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ISO 9001:2008 Clause Interpretations and Clarifications

R

Rajes

#1
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:
 
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A

Al Hector

#2
Re: ISO 9001:2008 clarifications

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
 
R

Rajes

#3
Re: ISO 9001:2008 clarifications

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.
 
Last edited by a moderator:
R

Rajes

#4
Re: ISO 9001:2008 clarifications

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.
 
R

Rajes

#6
Re: ISO 9001:2008 clarifications

thanks andyn,

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

Thanks.
 
A

Al Hector

#7
#8
Re: ISO 9001:2008 clarifications

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.
 
W

world quality

#9
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.
 
R

Rajes

#10
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.
 
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