Tags Posts tagged with "iso9001"

iso9001

0 2099

No matter how many audits someone has gone through, knowing that someone will come and check your work always generates some tension and anxiety. Here are some recommendations to get rid of the fear and prepare for a successful ISO 9001 audit.

Prepare employees.

  • Refresh the quality policy and make sure everyone understands it. There is no need for workers to memorize it, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Refresh quality objectives. Workers should know what the organization’s quality objectives are and how they contribute in achieving them. They should know and be able to explain how their day to day activities can influence these objectives.
  • Ensure that everyone has been properly trained to perform their tasks.
  • Make sure everyone knows where to find procedures, work instructions and forms relevant to perform and record correctly a specific activity or process.
  • Let everyone know the scope of the audit, what will auditors be checking in their areas and when they will be audited.
  • Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure what they are going to answer.

Check all documented information.

  • Make sure document and record list has been updated.
  • Check that all documents have been reviewed, approved, communicated and followed by everyone involved in the process or activity.
  • Make sure no one is using obsolete documents.
  • Verify that all records are being used and that they are being filled out correctly.

Ensure all processes are being performed correctly.

  • Make sure that all the procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (correct way) by everyone.

Review the corrective and preventive action process.

  • Review the findings from previous audits and make sure they have been attended.
  • All nonconformities must be properly recorded, investigated and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed need to have a proper verification of its effectiveness.

Organize the workplace.

  • It is very hard for quality control and assurance to happen in a messy, dirty and unorganized workplace, and auditors know that. So, take time to organize the workplace (offices, desks, warehouses, workshop floor, etc.).
  • Make sure records, forms, procedures and any relevant documents are at hand and easy to find.

Prepare to have a nice and professional audit.

  • Make a good first impression. Treat auditors professionally and with respect from day 1.
  • Do not be predisposed. Auditors are not enemies, they will come to help the organization uncover their defects and weaknesses in order to take the necessary actions to improve.

Do not wait for the last minute to prepare for the audit.

  • Preparing for an audit takes time and effort. The sooner the organizations begins to prepare for their audit, the more successful it will be. So start soon!

 

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Risk Management

The concept of risk has always been implicit in ISO 9001; this new revision only makes it more explicit and builds it into the whole management system.

In ISO 9001:2015, risk management is being added with focus on risk-based thinking.  Here a systematic approach to risk is established by considering and including it throughout the standard.

In the Introduction the concept of risk-based thinking is explained. Risk is defined as the effect of uncertainty on an expected result, where:

  1. An effect is a deviation from the expected – positive or negative.
  2. Risk is about what could happen and what the effect of this happening might be.
  3. Risk also considers how likely it is to take place.
Risk Management
The main goal of this quality management system is for an organization to achieve conformity and customer satisfaction. In the new ISO 9001:2015 a risk-based thinking is used to achieve this goal.

The main goal of this quality management system is for an organization to achieve conformity and customer satisfaction. In the new ISO 9001:2015 a risk-based thinking is used to achieve this goal.

  • In Clause 4 (Context) the organization is required to determine the risks which may affect its ability to meet the system’s objectives. The new ISO 9001 recognizes that the consequences of risk are not the same for all organizations, and this is why every organization will need to consider risk quantitatively as well as qualitatively, depending on their context.
  • In Clause 5 (Leadership) top management is required to demonstrate leadership and commit to ensuring that risks and opportunities that can affect the conformity of a product or service are determined and addressed.
  • In Clause 6 (Planning) the organization is required to take action to identify risks and opportunities, and plan how to address each of them.
  • Clause 8 (Operation) establishes that the organization is required to plan, implement and control its processes to address its risks and opportunities.
  • In Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyze and evaluate the risks and opportunities.
  • In Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

These requirements are considered to cover the concept of preventive action (which has been replaced) and takes a wider view that looks at risks and opportunities. By understanding those risks and exploring ways in which the risks can be mitigated, the organization will also have an opportunity to drive change and improvement.

In order to effectively meet the quality management system’s goal, ISO 9001:2015 will require organizations to consider their risks as part of their management’s plan, which will call for an improved commitment and more involvement of top management.

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The ISO 9000 family of standards is the most extensively used standards worldwide. They address various aspects of quality management and provide organizations with guidance and tools to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

The best known standard of the ISO 9000 family is ISO 9001:2008, Quality management systems- Requirements, which establishes the criteria for a quality management system (QMS) and is the only standard in the family that can be certified to. ISO 9001 certification is not a requirement; however, organizations of all kinds and sizes all around the world decide to seek certification for a variety of reasons. These include to ensure clients, customers and stakeholders that they can provide quality products and services that continuously meet their expectations, improve the image of their product or services, increase their competitiveness and also because, nowadays, it is essential in order to do business in many industry sectors.

ISO 9001 has been around for over 20 years, and since its release, over one million organizations have been certified and many more have used it as a guide to establish and improve their QMS.

As stated in the 2013 edition of the ISO Survey, by the end of 2013, “at least 1,129,446 certificates had been issued in 187 countries and economies”.

In recent years, China has shown a rapid growth of the number of certificates issued there, placing it as the number one country with more ISO 9001 certifications (over 290.000 certifications). China is followed by Italy and Germany for being, respectively, the second and third country with most certificates.

Trends show that in the years to come, many more organizations will become ISO 9001 certified. It is expected that, with the upcoming revision of the standard (ISO 9001:2015), organizations will find that implementing and certifying to ISO 9001 will support them in overcoming the many challenges faced by businesses today.

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Measuring Supplier Performance

Implementing and seeking certification for ISO 9001 is an important decision many organizations make to improve their quality management system (QMS) and increase their competitiveness within their market. After the decision is made, one of the first concerns is: how long will this process take? Will it take three months? six months? a year maybe? or two years?

This question does not have a definite answer, implementing and seeking certification for ISO 9001 requires time, money and effort and the overall time spent will depend on several factors:

  • The size and complexity of the organization.
    Is it a small or medium-sized organization? Is it a single site organization or a multinational? Does the organization have complex processes such as design, manufacture, installation, test, etc.?
  • The maturity of the quality system that is in use.
    Does the organization have a well developed and structured QMS? Does it have a simple one with deficiencies?.
  • The resources available (money and time).
    Does the organization have a team dedicated exclusively on the implementation of ISO 9001? Do employees have only a couple of hours a week to dedicate to this project? Will the organization be able to hire a consultant to guide them through all the process?

The major time consuming activities organizations need to consider when implementing ISO 9001 are:

  • Understanding ISO 9001. Time will need to be spent in studying and training the people responsible for the implementation.
  • Conducting a gap analysis. This analysis will allow organizations to identify exactly what needs to be done to meet ISO 9001 requirements.
  • Getting busy with the documentation. A number of documents (policy, manual, procedures and forms) need to be developed.
  • Implementation and training. Employees need to know and understand key ISO 9001 requirements, and their work needs to be aligned with what is required.
  • Preparing and conducting an internal audit. At least one internal audit needs to take place before the certification audit.
  • Correcting non-conformities. Audit findings need to be addresses with an action plan to permanently correct them.
  • Selecting the certification body (CB). A registrar or CB needs to be selected to undertake the audit certification.
  • The certification audit. After all the hard work, a certification audit is scheduled with the CB and if the audit is a success, the organization is certified.

Carrying through all these activities can take an organization from 9 to 18 months; however, it will all depend on the organization and its specific situation.

It is recommended that organizations take the time needed to effectively implement ISO 9001; a well established and implemented QMS will provide organizations with a valuable tool to improve their quality performance and continuously meet their client’s expectations.