What is ISO 9001 Audit Checklist for Organization’s QMS?

The ISO 9001 audit checklist is a key element for conducting or planning for a process audit for quality management system in any organization. ISO 9001 is a tool for considering Audit checklist requirements, including quality management system requirements, process performance criteria, and documentation created to avoid process. Now, when it comes to performing the laboratory procedure, there are some requirements that need to be considered when preparing an ISO 9001 Audit checklist.

How to Use ISO 9001 Audit Checklist

The audit is a process, based on systematic activities which are carried out to examine or measure the conformity of any process. In order to audit any process, the auditor uses a checklist to gather evidence to show that the process meets the requirements defined in the criteria. The example checklist above is specific for one laboratory. When performing a laboratory audit, the criteria for an audit will include two major factors. One would be the prescribed process requirements for that particular laboratory, and the other would be the ISO 9001 standard requirements for the ISO 9001 procedure.

If the laboratory does not have defined documentation for its processes, the auditor will be looking at process activities based on ISO 9001 standard requirements. In the results of the audit, there will be a non-conformity in the process because the requirement for documented information is not met. The lack of documentation means that corrective action will be necessary by the process owner, and noted in the result of the audit. 

The goal of the audit checklist is to review the effectiveness of the process

To audit the laboratory’s ISO 9001 compliance, will use the Auditor checklist to find evidence that laboratory procedures meet ISO 9001 requirements. Where the laboratory has not maintained process documentation, the auditor will use the general ISO 9001 standard requirements to review the process. One thing that should be clearly understood is that the purpose of using the audit checklist for the laboratory is to review the effectiveness of the process, and to ensure that non-consistency does not occur. The idea is not just to seek out non-conformities, the goal of the ISO 9001 Audit checklist for a Laboratory is to review the process and confirm that the records provide evidence that the process meets its requirements. The auditor only raises concerns about a corrective action to have the process owner correct instances when the process does not meet requirement.

Benefits of an Auditing Checklist

ISO 9001 provides an audit checklist that organisations are required to use when conducting internal audits.

The ISO 9001 audit checklist includes questions for assessing an organisation’s context, leadership, planning and quality management systems, support structures, operations, performance evaluation and areas for improvement.

  • Checklists provide a reference in the planning of future audits.
  • Audits proceed more smoothly when auditors know the specific requirements of the audit and further introduce consistency and objectiveness to the process.
  • The results documented on the checklist can be used as an internal communication platform to motivate for corrective measures and improvements.
  • The checklist becomes a repository for the findings of the internal audit and form part of the organisation’s requirements management documentation.
  • A completed checklist serves as evidence that an internal audit was conducted and may be reviewed by external auditors.


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What should you expect in any ISO 9001 Internal Auditor Training?

Quality management is not the job of one person; A team is formed to identify the risk and plan to overcome the risk. It is the responsibility of all organizations to maintain the quality of the product they produce. This team is called Quality management team and the ISO 9001 Auditors are quality analysts.

However, not any random employee can become an ISO 9001 auditor. A proper training and certification are required to become an ISO 9001 internal auditor who controls the quality system under a framework which also meets ISO standard.

The ISO 9001 auditor training takes a week to cover all topics, any employee can apply for, or any basic prior knowledge of the program and aim after it will not leave you empty-handed in the first instance. On a successful completion of the ISO 9001 auditor training, participants will be given an ISO 9001 Auditor Training Course certificate, which will make them eligible to conduct audits.

Any employee of the organization can apply to for the ISO 9001 Internal Auditor Training Course; they need to cover following topics to acquire the certification;

  • Purpose of the Quality Management System
  • Principles of QMS
  • Understanding ISO 9001
  • ISO 9001:2015 Requirement
  • Roles and responsibilities of Internal Auditor
  • Planning the audit
  • Conducting the audit
  • Reporting audit results
  • Follow up audit, announcing corrective actions
  • Understanding accreditation services

If you are looking for a good place to get an ISO 9001 certification, Punyam Academy should be the first choice. They provide internationally accepted leading set-up skills. Punyam Academy offers ISO 9001 Auditor Training E-learning Course. It provides lead auditing skill-set that is recognized internationally. It teaches participants the principles of the QMS, processes, and techniques as well as learn everything that need to know about ISO 9001 requirements and also how to perform an internal audit in your company when to use during the assessment of any product.

This ISO 9001 Auditor Training course can be taken by anyone who aspires to lead and manage a quality initiative or department. Those who seek to assess and manage the supply chain in the quality field and person with greater insight into the implementation and requirements of Quality Management Systems must attend this Certified ISO 9001 Internal Auditor Course.

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Posted by on September 25, 2020 in ISO 9001, ISO 9001 Training


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AS9100 Certification – Why it matters?

In order to provide products and services to customers, AS 9100- Quality Management System for the Aviation, Space and Defense is a collection of the organization policies, processes, documented procedures, and records. The AS9100 standard gives a set of guidelines to help to make sure that you don’t miss any important elements and because of that the aerospace QMS can be successful.


The aviation industry has different requirements for quality management, which is why many companies delivering products and services within the airline, space and defense agencies are working to obtain an AS9100 certification. This AS9100 standard puts the requirements for quality management with challenges in the aviation industry in mind.

The AS9100 quality management standards (QMS) are an extension of the ISO 9001 standards specified in the AS&D industry. These requirements include things related to Aviation Space & Defense direct risk management, product configuration, product validation and certification, supplier performance, and product monitoring and measurement.

Importantly, these standards do not replace any existing rules or regulations, but instead seek to perform functions to ensure that all products and services are safe and reliable. AS9100 certification can be obtained at all price levels offered by organizations worldwide to improve quality, cost and service delivery. This is done by reducing or eliminating the unique needs of the organization, the effective use of a quality management system and the widespread use of good business practices.

To ensure that the QMS procedures’ operations performed actually meet the AS9100 custom requirements, as well as the requirements you specified. The auditing function will look at the whole process, look at the preparations set for that process, and evaluate what happened in that process through interviews, observations, and record reviews. Once this data has been collected, the auditors will compare what is happening to what should happen, and then decide whether each process is carried out as planned. If flexibility is not available, they will expect you to take steps to fix the problem.

Once they have confirmed that everything is going as planned, any differences have been made in the adjustments, they will issue a certificate that QMS meets the requirements of AS9100 Rev D. Obtaining and using good AS9100 certification information can be one of the best benefits of your QMS in the long run. A good Certification body will help you succeed, without directly affecting the way you run your processes.

Step to take for AS9100 implementation

  • Identify your context and describe Scope.
  • Explain quality policy, as well as roles and responsibilities.
  • Identify your risks and opportunities and set your goals and plans for improvement.
  • Make sure you have resources that support QMS.
  • Set up all your processes and operating procedures that work.
  • Decide how you will evaluate performance, and set up these processes.
  • Set processes to detect and maintain progress.

So, being Certified AS9100 Lead Auditor with the help of Punyam Academy’s AS9100 Lead Auditor Training – E-learning Course which offers facility to learn about the requirements of AS 9100D Standards additional to ISO 9001:2015 as well as AS9100D Quality Management Principles with Awareness of the need for QMS for Aviation, Space and Defense industries.

Click here to get Outline of this E-learning Course and how Punyam Academy can assist to become AS9100 lead auditor for QMS standard.


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Posted by on June 4, 2020 in AS9100, AS9100 Rev D


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Preparation of Internal audit checklist for AS9100 Rev D

Considering the AS9100 Rev D standard, one of the most critical processes for managing your aerospace Quality Management System (QMS) is the internal audit is an important element. However, a few important things to remember when preparing these AS9100 documents in order to ensure they are beneficial to the AS9100 internal auditor and to ensure a successful audit.

AS 9100DBecause the purpose of the AS9100 audit is to compare what is actually happening in the audit with the planned arrangements, any process AS9100 audit checklist will begin by reviewing the planned arrangements for the process and this is where it is recorded.

While learning AS9100 Auditor Training Course; there are available AS9100 audit checklist which is simply a list of information to check and questions that the auditor wants to ask during the audit. While many of these audit questions come from the documentation review, there are a few other areas that can be important considerations, especially if there is no documented procedure for the process:

  • AS9100 Rev D requirements:

It is important to verify every so often that your processes have not strayed from the AS9100 requirements of the standard. It is imperative that you maintain alignment with the AS9100 requirements, and verifying this during AS9100 internal audits is a good way to do this.

  • Process inputs and outputs:

A process is any activity that takes one or more inputs and creates one or more outputs, and the output of one process will become the input to another process. There can be many problems that arise through the interactions of processes, and reviewing these interactions is important during AS9100 internal audits in these cases.

  • An overview of the process:

Especially when no documentation exists, the process is of creating and reviewing an overview can be useful. An AS9100 Rev D would be including the risks that are understood for that process and how they are addressed. This could be the completed AS9100 audit checklist for a simple process.

  • Process effectiveness:

By comparing this performance indicator against the planned results, the AS9100 internal auditor can tell if the process is implemented effectively, or if an improvement is needed in the process to meet the goals.

  • Defining samples:

It is not often practical or possible to look at every piece of data, which is why the AS9100 audit process relies on taking a sample to assess the processes. You will want to identify how you will choose your samples, such as randomly from a list of open contracts.

For a successful AS9100 internal audit Preparation is key, which is why an audit checklist is essential. Before going into the AS9100 audit area, many audits have a limited time for you to access the information you need, so you want to know what you are doing. And most importantly in case if you end up becoming sick and another AS9100 auditor has to take your place, they only requires to have enough information to perform the internal audit in your stead. An Online AS9100 Auditor Training is very helpful to become AS9100 certified auditor based on AS9100 rev D standard requirements.

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Posted by on December 7, 2019 in AS9100, AS9100 Rev D, Uncategorized


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ISO 9001 Certification – How It Could Help Your Business’s Bottom Line

As a business owner, it is vital that you have a Quality Management System (QMS) in place. Your customers will return if they know they can trust you, as well as the products and services you offer. Due to the fact that many companies have international relationships, it is also imperative that these quality standards are the same everywhere so that businesses are measured the same way.

ISO 9001 certification

The ISO 9001 is one of those international standards that ensures certain requirements for a QMS, and over a million companies across the globe are already certified. The ISO 9001 offers a wealth of benefits to a company and can be obtained by organizations of any size or in any sector, including the manufacturing one.

ISO 9001 Certification: Why Does It Matter?

If you’re running a company with ISO 9001 certification, then you’ve been deemed to demonstrate a consistent ability to provide products and services in accordance with customer needs and any applicable statutes or regulations. That’s a nice badge of honor, but there are financial advantages as well.

These are the benefits of ISO 9001 certification:

  • ISO 9001 certification increases the quality of your services and raises your staff’s awareness.
  • A certified ISO 9001 quality management system ensures clear processes and (communication) structures, tasks and responsibilities throughout the entire organization. This increases the involvement of your staff, which improves the working atmosphere and reduces the pressure of work.
  • You can detect and identify problems in good time, which means that you can quickly take steps to avoid the same mistakes in the future.
  • You make it clear to your staff, your partners, your clients and the outside world that customer satisfaction is at the core of your business.
  • ISO 9001 Certification quality management system gives you a positive company image, raising you up to the level of your competitors or perhaps even a level higher.

Is ISO 9001 Certification Right for Your Business?

Choosing to get ISO 9001 Certification requires careful thought. Although being ISO certified is a sign of credibility that could help you attract more business and score important contracts, you have to have the cash flow to get the process underway and then maintain your quality management system thereafter.


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What is the Role of an ISO 9001 Consultant in Growing Your Business?

Every industry needs to follow certain specific standards’ which creates the credibility and reliability among their customers and also a prominent place in the market. It also helps the organization to improve the efficiency of their overall performance, which in turn will yield more profits and market share. One such industry standardization is the ISO certification.

ISO 9001:2015 Certification is a statement or proof to your stakeholders that the organizations run or operates the business in a certain set of the defined framework to achieve business objective or goal. It shows the commitment of the organization towards their company objectives.

But now the next question is how can achieve or get this ISO 9001 certification for your organization. Here comes the role of ISO 9001 Consultant who is an individual, who provide the consulting services on how your organizations can acquire an ISO 9001 certification by suggesting certain changes in your origination processes. A good ISO 9001 Consultant would rapidly understand the existing processes that are part of your organization and will identify what would be the best approach to implement ISO 9001 requirements.

Let’s understand what role ISO 9001 Consultant will perform;

  1. They help you to assist in implementing and maintain international standards.
  2. They help you to develop the policies & guidelines which are in line with the international standards as defined by concerned authorities or agency.
  3. They ensure that the operational processes and techniques of the organization meet the quality parameters’ of the ISO 9001:2015 standards and suggest changes, if any improvement is required, within the structure of the organization.
  4. They need to check whether internal audits are being performed well or not and further they need to verify the results. This in turn indirectly ensures the financial health of the organization.
  5. ISO 9001 consultant needs to be well versed with all updated versions of the standards and also know how to apply the application knowledge to the respective processes.

So, ISO 9001 consultant help you to minimizes the mistakes, maintain industry standards, and efficient on become more reliable on production and delivery of quality products and services, and also improves the communication and reporting of the organization.

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Posted by on February 12, 2019 in ISO 9001 Certification


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Benefits of ISO 9001:2015 Implementation for Small Businesses

Small businesses are stressful to drive. If a small and medium-sized company continues to struggle with its routine quality problems, there are far fewer chances that the company can sustain and grow. Therefore, the most advantageous tool for a small company to achieve sustainability in its processes is ISO 9001 certification. A small company can reap significant benefits from the systematic approach to the process provided by the ISO 9001 standard. Let’s see how the practical implementation of ISO 9001 standard benefits SMEs to improve their various processes and activities.

Why ISO 9001 certification?

ISO 9001 certificationThe ISO 9001 standard is a basic structure for any organization, large or small, to ensure a good quality management system. The purpose of the standard is to allow a company to provide higher levels of customer satisfaction, along with the constant supply of products or services that meet the needs of customers, as well as the achievement of business goals and targets and to maximize profitability. ISO 9001 certification can help a small company in specific areas, in particular in the coherence of company processes and relationships with suppliers. Here are some examples of how the ISO 9001 standard helps SMEs:

  • ISO 9001 certification can help SMEs to increase their business and, ultimately, their profitability, establishing business with clients for whom certification is a contractual requirement.
  • ISO 9001 allows SMEs to get a clear understanding of their business by collecting all the valuable business information and data required by the various standard requirements.
  • ISO 9001 provides the basis for the development of a system that increases confidence in company stability, while providing reliable and recorded information and data to identify and advance with possible improvements.

ISO 9001 certification benefits all aspects of a business. Some of the key benefits of ISO 9001 certification are the following:

  • Structured and efficient processes management
  • High customer satisfaction and retention
  • Improved quality and service
  • Higher potential for clients and contracts
  • Trusted and valued information and results about the business
  • Better business reputation
  • Consistent processes
  • Increased business turnover
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Posted by on January 11, 2019 in ISO 9001 Certification


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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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The Importance of an ISO 9001:2015 Internal Auditor

ISO 9001 states that the purpose of an ISO 9001 internal audit is to determine whether a quality management system of an organisation:

  1. Meets your requirements for a QMS, and the requirements of the standard; and
  2. Is implemented and maintained effectively.

ISO 9001 internal auditorThe most important task of the ISO 9001 internal auditor is to continuously monitor the effectiveness of the QMS and help senior staff determine whether the quality objectives are aligned with the organisation’s business objectives.

In smaller organisations, the internal auditor often helps to prepare for ISO 9001 certification or maintenance visit. Therefore, it is very useful to have a solid knowledge of the requirements and processes involved in the ISO 9001 certification audit.

The smaller organizations will probably only need an ISO 9001 internal auditor, but larger organizations often require multiple internal auditors to focus on different departments. Appointing internal auditors for different departments increases accountability and reduces the possibility of errors.

Their work, and the help they provide, isn’t finished after the QMS has been implemented and the audit has been completed. They will continue to monitor the QMS and make recommendations to maintain compliance.

The general auditing skills required to become an ISO 9001:2015 internal auditor can also be used in environments outside those related to the Standard. Furthermore, internal auditors are valuable to organisations that audit third-party suppliers, as they can check that suppliers have adequate security controls in place.

The E-learning course on ISO 9001:2015 Certified Internal Auditor Training gives you the knowledge and skills you need to audit against the standard effectively, driving the continual improvement of your organisation’s QMS. Those who pass the included exam will receive the ISO 9001:2015 certified internal auditor training certificate.

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Posted by on September 29, 2018 in ISO 9001, iso 9001 audit


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How to Keep Your ISO 9001 Manual Relevant?

ISO 9001 manual

The first step in building an ISO 9001 Quality Management System is the creation of a “Quality Manual“. This is a separate and distinct step from developing quality procedures. The aim is to establish, in a short and concise format, the policies and objectives of the company required to achieve a desired level of quality for the organization or division.

ISO 9001 manual should be the document where the organization itself, its quality management system, and even his way of thinking and this quality management approach.

What should your ISO 9001 manual contain?

How you can define the contents of your ISO 9001 manual, include only what is useful for your company. So what should you write in the ISO 9001 quality manual? Add the information that will guide current and future employees as they build the business you imagined:

  • The objectives and vision of your company: To set the tone for your ISO 9001 manual, start with the answer to a question: Why does this company exist? Remember, your company does more than just making a product or providing a service. Its purpose involves improving people’s lives in a specific way. Figure out how, and write that down.
  • Products and services: For any product you create or service you fulfil, define the process behind it in the ISO 9001 manual. The quality depends to a large extent on consistency, therefore, clarify your expectations.
  • The definition of quality management system of your company: By itself, the word ‘quality’ is vague. Specifically define what is important to your client.
  • The relationship between different departments: Few products come from just one department. Be sure to define how different parts of your company work together. The easiest way to do this is with a clear flow chart.
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Posted by on August 31, 2018 in ISO 9001 Manual


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