6 Requirements for an ISO 9001:2015 Transition Audit

[roneljdsilva]

Re: 6 requirements for ISO 9001:2015 transition audit? Anyone?

Hello Kales!

I have just completed the gap analysis between the two standards and do not see a reason to update procedures/forms. Am I missing something here?

The main pointers I got from the analysis was

1. Make sure top management know what their responsibilities and accountabilities are in relation to effectiveness of the organization's QMS .
2. Risk-based thinking(QMS and product)
3. Improvement

Since the standard requires us to determine or consider a lot of things. I felt we could determine and document it in a manual(not mandatory but makes things easier)

Your comments on the same please. Thanks!

 

[LUV-d-4UM]

Re: 6 requirements for ISO 9001:2015 transition audit? Anyone?

I hope you find these comments helpful as we have succeeded in transitioning to the 2015 standards:

1. You are absolutely correct. New CB auditors can catch this one easy and can give a major or suspend the audit if Top Management does not know his accountability and commitment to get involve with the implementation.

2. Risk-based thinking ). That went well during the audit.

3. Continuous Improvement - Effectiveness of CI was examined during the transition.

Your comments on the same please. Thanks![/

 

[Kales Veggie]

Re: 6 requirements for ISO 9001:2015 transition audit? Anyone?

Hello Kales!

I have just completed the gap analysis between the two standards and do not see a reason to update procedures/forms. Am I missing something here?

The main pointers I got from the analysis was

1. Make sure top management know what their responsibilities and accountabilities are in relation to effectiveness of the organization's QMS .
2. Risk-based thinking(QMS and product)
3. Improvement

Since the standard requires us to determine or consider a lot of things. I felt we could determine and document it in a manual(not mandatory but makes things easier)

Your comments on the same please. Thanks!

Missing something? That depends on your current QMS.

1. 9001:2015 requires more than responsibilities and accountabilities
2. What about processes? What about external parties?
3. I do not know what you mean with that.

I suggest you look again both standards. Consider context, applicability, internal and external issues and relevant interested parties, changes in quality policy requirements, management review and corrective actions to name a few.

 

[John Mann]

Re: 6 requirements for ISO 9001:2015 transition audit? Anyone?

they will audit to BOTH standards during the transition audit. Unless you are transitioning during the 3 yr recert audit. You have to be compliant to both standards at once.

Really? can you point me to a requirement for that?

 

[Paul Simpson]

Re: 6 requirements for ISO 9001:2015 transition audit? Anyone?

Also, for the quality manual. I would not remove anything because they will audit to BOTH standards during the transition audit. Unless you are transitioning during the 3 yr recert audit. You have to be compliant to both standards at once. I added the 2015 things to the manual, like interested parties and risks and such. Over time I will dissolve the manual entirely.

As this has been picked up I thought it best to respond: There is no expectation at a transition audit that you will comply with both the 2008 and 2015 editions. It is highly likely, however that a system that meets 2015 will also meet 2008 as the only significant area where the 2015 edition places fewer requirements is for documented procedures.

If, in making any system changes to be ready for 9001:2015, the organisation decides to get rid of some procedures (for document control, records, audit, non-conforming, corrective or preventive action) you could find your system doesn't comply with the 2008 edition but you are already committed to transition to 2015 so any non-compliances will be written around that standard alone. Even if you can't be recommended for transition at the audit your CB will give you some time to implement a plan to address any Major NCRs for them to be able to certify the organisation to ISO 9001:2015.

 

[normzone]

Thanks all, a beautiful thread, bookmarked for future reference and entertainment as we transition next year.

But today, I'm prepping for next week's external 9001:2008 audit, so see ya later ...

 

[cc1987]

Hello,

I am currently trying to tie up loose ends for our ISO 2015 transition. I am hung up on items such as "Context of the Organization" and "Organizational Knowledge," I am sure that I am over analyzing both clauses. Does anyone have any advice on how to handle these items and any tips on how to get through transition audits.

 

[Sidney Vianna]

Extensively discussed here and here.

 

[cc1987]

Thank you so much.

 

[roneljdsilva]

Okay so I've been dealing with the transition myself and now have the audit in 2 weeks so I'm guessing I've got it somewhat figured out. Hope this helps.

1. Context of the Organization:

This is basically identifying (or in ISO terms, determining) the internal and external issues you have in your organization. I documented these issues in my Quality Manual to be safe (although not mandatory, you could even have your management say it verbally and it should work). Think of the real issues that can affect your organization's ability to provide on-time delivered product meeting quality requirements. For eg: Internal issues could be availability of competent personnel (considering you do high precision work) and external issues could be availability of suppliers or market conditions, etc.

2. Organizational knowledge:
This I tackled quite easily and although I'll only know if my approach worked after the audit(which I could update you if you like) I sure think it'll work.

What you need to show is explained quite clearly in the ISO clause. What must your people know to get the job done right? Although procedures are no longer mandatory I would suggest you hold on to them.

I made a form identifying the key positions in the organization (grab it from the organization chart which you MUST have) and then determined what procedures and standards (internal and external) are required by a person hired in that position needs to know to get his job done right. It's really easy to make and at the time of the audit this could be used to explain to the auditor how you identify training too!
Hope this helps!

Regards,

Ronel