Without knowing the rest of the sentence that each statement goes with I would suggest that number 1 probably comes from a section of the standard that's talking about your top level procedures - so for example your document control policy (it wouldn't make sense to have lots!), where number 2 is probably lower level - for example if you're manufacturing multiple products like ITL does, we have to have separate procedures for each product, hence the multiple.

G M Butcher Please do not be concerned about the singular/plural case used in the question. Write what is done and use one or more procedures (SOPS, etc) as you see the need.

Eckhard Jokisch ISO-13485 does not define where an how you document procedures. In fact there might be procedures that are part of a different procedure. In this case you have a sub-procedure which could be documented within the parent procedure. Main thing you need to take care of is that you quickly find the right procedure in the moment of an audit.
2) means that each and every procedure has to be documented. In other terms you may not have any procedure that is executed freely just on guts feeling. It also means that an answer to an auditor may not be "I do it this way because person x (or even worse 'someone') said so.
1) is telling you that it is not enough to define and establish a procedure for a specific purpose but also you need to document this procedure.

So both is true and has to be in place.

David P Norby, PhD, CQE (ASQ) It's a bit difficult to discern from your question whether you are referring to the need to prepare formal written statements of the steps needed or required in order to acceptably complete a particular task (i.e. prepare a standard operating procedure).

Or are you possibly referring to the need to record/document the sequence of activities actually undertaken/completed in order to complete a task - with or without the prior existence of a formal standard protocol (e.g. a redbook record of a laboratory investigation into an unexpected event or outcome).

Either way, recording/documenting is expected and required. Written documentation/justification of the rationale and explanation of the logic that interprets the laboratory data is expected as part of the record.

In most settings, you will find the easiest acceptance of recorded findings (when audited) if there are pre-approved protocols that are available and used for their intended purpose when conducting an investigation.

Ian Hendra Apologies Azza, but I'm as to why you're bothering with 13485:2016 as nobody wants it!

Health Canada wants MDSAP, the 2016 edition isn't harmonised in the EU or listed as consensus standard by the FDA (no version of 13485 ever has been).

As for MDSAP, the audit methodology and expected responses are public info so your question is moot.

OK, I can find the words "A documented procedure" only in clause 4.2.4 Control of documents. Everywhere else the plural applies (BTW table A1 is wrong about clause 7.5.8). In English the use of the singular implies a single procedure. I usually set up a matrix here where each row states a single 4.2.4 requirement with columns for each type of documentation ( hard copy, on-line, drawings, references , forms etc ).

There's a common misunderstanding in our profession that a "procedure" is a document, it isn't, it's "an established or official way of doing something" so it follows we all need heaps of them!

I hope this helps.

I dont think this is a big issue. You might have one procedure for each process or different procedures for each process. That depends on your quality system, the risk of the process and the company policy. If you provide me with more information, the context I will be able to provide you with a much more accurate answer/opinion.

1) Document procedure: describe a part of the process which the procedure refers to, this document may contain Work instructions, forms, checklists and other relevant elements that support the document description of the activities.
2) Having a procedure in place is not enough. The procedure must be maintained, including the changes that they may occur in the process (7.3.9).

Erik Hatlanek Erik Hatlanek ISO 13485:2016 use the term procedure, documented ptocedures and record (item 4.2.) So it is up to You to determine it in the Manuel.

Edwin Bills, ASQ Fellow, RAC There is no requirement in ISO 13485 for any specific number of documents. You have to be able to show where you have covered a requirement in a procedure. Some small companies have one procedure for example, that covers the requirements in 7.3 on design and development, where some large companies have a large number of procedures (e.g. 20-30) to cover the same topic.

Just create procedures appropriate for your situation to cover the requirements. Also be aware that there are some exclusions that you are allowed, such as not providing servicing and installation procedures if you don't produce devices that require installation and servicing. You just need to document the rational for not providing those procedures.

Karl-Heinz Spohn in the session 7.3.9 design changes it may make sense to have two procedures: one for changes during development (small process) and one after design freeze which includes e.g. a checklist which reflects all kind of influences of the change .

The standard tell you what you must have not how you have to do it. However, the standard practice is to have 1 Quality Manual which references the standard. I generally do 1 SOP per applicable element remember an SOP is an overview) and then reference down to Work Instructions 9think of them as recipes) for the actual tasks. So for instance I might have an SOP for Document Controls and then have a WI for Creating, revising, obsoleting documents and a WI for control of standards etc. This makes it easy for auditors and easy for training. No one likes 30-40 page documents.

Tina Krenc, M.S. The most important things are:; 1) the procedure (or procedures based on your organizational needs and procedural hierarchy) covers the activities required in the standard; 2) that people who follow the procedures are trained and there is evidence of that and 3) people follow the procedure and there is objective evidence of that.

Mark Proulx, CQA, cSSBB azza ghodhbani To answer your question, procedure or procedures is simply a "catch all" to let you know you need at least one established procedure (documented or shown to be the way you do things normally), but you may have more than one procedure if needed. Have a way to provide objective evidence that your company can demonstrate consistency in a process, whether documented or demonstrated.

Ruud Lans Yes! Write one or more in one procedure which is related to one chapter e.g. So keep the structure and avoid writing per subparagraph of a chapter individual procedure. Minimize and keep it simple but always unambigeous clear suitable and workable for all internal stakeholders involved!

Ruud Lans Are we all missing the clue? ISO standards are standards! QMS are company specific written as to follow by all working as employee, (sub) contractor. The applicable law(s), rules and guidelines are above and beyond to be in compliance with.

Jonathan Wacks You might be overthinking this one a bit. It’s a document written by industry volunteers, formed into bureaucratic committees...

Jonathan Wacks -that is the most honest answer I've seen on topics like this in ages. It reminds me of the late 90s and early 2000s when the standards all switched to bring process oriented- the standards all do require interpretation and thought to implement correctly, but more at the level of "what was their intent here" rather than "what did they mean with this specific word".

In answer to the specific original question-as long as you've got the requirement documented (in however many places and whatever forms are appropriate for you) no auditor will busy your chops. The real question is "what format will actually add value to your company?" For example, if you are regularly spinning up new internal auditors or making internal audit tasks be add-on duties to other employees, rather than a single procedure for "all internal audits" you may want to include the internal audit instructions in each sop individually, with schedule and response plans and an audit checklist built right into the procedure for process "x". Or, if you have a dedicated quality team that will handle all such duties, you might want to combine your management review and internal audit procedures, or you might want to keep everything separate.

azza ghodhbani Thank you everybody for your answers. As you all said, the number of procedures does not matter since we implement the requirement of the standard. This was confirmed by our auditor too.

Deryk Flood

You can download for FREE this checklist ISO 13485:
https://www.qmswrapper.com/files/whitepapers/Checklist_iso13485/QMS%20for%20ISO13485_2016.pdf