Gap Analysis for a non ISO 9001 company

[KCIPOH]

Hello cove members,

I just wondering the gap analysis :
If perform for a company which is existingly running on a basic system and heading towards ISO9001:2008 implementation it will show them which area they are lacking in and need to further improve to meet the standard requirements but if it is for a company which is never having any system in place and if they perform a gap analysis, i think the result they will have from the gap analysis will for them to start from the beginning, am i right?

Wondering

[samsung]

In Reply to Parent Post by KCIPOH

Hello cove members,

I just wondering the gap analysis :
If perform for a company which is existingly running on a basic system and heading towards ISO9001:2008 implementation it will show them which area they are lacking in and need to further improve to meet the standard requirements but if it is for a company which is never having any system in place and if they perform a gap analysis, i think the result they will have from the gap analysis will for them to start from the beginning, am i right?

Wondering

Infact a gap analysis is (and can be) done against a standard (or some criteria). Having said, you, at first, need to establish a criteria against which to evaluate your system. Since, there's no system in place, as you said, you can well start with the checklist (see the files section here).

Alternatively, if you search the forum or scroll down to the end of the page, you will get plenty of information on this issue. You can also try this one and here also.

You can also visit ISO website here for further information on implementation of ISO 9001.

[Boscoeee]

In Reply to Parent Post by KCIPOH

Hello cove members,

I just wondering the gap analysis :
If perform for a company which is existingly running on a basic system and heading towards ISO9001:2008 implementation it will show them which area they are lacking in and need to further improve to meet the standard requirements but if it is for a company which is never having any system in place and if they perform a gap analysis, i think the result they will have from the gap analysis will for them to start from the beginning, am i right?

Wondering

Not necessarily, if you currently are in business I suspect that will meet some if not many of the requirements of ISO 9001:2008. Perhaps the system is not formalized but if your are manufacturing and delivering product you have a system that you use.

The strategy is to clearly understand what you do and perform a gap analysis against what the standard requires. This will will allow you to create a plan plan for implementation.

Best of luck,

[AndyN]

Don't forget that a Gap Assessment/Analysis isn't a 2 dimensional thing. That is what do you does/doesn't comply with ISO 9001. You have to consider also the effectiveness of what's being practiced day to day. It's not unusual for an organization to overlook something which needs some work to make it effective!

[JaneB]

In Reply to Parent Post by Boscoeee

if you currently are in business I suspect that will meet some if not many of the requirements of ISO 9001:2008.

Yes, exactly.
Whether you're a manufacturing, distribution or service business, if you're successful enough to be even contemplating getting ISO 9001, then you DO already have some kind of system and you will already meet some of its requirements. (Otherwise, you'd be a failed/defunct/bankrupt business.) Give yourself/the business credit for what it's already achieved.

The only time you'd ever 'start from the beginning' is with a brand new startup business or a brand new contract for the scope. Always recognise that any business or organisation will already meet some of the requirements, even if only partially, or not very well/effectively. Andy makes a good point about considering effectiveness.

[The Specialist]

In Reply to Parent Post by KCIPOH

Hello cove members,

I just wondering the gap analysis :
If perform for a company which is existingly running on a basic system and heading towards ISO9001:2008 implementation it will show them which area they are lacking in and need to further improve to meet the standard requirements but if it is for a company which is never having any system in place and if they perform a gap analysis, i think the result they will have from the gap analysis will for them to start from the beginning, am i right?

Wondering

Whilst it may appear that they have "no system in place", this is extreamly unlikely.

They will have been operating to all sorts of internal specifications, whether documented, or not. The gap analysis will determine what needs to be done to align with ISO standard and what documentation and improvements need to be put in place.

I agree with all other posts, above.

[Colin]

See also previous post.

[John Broomfield]

In Reply to Parent Post by KCIPOH

Hello cove members,

I just wondering the gap analysis :
If perform for a company which is existingly running on a basic system and heading towards ISO9001:2008 implementation it will show them which area they are lacking in and need to further improve to meet the standard requirements but if it is for a company which is never having any system in place and if they perform a gap analysis, i think the result they will have from the gap analysis will for them to start from the beginning, am i right?

Wondering

KCIPOH,

Every company is a system (parts that work together).

Every established company has some form of management system for determining and fulfilling customer requirements (most of the time to stay in business).

Therefore a competent system auditor can determine the gaps between this natural management system and ISO 9001.

Experience tells us that natural management systems often lack processes for:

1. Document control and control of records
2. Control of nonconforming product
3. Internal audit (and perhaps management review)
4. Root causes removal before or after a nonconformity

Beyond the obvious gaps (like no documented quality objectives) the gap analysis tends not provide much more planning information than this.

Actual nonconformities (often missing process controls) with ISO 9001 can be determined by a systems/process analyst (also trained as a lead auditor) working with the process owners to analyze and document the management system and its processes (to the extent necessary for effective planning, operation and control).

Indeed, the system development team closely implementing the requirements of clause 4.1 makes the gap analysis unnecessary.

A survey to determine the architecture of the management system may be advisable for larger multi-site companies.

John