Hi All

Its so good to be back to my favourite cove.

My client is to be recertified for ISO 9001:2000 in April 2009. At present all processors are very messy. Each head of units from purchasing department, sales, after sales, hr, production and workshop department are not using any CPAR's, not following the SOP's, not stamping their drawings with Master copies and forwarding this to the Document Controller to place into the Master List, and many more flaws that i had observed during my inspection with the head of units.

I am employed as the MR to get them back in track and pass this certification. Before i begin with the Internal Audits, and Management Reviews, is there any framework that i can start on?

Please help.

Thank you.

Sincerely
Cheryl Lourdes
MR since 2006

Hi All

Its so good to be back to my favourite cove.

My client is to be recertified for ISO 9001:2000 in April 2009. At present all processors are very messy. Each head of units from purchasing department, sales, after sales, hr, production and workshop department are not using any CPAR's, not following the SOP's, not stamping their drawings with Master copies and forwarding this to the Document Controller to place into the Master List, and many more flaws that i had observed during my inspection with the head of units.

I am employed as the MR to get them back in track and pass this certification. Before i begin with the Internal Audits, and Management Reviews, is there any framework that i can start on?

Please help.

Thank you.

Sincerely
Cheryl Lourdes
MR since 2006

Cheryl,

Are you a consultant for them or actually an employee?

I would call for a meeting with the process owners (department managers) and help them with a plan to get this quality system back on track again. After the plan (who will do what, when where, and how?) has been developed, get approval from the top person. Then get started; let the managers do their work and be available for assistance. The managers must take ownership, otherwise they end up in the same mess as they are in now.

By the way, you will be recertified to ISO 9001:2008. ;)

Good luck.

Stijloor.

Hi Stijloor
I was working in this company many years ago but now i am on contract for them for 1 month as an MR to get them their certification. Thanks for the information.
regards
Cheryl

Hi Stijloor
I was working in this company many years ago but now i am on contract for them for 1 month as an MR to get them their certification. Thanks for the information.
regards
Cheryl

I would start with a Project plan (Gantt Chart) to track the deliverables vs actuals.

Btw, when you say "contract basis", is it time dependent or you could work until certification ? I am asking this question as 2 months (Mar and Apr 09) may be short to get the required documentation and QMS culture for ISO 9001 :rolleyes:

Hi Ajit,

Any examples on how to do this deliverable versus actuals?

I am only given lesser than 2 months to get them certified. I am really worried.

Perhaps a set of internal audits would be the right place to start. That will give you objective evidence of what is or is not working the way it is planned. You mention an inspection with the heads of departments but that may not be giving the full picture. I believe it is better to know fully what the situation is before you put together an action plan.

Perhaps a set of internal audits would be the right place to start. That will give you objective evidence of what is or is not working the way it is planned. You mention an inspection with the heads of departments but that may not be giving the full picture. I believe it is better to know fully what the situation is before you put together an action plan.

Agree. Inspection is superficial whereas internal audits (provided it is done properly) is akin to diagnosis. At least you know the true situation and where to start with.

Hi Ajit,

Any examples on how to do this deliverable versus actuals?

I am only given lesser than 2 months to get them certified. I am really worried.

To start with, as mentioned earlier, I would recommend a 6 months period for certification. This again depends on the size of the organization.

I have prepared a Road map specifying different action items that could be helpful to you for certification.

I would break these 6 months as follows :

Planning and development - 1 month
Develop processes and prepare documentation - 2 months
System Implementation - 3 months.

The system implementation includes running the QMS as defined, gathering records, performing Internal audits and Management Review with final certification as the last item.

Best Luck :agree1:

Agree. Inspection is superficial whereas internal audits (provided it is done properly) is akin to diagnosis. At least you know the true situation and where to start with.

The Food and Drug Administration (FDA) of the US do not call Audits but they call Inspections - thus both terms are the same and on another note, the auditor term is replaced by Inspector ;)

Cheryl,

Are you a consultant for them or actually an employee?

Lourdes,

There is a reason why I asked that question. Does this apply to you?

Who will be the MR when you leave?

5.5.2 Management representative
Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and
maintained,
b) reporting to top management on the performance of the quality management system and any need for
improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

Emphasis mine.

Stijloor.

Cheryl,

I agree with the excellent advice given. I can only add that based on the brief facts provided, that '1 month' sounds like a rather unrealistic timetable, unless you mean something like '1 month's total effort, over a longer timeframe' and that the company itself fully understands & expects that they will commit quite a lot of internal resources to all the corrective action needed.

I was in a similar situation 2 years ago - contract MR brought in shortly prior to recertification audit. I started with a comprehensive internal audit - all the processes / departments and initiated CARs to fix the problems. I then followed up with weekly meetings with all the managers to track progress on the CARS. In the end, the recert went well and the system continued to function after the audit. Hope this helps. :)

I have prepared a Road map specifying different action items that could be helpful to you for certification.



I was struggling to explain the certification process to my management. They just weren't getting it, this is a great tool to visually explain the process and a great way for them to see the progress.

a+ Ajit!!!:thanks:

I was struggling to explain the certification process to my management. They just weren't getting it, this is a great tool to visually explain the process and a great way for them to see the progress.

a+ Ajit!!!:thanks:

I am very glad that this was useful to you :)