According to 7.5.1.1, “Quality management system documentation,” IATF states that the organization’s quality management system must not only be documented but also include a quality manual. The format and structure can be defined by the organization and depends on the organizations size, culture and complexity. An organization’s quality management system will include a quality manual. Within the quality manual, a document such as a table, a list, or a matrix, will be available which indicates where within the organization’s quality management system their customer-specific requirements are addressed. Like IATF 16949 and ISO 9001 requirements, customer specific requirements are mandatory for an organization.Within their processes and/or other documentation, organizations must describe how they will implement the requirements. Documented information is required to include documents and records that are required by the standard and are essential for effective operations of your organizations. Documented information is key to your QMS because it is used as evidence of conformance, allows your organization to be consistent, and prevents loss of knowledge and information. The more complex your process is, the more important it is that it is greatly detailed.
Clause 7.5.1.1 Quality management system documentation
In addition to the requirement given in ISO 9001:2015 Clause 7.5 Documented information, Clause 7.5.1.1 requires that organization’s quality management system to be documented and must include a Quality manual either as a hard copy or in electronic form. The format and structure of the quality manual is at the discretion of the organization and will depend on the organization’s size, culture, and complexity. It can be a single document or a series of documents . If a series of documents is used, then a list shall be retained of the documents that comprise the quality manual for the organization. It must include at a minimum the scope of the quality management system, including details of and justification for any exclusions; documented processes established for the quality management system, or reference to them:the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes; a document (i.e., matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed.A matrix of how the requirements of this Automotive QMS standard are addressed by the organization’s processes may be used to assist with linkages of the organization’s processes and this Automotive QMS
Please click here for ISO 9001:2015 Clause 7.5 Documented information
The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements.To establish means to set up on a permanent basis, and the requirement therefore emphasizes that the quality system should form part of the infrastructure of the organization. One of the first decisions to take should be to define the purpose of the quality system, what you want it to do, why you want to create it. Your reasons for creating a documented quality system may be to:
- Ensure products and services satisfy customer requirements
- Maintain the standards which you have been successful in achieving
- Improve standards in those areas where performance is lacking
- Harmonize policies and practices across all departments
- Improve efficiency
- Create stability and minimize variance
- Eliminate complexity and reduce processing time
- Benchmark current performance
- Focus attention on quality
- Ensure products and services are delivered on time
- Reduce operating costs
These are only some of the reasons for creating a quality system. Whatever your reasons are, define and document them and review them frequently. When you evaluate the system these reasons will help determine whether your system is effective.
The standard outlines several types of documents and records that should be included. Here are the key documentation requirements for IATF 16949:
- Quality Manual: As mentioned earlier, the quality manual is a documented statement of the organization’s QMS policies and procedures. It provides an overview of the QMS and its scope.
- Procedures: IATF 16949 requires organizations to establish documented procedures to support the effective operation of their QMS. These procedures should cover various processes, such as control of documents, control of records, internal auditing, corrective actions, preventive actions, management review, etc. The procedures should be documented in a clear and understandable manner.
- Work Instructions: Organizations may need to develop work instructions that provide detailed instructions on how to carry out specific tasks or activities within the QMS. Work instructions are typically used for processes that require a high level of consistency and precision.
- Process Descriptions: The standard requires organizations to document the key processes within their QMS. These process descriptions should include information such as process inputs, outputs, activities, resources, responsibilities, controls, and measures. Process descriptions help ensure a common understanding of how processes are carried out and how they interact.
- Forms and Templates: Organizations should establish and maintain appropriate forms and templates to support the collection and recording of data within the QMS. These forms may include customer complaint forms, non-conformity reports, audit checklists, training records, etc.
- Quality Policy and Objectives: The organization’s quality policy and quality objectives should be documented and communicated within the organization. The quality policy should be a clear statement of the organization’s commitment to quality, and the objectives should be measurable and consistent with the policy.
- Records: IATF 16949 requires organizations to maintain records to provide evidence of conformity to requirements and the effective operation of the QMS. Records may include audit reports, corrective action reports, management review records, product inspection and test records, training records, customer satisfaction records, etc. These records should be controlled and retained for a defined period.
It’s important to note that while IATF 16949 provides general guidelines for the required documentation, the specific documentation needs may vary depending on the organization’s size, complexity, and industry requirements. Organizations should carefully review the standard and consult with their certification body or quality experts to ensure they meet the necessary documentation requirements.
Mandatory documents and records required by IATF 16949:2016
4.3- Determining the scope of the QMS
4.4.1.2- Product Safety
5.2- Policy
5.3.1 Organizations roles, authorities and responsibilities
6.1.2.1 Analyzing Risk
6.1.2.2 Preventive action
6.1.2.3 Contingency plans
6.2 Quality objectives and plans to achieve them
7.1.5.1.1 Measurement system analysis
7.1.5.2.1 Maintenance and calibration of records
7.2.1 Document competence of workers
7.2.2 Document competence of on the ground training
7.2.3 Document Competence of internal auditors
7.2.4 Document Competence of second party auditor
7.3.1 Document awareness of employees
7.3.2 Document employee empowerment and motivation
7.5.1.1 Document quality management system
7.5.3.2.1 Must control and document record retention
7.5.3.2.2 Document engineering specifications
8.2 Document products and services in regard to customer communication
8.2.3.2 Document product and service changes
8.3.1.1 Document the procedure for design and development or products
8.3.2 Document output reviews on design and development
8.3.2.3 Document information on software development
8.3.3.1 Document product design input
8.3.3.2 Document manufacturing process design input
8.3.3.3 Document process to identify special characteristics
8.3.4 Document design and development
8.3.4.4. Documented the product approval process
8.3.5 Document design and development outputs
8.3.5.2 Document the manufacturing process for design output
8.3.6 Document changes for design
8.3.6.1- Supplemental documentation for design and development changes
8.4.1.2 Document supplier selection process
8.4.2.2 Document requirements for externally provided processes, products and services that are considered statutory and regulatory
8.4.2.4 document process and criteria for supplier evaluation
8.4.2.4.1 Document records of second-party audit reports
8.5.1. Characteristics of product to be produced and service to be provided
8.5.1.5 Document the total productive maintenance system
8.5.2.1 Document identification and traceability
8.5.3 Keep documentation of all property belonging to external providers or customers
8.5.6 Document the process of control of changes
8.5.6.1 Document control of changes- supplemental
8.5.6.1.1 Document temporary change of process control
8.6 Document releases of products and services
8.7.1.1 Document expiration date or quantity authorized under concession
8.7.1.4 Document control of reworked product
8.7.1.5 Document the control of repaired products
8.7.1.6 Document customer notification about the nonconformity
8.7.1.7 Document the process for disposition of nonconforming
8.7.2 Document nonconforming outputs
9.1.1 Document monitoring and measurement results
9.2 Document internal audit
9.2.2.1 Document internal audit programs
9.3 Document results of management reviews
9.3.3.1 Document an action plan when customer performance targets are not met
10.1 Document results of corrective actions
10.2.3 Document a process for problem solving
10.2.4 Document a process for error-proofing
10.3.1 Document a process and plan for continual improvements
Quality Manual
The standard requires the supplier to prepare a quality manual covering the requirements of the standard and also requires the quality manual to include or make reference to the quality system procedures and outline the structure of the documentation used in the system. For a quality manual to be a “manual” it should contain the procedures and instructions, so whether one volume of the manual contains or refers to other documents does not prevent the collection of documents being referred to as the quality manual. Manuals tend to include operating instructions, hence the word manual. The quality manual should therefore contain all the policies and practices but not necessarily in one volume.
The quality manual will typically include following sections:
The scope of the QMS: This is in place to define the boundaries of your QMS, and the scope will be stated in your new IATF 16949 certificate. Basically, the scope explains in short what your company does, for example: “wire and harness production” or “seat belt production.” Besides the type of business you are in, you need to define locations and processes that are included in the scope, as well as the exclusions and justifications for those exclusions. Remember that in IATF 16949, the only permitted exclusion is from clause 8.3 product design and development.
The documented procedures established for the QMS (or references): IATF has requirements for documented procedures, and it is safe to assume that the company will create some additional ones that are not required by the standard, but are necessary for an effective QMS. Simply put, if you need to have a written procedure to make sure that mistakes are not made, you need to have a written procedure. If these procedures are simply in flowchart form they could be incorporated into a short Quality Manual, but more than likely they will include some additional information, and most companies will have some additional procedures as well, so references in the Quality Manual are the simplest thing to do. This also gives you a quick place to look when trying to find a procedure.
A description of the interactions between processes: This is most simply done with a flowchart that identifies all the processes in the organization, with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics. This is what is needed in the Quality Manual. IATF 16949 requires the Quality Manual to include a document (i.e., matrix) indicating where within the organization’s QMS the customer-specific requirements are addressed.
Customer-specific requirements: Depending on the approach you take to develop the manual, you will have different options to meet this requirement. The standard itself mentions the matrix as one way of documenting this requirement, so you can just develop a separate document where you will connect the customer-specific requirements with elements of your QMS that are related to those requirements. If you decide to incorporate the correlations of the customer-specific requirements and your QMS into the manual, you can do it the same way as the manual refers to the requirements of the standard.
Here are some key elements typically found in the Quality Manual for IATF 16949 compliance:
- Quality policy: A statement of the organization’s commitment to quality and customer satisfaction, aligned with the requirements of the standard.
- Scope of the QMS: A description of the boundaries and applicability of the QMS, including any exclusions.
- Organizational structure: An overview of the organization’s structure, including responsibilities, authorities, and relationships of personnel who manage, perform, or verify work affecting quality.
- Process descriptions: Detailed descriptions of the processes within the QMS, including inputs, outputs, activities, and interactions. These may cover areas such as design and development, purchasing, production, control of nonconforming products, corrective actions, etc.
- Quality objectives: The organization’s measurable objectives related to product and process quality, along with targets and plans for achieving them.
- Documented procedures: A list or reference to the documented procedures required by the standard or the organization’s QMS. These may include procedures for control of documents, control of records, internal audits, management review, etc.
- Monitoring and measurement: A description of the methods used for monitoring, measuring, analyzing, and improving processes, products, and the QMS as a whole.
- Risk management: A section on risk assessment and mitigation activities, including preventive actions and contingency plans to address potential risks and opportunities.
- Customer-specific requirements: Identification and incorporation of any specific customer requirements that go beyond the standard’s provisions.
- Control of external providers: Processes and criteria for the selection, evaluation, and monitoring of suppliers and subcontractors.
- Control of nonconforming products: Procedures for identifying, documenting, evaluating, and controlling nonconforming products or services.
- Management review: A description of the management review process, including the frequency, attendees, inputs, and outputs of the reviews.
The manual is a document that connects all parts of your Quality Management System, and by reading the manual, one can learn a lot about the company’s QMS – not only whether the requirements of the standard are met, but also how they are met. It is very common for many companies to ask for a Quality Manual when they are first assessing a potential supplier, and this is why making your manual an easy-to-read, informative brochure can be helpful. If the person assessing your manual can easily see that you have everything in place for a successful QMS, then they are more likely to look further into your capabilities and capacity to fulfill their business needs. So, when creating your manual, think to yourself, “What do I want customers to see?” Is it a lot of words that will take some time to wade through; or would it be better to give them everything in one easy document so that they can move on to placing an order?
