedback (9.1.2).

·         One of the strangest record issues of all is the omission of calibration records in ISO 9001:2015. This has been replaced by the requirement to ‘retain information on fitness of purpose for measuring instruments,’ which would include calibration. I expect many people implementing ISO 9001:2015 will get a bit confused by this. 

Do not let anyone tell you that the “correct” terminology is retained documented information. If you like that term, then by all means use it. If you prefer the term ‘records,’ you can use that in its place. Always remember that documents are records are two different things. That one fact alone will make any QMS easier to use and understand. 

Nobody believes in communication more than Darryl Keeler. As President of Tech Systems Inc., communication is possibly the single biggest part of his job. After all, Tech Systems Inc. (www.techsystemsinc.com/) is security systems integrator with employees in over 32 states, Canada, and Puerto Rico. Being a medium-sized company with business across such a wide geographic has its challenges. Darryl Keeler long ago decided that robust and continuous communication needed to be a guiding principle. “Communication is the key factor in maintaining a high level of employee satisfaction,” Darryl assured me. “And satisfied well-informed employees ensure that we have highly satisfied clients.” Darryl personally writes the Friday Finale, a company newsletter summary that ends each week and which goes out to every employee. It maintains a warm touch, covering birthdays, work anniversaries, and anything personal of importance that is happening with teammates. It also addresses business updates from the previous week. TSI Family Emails (TSI stands for Tech Systems Inc) is their way of communicating items that are of high importance to the entire company, sort of “red alert” emails. These include process changes, policy changes, and major customer developments. The TSI Family Emails are one step beyond the Friday Finale’s in terms of business importance. The Tour De Focus is one of the company’s most impressive communication processes. This is where Darryl Keeler travels around the country and meets with every company employee. He simply sits down and asks for comments or opportunities for the company to improve based on individual opinions.  These are all captured and recorded, and the leadership team works through all of them and gets back with the folks who suggested the improvements.  This entire list is posted on SharePoint for everyone to review, and the ideas always number in the hundreds. The employee portal is the live repository of information that team members use for their jobs. Only the most current versions of documents are available, and it also includes phone lists, updates, tutorials, and training materials. Finally, the leadership team of Tech Systems meets every Monday to go over financials, hot company topics, and opportunities for improvement. The Monday meeting also serves as the primary feeder of information into their monthly management review. Communication is clearly the oil that flows through the engine of Tech Systems Inc. And the president of the company, Darryl Keeler, is head mechanic and communicator. 

Control of production at I. Technical Services

Managing operations can be as simple as ringing a bell. That’s the philosophy that I. Technical Services has taken in Alpharetta, Georgia. I. Technical Services (www.itechserv.com) performs electronic manufacturing services, including PCB assembly, system assembly, test engineering, repair, and logistics. They compete against low-cost companies in Asia and elsewhere, so they have to be as efficient and lean as possible. One of their most efficient processes for managing production is their “bell meeting.” At 9 AM every morning, their production supervisor rings a ship’s bell mounted on the wall. All the managers and supervisors assemble under the bell for a stand-up meeting that lasts about 15 minutes. They discuss what is running that day, what needs to be shipped, and any obstacles or concerns. Important notes are recorded on a white dry-erase board right below the bell. “Everybody leaves that meeting knowing exactly what needs to happen,” Quality Manager, Hector Rivera, stated. “It’s the best investment of 15 minutes you can imagine.” Throughout the day, employees refer to the production notes on the white board, keeping themselves focused on what was agreed to. They ring the bell again at 3 PM every day, and the key players once more gather around the bell. The focus of this later meeting is to get everybody caught up on the current status of production. Where are we right now? What is left to be done? Will we meet all of our commitments today? Resources are re-arranged, as needed, and last minute roadblocks are removed. The General Manager, Lauren Thompson, summarized the process by saying, “When we come together under the bell, we’re not managers of different departments. We’re a single team working to wow the customer. It reminds us why we’re there in the first place.” I. Technical Services has conducted their bell meeting twice a day for years. It’s a very simple, yet powerful process for controlling production.