There are many myths surrounding ISO 9001.
Let’s start off by dealing with the twelve most common ones.
Myth #1 – Implementing and maintaining ISO 9001 is expensive.
Beyond the costs of third-party assessment there should be no additional costs. All organisations should have clearly defined how they work to ensure customer satisfaction.
If you document what you do and put in place processes to improve what you do it doesn’t need to be expensive. You probably already have most of what you need.
Myth #2 – ISO 9001 is the responsibility of the Quality Department and you must have a Quality Manager.
You don’t need a Quality Department to run ISO 9001 and you don’t necessarily need anyone full time to run it. Your ISO 9001 quality management system should be about how you run your business – not how you run your Quality Department if you even have one.
Myth #3 – To implement ISO 9001 you just copy the standard inserting the name of your company.
There are many quality consultants who offer to provide a customised quality manual based on rewording the ISO 9001 standard. The quality manual should describe how your business works, the scope of the management system, the procedures used and their interaction. The ISO 9001 standard lists the requirements your management system needs to meet – it isn’t a quality management system itself.
Myth #4 – Every process must be documented.
The ISO 9001 standard says that the extent of the documentation can be tailored according to the size of organisation, the type of activities, the complexity of the processes, and the competence of personnel. The ISO 9001 standard only requires six procedures to be documented – plus any procedures that are needed to ensure that the planning, operation and control of the organisation’s processes is effective.
Myth #5 – A cross-reference must be maintained showing how each process meets each requirement of the standard.
Whilst this is useful in ensuring that all the requirements of the standard are met it is not, in itself, a requirement of the standard. It is often “demanded” by assessors and auditors because it makes their work easier. [See ISO 9001 4.1]
Myth #6 – Procedures (and forms) have to be signed, numbered and have version numbers and dates on them.
The standard requires that documents have to be controlled but there is no requirement for them to be signed, dated, numbered or version controlled. Forms are not mentioned in the standard. [See ISO 9001 4.2.3]
Myth #7 – A master list of documents (procedures and forms) has to be maintained showing what the latest version of each document is, where it is kept and for how long.
The standard does not require such a list. [See ISO 9001 4.2.4]
Myth #8 – The management review has to be a meeting that covers all the inputs of ISO 9001 5.6.2 and outputs of ISO 9001 5.6.3.
The review does not have to be a meeting and only the relevant requirements in 5.6.2 and 5.6.3 need be considered. [See ISO 9001 5.6]
Myth #9 – All suppliers have to be rated and regularly re-assessed.
The organisation should decide when and how it evaluates its suppliers based on the impact the purchased product has on the finished product. [See ISO 9001 7.4.1]
Myth #10 – Every piece of measuring equipment has to be calibrated or be given a reference-only sticker or label.
There is no requirement for stickers or labels. [See ISO 9001 7.6]
Myth #11 – Customer surveys have to sent out regularly to customers to measure their satisfaction.
The standard requires that the organisation monitors their customers perception as to the extent to which the organisation has met their requirements. How this is done is up to the organisation to decide. [See ISO 9001 8.2.1]
Myth #12 – The audit schedule must cover 12 months, all procedures must be audited within 12 months and all clauses of the standard must be audited over a 12 month period.
The standard requires that audits are planned and take into account the status and importance of the activities to be audited and what happened at previous audits. No timescales are defined. [See ISO 9001 8.2.2]
There is no substitute for carefully reading the ISO 9001 standard, being clear about what it requires, and deciding how best to meet those requirements in your organisation. Don’t let any consultant, auditor, or assessor try to tell you that there’s a “best practice” that you should follow. Decide what’s right for your organisation, check that it meets the actual requirements of the ISO 9001 standard, and you will have nothing to worry about!
The requirement for a “Quality Manual” from ISO 9001 is a long standing one from BS 5750 (the precursor to ISO 9001) and was typically a large document (“never mind the quality – feel the width”).
