Tag Archives: iso 9001:2015 procedures

Does ISO 9001:2015 Procedure Document Require for Addressing Risks and Opportunities?

With the release of ISO 9001:2015, there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System (QMS). These new requirements have created confusion not only about what should be done, but also about in ISO 9001:2015 documentation, what should be documented about risks and opportunities for your QMS. There are a few activities that must be carried out in relation to the risks and opportunities of the QMS:

  • Identify the risks and opportunities – what should be addressed to ensure that your QMS does what is necessary, is based on the desired results, prevents or reduces the results of the problem and obtains an improvement?
  • Plan your response – What actions should you take to address the risks and opportunities identified?
  • Integrate into your QMS – how can these plans be adopted and adapt to the usual activities so that they can happen easily?
  • Evaluate effectiveness – How will you know if your actions have worked, or need to be updated? This involves analyzing the information and management review to assess the effectiveness.

Do you need a document ISO 9001:2015 procedure?

It is important to note that there is no mandate for documented information for any of these steps. The standard itself does not state that it is necessary to document ISO 9001:2015 procedures that concerning risks and opportunities, just that you must perform the processes in the section above, as well as update the risks and opportunities as an outcome of process non-conformities.

For instance, you could choose to assess your risks and opportunities at a management meeting, identify a risk, decide what you want to do and make sure that employees who are executing the QMS process are aware of what they need to do and you could then claim that you are compliant with the ISO 9001:2015 requirements, even if none of these are written.

Therefore, in accordance with ISO 9001: 2015, a documented procedure is not required, but your company may have a different need for documented information and records regarding QMS risks and opportunities.


Tags: , ,

Why Have Procedures? What are the Mandatory Procedures for ISO 9001:2015?

Why have procedures? Some would answer this question by providing very long lists of reasons why, these lists are sometimes not useful. They are too long to remember and absorb them, and there is too much overlap and redundancy. There are four very basic reasons that demonstrate why we should develop procedures to document important process.

  • Compliance
  • Operational Needs (i.e. consistency)
  • Manage Risks
  • Continuous Improvement

What to cover in Mandatory ISO 9001:2015 Procedures?

These mandatory ISO 9001:2015 procedures are specified by ISO 9001 and are included in quality manual template. There are the six procedures that are mandatory to be documented. Organization need to ISO 9001:2015 document these six procedures. This doesn’t mean simply will go away with just these six, the ISO 9001:2015 procedures you wish can abundantly rely upon the scale and complexness of your organization, these six but are those that you simply should have.

Six Mandatory ISO 9001:2015 Procedures

ISO 9001:2015 Mandatory Procedures

1. Control of Documents:

In this ISO 9001:2015 procedure, a written procedure to control the approval and re- approval of procedures and ensuring that the current revision status is displayed. It is the process to ensure that the obsolete documents are controlled and legible and that documents are intended for the external parties such as their clients or the process owner. The documents must be approved by senior management

2. Control of Records:

This is the procedure for checking the archiving of identification, protection, storage and deletion of records by the owner of the process and also keeping records in a specific location. The established records will be checked to provide confirmation of compliance with the requests and the effective functioning of the quality management system.

3. Internal Audit:

The purpose of the ISO 9001 internal audit is to assess the effectiveness of the quality management system and the organization’s overall performance. Your internal audits demonstrate compliance with planned arrangements, e.g. QMS manual, procedures or process maps and that the planned arrangements are implemented and maintained.

4. Control of Non-Conforming Product:

As regards the ISO 9001 standard, the documents are necessary and the records of the non-conformity problem are kept in order to identify them and act in this way. This is a procedure that ensures that the testimonial of the useless product and no action is performed and documented procedure is established to define the controls and the related responsibilities and authorities to deal with non-compliant products.

5. Corrective Action:

A corrective action should be considered as a reactive response to a problem since it is taken when a non-conformance is detected or upon receipt of a customer complaint or other event. Your organization should first contain the problem and then determine its root cause in order to take appropriate corrective action to prevent the problem’s recurrence.

6. Preventive Action:

The Preventive actions are pro-active – something could go wrong and these are actions taken to prevent it from happening, or to prevent it from becoming too severe. If something has already gone wrong, it is a non-compliance that is addressed with corrective actions. ISO 9001: 2015 requires documenting the preventive action procedure. Furthermore, it is necessary to keep a record of the identified preventive actions and actions taken.


Tags: , ,

Steps to Develop QMS Policies and Procedures for ISO 9001

At some point during your implementation of an ISO 9001 Quality Management System (QMS), it will be necessary to write some QMS policies and procedures. While it is useful and important to make sure you don’t have too much documentation, there are definitely some policies and procedures that need to write down to avoid non-compliance. For this reason, it is necessary to have a standard way in your organization to write these ISO 9001:2015 documents in a way that is consistent and easy to understand.

QMS Policies and Procedures1. Decide on the process limits.
After deciding that a process needs to be documented in ISO 9001:2015 procedures, you first need to know the limits of the process you are documenting. Knowing the limits of the process will help you to know when to stop documenting.

2. Collect the information
There are different ways to view a process, but making sure you understand the whole process is important to ensure that nothing is missed, even if you don’t need to document everything. Regardless of how you choose to observe the process, be sure to observe all aspects of the process when gathering information for ISO 9001 documentation.

3. Align with other documents & processes.
Aligning with other processes is very important, and making these interactions work well is one of the best ways to make the whole system more efficient. One place to focus your attention is the inputs and outputs of the process. For the inputs, does the process that creates the input know the requirements of the process using it, or might they change the input later? For the process output, is it used somewhere as an input? If not, then you need to question if this output is actually necessary.

4. Define your document structure.
There are many different ways to document a procedure. For example, you can choose to have documentation that is a series of paragraphs, or you can choose to have a procedure that is in a flowchart format. Regardless, many companies have a standard document structure to help people know where to look for certain important pieces of information, such as the applicability of the document. Knowing where to look for the information needed can save employees time and improve the efficiency of the QMS documentation.

5. Write your document.
Take what you have found and write enough detail that competent people reading it can perform the job required without causing non-conformances. This is the reason you have a document. Adding unnecessary information will not only make your ISO 9001:205 document more cumbersome, it could also confuse your audience.

6. Get approval for your document.
In all cases, you need to make sure the right people approve a document for use. This could be the production manager for production procedures or the purchasing manager for purchasing procedures. A good QMS will define who need to approve which documents so that the right experts are ensuring that the procedure is correct.

7. Train the relevant employees.
It is best to find some way to make sure that the people who need to use a procedure have not only read it, but also understand and have implemented any changes into the process. This can be done through audits or even questioning employees to make sure they understand the important parts of a procedure. In this way, it is also possible to verify the effectiveness of the documented procedure to verify if it is necessary to make some improvements.



Tags: , , ,