ISO 9001 QMS - The Easy Way !

Establishing Quality Policy

2010-04-12T17:53:00.001+04:00

Now the next step in developing your Quality Management System ( Steps for implementing Quality Management System) is to establish a Quality Policy. What is a Quality Policy?

As per ISO 9001:2008 Clause 5.3, the top management shall ensure that the Quality Policy

a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability

So how do you frame a Quality Policy for your organisation?

Let us look at an example which can be used for your organization too:

We at (COMPANY NAME) are committed to :

- produce, distribute and market high quality products that meet customer requirements

- establishing quality objectives at relevant departments and exceed those objectives

- continuously develop the Quality Management System as part of our improvement activities

- abide by all local and international statutory and regulatory requirements

This is a very simple example. The Quality Policy should focus on the business aspect of the industry of the organization as much as possible along with other criteria as addressed by the standard.

MR has to ensure that the Quality Policy is communicated (emails, notice boards,etc.) to every one in the organization.

During an audit every employee should be able to at least point out a correspondence regarding the Quality Policy being communicated. It is better advisable to have the Quality Policy displayed in each department / office.

Evidence of the Quality Policy being subject to review should be recorded in the management review meetings.

More samples of Quality Policy can be found here (Quality Policy Examples) . For more details you can email me at grahak.thecustomer@gmail.com

ISO 9001:2008 Quality Management System

2010-03-07T22:23:00.000+04:00

Easy steps to implement ISO 9001:2008 in your organisation?

1. Appoint Management Representative (MR)

2.Gap Analysis with the existing system ( if any)

3. Arrange for ISO 9001:2008 Awareness Training

4. Establish Quality Policy

5. Establish Quality Objectives at all functions / departments

6.Review exisiting documents, procedures and formats

7.Develop Quality Manual

8.Revise the existing documents, procedures and formats as per ISO 9001:2008

9.Develop other required documents, procedures and formats as per ISO 9001:2008

10.Distribute and get feedback for all documents from all departments

11.Implement the Quality Manual, Procedures and Formats in each department

12..Attend ISO 9001:2008 Internal Audit Training and appoint internal auditors

13.Schedule, plan and conduct Internal Audit

14.Propose and take corrective actions for all non conformances identified during Internal Audit

15. Conduct Management Review

16.Choose third party certification body for external audit

17. Undergo 2-stage audit for initial certification

18. Review findings and close NCRs

19. Congratulations !!!

Free ISO 9001 2008 Awareness Training

2010-03-07T11:05:00.013+04:00

Before implementing anything new in your organization it is very important that your employees are aware of what is happening. What usually happens is that ISO 9001 ( or any other standard) is implemented with only some people involved in it and most of the employees are not sure what is happening.

In order to successfully implement ISO 9001 in your organization it is very important that employees at all levels are aware about the ISO 9001 standard and its requirements.

If this is not done, employees will be filling up documents without understanding why it is done. The success of implementing a system lies in making everyone aware why it is important to document what they are doing. This also improves the interaction between the employees and they can also contribute positively in developing and optimizing documents for the ISO 9001 system and thus reducing paperwork.

It may not be possible to send each and everyone for training to understand the requirements of the standard. So it would be advisable that somebody competent (MR or Quality Manager) within the organization deliver trainings to all employees.

A simple, easy to understand ISO 9001 2008 awareness training material is made available here. For any clarifications and comments you can email to grahak.thecustomer@gmail.com . Click here for the ISO 9001 2008 training material.

ISO 9001:2008 Gap Analysis

2010-03-03T17:25:00.003+04:00

One of the most important steps before implementing of ISO 9001:2008 Quality Management System in your organization is conducting a Gap Analysis.

What is a Gap Analysis?

Gap Analysis is done to compare your existing system ( if any) to the requirements of ISO 9001:2008. During the Gap Analysis you are able to identify the requirements your organizations already meets and the ones that need to be addressed.

The most important tool for the Gap Analysis is the Gap Analysis Audit Checklist. For a free copy of a Gap Analysis Checklist please send your request to grahak.thecustomer@gmail.com or click here

The auditor can use this checklist to compare your current system with the requirements of the ISO 9001:2008 standard. This checklist gives the auditor a specific place to document what they saw that did or did not meet the standard.

From the Gap Analysis you can list down all the documents that are available and that need to be developed. Other requirements as per the ISO 9001:2008 standard can also be clearly identified after the Gap Analysis.

Management Representative

2010-01-19T21:56:00.003+04:00

The first step in implementing ISO 9001 in your organisation is the appointment of a management representative (MR). This is a requirement as per the clause 5.5.2 of ISO 9001:2008

There is a clarification in the ISO 9001:2008 version that the MR should be from the organization itself and not an external person or consultant.

Now the obvious question arises : Who can be appointed as a MR?

The answer depends on the size of the organisation. Usually it is the Quality Manager of the organization that takes up the role of the MR. That does not mean that if you do not have a Quality Manager you have to go and hire one.

Anybody who has good understanding of the ISO Requirements, Quality Management Systems can be appointed as a MR.If you do not have anybody like that, it is better to find someone from your team who can be trained for ISO knowledge ( ISO Awareness, Internal Auditor or Lead Auditor)

It is not mandatory to have somebody in a managerial position but still it would be better to have a manager.MR should be someone who has a fairly high authority in the organization.Someone who is in a low position authority will not be able to effectively implement and manage the QMS

In smaller companies it would be much better if a member of the top management ( Managing Director, General Manager etc.) directly takes up the responsibility of the MR.

In bigger companies the Quality Manager ( if they have one) is appointed as the MR.

Please ensure that you have evidence to show that the MR has been appointed. It can be through an appointment letter or an approved organisation chart that has MR in it. Any other evidence that can prove that appointment has been done is also acceptable.

Now let us go to the details of the qualifications, skills and experience to be the perfect MR

Qualifications:

Internal Auditor Training for ISO 9001(preferred)
Lead Auditor Training for ISO 9001 (not mandatory)

Job Responsibilities:

Able to develop and implement the QMS in the organization
Able to develop the manual, procedures, formats and any other document required for the QMS
Able to train and develop awareness among the employees for the QMS
Prepare internal audit schedule, conduct internal audits and raise non conformities
Initiate necessary corrective and preventive action
Review the Quality Policy and Quality objectives periodically
Conduct Management Review as per ISO 9001
Coordinate with External certification body for ISO 9001 certification
Represent the management during certification audits and surveillance audits

Skills:

Good Analytic skills
Good communication skills
Good auditing skills

Experience:

Previous experience in a Quality Management System implemented organisation
Previous Auditing experience

ISO 9001:2000 to ISO 9001:2008 Transition - What needs to be done?

2010-01-02T11:28:00.005+04:00

For those who are already certified to ISO 9001:2000, you can follow the following simple list to ease your transition to ISO 9001:2008 version.

Since most of the changes in ISO 9001:2008 version are only clarifications, some of the below mentioned points may already be included in your QMS .

Action Plan for ISO 9001:2000 to ISO 9001:2008 transistion:

1. Ensure that the Management Representative (MR) of your organisation is employed by your organisation and is appointed by the Top Management. No external member of the organisation shall be appointed as the Management Representative from now on.

2. Identify areas/sections in your QMS documentation that can be simplified. Use this transistion opportunity to rewrite the manual and delete any procedures, paragraphs or formats which are redundant. Combine two or more procedures into one wherever feasible. ( Eg: Combine Control of Documents & Records into one procedure)

3. Change the "ISO 9001:2000" term to "ISO 9001:2008" at all places in the Quality Manual/ Procedures and formats. ( Or better still change it to ISO 9001 , so that in future when u need to make changes to the next version you do not need to keep changing everywhere)

4. Ensure that all the processes determined by the organisation are mentioned in the QMS documentation. It can be done in the Quality Manual , procedures or any other document of the QMS.

5. Indicate Outsourced processes and evaluate the sub contractor as per clause 7.4 ( Supplier evaluation)

6. Clearly indicate in the Quality Manual if there are any exclusions to the ISO 9001:2008 standard. Mentions the reasons for exclusions.

7. Prepare competence for personnel effecting conformity ( directly or indirectly ) and identify the person / function.

8. Replace the word " Device" with "Equipment" in all QMS documentation and ensure that a list of equipments which require calibration is identified and documented.

9. Ensure that data analysis covers :

Customer Satisfaction, Product Conformity, Suppliers and Process Effectiveness

Include formats which will be used for data analysis and the function responsible

10. Include Corrections and Effectiveness of Corrective Actions in Non Conformance Report. (Sample will be uploaded here soon !!)

11. Ensure Root Cause Analysis is conducted for finalizing Corrective Actions. ( Method of conducting root cause analysis and a sample shall be uploaded here soon !!)

12. Ensure that the internal audit procedure includes all aspects of audit plan, audit team, audit report, audit checklist, correction and corrective action.A list of approved internal auditors is to maintained. Competence for internal auditors shall be indicated. ( A General Internal Audit checklist for QMS shall be uploaded here soon !!)

Ensure that your internal auditors have undergone a training for the ISO 9001:2008 changes.

Once you have completed the required changes, you can conduct an internal audit and management review. Then inform your certification body for a surveillance or recertification audit so that you get certified to the ISO 9001:2008 version.

For further clarifications, please feel free to write to us : grahak.thecustomer@gmail.com

Management Systems

2009-12-29T17:51:00.002+04:00

A management system is the framework of processes and procedures used to ensure that an organization can fulfill all tasks required to achieve its objectives. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met. It is designed and intended to apply to any process, product or service.

The most common management systems we hear of are :

ISO 9001 - Quality Management Systems

ISO 14001 - Environment Management Systems

OHSAS 18001 - Occupational Health and Safety Management Systems.

Check out the details below for:

ISO 9001:2008