If we are not meeting our Quality Objectives are we ready for ISO 9001?

[Ralph Long]

You should make sure that your management review(s) notes or minutes highlight your concerns. Be specific but brief. Use internal audit results to show where the system is failing. Product conformance, process performance and delivery issues are results of system failure. Those should be addressed but, separately from the management system audit review.

The management review is a KEY component of the overall system. After your input management should produce some actions and/or decisions. If you present the information correctly, then those actions/decisions should highlight a course of action - either continuing with the cert. audit (with corrective action) or delaying.

Back to the original post: In my opinion, you do not have to meet the overall quality objectives to become certified. BUT you should have clear actions in place to achieve those goals. It would help if by the time of the audit that some of the corrective action was effective (if not meeting the goal, at least moving in the right direction).

Unfortunately - you have to abide by the decisions of management. If the organization goes ahead with the cert. audit at least you presented the options. Most likely - based on what you have provided - the organization will have to make some corrective action to make the system compliant (at best)....but this time the directive will come from the cert. auditors.

Good luck!

 

[tammydiz]

Best reply yet!

 

[JaneB]

We are currently in the process of certifying our QMS. The auditor company did a pre-audit prior to setting the certification audit date.

From the pre-audit we got a list of corrective actions and nonconformities that we need to address before the certification audit can take place.

Is this something that your certification auditor can offer?

That's part of the certification process itself.

 

[JaneB]

I would simply lay out the facts as they are to Management.

If we have an audit based on the current plan we will not get certified because of A, B and C ...

Not only that but we will then have to accomplish corrective action to those issues within time frame described by CB and it will cost us more.

Just plain give the facts. Do not over state the facts do not be a dooms dayer just state the facts. When the facts have been stated ask, "would you like me to schedule the external audit as was first scheduled"?

That is what I think your role in this situation is.

Good advice. I agree entirely.

Put the facts in front of management and allow them to make the decision. That's their job and their responsibility. They can still plough ahead and try to meet their original goal date... but you'll have given them plenty of factual data that indicates this is not a wise decision. At least if/when they flunk, they'll know who to blame (if blame they seek).

Yes, start-ups are hard. I agree, for what it's worth, that you do need to get processes at least reasonably stable and be achieving at least some of the targets before certification becomes possible. But I would be looking for a way (as suggested above) to present them with factual data on which they can make their decision. (And if they ignore it, at least that's down to them, not you.)

 

[Bunny]

Sounds to me that the question is not about the company meeting it's objectives, the question is are they meeting the requirements of the standard. The answer is simply NO. There is absolutely no way the company is ready for an initial assessment audit without having completed internal audits, management review, training and without having released all the required documents. The internal audit piece along with the management review piece are critical and no auditing agency will even begin the audit without those met. If the management team of the OPs company is not listening to the OP, I suggest the OP go ahead and schedule the audit. The OP then can ask the certification audit team to perform a desk review. At that time the audit team will see the gap and postpone the audit. Then the OP can say " I told you so".

 

[Sidney Vianna]

The real question is the organization ready to move forward with the certification audit?

The IAF devised a 2-stage process for certification. Stage 1 audit is a readiness review. An excerpt of the APG Paper on the need for a two-phases approach to certification reads:

Auditing ISO 9001 requires auditors to obtain a good understanding of an auditee’s quality management system (QMS) and the nature of its business. This is why it is beneficial for an organization to be visited prior to its certification audit and for a 1st stage audit to be conducted.
This 1st stage audit is primarily for scoping and planning a certification audit (the stage 2 audit) and to allow the auditor to obtain an understanding of the organisation. For example, to gain knowledge of its QMS, policies, objectives, risks, processes, locations, etc. It is also may be used for the auditing body to communicate its needs and expectations to the auditee.

Activities performed at a preliminary 1st stage audit include:
• auditing the client's management system documentation;
• evaluating the client's location and site-specific conditions, and undertaking
discussions with the client's personnel in order to determine the preparedness of the client for the stage 2 audit;
• reviewing the client's status and understanding regarding the requirements of the standard, in particular with respect to the identification of key performance indicators, processes, objectives and operation of the management system. [If the system is lacking in any way, the auditor should note this in the audit report, so that the client has an opportunity to rectify the identified deficiencies prior to its certification (2nd stage) audit].
• collecting any necessary information regarding:

o the scope of the management system,
o the processes and location(s) of the client,
o related statutory and regulatory aspects and compliance requirements (e.g. for quality, legal aspects of the client's operation, associated risks, etc.);​

• reviewing the allocation of resources needed for the stage 2 audit, and reaching agreement with the client on the details of the stage 2 audit;
• providing a focus for planning the stage 2 audit, by gaining a sufficient understanding of the client's management system and site operations in the context of possible significant aspects;
• evaluating if internal audits and management reviews are being planned and
performed, and whether the level of implementation of the management system substantiates that the client is ready for the stage 2 audit.
• agreeing a date for the stage 2 audit

So, the OP should have the stage 1 audit performed ASAP so the CB can provide feedback about the adequacy of moving forward with the certification process, or not.

 

[John Broomfield]

Thanks for your reply though. Objectives are set so that we have a way to measure ourselves and a goal to achieve (and to improve). At this point we are failing to our objectives, not achieving any goals and certainly not improving on them! One would think that eventually we would make our objectives more difficult (tighter), so that we can show more improvement to them or show that we are at some point able to maintain them, but we have to reach that objective first.

Tammy,

If your system is causing the necessary actions and improvements then it may still conform to ISO 9001 and be ready for certification.

Did you start with the system that was already running the business?

Surely, because the company was in business, it was fulfilling even modest goals for:

• Product conformity?
• Customer satisfaction?
• Process performance?
• Supplier performance?

Now TM have set new objectives and are investing in the changes necessary to meet them per your system's process for "investing in improvement"?

Or did you impose these objectives?

If your new system is neglected then look at the reasons for this. It may be that you did not start with the system that was already running the business.

John

 

[tammydiz]

Good advice. I agree entirely.

Put the facts in front of management and allow them to make the decision. That's their job and their responsibility. They can still plough ahead and try to meet their original goal date... but you'll have given them plenty of factual data that indicates this is not a wise decision. At least if/when they flunk, they'll know who to blame (if blame they seek).

Yes, start-ups are hard. I agree, for what it's worth, that you do need to get processes at least reasonably stable and be achieving at least some of the targets before certification becomes possible. But I would be looking for a way (as suggested above) to present them with factual data on which they can make their decision. (And if they ignore it, at least that's down to them, not you.)

I appreciate your reply very much...it was sensible and well written.

 

[tammydiz]

Did you start with the system that was already running the business?

Surely, because the company was in business, it was fulfilling even modest goals for:

Product conformity?
Customer satisfaction?
Process performance?
Supplier performance?

These were not objectives that I established while implementing the QMS. They were in place prior to me coming on board. Top Management established overall goals and cascaded them down to each functional area, the functional areas established objectives to these goals (KPI's). As part of my gap analysis I have reviewed the KPI's and this is the current state of the company.
Because this is a start-up company they took in orders before they were capable to fulfill them thinking that they would have a smooth ramp up and a short trial phase. Unfortunately the equipment has not met expectations and in many cases has not been accepted by the company (or released by the OEM). However product is still going out the door. This product does not always meet customer specs nor is it timely. Our customers are not happy and have not been happy, but luckily we have sister facilities that can provide product as well (which requires additional lead times). As for supplier performance - it is still under development until the end of the month.

 

[tammydiz]

What - I can't get all this done by summer?? Are you kidding me....LOL!!! I like saying "I told you so!!"