Category Archives: ISO 9001 Documents

Steps to Preparing Quality Manual as per ISO 9001:2015 Standard

Quality Manual – ISO 9001 Manual is a typical form of main document used in drawing up and implementing a quality system. It is expected to provide an adequate description of the Management intention to fulfill system requirement while serving as a permanent reference for implementation and maintenance of the system.

Steps to be followed while preparing ISO 9001 Manual

ISO 9001 Manual

  1. An ISO 9001 Manual should be first evolved by the Chief Executive. He can take the help of senior managers.
  2. A person from the steering committee who is from the top management should write the Quality Manual. In most of the cases, the management representative writes the manual.
  3. Based on the company’s ISO 9001 Quality Policy, the broad objectives and activities for each department have to be decided and fitted into the relevant clauses. For this, the department heads should give draft write-up of the activities in their department. Then it should be meticulously scrutinized to ensure that the system is sufficient to achieve the company’s Quality Policy objectives or benchmarks. The clauses applicable to each department of the company are identified.
  4. Organisation chart should be chalked out and the responsibility and authority of each personnel mentioned in the organisation chart should be documented. Personnel authorized to take decisions must be included in the organisation chart. Preparation of the chart will help in identifying and documenting the responsibility for activities under each clause.
  5. A suitable numbering system, department wise and clause wise should be decided which can be made applicable to the remaining tiers of documentation. This will help in cross-referencing ISO 9001 quality manual with other tiers of documentation like, procedures, work instructions and records. It is very important that all the tiers should have cross linkages with each other.
  6. No confidential document / procedure should be included in the Quality Manual because it is an open document.
  7. After preparing the draft of ISO 9001 Manual it should be circulated to all department heads to ensure that there is no discrepancy or that no important activity it left out.
  8. After their approval, the final draft should be prepared. The final draft should have company name and logo, issue number, issue date, controlled-copy identification on each page, page number and signature of preparing and approving authority.
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Posted by on December 15, 2018 in ISO 9001 Documents, ISO 9001 Manual


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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.


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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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Objectives of ISO 9001 Quality Manual

An ISO 9001 quality manual is written to explain a company’s International Standards Organization quality management program. It’s many sections describing the scope, procedures, processes and news procedures of the program. The quality manual could be a handbook and reference for workers and managers concerned within the program.

Quality Management System

The quality management system section of the ISO 9001 manual provides general data regarding the company’s program. It includes ISO 9001 documents and descriptions the management of these documents. It conjointly includes news procedures.

Management Responsibility

The management responsibility section of the manual outlines the company’s commitment policy because it pertains to a quality management program. The section provides goals and objectives for the program. It conjointly outlines the responsibility of every management level.

Product Comprehension

The product realization section of the manual is a very important side of the program. This section explains the method of the product, the design, development, production, purchasing, delivery ways and also the client. The section outlines the controls and activity devices in situ to guide production.

Measurement, Analysis and Improvement

The activity and analysis section of the quality management manual includes product activity processes, client satisfaction, improvement processes, news and documents. It conjointly includes the inner audit method.


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A Short Explanation about ISO 9001 Procedure

When our company will implement Quality Management System, we should always prepare quality management system documentation that has documented statement of quality policy and quality objectives, a top quality manual, quality procedures and geographical point references or work directions to make sure the effective designing, operation, and management of company processes.

In regard with quality procedure, it ought to be established, documented, enforced and maintained. The ISO 9001 procedure is also completely different from one company to a different thanks to the dimensions of company and sort of activities, the quality of processes and therefore their interactions and the ability of their personnel.

In observe, format of ISO 9001 procedures may additionally take issue from one company to a different. For an organization that’s making an attempt to form their own quality procedures for the first time, Readymade sample ISO 9001 procedure will be terribly useful. It doesn’t mean duplicating the all sample procedures for the organization own use.

An ISO 9001 system procedure could encompass cowl sheet, multidimensional language, and procedure thoroughly. The quilt sheet contains name, title of procedure ISO 9001, sheet range, document range and revision record revision range, description of revision, date of revision and signature of the person to blame.

The multidimensional process explains step by step from the start however the ISO 9001 procedure flows. and therefore the procedure itself ought to a minimum of have associate objective, scope, general clarification, definitions employed in the procedure, content of the procedure, records used, connected documents and necessary attachments. The outline is started with the persons to blame and followed by clarification of their tasks or jobs as per the requirements.


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What are Requirements of ISO 9001 Quality Management Systems?

The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.


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ISO 9001 Procedures Templates for Better Implementation of Quality Management System

iso 9001 proceduresIn this blog post, we are going to discuss about the requirement of mandatory QMS procedures and features of the ISO 9001 procedures templates, which is designed by team of ISO 9001 consultants to help organizations in implementation of better quality management system (QMS) as per ISO9001:2008 standard requirements. This ISO 9001 QMS procedures document is covering all the details like purpose, scope, responsibility for how ISO9001 Quality systems are implemented. The list of ISO 9001 procedures that required during documentation for QMS is given bellow:

  • Procedure For Management Review
  • Procedure For Document And Data Control
  • Procedure For Corrective And Preventive Action
  • Procedure For Control Of Quality Records
  • Procedure For Internal Quality Audit
  • Procedure For Control Of Monitoring And Measuring Devices
  • Organization Structure of company
  • Procedure For Control Of Non-Conforming Products

The ISO9001 procedures templates are well written in English and available online with easy to edit features. Some of more advantages of highly popular ISO procedures templates are given bellow.

Advantages of ISO 9001 Procedures Templates

  • The user can modify the ISO 9001 procedures templates as per their industry and create own list of ISO 9001:2008 procedures documents for their organization
  • Ready-made templates are available which can reduce your time in document preparation
  • Process flow charts and formats provided in document kit can help in fine-tuning the processes and establish better control
  • Saves much time and cost in document preparation in USA
  • Takes care for all the section and sub sections of ISO 9001:2008 and give better confidence in the system.

You can download sample ISO 9001 Procedures documents Click Here


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