quarta-feira, 30 de abril de 2014

Have you ever been in an ISO 9001 external audit?

Hello there!

Today I would like to ask you?  Have your ever been in an ISO 9001 external audit?

A lot of people that haven´t been this experience, don´t imagine how easy and pleasant is to be in an external or internal audit.  I don´t know why but the market has created a fake image that audits are the worst moment in QMS.

Let´s see three thinks that you should consider to feel fine before an ISO 9001 audit.

1 - Audits must find conformities in QMS, this is your main objective.

Don´t worry about non conformities, yes we don´t expect them but sometimes they can revealed.  Are you prepared for the treatment?  This is important!  It´s rare audits without non conformities, you must be prepared to understand and treat them too.

2 - Have you done your work with attention and zeal?

If you are doing your job honestly, with attention and dedication you probably is on the way to have success in you next audit.  Don´t worry, just keep doing all the procedures and following the rules as every day you have done.

3 - A lot of organizations around the worl have had this experience before, and now they are nice.

Everyone after a audit keep living without problems, in many cases your organizations are certified and you can be the next on this way to glorious.

Hope that now you enjoy every internal or external audit in your QMS.

Bye bye.

Source image:  http://www.bogmisailac.org/index.php?p=1_76_L-audit-et-ses-enjeux

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quarta-feira, 12 de março de 2014

5.6 Management Review ISO 9001

Are you struggling to implement ISO 9001?

Today we will discuss another requirement.  I would like to explain 5.6 Management Review.  Firstly, let´s have a read in the complete requirement.

5.6 Management Review  

5.6.1 General 

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. 

Records from management reviews shall be maintained (see 4.2.4). 

5.6.2 Review Input 

The input to management review shall include information on: 

a) results of audits, 

b) customer feedback, 

c) process performance and product conformity, 

d) status of preventive and corrective actions, 

e) follow-up actions from previous management reviews, 

f) changes that could affect the quality management system, and 

g) recommendations for improvement. 

5.6.3 Review Output 

The output from the management review shall include any decisions and actions related to: 

a) improvement of the effectiveness of the quality management system and its processes, 

b) improvement of product related to customer requirements, and 

c) resource needs.  

The responsibles for each process in certified organizations must meet and discuss important issues about Quality Management System at planned interval and record it.  It´s necessary do write a meeting agenda that must contain, at least, the 5.6.2 contents.

You must check records of previous management reviews, customer complaints, non conformities,  audit records, includin internal and external audits, posible improvements, etc.

In this moment, top management becomes aware from and will can provide resources for develop and improve Quality Management System.

I have seen in many projects about implementation that committed top management always help the QMS.  Unlike without participation of top management the implementation of a QMS could be damaged.  And a great moment to envolve top management and engage them is in Management Review.

If you have a strategic plan could be a good idea integrate both process.  And do not forget record it.  In external audit you must show that you have carried out Management Reviews at planned intervals.

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segunda-feira, 24 de fevereiro de 2014

Controlled Copy vs. Uncontrolled Copy ISO 9001

One important doubt for ISO 9001 beginners is: what´s the difference between controlled and uncontrolled copies in QMS? When must I use one or another?

One important requirement of ISO 9001 and also others Management Systems as ISO 14001, ISO 22000, ISO 17025, OHSAS 18001, for example, is the control of documents.

Documents of a QMS must be controlled.  It means that you must:

Making a list of all documents.
Selecting the ones will receive these documents and your further revisions.
Controlling each issued copy.

For example, you can define the procedure of painting must be sent to the manager of production and also design.  Then you will produce two controlled copies to send to these ones.

Onde day, when you revise this document, you will send another revision for both and remove the obsoletes versions.  It means control of documents.

Other activity also important and mandatory on 4.2.3 Control of Documents like approval documents and control of external documents.

Well, I´ve just understood about controlled copies, what about uncontrolled copies?

These copies don´t need management, you can take one uncontrolled copy for a trainning, an event, or to study at home.  In other words, these copies are not that you and your team will use to consult about your processes.

Do you need a mandatory procedure about 4.2.3 Control of documents?  Then click here!

Hope thay you´ve enjoyed this article, and it has been useful to you.

quarta-feira, 5 de fevereiro de 2014

How to get ISO 9001

Hello there,

Today I´ll show to you important steps when implementig ISO 9001 in your business.  The Quality Management System proposed by ISO 9001 is a important manner to manager a business with quality focus.

Today more than 1 million business are certifieds around the world.

Step 1 - Define a team work and Study ISO 9001:2008.

That is the principal and the first step, you must to know the requirements and understand how they can be aplicable to your business.  There are courses about interpretation of ISO 9001 requirements, internal auditor formation, management representative formation, and many others.

We can teach you for free about ISO 9001 requirements, in our website you can find many contents, just clik here to see our commentary about ISO 9001.

Step 2 - Schedule your project

I never start a project without a Gantt Chart.  It´s necessary to control the time and the project efficacy.

Step 3 - Developing a documentation

You must now develop your documentation, that at least, must contain:

A Quality Manual;
Quality Policy;
Objectives and KPY;
Procedures, see here what are the mandatory procedures;
Work instruction;

This documentation are the basis to the next step.

Step 4 - Trainning and implementing

Now, everyone in the organization must to know how to procedure, in other words, it´s necessary train the people, show them the Quality Manual, do awareness about Quality Policy, explain procedures and work instructions, how to record the activities and how to live in a QMS - Quality Management System.

Step 5 - Audit and Management Review

Maybe 2-3 months after the implementation you can check the efficacy of your Quality Management System, it´s mandatory execute Internal Audits at planned intervals (requirement 8.2.2) and the Top Management must to carry out the Management Review (requirement 5.6).

Step 6 - Certification

There are organization in each country that are acredited to national controllers organizations.
In Brazil the list is provided for INMETRO.
In USA for IAS.
In U.K. for UKAS.

You must to find and contact a certification body in your country and schedule the dates with them.

The duration of an external audit carried out by a certification body follows the table bellow provided by IAF (International Accreditation Forum).

Step 7 - Time for Celebration!

Yes!  It´s necessary to celebrate this conquest!  You and your team work deserve this.  Don´t let this time empty, without a good  dose of celebration.

Helping on implementing ISO 9001?  Email me jose.rigoni@yahoo.com.br

Best Regards!

terça-feira, 4 de fevereiro de 2014

What is a QMS? Quality Management System

What is a QMS – Quality Management System?

A Quality Management System is a systematic method of manage a business with customer focus,  meeting the customer satisfaction and ever pursuing the continuous improvement.  A Quality Management System more famous in the world is that required by ISO 9001, the Standard of requirements for Quality Management Systems  that is part of ISO 9000´s family.

A Quality Management System is composed for:

Quality Policy;
Quality Manual;

Procedures and Processes;
Audits (Internal and External);
Monitoring and Measurement;
A Management Representative;
Management Review made by Top Management;

And other activities and documents necessaries to achieve the ISO 9001 requirements for a QMS.

A business that implement a QMS perceive improvements on customer satisfaction and reduce internal wastes and costs in your processes.

That is the principal image, presents in ISO 9001 that resume a Quality Management System.

The start of any business is the customer requirements,  after production and services are provided and feedbacks of customers must be verified.  At this point the top management must check if the organization needs resources or changing in products, people or process.

One of the principal features of a QSM is the documentation.   Many kinds of business around the world now are being managed without documented procedures, manuals or declared quality policies.
Without a robust and effective documentation is impossible to manage complex business and principally interact with other enterprises in other countries.

A QMS based in ISO 9001 requirements is essential to the international commerce and the sustainability of supply chain around the world.  We have commented in our both Portuguese and Spanish website that is very important to have a ISO 9001 certification for exportation.

Look at the quantity of ISO 9001 certificates that business in China have now, just 334.032 is the principal country , USA has 26.177 thousand at the moment of this article and U.K. has 44.670.  

A QMS represents control of your processes and a great expectation of quality in each business that has your own ISO 9001 certified.

Looking for ISO 9001 contents, read also our comments about each requirement of  this Standard now.

Do you need to implement ISO 9001 in fast and economic way?  Know more here!

segunda-feira, 3 de fevereiro de 2014

Procedures for ISO 9001 Implementation

Why develop mandatory procedures without samples?  Writing your procedures with samples is a easy, fast and effective way to implement ISO 9001.  In our website we offer now the six mandatory procedures that every Quality Management System must maintain.

If you have doubts about writing procedures, try our developed documents in WORD, they are editable, you can use and adapt for your organization.  These samples will help you, avoiding mistakes, saving time and money.

We offer today:

P01 - Control of documents and records;
P02 - Control of Nonconforming Product;
P03 - Internal Audit;
P04 - Corrective and Preventive Action

These procedures contain 11 forms that will help your development of Quality Management System.  We delivery these materials electronically 24 hours after your purchasing by e-mail.

How could you buy it?

Only US$ 40 dollars, and we offer the best and safest way of buying on internet, the Paypal.  Now you have all that you need to beggining ISO 9001 implementation.

If you have some doubt, email - me at jose.rigoni@yahoo.com.br

quarta-feira, 1 de janeiro de 2014

8.2.2 How to carry out internal audits

Internal Audits are an important requirement of ISO 9001 Standard and they must be carry out by a sistemathyc procedure. 

We have comented that is mandatory develop a procedure to conduct audits.  If you need more informations about obligatory procedures in ISO 9001 check this article for more information.

Every certified organization must be audited by certificators yearly or each six months. The intervals for internal audit can be diferent, your quality management team must define how many audits will be carry out every year.  This a topic about audit program, when you prepare all arrangements to select and train auditors, you define the areas that you will be audit, the risks of audit program, and other subjects related to the audit.

The audit program is an long-term work, and it will help to plan each particular audit.  The result of planning an unique audit is called audit plan and must be recorded and filed to provide evidence about the audit activities.

After concluding an audit you must to record all the activities, non conformities, observations, including conformities with the audit criteria, this is very important to provide evidence and help the areas from an organization to fix all the problems observed.

The principal records that you must create and file are according to the list bellow:

Audit Program;
Audit Plan;
Audit Report;
Non conformities;
Records of valuation and training auditors.

I often file this records for more than 5 years in paper format, but I keep for a long time in eletronic format.

I have carried out audits in organizations of many diferent markets, and I would like to share some tips with you, let´s read:

1st – Define the objectives, scope and criterias for audit.

This is a recomendation of ISO 19011:2012 Guidelines for auditing management systems. When you have this clearly defined the things can be better managed.  Some quality managers don´t know exactly which standards, laws, or regulations must be audited, this is a problem that will drop in the auditor’s hand during audit.

2nd – Develop a schedule with each audit divided by areas.

Doing this you can comunicate every area and maintain the things under control. A schedule is a important part of an audit program.

3rd – Asure that every auditor has the necessary competence.

Sometimes auditors without knowledge and experience, carry out internal audits, and this is the same of don´t apply audits in my opinion.  How an auditor without experience in construction can manage an internal audit in a building?

  • It is very important that internal audit has the competence necessary:
  • Knowing the ISO 9001 Quality Management System;
  • Knowing the ISO 19011:2012 - Guidelines for auditing management systems;
  • Knowing the laws and regulations necessaries;
  • And having the necessary experience in the applicable market.

4th – Take care with the records and comunication

If you want implement the improvements, solve non conformities and get better your quality management system you must take care and conduct clearly the opening meeting,  closing meeting, and produce a complete and clear audit final report.  You should not avoid this advice because two weeks after audit every details can be forgotten and the final report can assure you the maintenance of this information.

Don´t waste your time preparing this document.

If you need develop now a internal audit procedure based on 8.2.2 ISO 9001:2008 requirement, than you can have our complete procedure.  The files are completely editable and you can change the informations acoording to your needs.  The package contains more than this only procedure, it also contains a Quality Manual and all mandatories procedures, like Control the documents and records, Internal Audit, Control of Product non conformity, Corrective and Preventive Actions.  All the files will be sent to you after payment in 24 hours.  You can have more information clicking here.

If you need more informations about implementation ISO 9001, email me at jose.rigoni@yahoo.com.br