Myths Buster | ISO 9001
I spend a lot of time researching and listening to clients and so-called 'experts' in the field of ISO Standards and thought, well hoped that I could clarify a few things and help dispel many common miss-conceptions associated with the ISO Standards.
Here a few of my favourite picks:
"We need to write procedures for everything that we do for ISO 9001"
No, the ISO 9001:2015 standard no longer requires any documented procedures.
Where a procedure may benefit, for example, to reduce business risk, then we would certainly recommend it, however, the spirit of the standard is continual improvement and not endless reams of procedures.
We are ISO specialists and not 'wordsmiths' so we will document your system, as opposed to giving you a system of documents.
"All businesses that have ISO 9001 must have procedures and work instructions where people work."
Again not the case, how many employees/staff come into work each day and open a procedure manual before they start work? Competent staff do not require procedures to do their job properly- In our opinion, it is far better to have well-trained staff.
Additional formal documented procedures should only be implemented where the 'business' feels they are needed, and not because somebody 'thinks' the standard demands it.
"We have to have a quality manual like a door-stop that nobody reads."
A Quality Manual is not a mandatory requirement of ISO 9001:2015.
Even before the ISO 9001 2015 standard, back in the days of ISO 9001:2000 (including the 2004/2007 versions). The requirements of ISO 9001 stipulated that the Quality Manual only needs to include the scope of your management system, details of any justifications for any exclusions, a 'reference' to any procedures and a description of the interaction between the processes - That's it - You could fit it on one page !!
So there's certainly no need for a dusty door-stop. However in some cases, Q-Manuals can be quite useful for some businesses to assist with the navigation of the system, so should a manual be required by our clients, we are more than happy to write up a 'Quality Reference Manual' as a reference/training aid.
Unfortunately, the common practice still is to copy the clauses of the standard and replace 'shall' with ''we do' - This is very bad yet common practice. It serves no purpose whatsoever for the business and can be a liability during audits and with the administrative burdens associated with maintaining the manual. The manual should belong to the business, and not just be an edited copy of the standard. A 'Quality Reference Manual' used for training/reference/guidance purposes is, in our opinion the better option.
"We will need to appoint a Quality Manager when embarking on ISO 9001?"
Not the case, this is a business decision and certainly not an ISO requirement. The older versions of the standards did have a requirement for a Management Representative' but this was removed in the 2015 version of ISO 9001.
in some SME's the responsibilities of the representative/Q-Manager can be shared out among current staff.
"Document Control is an administrative nightmare, we may have to recruit an administrator of the quality system to approve and distribute everything."
This is one of the biggest and potentially most damaging beliefs that surround the ISO standards, and assessors should not contribute to this problem by demanding the adoption if inappropriate large complex company techniques.
Also, we have noted that many authors of books do not help the situation when 30% of their books often focus on document control and brush over the really important requirements like customer focus, improvement objectives, performance evaluation and continual improvement.
It's worth mentioning the ISO 9001:2015 Quality Standard itself dedicates 294 words to Documented Information and a mere 65 words to Customer Focus!!
The missed trick by many is in fact within the 9001 standard. It's the 'Note' tucked away below clause number 7.5.1 (b).
The extent of documented information for a quality management system can differ from one organisation to another due to:
— the size of organisation and its type of activities, processes, products and services;— — the complexity of processes and their interactions;
— the competence of persons.
I would also add - the risk to the business
"Why do we have to produce loads of flowcharts, we end up getting all confused and really don't see the point."
The ISO 9001 standard does not ask for any flowcharts or process maps at all. These are usually recommended by consultants as a business improvement tool or to see the business processes more clearly. They can also be useful for internal audits.
We believe they are a benefit to the business, consultant, certification auditor/assessor and the business's client therefore we provide these at no additional cost however they are not a requirement of ISO 9001.
The standard actually only requires you to describe the business processes and their interaction, theoretically, this may be done, if you wished to, using a camcorder !!
"I keep my client details and communication in files, some are on e-mails and some are in design files. I was told that I must set up specific customer files and number them in a certain way."
Not true, it may be preferable to maintain a customer file if it helps your business, however there is no requirement in the standard for this. The standard states that records shall remain legible, readily identifiable, and retrievable. If you can demonstrate this with your records being in files, folders, cabinets or on e-mail and it works for your business and customer then fine.
"ISO 9001 will take away our flexibility as a business."
Not at all true, the ISO 9001 standard allows flexibility throughout its requirements, businesses need to be flexible, and the standard does not hinder this in any way.
"Getting ISO 9001 is simply documenting what you do then always do it?"
Not true and arguably a bad way to approach the entire project.
The ISO standard is really about focusing on your customers, setting measurable business improvement objectives, monitoring your processes, and continually improving how you operate as a business.
Also how could you possibly improve if you always do what you have done in the past?
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