How Can Organizations Demonstrate That QMS Processes Are Being Followed as Intended?

An internationally recognized standard for developing, implementing, and maintaining a quality management system for a business is ISO 9001:2015. It can be used by any business and is intended for usage by organizations of any size and in any sector. Due to the fact that it is an accepted international standard and serves as the foundation for any business to develop a system to guarantee customer satisfaction and improvement, many businesses demand the ISO 9001 QMS certification from their suppliers. Customers will feel more secure knowing that you have a Quality Management System in place that is based on the seven ISO 9001 quality management principles when you are certified to ISO 9001.

The Quality Management System (QMS) is made up of numerous different steps that must be correctly integrated in order for them to work. Making sure that each process is carried out according to plan is essential to ensuring that operations further down the line may accomplish their goals since the product of one process frequently becomes the input of another. In ISO 9001:2015, clause 4.4.1 summarises the process approach, and clause 4.4.2 explains it further by stating that you must “retain documented information to have confidence that the processes are being carried out as planned.” Here are a few examples of how to show that the QMS process is being followed correctly.

Key performance indicators: An overview of the efficiency of the process

Monitoring a performance indicator, which is selected for that process to be able to inform you that the process is correctly running, will allow you to determine at the highest level whether a process is carried out as planned. For instance, your purchasing procedure is set up so that you fill out your purchase orders completely and decide which supplier to acquire from, ensuring that the goods and services you get from suppliers are perfect the moment you receive them. Thus, a key performance indicator (KPI) for the purchasing process may be the number of goods or services your supplier supplies to you that totally match your needs. You can get a good sense of how well your purchasing process is working overall by monitoring the percentage of conforming deliveries. This will help you determine whether the process is proceeding according to plan. Your process is documented in your KPI, which is information.

Internal audits: A thorough examination of process effectiveness

The internal audit examines the effects of processes in greater depth. As stated in ISO 9001:2015 clause 9.2, the declared objective of the internal audit program is to guarantee that the QMS complies with the specifications or to verify that the processes follow the planned arrangement. When implementing an internal audit program using the process approach, you start with the requirements for a process (the planned arrangements), gather audit proof that the process outputs satisfy the requirements, and then pinpoint any areas where corrections are required because the outputs are not conforming.  

For instance, in the previous example of purchasing, you would develop an audit checklist using any purchasing procedures (recorded knowledge on the process), giving you the intended audit arrangements. The next step would be to compare the records from the purchasing process—documented information on the outcomes of the process with the anticipated arrangements. These records might include purchase orders, supplier approvals, and records of goods and service receipts. The goal of auditing for conformity is to ensure that the records show that the procedure was carried out according to plan.

The key point is that company must consider what records it will maintain while creating its processes. As you create the process stages, ask yourself, “What ISO 9001 documents record organization need to keep at this stage to demonstrate that it was done correctly so that product conformity is maintained?” Keep this in mind when you create your procedures, and make sure that you can demonstrate that everything went according to plan.

Records: Evidence that a process was carried out as intended

To put it simply, you must be able to demonstrate through your records that your process was followed exactly as intended in order to achieve product and service conformance. Designing your records to readily demonstrate this is crucial because if a procedure affects the conformance of your good or service, you must be able to demonstrate that you carried out the process as you had intended.

Not only will you have to demonstrate this to the auditors of your certifying body, but also to your clients, possibly a government agency depending on the circumstances, and finally to you. If there is any doubt that the product or service compliance is accurate, then you will want to have the proof ready to show unequivocally that your process was carried out as intended to satisfy the product and service standards.

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Quality 4.0: The 3 Important Characteristics of Successful Initiatives and Their Components

Global Quality is continually changing. For example, steam engines and looms kicked off the mechanization of work during the first industrial revolution in the late 18th century. The vast production of automobiles during the second industrial revolution in the early 20th century contributed to boosting the world economy to unprecedented heights. These changes in the industry also led to a shift in the quality approach, from one that was product-based and focused on checking for quality to one that was process-based and concentrated on quality planning and error-proofing. With the widespread use of computers, CAD/CAM, and other technologies to better design, manufacturing, and automation, the third industrial revolution brought about the Programmable Logic Controller (PLC) and a trend toward digital technology.

The fourth industrial revolution, often known as Industry 4.0, is applied to the field of quality through Quality 4.0. Using technological advancements like the Internet, connected devices, automation, and smart manufacturing to foster human-technology collaboration. These developments will ultimately employ big data to enhance and decentralize decision-making in real-time while also boosting efficiency, cutting expenses, and scaling operations.

Digital transformation and “smart manufacturing,” which involves internet-connected devices utilizing human-machine interfaces to communicate with one another, are key components of the fourth industrial revolution. Data are gathered by these systems using cloud technology, which simplifies decision-making and offers real-time insights.

The development of Quality 4.0 and its application to future business will be significantly influenced by Industry 4.0 technology. Appropriate quality 4.0 awareness training can strengthen the capacity to organize strategic quality initiatives, ensure operational quality, and further drive continuous improvement transformations in each of the sectors. Here are mentioned three important characteristics of Successful Quality 4.0 Initiatives:

• Target Areas Where Quality 4.0 Technology Will Improve Performance the Most: In any Quality 4.0 initiative, strategy is always the first step. Start by finding prospective applications for sophisticated analytics, apps, or other connectivity-enhancing technology. Setting reasonable expectations and creating a plan for success will be easier if you evaluate the many sorts of tools available against the specific areas where improvement is required.
• Pay attention to the Quality 4.0 Core Elements that are most essential to business needs: There are 11 key elements, or “axes,” of Quality 4.0. Depending on the particular conditions and business needs of your firm, different ways will be used to leverage and sync each aspect with the other Quality 4.0 components. Based on the company’s present situation and anticipated future state, examine each of the following crucial elements and combine them into use cases. These evaluations should be done for any Quality 4.0 initiative.
• Targets of the digital transformation should be in line with Quality 4.0 objectives: An organization’s overall digital transformation plan must be in line with a Quality 4.0 initiative’s goal of improving connectivity and the quality culture across the entire organization. Digital changes within some organizations might not be as advanced as planned or not be enough to meet Quality 4.0 requirements. In such situations, Quality 4.0 initiatives offer a fantastic chance to realign and refocus quality and corporate digitalization strategies and show how new technology can help and synergize them both.

Embracing the future of quality means striving toward greatness via quality. The ability of quality professionals to assist their organizations in making the critical connection between quality excellence and their capacity to thrive in disruption by utilizing quality principles to enable transformation and growth is crucial for the creation and implementation of Quality 4.0. The following factors need to be considered.

• Technology: The ability to perform things that were previously only possible for large organizations is now available to everyone because of technology, which acts as a great balancer. For instance, using a quality management system (QMS) that is integrated throughout the supply chain offers chances to automate demands like the quality 4.0 certification of conformity. Quality specialists must transition from being data analysts to data wranglers by interacting with new technologies, comprehending them and the potential outputs they bring, and choosing how and when to use them.
• Process: As more work is automated, the demand for streamlined processes is as critical as ever. As a result, not only will new tactics and methods be used, but also current practices, making it crucial to train the upcoming workforce in how to do so. In the end, Quality 4.0 is a crucial link that businesses should include in their digital transformation strategy to guarantee long-term sustainability.
• People: Quality 4.0 incorporates much more than just technology. The use of modern digital tools to maintain quality and master their application is a new way for qualified experts. By speaking the digital language and arguing for quality in disruptive environments, quality experts may transition from being enforcers to navigators, successfully guiding businesses through the digital revolution toward excellence.

 

How Should Nonconformities Be Handled During the ISO 9001 Certification Audit?

Currently, one of the most widely used quality management system standards is ISO 9001. It gives procedures a framework to steadily enhance every aspect of a company. With good cause, more than a million businesses of all kinds are accredited to the ISO 9001 standard worldwide. Due to its adaptability, it may influence organizations in different areas to make necessary adjustments. The ISO 9001 quality management system is the solution if you’re looking to create a culture of ongoing improvement. Root and branch process improvements must be made throughout your firm as part of the adoption of an ISO 9001-compliant quality management system. Planning to support risk management strategies and highlight opportunities is a part of this.

The flexibility of the ISO 9001 standard is one of its primary key features. It is utilized by a wide range of companies and customized to meet their particular business needs. The goal of quality management systems like ISO 9001, which provide best-practice procedures and standards to guarantee the most effective operations, is to increase performance in a manufacturing environment. 

Understand first How are audit findings applied? A set of criteria, such as the ISO 9001 requirements, along with quality policies and ISO 9001 procedures, are taken into consideration by the auditor during an audit, and evidence is gathered to show if the criteria are being met. This proof can be in the form of documents, declarations of fact, or other details about the audit criteria. For instance, the ISO 9001 standards for record control mandate that you have controls in place to identify, store, safeguard, retrieve, and keep documents. The auditors will examine your records to ensure that they meet each of these requirements during the audit.

The auditors will assess whether the criteria were met after gathering the audit evidence and comparing it to the criteria. The comparison is intended to demonstrate that the process complies with the requirements, but it may also demonstrate that it does not. An audit nonconformity is noted in the audit report if the process is found to be non-conforming based on the audit findings.

What exactly are audit nonconformities and what do they imply?

Nonconformities found during a registration audit are often categorized by certifying organizations into two categories: major and minor. Both nonconformities need to be addressed, but each can mean a different thing when it comes to the organization certification being granted.

Significant nonconformities are frequently seen as a lack of compliance with a quality management system requirement (QMS). For instance, according to the ISO 9001 requirements, you must stop inadvertent usage of old documents. You might specify in your procedure that employees must utilize the latest edition of ISO 9001 documents that are accessible on your network rather than printing copies to retain at their desks to address this issue. This may be viewed as a significant nonconformity if the auditors discovered that many different employees throughout your organization were using printed versions of outdated procedures for their work.

A minor nonconformity arises when a problem is discovered that is more limited in extent throughout your organization. If the evidence for printed versions of old documents presented above occurred just with one or two persons in one department, the matter would be classified as a minor nonconformity.

What should you do if a nonconformity is discovered?

Whether an audit nonconformity is big or minor, you should still address it by following the corrective action process to make the necessary corrections. The only significant distinction between a corrective action raised internally within the organization and one raised as a result of a certification audit nonconformity in this procedure is who should assess the sufficiency of your plan and carry out the follow-up. While your certification body auditor will document your answer to the nonconformity in their audit report and follow up on the completion of the remedial action at their subsequent audit, this should be done with them when dealing with a certification audit nonconformity.

The certification can be granted when the corrective action plan is received, and the audit team will follow up at the next maintenance audit by the certification body if any minor non-conformities are still present. Minor non-conformities are frequently found during an audit and frequently need to be addressed within a certain timeframe. If there are significant nonconformities, the certification may not be awarded until the necessary corrective action has been taken and has been evaluated by the certifying body auditors.

 

ISO 9001 Standard: Understand the Gap Analysis for QMS

A gap analysis is a very straightforward process that involves comparing what your business now does with the criteria of ISO 9001:2015 to determine which requirements you have not yet met. This doesn’t involve walking around and auditing your operations to see if you carry out your plans, like an internal audit, but rather involves a paperwork exercise where someone familiar with your company’s management compares what the requirements ask of you to what you already do to see if it satisfies them. Therefore, the procedure would be as follows:

• Use an ISO 9001:2015 gap analysis tool or the standard itself for a very detailed examination, and have someone knowledgeable with the processes analyse each requirement.
• For each standard requirement, record everything you currently do to address that requirement. For this reason, the ISO 9001 QMS documents are essential, and they must be maintained throughout the process.
• You’ll be able to make a list of the requirements that your business has not yet been able to meet once this is complete. This is seen as the gap between what you do and what an ISO 9001:2015-compliant QMS must do.
• The next step is to develop a strategy for putting new processes and procedures in place to address the requirements that are currently unfulfilled by the QMS.

When putting ISO 9001:2015 into practice, a gap analysis is not necessary. No certification body auditor will request to view your gap analysis during your certification, and you won’t fail your audit if you don’t have one. The decision to adopt the gap analysis tool, along with many other aspects of adopting ISO 9001:2015, is completely up to you. Therefore, the actual question is: “Is a gap analysis required for ISO 9001:2015 implementation?”. The answer is up to you and is strongly influenced by your organization, your employees, and the development of any QMS that you may already have in place.

A gap analysis is important for many organizations, especially if they already have some components of a QMS in place for other reasons. Some industries, such as automotive and aerospace, have had some QMS processes in place for many years before ISO 9001 was developed, and these processes will fulfil many of the ISO 9001:2015 requirements. The more elements of a QMS you already have in place, the more valuable a gap analysis will be because it will identify the few things that are missing.

However, if you don’t have anything in place for controlling your operations and procedures, a gap analysis, particularly a detailed one, may be useless. If you know you will need to create a significant amount of ISO 9001:2015 processes, you may want to start the implementation with the assumption that you have created the required processes – and, on the off chance that you discover a process you’ve accomplished, you can get a pleasant surprise and close that action immediately.

Also, the key benefit of a gap analysis is being able to effectively budget the time, money, and resources needed to implement the QMS in compliance with the requirements of ISO 9001:2015. This is especially helpful if you are working under time pressure because of the ISO 9001 certification criteria, compulsory they need to comply with a strict schedule. If you have a self-imposed deadline, it can also be important to set a realistic objective for implementation.

Also, the key benefit of a gap analysis is being able to effectively budget the time, money, and resources needed to implement the QMS in compliance with the requirements of ISO 9001:2015. This is especially helpful if you are working under time pressure because of the ISO 9001 certification criteria, compulsory they need to comply with a strict schedule. If you have a self-imposed deadline, it can also be important to set a realistic objective for implementation.

 

3 Elements That Ensure Competence and Awareness in ISO 9001

Training, competence, and awareness are specifically addressed in ISO 9001:2015 clauses 7.2 and 7.3, and the 2015 revision will include the same terms and responsibilities. The significance of competence and awareness is self-evident; after all, it doesn’t matter how wonderful the processes and documentation are if employees aren’t aware of what exists; otherwise, the Quality Management System (QMS) will be ineffective. Three crucial criteria will be discussed here about ISO 9001 competence and awareness: where to begin, how to sustain, and the evidence required.

Know where to start for the ISO 9001 Competence and Awareness.

Not everybody in the organization needs to know every word of the ISO 9001 standard, and some theories believe that not everyone even needs to read the standard. Disapprove of that, anytime an organization begins an ISO 9001 implementation process with an organization, start with an implementation ISO 9001 QMS training ppt session, which usually ends by asking everyone to follow the standard, where applicable based on the size of the company, and sign to provide evidence for their training record that they have done so. Of course, in larger organizations, this may be restricted to the project team. Wherever possible, consider it is important; after all, how can the company expect to accomplish compliance and excellence against any standard if some team members are unaware of what the standard requires? Employees who join the organization during the process are expected to do the same. So, it gets us started, but what happens next?

How to maintain ISO 9001 Competence and Awareness?

Whether an organization is pursuing certification or simply seeking to recall the QMS after a good audit, the organization must have competence and awareness at the lead of its awareness. There is no set way to accomplish this, but here are some suggestions that may work for the organization:

• Create a monthly bulletin to keep the employees up to date via email.
• Ask the production and quality managers if they can hold a 5-minute update during the regular quality and production meetings to provide teams with first-hand knowledge.
• Develop an “interesting” questionnaire to evaluate staff’s continuing knowledge – schedule and arrange the ISO 9001 awareness training based on where they believe the gaps may be.
• Include the most recent information about the ISO progress on the company’s visual displays in the lobby area.
• Make certain that the organization’s leaders are participating in the communications.
• Importantly, keep track of every proof of training and communication in the Training Matrix to demonstrate that it is continuous.

Depending on the understanding of the organization’s employees, dose individuals will be able to assess what steps must be made to ensure that competence and awareness are at appropriate levels. Again, ensuring that any changes in legislation are conveyed or any queries answered, and dose training evidence is recorded or not.

Is Evidence required in ISO 9001 Competence and Awareness?

When it comes to ensuring that competence and awareness are at an appropriate level during the audit preparation process, as well as an organization will need to show proof of the work that have done to accomplish this, as described above. As previously noted, providing the auditor with documented evidence is essential, but a good auditor will rapidly evaluate the staff’s understanding and the significance they place on the ISO 9001 process itself simply by speaking with them throughout the audit. As a result, it is critical to provide the necessary direction and information to guarantee that the workforce is educated and focused on the critical parts of the QMS and 9001 standards.

 

Understand the Myths and Misconceptions About ISO 9001 Certification and Implementation

Many organizations consider the ISO 9001 certification to be an important standard that all businesses should follow to improve customer satisfaction and produce high-quality products and services. Executing an ISO 9001 Quality Management System supports the organization in developing a comprehensive control system to help in quality control and the achievement of quality objectives and commercial goals. However, there are certain myths and misconceptions about ISO 9001 that may be inducing personal or someone who know the impression of the standard and quality management systems. Here are some of the public myths about ISO 9001 Certification:

• ISO is complicated: At first glimpse, ISO Certification requirements and procedures look to be slightly hard. They are written in a way that is not always easy to grasp for newcomers, using phrases and words that we may not be familiar with. We understand why organizations offer entire courses devoted to understanding ISO 9001.

• ISO Follows Very Old Documentation: ISO 9001 was first published in 1987 and has been reviewed and updated regularly since then. Due to feedback, industry trends, and changes in global demand, updates have been made. ISO 9001 is updated and revised to keep it relevant and useful to consumers. To meet the increasing needs of modern business, ISO 9001 contains components such as a deeper focus on stakeholders and the larger context of an organization.

• ISO 9001 is Only for Large Businesses: ISO Certification Standards are intended to be broad and adaptable, allowing businesses to tailor them to their specific requirements. The framework can be used by any company, regardless of its size or industry. The ISO 9001 Standard is disturbed with the definition, measurement, and improvement of processes. It establishes quality norms and procedures for the firm, ensuring that personnel at all levels adhere to continuous improvement and best practices. The procedure for implementing a QMS System is the same in large and small businesses.

• ISO 9001 Certification is Very Expensive: Employee size, nature of business activity, amount of technology adoption, extent of quality management system installation, employee training requirements, ISO Consultant repute, ISO Certification body selected, and other factors all influence the cost of ISO Certification.

• ISO 9001 is Only for Manufacturers:  Many industries, including hospitals, banks, universities, software companies, and other service or manufacturing businesses, adopt the ISO 9001, Certification Standard. ISO certification enables businesses to demonstrate their ability to produce high-quality products and services. ISO Certification is a globally recognized standard for the quality and standardization of any organization’s products and services. All types of businesses can benefit from guidelines and best practices for streamlining operations and focusing on improving service quality and increasing customer happiness.

• ISO 9001 Requires a lot of Paperwork: ISO 9001 does not have any written processes or procedures that must be followed. Though, ISO 9001 documents help to support the functioning of the procedures and show that they are being carried out as planned. Organizations also preserve documented information relevant to the success of the QMS if they have deemed it important or necessary for their operations.

• Organization needs a perfect system to get ISO certified: It must be an effective system. While ISO 9001 provides instructions for transforming a current management system or creating one from the ground up, certification necessitates a few more processes. To become certified, the organization and its QMS must effectively execute quality management system practices, which means that the ISO 9001 framework must be followed, and customized as per the organization, processes must be documented when necessary, and systems must be audited regularly basis. Certification takes place in several stages over the course ours of three years and includes both an internal and external assessment.

 

5 Major Factors of ISO 9001 Help To Boost the Performance of an Organization

As we all know today’s marketplaces work in a highly competitive environment and for that improve their business performance and stay ahead of their competition. An organization must upgrade its performance by improving product quality, waste control, cost decrease, competitiveness improvement, sales volume, and profitability. Also, ISO 9001 system guarantees each of these factors improves with the execution of requirements that are built from the various clauses of the ISO 9001 standard.

1. Product Quality
   Product Quality and accomplishment of higher customer satisfaction are the fundamentals of the ISO 9001 standard. ISO 9001 defines several controls within its clauses that ensure that an organization offers high-quality output to its customers and meet its customers’ expectations. Some of the ISO 9001 requirements that ensure these are:
   1. Considerate the Context: ISO 9001 requires that an organization understands the requirements of all its interested parties and knows the internal/external problems that are relevant to the organization while defining the scope of the Quality Management System. This confirms that the requirements of customers are well understood and provided when defining the Quality Management System.
   2. Risk Management: Risk-based thinking is important in the new version of ISO 9001 helps to know the risks intricate in delivering a quality product/service to the customer and taking actions to address these risks.
   3. Operational Controls: Numerous controls are built into the standard with the various clauses to confirm all deliveries are revised and tested before it reaches the customer. But some of these need to review, including quality inspections of both raw materials/final product, monitoring of suppliers, and, etc.
   4. Resources and Infrastructure: ISO 9001 touches on all the features of a business and support systems which are essential to ensure product quality to the customer. It also contains infrastructure, communication, resources, both human resource and gear/tools that may be mandatory.
   5. Data-Driven Approach: Here It is required that the organization describes its quality objectives and continually progresses on its performances. Organizations with a constant focus on the quality objectives and with the development of the goals can achieve their business aims.
   6. Process-Approach: ISO 9001 emphasizes having a standard set of procedures and having efficient processes in all departments of an organization. It ensures that the processes are constant and produce an identical quality of product every time. This method provides the required controls that are required to keep the risks at a tolerable level and deliver a more constant result.
   7. Empowered and Involved Employees: It is also a pressure to have empowered and involved employees, access to ISO 9001 awareness training for a better knowledge, and suitable work culture. It benefits to progress the overall confidence of employees and employees put in their best efforts towards customer satisfaction and ensure better product quality.
2. Waste Control
   To accomplish difficult business performance, waste control is a vital decision to make the processes leaner and more effective and origination deliver faster. It also confirms that the actions are enhanced and the product quality improves.
   1. Non-Conforming Product or Process: ISO 9001 requirements describe a very comprehensive method for handling non-conforming products or processes. It requires that an organization analyze all features of the non-conformities and confirm that the non-conformities do not re-occur. This practical approach expands processes and decreases waste in the development.
   2. Continual Improvement: ISO 9001 attentions to constant improvements, which requires that the organizations explore various ways to expand the current set of procedures and develop optimized ways of working.
3. Cost Reduction
   Implementing the Quality Management System based on ISO 9001 that means the organization works on a set of constant procedures which are endlessly improving with time. This helps in productivity and the organization delivers more with the same set of resources. Also, waste control and small rework can help to reduce the cost of deliveries.
4. Competitiveness
   Effective risk management will ensure that the organization has analyzed business requirements well. The reduction of all risks due to external aspects likes competition, marketplace, trends, technological improvements, etc., which improve business stability in a competitive market. The ISO 9001 certification can also improve customer confidence. It also increases customer satisfaction and working towards enlightening customer relationships at all levels.
5. Sale Volume and Profitability
   The complete growth in the status of the organization in the market due to outstanding customer satisfaction and better-quality product deliveries carries a new business and increases sale. So, the reduction in the costs and increase in sales result in increased effectiveness in business.

 

ISO 9001:2015 Documentation Structure and Its Requirement

Every organization wants to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively, or improving customer satisfaction. ISO 9001 quality management system (QMS) gives a framework you need to monitor and improve performance in any area you choose. ISO 9001 is now the world’s most established quality framework, being used by an estimated over three-fourth of a million organizations across the globe. The current version of the QMS standard, ISO 9001:2015, sets the standard not only for quality management systems but for management systems in general. It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation, and continual improvement.

ISO 9001:2015 Documentation

ISO 9001:2015 standard requires the organization’s quality management system to include documented information required by this standard as well as documented information determined by the organization as being necessary for the effectiveness of the quality management system. The term ‘Documented information’ refers to information and its supporting medium. It is a guideline that should be followed to comply with the requirements of the standard to prevent any mistake, and therefore, its effective implementation should be ensured. In ISO 9001:2015, “Documented information” is a common term used for both “documents” and “records”.
Documented information of ISO 9001:2015 quality management system is categorized as Maintain Documented Information and Retain Documented Information.  The former is basically all the documents of the management system. Examples of such documents are Quality Manual, Policies, Procedures, SOPs, Plans, drawings/maps/charts, software specifications, Instructions and manuals, standards, normative documents, etc. Retain Documented Information refers to forms, registers, and other records of the management system. Records are evidence of the results achieved and that the system is followed.

ISO 9001: 2015 Documentation Structure

The ISO 9001: 2015 standard does not require any specific form of documentation or many procedures. It suggests some documented information only. However, for establishing and implementing a good quality management system and ISO 9001 certification, organizations should have four- a tier documentation structure:

1. Quality Manual
2. QMS Procedures, Process Approach, etc.
3. Work Instructions, Operating Procedures, Exhibits, etc.
4. Forms, Registers, Records

ISO 9001 Quality Manual

It states the Quality Policy and describes the QMS of an organization. It may relate to an organization’s all activities or a selected part of it, e.g. specified requirements depending upon the nature of products or services, processes, contractual requirements, governing regulations, etc. ISO 9001 Quality Manual is a typical form of the main document used in drawing up and implementing a QMS. It is expected to provide an adequate description of the management’s intention to fulfill system requirements while serving as a permanent reference for the implementation and maintenance of the system. Some people might confuse between Quality Manual and Quality Plan. A Quality Manual describes the totality of the system of quality management system operated by a company with regard to all the products/services of the company.   The quality manual gives macro-level details of how the system is implemented for all ISO 9001: 2015 requirements.

Procedures

Quality procedures are the core of the documentation system. They support the operation of QMS processes to establish confidence in the system. Quality procedures describe the methods of meeting the requirements of relevant clauses of ISO 9001:2015. These documents are meant for internal use or external use and should be protected from inadvertent exposure.

Work Instructions and Standard Operating Procedures

As a good work practice, it is advised to prepare work instructions to be available, whereas the absence of such instruction would adversely affect quality. In the practical sense, work instruction may be written, drawings, photographs, computer menu options, machine care/operation, work production documentation, etc. These are practical documents. Work instructions deal with the shop-floor level of activities. Their purpose is to clearly direct the operator as to what must be done and what standard of workmanship is required. The instructions must therefore clearly identify:

• What has to be done?
• The correct sequence of activities
• Any special, environmental conditions, e.g. temperature, humidity cleanliness, etc.
• Reference to standards/codes of practice that must be complied with

Quality Records, Forms, and Other Documents

These are required to be retained in a QMS. All these are supporting documents used by the company to record information for different procedures followed. They belong to the last and fourth tier of documentation. They link the activities written in the procedure to the records kept in the department. This type of documentation serves to demonstrate that the QMS is operating efficiently to produce the products or services in accordance with specified requirements of the QMS.

ISO 9001:2015 Audit Checklist

In addition to the above-mentioned ISO 9001 documents structure, organizations should prepare an audit checklist based on the requirements of the ISO 9001:2015 standard. Depending on the organization structure, a department-wise audit checklist can also be prepared. Basically, audit checklists are a set of questionnaires based on ISO 9001:2015 requirements. Checklists are considered a very useful tool for QMS implementation and internal audit of the implemented system for its effectiveness. It is also very useful for organizations and auditors in preparing for certification audit or any third-party audit.

Flexibility in documentation

ISO 9001:2015 allows flexibility to the organization in developing quality management system documentation, which may differ from one organization to another, due to the different size of the organization and the type of its activities, processes, goods, and services, the complexity of processes, and their interactions and training and competence of personnel. The bottom line is that the amount of ISO 9001:2015 documentation should support an efficient quality management system without creating a paper bureaucracy.

Article Source: https://cpduk.co.uk/news/iso-9001-2015-documentation-structure-and-its-requirements

 

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.

 

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.