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How to Write a Good Quality Policy?

One of the first things to do when implementing a Quality Management System using the requirements of the ISO 9001:2015 standard is to write a Quality Policy for your company. Quality policy should be a brief statement that shows a commitment by top management to the quality management system.

One reason to create and implement a quality policy for your organization is to ensure that all staff are aware, aligned and supported their intentions on quality management. Another reason is because it is a requirement of ISO 9001:2015 Certification. In some ways, it seems a simple process; however, in other ways, making sure that the policy is effective in helping your company succeed can seem like an overwhelming task. You may be wondering: what are the important things to consider when creating the quality policy of our company?

Start with Customer Requirements

The key to starting any quality management system is to make sure that you understand customer requirements. If you want to successfully promote your QMS to improve customer satisfaction, it is essential to ensure that you understand all the requirements you need to meet to achieve it. These requirements may come directly from customer specification, through industry standards, or even through legal requirements related to their products or services. Making sure you have all these necessary inputs will help you ensure that your quality policy focuses on the important elements to achieve customer satisfaction.

Collect Inputs of Internal Parties

The quality policy is the main objective of the quality management system and is designed so that all employees can use it as a reference point for their work. In this case, it is important to gather input from all areas of the company to ensure that the Quality Policy is applicable to all those areas. In order to do this, it is important to get the input of people in the areas who will need to apply the policy.

Include Required Information of ISO 9001:2015

The standard does impose some requirements on the Quality Policy that are important to note. The quality policy must demonstrate the company’s commitment to meeting the requirements and improving the efficiency of the QMS.

Write and Communicate the Quality Policy

With all of this information in mind, you need to draft a policy that can guide the organization and provide direction to create quality objectives It is said that a good quality policy is simple, concise and easy to remember when under pressure. It is important that all employees not only know the policy, but also understand what it means and how their work supports compliance with the Quality Policy.

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Posted by on February 14, 2018 in ISO 9001 Certification

 

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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.

 
 

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ISO 9001:2015 Consultant – What Services Can Offer to Your Business?

Do you know the importance of having an experienced ISO 9001 consultant? In real terms, ISO 9001:2015 consultant services help a business to save both money and time, thereby helping your organization to gain an edge over the competition together with several other advantages to seek as well.

An ISO company ensures ISO 9001 quality management system (QMS) which can be very helpful in improving your company’s prospects. To achieve advantages of ISO 9001:2015 Certification, a business should have the knowledge to implement the ISO 9001 in right manner. ISO 9001 Consultant offers a number of services.

What Services ISO 9001:2015 Consultant Provide?

ISO 9001:2015 consultanting services benefited the most in terms of speed of implementation, effectiveness and payback. Let us check out some of these so that you can determine what selection of services would best suit your company:

ISO 9001 Standard Interpretation

The ISO 9001 quality management system standard can be a hard document to understand. It is written in quasi-legal language and points out requirements in very general terms. This is deliberately so, as it is meant to be applicable to all types of business activity. Quite a few companies have issues interpreting it to their organizations. An experienced ISO 9001 consultant can help you apply the standard to your specific business processes.

ISO 9001 Gap Audit

Before applying the ISO 9001 standard to your business, you need to know what is missing between your existing business practices and controls relative to ISO 9001. The ISO 9001 consultant will provide you with a detailed verification report that shows gaps in your company, along with their recommendations.

ISO 9001 Project Planning and Organization

Depending size and complexity of your company, your ISO project needs to well-planned in terms of how much time and various resources needed specific activities to be carried out, training, dealing with problems, etc. An ISO 9001 consultant can be a valuable aid to help a company with this important activity

ISO 9001 System Development and Implementation

The main emphasis of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the longest and most challenging part of any ISO implementation project. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide required focus and facilitate implementation.

ISO 9001 Management System Documentation

The latest ISO 9001:2015 standard reduces the attention on documentation and maximizes its attention on effective planning and control. Sufficient ISO 9001:2015 documentation is however needed for many business processes in order to ensure consistent application of effective controls. An export ISO 9001 consultant can help your organization determine where it is needed, how much and how it should be documented.

ISO 9001 Training

ISO 9001 Consultancy services often offer a number of training alternatives. These include

  • ISO 9001 awareness training to employees at all levels
  • An executive overview of the ISO standard to top management
  • Process identification, mapping, analysis and improvement
  • ISO project management
  • ISO documentation and implementation
  • Internal audit
  • Use of problem-solving tools

Develop and Maintain your ISO 9001 Internal Audit Program

To be certified and remain so, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, many organizations are short on resources, internal audit expertise and employee availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.

ISO 9001 Continual Improvement Process

The ISO 9001 standard expects your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Many ISO 9001 consulting firms have diversified skills and experience in strategies and methods of continuous improvement.

 
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Posted by on January 9, 2018 in ISO 9001 Certification

 

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What is ISO 9001:2015 Awareness Training and its Benefits?

ISO 9001 training comes in several varieties, from training to help support the creation and maintenance of a quality management system for a company, to training of people who will be certified for auditing the QMS of companies for certification bodies. When implementing ISO 9001, it is essential that everyone knows what they are doing and why. ISO 9001 may start from the top management, but it is essential that all employees on board for its implementation are successful and effective. This is why everyone should be given some training in ISO 9001 awareness.

ISO 9001:2015 TrainingISO 9001 training provides a structure and set of principles that makes sure there is a reasonable approach to the management of an organization to constantly satisfy the requirements of clients and other investors. It delivers the basis for operative processes and active people to supply a quality product or service at all times.

ISO 9001:2015 Awareness training helps participating organizations to gain better knowledge of what a quality management system is, how the requirements of ISO 9001 is implemented and how to audit your quality management system. The training is suitable for the needs of new quality managers and organizations implementing ISO 9001 for the first time.

Benefits of ISO 9001:2015 Awareness Training to Organizations

All organizations, be they small or large, can make a profit by implementing ISO 9001, since then

  • Helps reduces operating costs A continual improvement of procedures and resulting operational productivities mean money saved.
  • Provides legal compliance Organization will understand how legal and supervisory requirements impact the organization and its clients.
  • Provides improved investors or partners relationships improving the perception of your organization with clients, suppliers and employees.
  • Offers client satisfaction by supplying products that constantly meets client’s requirements.
  • Allows organizations gain improved risk management; having greater stability and traceability of products and services denotes that problems are avoided and rectified with ease.
  • Give organization the ability to win more business. The Obtaining conditions sometimes require ISO 9001 certification as a condition to deliver.
 
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Posted by on December 23, 2017 in ISO 9001 Training

 

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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.

 

 
 

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Why ISO 9001:2015 SOPs are Key Requirements in Documentation

An important aspect of any quality system is to work according to clear-cut Standard Operating Procedures (SOPs). An ISO 9001:2015 SOP is a policy and procedure document which describes the regular recurring activities appropriate to quality operations. If it is Critical to Quality then ISO 9001:2015 standard operating procedure is a one of key requirements for documentation. Consistency is the goal or purpose of an ISO 9001 SOP, to carry out all operations correctly and always in the same manner.

The ISO 9001:2015 SOPs documents must be designed and developed as per Quality Management System requirements for ISO 9001:2015 Certification. One of the leading market leaders for ISO consultancy solution, Global Manager Group is offering readymade ISO 9001:2015 Standard Operating Procedures that are very useful to those organizations who are interested to learn documentation process and purchasing partial content of ISO 9001:2015 QMS total documentation kit.

List of ISO 9001:2015 Standard Operating Procedures designed by Global Manager Group

ISO 9001 SOPs documents covers sample copy of SOP to link with good manufacturing practices and guideline for understanding to users to make own standard operating procedure for making good Quality management system. The ISO 9001 Standard Operating Procedures documents have 9 engineering SOPs and 21 operation SOPs to help the organization to make the best Quality Management System and quick process improvements.

ISO 9001:2015 SOPsEngineering SOP :

  1. SOP for Diesel generating set
  2. SOP for Steam boiler
  3. SOP for Water softening plant
  4. SOP for Air compressor
  5. SOP for Thermic fluid heater
  6. SOP for Chilling plant
  7. SOP for Reverse Osmosis Plant
  8. SOP for Hot Air Generator
  9. SOP for Ice Plant.

Operation SOP :

  1. SOP for Finished product handling
  2. SOP for Awareness regarding environmental, health and safety
  3. SOP for Review of country specific requirements
  4. SOP for Personnel security
  5. SOP for Change control
  6. SOP for House keeping
  7. SOP for Label control
  8. SOP for Ware house operations
  9. SOP for Raw material issue
  10. SOP for Operation of Power Plant
  11. SOP for Effluent treatment plant
  12. SOP for Waste Filling and Transportation
  13. SOP for Testing of Raw materials
  14. SOP for Chemical reaction
  15. SOP for Filtration
  16. SOP for Blending
  17. SOP for Tray dryer
  18. SOP for Product change over (cleaning and washing)
  19. SOP for Product withdrawal
  20. SOP for Research and development
  21. SOP for General Requirement of Sampling

Benefits of Using ISO 9001:2015 SOP

  • Establishes guidelines for employees
  • Ensures that all members of the team perform the same task with the same method
  • Provides training support
  • Ensures that production operations are performed consistently
  • Ensures standard compliance
  • Conformity
 
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Posted by on November 16, 2017 in ISO 9001 Certification

 

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Five Tips to Ensure the Successful ISO 9001:2015 Implementation

Implementing ISO 9001:2015 can be a complex and challenging process, which can take 6 to 12 months, depending on the size and organizational structure and other factors that influence it. Most project managers will face many challenges during the implementation phase, but for the new project manager implementing an ISO 9001 based system, there is certainly some useful advice to help focus on the critical parts of the implementation.

Ensure Proper ISO 9001:2015 Implementation

ISO 9001:2015 Implementation

Effective Planning:

Lack of planning is the downfall of many ISO 9001:2015 Certification projects. Good planning is the basis of each implementation project of ISO 9001:2015. Like any project, your implementation will have risks and opportunities – assess and action them intelligently and your project will benefit.

Leadership:

This is another critical element, especially in light of the recent ISO 9001:2015 requirements. It is absolutely critical that you have 100% management commitment in terms of your ISO 9001:2015 implementation. Ensuring that the organizational leaders are committed to the QMS (Quality Management System) and its outcomes and objectives can help greatly to smooth the implementation for the project manager.

Employee Support:

If you see this project as a transfer of knowledge, ISO 9001:2015 awareness training or consultation, it is crucial to have a plan to get support from key employees and stakeholders for an implementation project. Ensure that you consult people on key changes, seek opinions and advice, and provide clear communication to the people affected by the changes that your project outcome will bring.

Communication:

This is closely related to the previous point, but during such a time of change it is critical that your communication is accurate, concise, time sensitive, and delivered by the correct person to give it maximum impact. The correct person may sometimes be the project manager, and sometimes organizational leaders. This means that the employees’ perception of the importance of the project will be accurate.

Performance Evaluation:

This is a critical method of measuring and improving your QMS. Don’t wait until everything is in place to begin measuring yourself; begin as soon as is practical. This is an effective method of measuring progress and performance against objectives, including your own implementation milestones, and it should be used frequently to help your organization to perform and improve itself.

 
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Posted by on October 17, 2017 in ISO 9001 Certification

 

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