We've prepared page quality manuals and other manuals with more than pages that included all the documented procedures and forms. Each version of the quality manual was certified, along with QMS, because it met the requirements - not because they were a certain page length. It conveys how the quality management system works and what controls are in place to manage each process. Therefore, the size, context and complexity of your organization and extent of its individual processes will heavily influence the volume of content in the quality manual.
You need to write the quality manual so that the intended audience will use it. The primary audience should never be the External Auditor. A good quality manual document is one that has a clear purpose is it easy to follow? It would be difficult address all the requirements in 3 or 4 pages. Most quality manuals are typically 30 or 40 pages in length.
Our quality manual template addresses each quality requirement in 37 pages of text, while the quality procedures supplied as separate documents carry the burden of defining how compliance is achieved at an operational level. The key is to decide who needs to read the quality manual and write the content for them. Most internal auditors, regulatory bodies, suppliers, employees and customers who are likely read your quality manual will know what they are looking for.
To add value, you need to decide what is useful to your organisation in meeting your unique needs and in your unique context.
Ask your business partners, suppliers and customers for a PDF copy of their quality manual if they are ISO certified. It will help inform and manage their expectations, while providing a benchmark for your industry. People often argue that you should create the quality manual based on your operations, not on the numbering system of the standard.
While linking the quality manual to the clause numbers acts as a useful cross-reference in the early stages of implementing ISO , doing so might create a bit more work when the standard itself is revised. Though this extra work helps you to look more closely at the clauses of the standard, making sure you did not miss anything, keeping such references can be helpful for an External Auditor and new employees but it might also be helpful for management too!
As such, the heading titles and numbering used in our quality manual template relate to the standard for ease of reference. We recommend to clients they gather and review a number of relevant quality manuals before starting their documentation.
Ask your business partners, suppliers and customers for a PDF copy of their business quality manual. There are many quality manual examples available online - some good, some poor Here are some TIPS:. Some of the more common ISO templates include:.
As such, we recommend:. The quality manual contents will be the same, no matter what industry you're in. If you're a small one-man engineering business or a large manufacturing, ISO 's requirements are the same; the difference will be in your operating procedures. The introduction of the quality manual introduces you to both the ISO standard and the Scope of the manual itself. The quality management principles section will cover the core principles that drive ISO operations, in addition to your quality management system.
You should include the boundaries of the new quality management system in your quality manual. Mention the types of products or services your organization offers, in addition to the industry you work in.
Learn more about how to write your scope. Also, make sure you mention exclusions for your business, rather than omitting them entirely. Some ISO requirements, for example, may not apply to your specific organization, such as Clause 8. This section of the quality manual offers a glossary of terms that will be mentioned throughout the remainder of the manual.
The context of the organization section has a lot of information discussing various types of issues that may arise while implementing or updating the quality systems documentation.
This section also features strategies that can help overcome such issues. Internal issues are problems found within the organization itself. Some internal problems can be related to the following:. A SWOT analysis Strengths, Weaknesses, Opportunities, and Threat Analysis can be performed by an organization in order to get a baseline of where they stand in comparison to where they want to be after implementing the new QMS.
External issues are problems that exist outside of your organization and can be much more challenging to overcome. External problems are usually associated with requirements that need to be met within your industry, in technology, globalization, and more. Leadership is one of the biggest principles expressed by the ISO standard.
This is who is responsible for making sure that the development and implementation of the policies regarding your quality management system are going according to plan. Some of their responsibilities will include directing strategies and providing communication in processes and performance.
They will also need to make sure that resources for ISO implementation are allocated to areas that need more focus on improvement and responsibilities are distributed to the right people or departments. For example, leadership may need to ensure that the quality manager has all of the necessary resources — such as finances or technology — to initiate processes and complete them successfully.
In the PDCA plan-do-check-act cycle, there are four different phases necessary for leaders to go through. These steps are:. The governing leaders of the organization will also be responsible for verifying the system itself, usually through the form of internal audits and reviewing data.
Leaders with this responsibility should look at current trends as well as looking out for risks that the organization should plan to overcome.
Most importantly they should continuously monitor the effectiveness of the QMS system in addition to any improvements or success it achieves. This next chapter in the quality manual is focused on management system planning. The best QMS will consider maintaining a balance between the number of risks versus opportunities available from certain processes. This balance must be managed internally in order to achieve effectiveness. The risk evaluation cycle is one way for leaders to assess risks regularly.
The cycle includes the following steps:. Following this cycle will help your organization actively recognize problems before they become problems and create proactive strategies to combat them. Top Management is responsible for ensuring that a risk-based style of thinking is implemented within your organization. Top Management will also be expected to provide the resources necessary to cover any processes within their departments, as well as planning and assigning responsibilities for ISO certification.
The next chapter that is covered in the quality manual is support. Support can come in many forms, including customer support, financial support, and even human resources.
The goal of support is to ensure improvements are made in some of the following areas:. Without customer satisfaction, your business risks profit losses in addition to a reduced customer base and market.
On the positive side, having good customer satisfaction leads to higher spending, more frequent customers; in addition to an increased chance of bringing in new customers. This will eventually result in higher profits. General support includes resources such as human resources and financial resources, as well as the working environment. Making sure your employees are satisfied with their work environment is important.
With comfort, efficiency, and productivity in the workplace, your employees will produce more quality products and services. However, this might be fine until you actually try to use the product, or in the case of an ISO standard, face an audit.
Yes, some ISO Consultants seem to enjoy generating paper and big invoices. And a good auditor will spot this kind of DIY bolt-on fakery straight away. Why waste time? This white paper explains each clause of ISO , plus provides guidelines on how to meet each requirement of the standard.
It also gives an insight on how to apply process approach. Additionally it outlines the procedures required to plan and analyze processes within your organization. The matrix shows the relationship between clauses of ISO and ISO , and gives an overview of common requirements of these two standards with tips on how to fulfill them with as little documentation as possible.
The purpose of this document is to present possibilities for combining these two systems in organizations that plan to implement both standards at the same time or already have one standard and want to implement the other one.
This document is intended for environmental managers, project managers, and other employees who need guidance on how to identify and evaluate environmental aspects according to ISO Get an overview of the key tasks you should consider while implementing your Environmental Management System, and links to useful resources that will help you understand environmental aspects.
This white paper is intended for companies that need to perform an internal audit as part of their ISO management system. Learn how ISO can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard. This white paper is intended for environmental managers and consultants in companies which already implemented quality standard s and need guidance on what to expect at the ISO certification audit.
It outlines why you should consider an Integrated Management System, and it provides an overview on how to get started with triple implementation. This helpful document gives an overview of benefits that the implementation of the new standard ISO can bring for business.
Completing your ISO transition project before the deadline, when time is an issue, can be challenging — even to the most streamlined businesses. This case study aims to help speed up the process, with a real example showing the timeframe and the steps to follow. It also shows the options that exist for the transition and how this company resolved their doubts in the transition process.
Deciding which method to follow when implementing ISO can be confusing. This white paper outlines the pros and cons of both going it alone, and hiring a consultant. It offers detail on both techniques, as well as what to look for in a good online solution, helping you make an informed decision on the best approach for your business. Implementing a project like ISO can be costly if you do not budget in advance.
This white paper is designed to help you plan your finances efficiently, while preventing any unnecessary expenses.
In addition to learning budgeting benefits and tips, you will also discover how different implementation options can affect your overall budget. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization.
Management of the processes and the system as a whole can be achieved using the PDCA cycle see 0. The application of the process approach in a quality management system enables: a understanding and consistency in meeting requirements; b the consideration of processes in terms of added value; c the achievement of effective process performance; d improvement of processes based on evaluation of data and information. Figure 1 gives a schematic representation of any process and shows the interaction of its elements.
The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.
The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity.
Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.
This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards. This International Standard relates to ISO and ISO as follows: — ISO Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; — ISO Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.
This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.
Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document including any amendments applies. ISO , Quality management systems — Fundamentals and vocabulary. The organization shall monitor and review information about these external and internal issues. NOTE 1 Issues can include positive and negative factors or conditions for consideration. NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. The organization shall monitor and review information about these interested parties and their relevant requirements. When determining this scope, the organization shall consider: a the external and internal issues referred to in 4.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a determine the inputs required and the outputs expected from these processes; b determine the sequence and interaction of these processes; c determine and apply the criteria and methods including monitoring, measurements and related performance indicators needed to ensure the effective operation and control of these processes; d determine the resources needed for these processes and ensure their availability; e assign the responsibilities and authorities for these processes; f address the risks and opportunities as determined in accordance with the requirements of 6.
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a customer and applicable statutory and regulatory requirements are determined, understood and consistently met; b the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c the focus on enhancing customer satisfaction is maintained.
Top management shall establish, implement and maintain a quality policy that: a is appropriate to the purpose and context of the organization and supports its strategic direction; b provides a framework for setting quality objectives; c includes a commitment to satisfy applicable requirements; d includes a commitment to continual improvement of the quality management system.
The quality policy shall: a be available and be maintained as documented information; b be communicated, understood and applied within the organization; c be available to relevant interested parties, as appropriate. Top management shall assign the responsibility and authority for: a ensuring that the quality management system conforms to the requirements of this International Standard; b ensuring that the processes are delivering their intended outputs; c reporting on the performance of the quality management system and on opportunities for improvement see Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. The quality objectives shall: a be consistent with the quality policy; b be measurable; c take into account applicable requirements; d be relevant to conformity of products and services and to enhancement of customer satisfaction; e be monitored; f be communicated; g be updated as appropriate.
The organization shall maintain documented information on the quality objectives. The organization shall consider: a the purpose of the changes and their potential consequences; b the integrity of the quality management system; c the availability of resources; d the allocation or reallocation of responsibilities and authorities.
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization shall consider: a the capabilities of, and constraints on, existing internal resources; b what needs to be obtained from external providers. The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE Infrastructure can include:. The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical factors, such as:.
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a are suitable for the specific type of monitoring and measurement activities being undertaken; b are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b identified in order to determine their status; c safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re- assignment of currently employed persons; or the hiring or contracting of competent persons.
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:. When creating and updating documented information, the organization shall ensure appropriate: a identification and description e. Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations. NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled see 8.
Communication with customers shall include: a providing information relating to products and services; b handling enquiries, contracts or orders, including changes; c obtaining customer feedback relating to products and services, including customer complaints; d handling or controlling customer property; e establishing specific requirements for contingency actions, when relevant.
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: a the requirements for the products and services are defined, including: 1 any applicable statutory and regulatory requirements; 2 those considered necessary by the organization; b the organization can meet the claims for the products and services it offers.
The organization shall conduct a review before committing to supply products and services to a customer, to include:. The organization shall ensure that contract or order requirements differing from those previously defined are resolved. NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.
The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
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