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ISO 9001:2015

Every organization wants to improve its performance, whether it's to increase market share, reduce costs, manage risk more effectively or improve customer satisfaction. An ISO 9001 Quality Management System (QMS) provides the foundation 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 the ISO 9001:2015 documentation structure with +60 downloadable templates.
ISO 9001:2015 documentation
The ISO 9001:2015 standard requires that the organization's quality management system contains the documentary information required by this standard, as well as the documentary information determined by the organization as necessary for the effectiveness of the quality management system. The term "documented information" refers to information and its supporting medium. This is a guideline that must be followed to avoid any errors as per the requirements of the standard and thus ensure its effective implementation. In ISO 9001:2015, 'documented information' is a common term used for both 'documents' and 'records'.
Documented information of the ISO 9001:2015 quality management system is classified as the production of documented information and the maintenance of documented information. The first includes all documents of the management system. Examples of such documents are: quality manuals, policies, procedures, SOPs, plans, graphics/maps/diagrams, software specifications, instructions and manuals, standards, statutory documents, etc. Maintaining documented information refers to forms, registers and other records that document the results achieved and the effectiveness of the system.
ISO 9001: 2015 documentation structure
The ISO 9001:2015 standard does not require any specific documentation or many procedures. It only offers some documentary information. However, to implement an effective quality management system and obtain ISO 9001 certification, organizations must have a four-step documentation structure:
◾️ Quality Guide;
◾️ QMS procedures, process approach, etc.;
◾️ Work instructions, operating procedures, exhibits, etc.;
◾️ Forms, registers, records.
Quality guide
It establishes the quality policy and describes the organization's QMS. It may refer to all activities of the organization or to a selected part of it, e.g. Defined requirements depend on the nature of products or services, processes, contractual requirements, regulatory regulations, etc. The ISO 9001 quality manual is a typical form of basic document used in the development and implementation of a QMS. Management should provide an adequate description of the intent to fulfill the system requirements, which will be a permanent indicator of the implementation and maintenance of the system. Some may confuse a quality manual with a quality plan. The quality manual describes the totality of the quality management system implemented by the company for all its products/services. The quality manual provides macro-level details of how the system is implemented for all requirements of ISO 9001:2015.
Quality procedures are the core of the documentation system. They support the operation of QMS processes to build trust in the system. Quality procedures describe the methods of meeting the requirements of the relevant clauses of ISO 9001:2015. These documents are intended for internal or external use and should be protected from accidental exposure.
Work instructions and standard operating procedures
As a good work practice, it is recommended that work instructions be prepared and readily available, while the absence of such instructions will adversely affect quality. In a practical sense, work instructions can be written, graphic images, photographs, computer menu options, machine maintenance/operation, work production documentation, etc. These are practical documents. Work instructions refer to production stage activities. Their purpose is to provide the operator with clear information about what needs to be done and what standards need to be met. Therefore, the instructions should clearly state:
◾️ What should be done?
◾️ Correct sequence of actions;
◾️ any special environmental conditions, e.g. temperature, humidity, cleanliness, etc.;
◾️ Reference to standards/codes of practice to be followed;
Quality records, forms and other documents.
They must be maintained in the QMS. These are all supporting documents that the company uses to record information for various procedures. They belong to the last and fourth level 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 effectively and that products or services are being produced in accordance with the requirements defined by the QMS.
ISO 9001:2015 audit checklist
In addition to the above ISO 9001 document structure, organizations should prepare an audit checklist based on the requirements of the ISO 9001:2015 standard. Depending on the organizational structure, an audit list can also be prepared by department. Basically, audit checklists are a set of questionnaires based on ISO 9001:2015 requirements. Checklists are considered to be very useful tools for QMS implementation and internal auditing of the implemented system. It is also very useful for organizations and auditors to prepare for certification audits or any third party audits.
Flexibility in documentation
ISO 9001:2015 gives the organization flexibility in developing quality management system documentation, which may differ from one organization to another, depending on the organization's different performance and activities, processes, goods and services, complexity of processes and their interactions, training and competence of personnel. The conclusion is that the volume of ISO 9001:2015 documentation should ensure an effective quality management system.
In general, there are two types of documented information:
◾️ Documented information to be produced and
◾️ Documented information that must be kept.
When documented information is to be produced, it refers to how an activity or process is to be carried out (formerly known as a "documented procedure"). This is information that can be changed and updated constantly. This is information that supports the company's processes, quality policies and quality objectives.
This includes the quality management system itself, which of course requires documentation. However, ISO 9001:2015 gives you flexibility in choosing to document your system in terms of the amount of documented information needed to demonstrate effective planning, operation and control of processes and to provide evidence of continuous improvement. After all, if you don't have any documentation, how are you going to demonstrate the effectiveness of your QMS to an auditor?
When documented information must be kept, it refers to what is called "registration". It is something that should be preserved as proof of the outcome of an activity or process. (formerly known as "Records"). This is factual and cannot be changed.
Documented information control
First of all, it should be noted that long gone are the days when shelves collapsed under the weight of folders full of printed documents. This is impractical and in many cases not safe.
So, naturally, much of your documented information will not only be printed (including photos), but stored digitally and in all formats, such as spreadsheets, specifications, procedures, process diagrams, videos and templates.
Naturally you will need some sort of system to control your documented information, ISO 9001:2015 requires you to have something in place to enable this. Document control allows you to control your processes, and it is this strong governance that drives compliance.
The issue of document control is a specialty in itself, and how you approach it depends on a number of factors, particularly the size of your organization, the type and complexity of your processes.
Mandatory documented information for production
1. Scope of the quality management system (4.3)
A scope statement accurately describes your products and/or services, regulatory requirements, activities, remote locations, and facilities that are supported and documented by your company's quality management system.
Essentially, your scope defines exactly what your business does.
Make sure your scope details are fully documented in your QMS. Remember to keep it short and simple. Your customers should be able to read it and understand it easily.
Usually, the scope covers the entire organization, but there are exceptions when it comes to companies that are multi-locational, such as national and international offices. It can also be limited where the business has two different parties and the QMS applies to only one of them.
What exact elements should the scope contain?
◾️ The organization as a whole;
◾️ Support offered by centralized bodies;
◾️ Processes, location-specific instructions and procedures;
◾️ Specific departments of the organization;
◾️ Business specific functions;
◾️ Various functions in a group of units;
There are three factors to consider when determining the scope:
◾️ Related Party Requirements: Directors, Investors, Suppliers and Employees;
◾️ Internal and external issues affecting the organization;
◾️ products and services.
The scope includes the ISO requirements that are relevant to the organization. Standards that are not applicable must be justified. In short, it includes the organization's physical location, products and services, and relevant industries.
2. Quality policy (5.2)
Top management is responsible for formulating, reviewing and maintaining quality policies and quality objectives. A quality policy should be based on corporate goals and values and be consistent with the organization's goals and context.
The policy must demonstrate a commitment to continuous improvement. The quality policy must be communicated, understood and applied throughout the organization.
Quality policy is often known by other names such as:
◾️ mission;
◾️ vision;
◾️ Strategic concept;
◾️ Charter;
◾️ statement of principles.
A well-written quality policy statement ensures that your employees understand that their work affects product quality and quality control, and therefore the company's success. Employees need to know that their individual contributions are important to the company's overall success and commitment to quality.
3. Quality objectives (6.2)
Quality objectives must be measurable, consistent with the quality policy and content of the product and service. They should help increase customer satisfaction. Quality objectives must be understood throughout the organization and updated to ensure relevance to changing business needs. An effective quality management system must be consistent with the objectives of the quality policy.
A goal-oriented framework allows goals set at the highest levels of the organization to flow through the QMS to be understood throughout the organization and to influence functional and personal goals. Goals can be organization-wide, location-specific, or specific to individual activities. The appropriate level(s) of management personnel should define goals and objectives. Remember that a mission is a set of goals that are reflected in the principles established in the quality policy. The scope and number of tasks and objectives should be realistic and achievable. Otherwise, the success and continued commitment of top management and employees will decrease.
Consider these factors as you begin to formulate your goals:
◾️ Legal and Compliance Requirements;
◾️ Important aspects (aspects directly related to significant impact);
◾️ Significant hazards (hazards directly related to risks);
◾️ Financial, operational and business requirements;
◾️ views of interested parties.
Targets should be quantified where possible, and the units used to quantify the targets are referred to as key performance indicators (KPIs). A KPI is defined as an expression used to provide information about the performance of a management system.
Below are some examples of KPIs:
◾️ Amount of raw materials or energy used;
◾️ Amount of produced waste;
◾️ Number of incidents/accidents;
◾️ Percentage of recycled waste;
◾️ Investment in environmental protection.
4. Evaluation and selection criteria of suppliers (8.4)
ISO 9001:2015 requires organizations to ensure that outsourced (outsourced/outsourced) processes, products and services conform to requirements. Controls should be applied to outsourced processes, products and services when:
◾️ Products and services are intended to be incorporated into an organization's own products and services;
◾️ They are delivered directly to customers from an external provider on behalf of the organization;
◾️ A process, or part of a process, is provided by an external provider as a result of the organization's decision. eg: subcontract.
Organizations are also required to define and use criteria for evaluating, selecting, monitoring and re-evaluating the performance of external providers based on their ability to provide processes or products and services in accordance with requirements. Documented information about these activities and any necessary actions resulting from the evaluations should also be kept. Eg: records.
Storage of mandatory documented information:
1- Monitoring and measurement resources (
Information as evidence of compliance for monitoring and measurement resources.
2- Competence (7.2)
Information as evidence of competence.
3- Overview of requirements (8.2.3)
Information that describes the results of the review of requests 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 tools (8.3.3)
The organization shall maintain documented information on design and development inputs.
6- Design and development control (8.3.4)
Documented information about this activity is kept.
7- Design and development (8.3.5)
Information from the design and development process.
8- Design and development changes (8.3.6)
Information on design and development changes, review results, authorization of changes, and actions taken to prevent adverse impacts
9- Production and service provision control (8.5.1)
Information that determines the characteristics of manufactured products, services
10- Property belonging to clients or external providers (8.5.3)
When a customer's or third-party provider's property is lost, damaged, or otherwise found to be unusable, the organization must notify the customer or third-party provider and keep a documented record of the incident.
11- Change control (8.5.6)
Information describing the results of the change review, the persons authorizing the changes, and any necessary action resulting from the review.
12- Release of products and services (8.6)
Information about the release of products and services, including evidence of compliance with acceptance criteria; and traceability to the authorized person(s) of release.
13- Control of inappropriate results (8.7.2)
information on non-compliance; actions taken; accepted concessions; Authority to take action on non-compliance.
14- Monitoring, measurement, analysis and evaluation - general (9.1.1)
Results of monitoring and measurement activities.
15- Internal audit program (paragraph 9.2)
Information as evidence of the implementation of the audit program.
16- Results of internal audit (paragraph 9.2)
Results of the implemented audit program.
17- Management review (9.3.3)
Information as evidence of management review results.
18- Results of corrective actions (10.1)
Information as evidence of the nature of the nonconformities, the actions taken, and the results of any corrective actions.
Examples of optional documented information to store:
◾️ Procedure for determining the context of the organization and stakeholders (paragraphs 4.1 and 4.2);
◾️ Procedure for overcoming risks and opportunities (clause 6.1);
◾️ Competency, Training and Awareness Raising Procedure (Sections 7.1.2, 7.2 and 7.3);
◾️ Equipment maintenance and measuring equipment procedure (paragraph 7.1.5);
◾️ Document and record control procedure (paragraph 7.5);
◾️ Sales procedure (clause 8.2);
◾️ Design and Development Procedure (Section 8.3);
◾️ Production and service delivery procedure (paragraph 8.5);
◾️ Nonconformance Management Procedure and Corrective Actions (clauses 8.7 and 10.2);
◾️ Customer satisfaction monitoring procedure (clause 9.1.2);
◾️ Internal audit procedure (clause 9.2).
ISO 9001:2015