ISO 9001 2015 Documentation Structure- Downloadable Templates

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. 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.
In this article we explain ISO 9001:2015 documentation structure with +60 downloadable templates

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.

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

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.

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.

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

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.

In addition to the above-mentioned ISO 9001 document 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.

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 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.

There are generally two types of documented information:
Documented information that is to be maintained and
Documented information that is to be retained.
When documented information is to be maintained, it refers to how an activity or process must be performed (previously known as a ‘documented procedure’). This is information that can be changed and updated continuously. It’s information that supports the company's processes, quality policy and quality objectives.
This includes the Quality Management System itself, which of course requires documenting. However, ISO 9001:2015 gives you flexibility in the way you choose to document your system, both in terms of the amount of documented information needed to demonstrate effective planning, operation and control of processes and to provide evidence of continual improvement. After all, if you don’t have any documents on this, how are you going to demonstrate the effectiveness of your QMS to an Auditor?
When documented information is to be retained, it relates to what is called a ‘registration’. This is something that must be kept as proof of the outcome of an activity or process. (previously known as ‘records’). It is something that is factual and cannot be changed.

Firstly, it should be pointed out that long gone are the days when you had shelves buckling under the weight of folders full of printed documents, often to be found under half an inch of dust! It’s not practical, and in many cases not secure.
So naturally, much of your documented information will be not just be in print (including photographs) but also stored digitally and in all manner of formats such as spreadsheets, specifications, procedures, drawings, process diagrams, videos, images reports and templates.
Naturally, you will need some system for controlling your documented information, and ISO 9001: 2015 requires that you have something in place to enable this.
Keeping control of your documentation puts you in control of your processes, and it’s this strong governance that drives compliance.
The matter of document control is a specialism in its own right, and the way you approach it depends on a number of factors, most notably the size of your organisation and the type and complexity of your processes.

The Scope Statement precisely describes your products and/or services, the regulatory requirements, activities, remote locations and facilities supported and documented by the quality management system of your company.
In essence, your scope identifies exactly what your business does.
Make sure your Scope details are fully documented in your QMS. Don’t forget to keep it short and simple. Your customers should be able to read it and understand without a struggle.
Normally, the scope covers the entire organization. But there are exceptions when it comes to companies with multi-location sites such as national and international offices. It can also be limited where a business has two different sides and the QMS is only applicable to one of them.
What Precise Elements Should The Scope Include?
The organization as a whole
The support offered by centralized functions
Processes, site-specific instructions, and procedures
Specific sections of the organization 
Specific functions of the business
Various functions across a group of entities
When Establishing the Scope, There Are Three Factors You Must Consider
Requirements of relevant parties: directors, investors, suppliers, and employees
The internal and external issues affecting the organization
Products and services
The scope includes the ISO requirements that apply. A justification should be provided for the standards that do not apply. In summary, it covers the physical location of the organization, products and services, and the relevant industries.
Scope Statement Example

Top Management is responsible for establishing, reviewing and maintaining the quality policy and quality objectives. The quality policy should build on corporate objectives and values and be appropriate to the purpose and context of the organization.
The policy should demonstrate a commitment to continual improvement. The quality policy must be communicated, understood and applied throughout the organization.
The quality policy is often know by other names such as:
Mission statement
Vision
Strategic concept
Charter
Statement of principles
A well written quality policy statement will ensure your employees understand their job affects product quality and quality control, and therefore the success of the company.
Employees must be made aware that their individual contribution is important to the company’s overall success and commitment to quality.
Sample Quality Policy (docx)

Quality objectives should be measurable, consistent with the quality policy and relevant to product and service conformity. They should contribute to the enhancement of customer satisfaction.
Quality Objectives should be communicated throughout the organization and updated to ensure relevance to changing business needs.
An effective quality management system should align the quality policy with objectives. It will provide the framework upon which to translate these objectives into functional targets.
A goal-oriented framework allows the goals established at the uppermost levels of the organization to flow down through the QMS to influence functional and personal objectives and targets.
Objectives can apply to an entire organization, can be site-specific, or can be specific to individual activities.
The appropriate level(s) of management personnel should define the objectives and targets. In some cases, personnel who set objectives may not be the same as those who set targets. Remember that the objectives are the overall goals as reflected in the principles established in the quality policy.
The scope and number of the objectives and targets must be realistic and achievable. Otherwise, the success and continued commitment from Top Management and employees will diminish.
Consider these factors , as you begin to formulate your objectives:
Legal and compliance requirements
Significant aspects (aspects directly related to significant impacts)
Significant hazards (hazards directly related to risks)
Financial, operational, and business requirements
Views of interested parties
Targets must be quantified where practicable and the units that are used to quantify the targets are referred to as key performance indicators (KPIs). A KPI is defined as an expression that is used to provide information about management system performance.
The following are some examples of KPIs:
The quantity of raw material or energy used
The amount waste produced
The number of incidents/accidents
The percentage of waste recycled
Investment in environmental protection

ISO 9001:2015 requires organisations to ensure that externally provided (supplied / subcontracted) processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:
The products and services are intended for incorporation into the organisation’s own products and services,
They are provided directly to customers by the external provider on behalf of the organisation,
A process, or part of a process, is provided by an external provider as a result of a decision by the organisation. IE Subcontracted.
Organisations are also required to determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. Documented information of these activities and any necessary actions arising from the evaluations must also be retained. IE Records!

1- Monitoring and Measurement Resources (7.1.5.1)
Information as evidence of fitness for the purpose of monitoring and measurement resources.
2- Competence (7.2)
Information as evidence of competence.
3- Requirements Review (8.2.3)
Information describing the results of the review of requirements related to products and services.
4- Design and Development Planning (8.3.2)
Information needed to demonstrate that design and development requirements have been met.
5- Design and Development Inputs (8.3.3)
The organization shall retain documented information on design and development inputs.
6- Design and Development Controls (8.3.4)
Documented information of these activities is retained.
7- Design and Development (8.3.5)
Information resulting from the design and development process.
8- Design and Development Changes (8.3.6)
Information on design and development changes, results of reviews, authorization of changes and the actions taken to prevent adverse impacts
9- Control of production and service provision (8.5.1)
Information that defines the characteristics of the products to be produced, the services to be
10- Property belonging to customers or external providers (8.5.3)
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
11- Control of Changes (8.5.6)
Information describing the results of the review of changes, the persons authorizing the change, and any necessary actions arising from the review.
12- Release of Products and Services (8.6)
Information on the release of products and services including evidence of conformity with the acceptance criteria; and traceability to the person(s) authorizing the release.
13- Control of nonconforming outputs (8.7.2)
Information on the nonconformity; actions taken; concessions obtained; the authority deciding the action in respect of the nonconformity.
14- Monitoring, measurement, analysis, and evaluation – General (9.1.1)
Results of monitoring and measurement activities.
15- Internal audit program (clause 9.2)
Information as evidence of the implementation of the audit program.
16- Results of internal audits (clause 9.2)
Results of implemented audit program.
17- Management Review (9.3.3)
Information as evidence of the results of management reviews.
18- Results of corrective actions (10.1)
Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

Procedure for determining context of the organisation and interested parties (clauses 4.1 and 4.2)
Procedure for addressing risks and opportunities (clause 6.1)
Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
Procedure for document and record control (clause 7.5)
Procedure for Sales (clause 8.2)
Procedure for design and development (clause 8.3)
Procedure for production and service provision (clause 8.5)
Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
Procedure for monitoring customer satisfaction (clause 9.1.2)
Procedure for internal audit (clause 9.2)
Procedure for management review (clause 9.3)

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