Hi all,

I have made some amendments in the quality manual for upgrading to the new standard, pls clarify and reivew is this can be applied or not? (all the new revision made on the existing manual was highlighted in bold)

4.1 QMS Requirements

The QMS satisfies the requirements of ISO 9001:2008 and applies to all key activities and processes (including “outsourced process” which had potential impact on the QMS) of the organization that affects the quality of its final products.

An “outsourced process” is a process that the organization needs for its quality management system and which organization chooses to have performed by an external party. Outsource process of FPL which are having potential impact on QMS shall be determined as follows:

Hi,

IMO. although is not absolute necessary to contain the definition of outsourced process, I think that you can live with that; but is not enough and you should define within your quality management system “the type and extent of control to be applied to these outsourced processes “.

Alin

Hi Al hector,

Thanks for the reply, actually our comp dealt with the building maintenance services, so they outsourced some of their systems like Lift, Escalator etc,

I have listed all the services in lieu continuation with the "outsources definition" para.

Actually those sub-contractor were involved all the preventive & repair works on their relevant systems. how i determine the "type & extent" for this case. These sub-contractors were listed in the inspection & test plan and their relavant method of recording (checklists) were included with the list.

Thanks.

for upgrading to ISO 9001:2008 i have made the following changes in the previous version of manual for the following (all the changes made were identified in bold letters) , pls review and clarify.

4.2.4 Control of Records


All the QMS records are registered and its distribution controlled. To control the distribution, a list of records is maintained by the each department heads and QMR.


And in the control of records procedure i have added a new form " Master list of records contains, name of file, ref, revision,retention period, medium, responsibility & disposal authority.

6.2.2 Competence, Awareness and Training

Recruitment of personnel performing work-affecting quality is based on job description of the position, which describes competence in education, experience, training and skills.

If the selected candidate does not meet the specified job description then appropriate training should be arranged to meet the job scope.

It is the responsibility of the department HOD’s to identify & monitor all the personnel performing relevant task with in the organization to check whether they are affecting “directly” or “indirectly” the conformity to the product requirements.

It is the responsibility of the department managers to determine if the competency level of personnel performing work is sufficient to produce quality product. Otherwise, the manager has to nominate the personnel for appropriate training to achieve the necessary competence.

On completion of training, the effectiveness of the training undergone employee should be evaluated.

Organization also shall routinely conduct QMS awareness training to all personnel, to create awareness on the relevance and importance of their work to QMS.

Human Resource department is responsible for collating Training Need Analysis, organizing training and maintaining personal records on education, experience, skill and training. Respective HOD to evaluate effectiveness of training for their staff.

6.4 Work Environment

The human and physical factors of the work environment, such as sufficient lighting/weather, noise, temperature, humidity, workspace, etc which are needed to achieve product conformity shall be identified and managed by Maintenance Department.

Organization determines and manages suitable work environment for personnel safety and security while meeting tenant’s expectation through security department.

Top management through security department shall ensure the implementation of safety, health and work environment regulations in order to provide a suitable safe work environment.

Safety, health and environment awareness are indicated by displaying relevant signs, taking corrective actions whenever accidents occur.

(I also want to clarify that whether i have to do some sort of impact & aspect monitoring module for those factors mentioned in the new standards)


Process Approach:

In the process Approach (process flow chart) i have identified all the building maintenance services such us checking all the M&E systems as "OPERATION". now how & where i could include the outsources process, whereby those processes is a part of an activity/process - "OPERATION".

0.1 Introduction

I have added one more input in my management review agenda "Risks associated with changes in organization environment". Is it enough. or I have to determine further more.

7.6 Control of monitoring & measuring equipment

Is necessary to monitor, verify & validate, Record all the general softwares used with in the company like Microsoft office, Some free antivirus software, etc which is not used to measure the services.

We also involved with an building automation system. Is it necessary to do the verification & validation for tht also.

Thanks.

Rajes.

You are confusing records and documents. The controls are not the same!

thanks andyn,

is there any other ways to control records, pls clarify.

Thanks.

Hi Rajes,

I think that you should read the Guidance on outsourced processes which can be found on this link
http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/guidance_on_outsourced_processes.htm

About the difference between document and records control my suggestion is to read Mr. Craig Cochran excerpt from "ISO 9001 in Plain English" which was posted on Cove in the following thread
http://elsmar.com/Forums/showthread.php?t=27836

Alin

thanks andyn,

is there any other ways to control records, pls clarify.

Thanks.

Rajes:

You wrote:-

4.2.4 Control of Records


All the QMS records are registered and its distribution controlled. To control the distribution, a list of records is maintained by the each department heads and QMR.


And in the control of records procedure i have added a new form " Master list of records contains, name of file, ref, revision,retention period, medium, responsibility & disposal authority.

You have combined elements of document control - which aren't applicable to records - with records control. Records aren't usually 'distributed'. They are normally 'filed' or retained or archived etc. You might want to re-read the standad which makes clear the requirements. They should be kept separate, IMHO, as they are shown in ISO 9001, because the requirements and controls are different.

How do you store or protect


4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable.

Hi Andyn, Al Hector,

Thanks for the reply. Ya i have read through the guidelines. Very useful. Please also clarify the other changes interpretations also.

Rajes.

Hi all,

I have made some amendments in the quality manual for upgrading to the new standard, pls clarify and reivew is this can be applied or not? (all the new revision made on the existing manual was highlighted in bold)
<snip>

Who is requiring you to upgrade the manual to the new standard?

Hi,

Our organization is planning for transition to ISO 9001:2008 standards
I have some confusion regarding training of internal auditors

Do all the internal auditors need to be trained on the new standards ? or only MR needs to be trained.

Regards
Ram

Hi,

Our organization is planning for transition to ISO 9001:2008 standards
I have some confusion regarding training of internal auditors

Do all the internal auditors need to be trained on the new standards ? or only MR needs to be trained.

Regards
Ram

Ram,

Welcome to The Cove Forums! :bigwave: :bigwave:

No, no training required. No new requirements.

Stijloor.

Who is requiring you to upgrade the manual to the new standard?

Actually the certification body advised us to transit the ISO 9001:2000 to ISO 9001:2008 when they conduct audit last month. so we started ourself to revise the QMS system.

Rajes.

Then the CB should tell you what they require. I expect all registrars to say what needs to be done.

Although I have seen one say "do your own review, and classify the impact of the changed text using our suggested scale".

Moving (changing) without getting a clear idea of where you are going is a good way to get lost.

Do they actually require changing the text in the manual?


Stiljoor - I'd suggest internal auditors (for companies which did not use the current interpretation for the last version) be given a short "awareness" on including information systems, personal data and auditing the review of effectiveness of Corrective and Preventive actions.

Stijloor - I'd suggest internal auditors (for companies which did not use the current interpretation for the last version) be given a short "awareness" on including information systems, personal data and auditing the review of effectiveness of Corrective and Preventive actions.

See post # 15.

Stijloor.

Thank you for the redirect.

hi cove,

Please clarify the interpretation of clause 8.3 - control of non-conforming product in ISO 9001: 2008.

"d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started".


We are a construction company, basically all the defects identified after the hand over (delivery) is to be rectified during defect liability period. we also been established with a individual procedure on handling this.

Is enough i refer back this procedure in the non-conforming product. pls clarify.

Rajes.

hi cove,

Please clarify the interpretation of clause 8.3 - control of non-conforming product in ISO 9001: 2008.

"d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started".


We are a construction company, basically all the defects identified after the hand over (delivery) is to be rectified during defect liability period. we also been established with a individual procedure on handling this.

Is enough i refer back this procedure in the non-conforming product. pls clarify.

Rajes.

The sub-clause you refer to is basically about risk management. If, for example, some defect in something your company has constructed has the potential to cause the building to fall down, your reaction to being made aware of the defect would likely be different than if you had used the wrong color of paint in one of the rooms. Your reaction must be appropriate to the level of risk.

The sub-clause you refer to is basically about risk management. If, for example, some defect in something your company has constructed has the potential to cause the building to fall down, your reaction to being made aware of the defect would likely be different than if you had used the wrong color of paint in one of the rooms. Your reaction must be appropriate to the level of risk.

Hi JIM,

Thanks for the reply, i am also need a clarification that whether this sub-clause is also covers the appropriate actions if the non-conforming product is not detected during the inspections concerned, and been identified during use or after delivery (in supplier case)?

Thanks

Rajes

Greetings people,

I'm anticipating a clarification on following;

Introduction
0.1 General (Line 2)
The design and implementation of an organization's QMS is influenced by

a. Its organizational environment, change in that environment, and the risks associated with that environment.

Bullet A is an addition to the earlier version.

How does organizational environment affects the design and implmentation of QMS?

Is this environment is what they describe in Note mentioned in 6.4?

Thanks!!

Hi JIM,

Thanks for the reply, i am also need a clarification that whether this sub-clause is also covers the appropriate actions if the non-conforming product is not detected during the inspections concerned, and been identified during use or after delivery (in supplier case)?

Thanks

Rajes

Please refer clause 7.5.2 Validation of Process

"The organization shall validate ANY process for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement AND AS A CONSEQUENCE DEFICIENCIES BECOME APPARENT only after the product is in use or the service has been delivered."

Hi JIM,

Thanks for the reply, i am also need a clarification that whether this sub-clause is also covers the appropriate actions if the non-conforming product is not detected during the inspections concerned, and been identified during use or after delivery (in supplier case)?

Thanks

Rajes

The language in question is specifically about "...nonconforming product...discovered after delivery or use has started." Although the grammar is lousy, it's still pretty clear that the answer to your is "yes."

Please refer clause 7.5.2 Validation of Process

"The organization shall validate ANY process for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement AND AS A CONSEQUENCE DEFICIENCIES BECOME APPARENT only after the product is in use or the service has been delivered."

The issue the OP ia asking about doesn't necessarily involve "special" processes--it applies in any instance where nonconforming material is delivered or in use by a customer.

I'm anticipating a clarification on following;

Introduction
0.1 General (Line 2)
The design and implementation of an organization's QMS is influenced by

a. Its organizational environment, change in that environment, and the risks associated with that environment.

Bullet A is an addition to the earlier version.

How does organizational environment affects the design and implmentation of QMS?

Is this environment is what they describe in Note mentioned in 6.4?

Thanks!!

No clarification to this query!!! :(

The issue the OP ia asking about doesn't necessarily involve "special" processes--it applies in any instance where nonconforming material is delivered or in use by a customer.

Absolutely correct. I didn't read it so carefully & assumed it to be the same thing once I was struggling to know & I remember you helped me understand the problem.

Thanks for the correction,

Best regards,

There’s one registered ISO 9001 Organization which business is retail of beverages.
Their process starts by going everyday with a large truck to a beer factory to pick up the product. When the product arrives their large warehouse is stored under controlled conditions. The final phase of their business is the delivering of the product to bars and restaurants.
Factory (supplier) – Organization – Bars, Restaurants (customers).
Their customers are the bars and restaurants where they deliver the product.
So, in order to be according to requirement 8.2.1 of ISO 9001:2008, they have to “monitor information relating to customer perception as to whether the organization has met customer requirements”.
That’s what they have been doing!
The Organization distribution teams, every 6 months, ask their customers (bars and restaurants owners) if the service is being done in order to satisfy their requirements. In this process they use customer satisfaction surveys.
Last year the quality manager started a lost business analysis program, which also was used to check customer satisfaction.
In this year’s survey audit the auditor wrote one nonconformance related to requirement 8.2.1, because he considered that the Organization is not checking “user opinion survey”.
In other words, the auditor wanted that the Organization asks the people that are consuming the products (beer drinkers at bars and restaurants) if they are satisfied with the product.

My opinion about this is as follows:
- The customers of this Organization are bars and restaurants, not the users of those establishments. In this situation they should never consider asking the drinkers opinion, because they don’t produce the beer. That is for sure being done by the factory quality services!
- This “user opinion survey” is written in the note in requirement 8.2.1, and so it can never be support to write a nonconformance. The auditor could have just written one OFI…, but considering what I wrote in the paragraph before this one, it was also not correct.
- I think the Organization should protest to the register about this situation.

Any comments?
Thanks
AV

Hello!
What do you think on the requirement in 8.2.2 Internal audit "Records of the audits and their results shall be maintained (see 4.2.4)."

Normally I keep only audit plans and reports (with all findings, evidences and conclusion).

Now I've heard that you have to keep check-lists as records of the audits. ???

Hello!
What do you think on the requirement in 8.2.2 Internal audit "Records of the audits and their results shall be maintained (see 4.2.4)."

Normally I keep only audit plans and reports (with all findings, evidences and conclusion).

Now I've heard that you have to keep check-lists as records of the audits. ???

Sveta,

No, you don't have to maintain checklists. That's you choice.

Stijloor.

Hello!
What do you think on the requirement in 8.2.2 Internal audit "Records of the audits and their results shall be maintained (see 4.2.4)."

Normally I keep only audit plans and reports (with all findings, evidences and conclusion).

Now I've heard that you have to keep check-lists as records of the audits. ???

I would like to suggest that, if the checklists are used by an internal auditor to record the objective evidence they observed during the audit, including who they spoke with, product i.ds, locations, projects, orders etc etc etc. the checklists should be maintained!

There are a couple of really good reasons for doing that;

They can be used by the next auditor to plan their audit of a similar scope - and make sure they don't sample the same things. They can also see what was sampled that needed action to be taken etc.

They provide the audit manager with a basis for evaluating the auditor's technique of note taking etc. for the purposes of determining competency.

In addition they can help show a CB auditor that the audit was actually conducted, rather than being done from an office somewhere and a report generated. It can lend significant credibility to an audit program.

I have a question about 6.2 Human resources

"Personnel performing work" and "personnel performing any task" have the same meaning?
Should the personnel mentioned above have the responsibilities and authorities defined in 5.5.1 Responsibility and authority?

I have a question about 6.2 Human resources

"Personnel performing work" and "personnel performing any task" have the same meaning?

Yes.

Should the personnel mentioned above have the responsibilities and authorities defined in 5.5.1 Responsibility and authority?

Yes.

Stijloor.