ISO 9001:2015 – list of Mandatory Documents and Mandatory Records

It is very interesting to see and study about Mandatory Documents and Mandatory Records but before going to study bifurcation of Mandatory Documents and Mandatory Records listed in ISO9001:2015, it better to understand what is,

1. Documents and
2. Records

So, for this we will take help of ISO 9000:2015 (Quality Management Systems – Fundamentals and Vocabulary) and accordingly, Document – Clause 3.8.5 Information and the medium on which it is contained Information: As per 3.8.3, a meaningful data Data: As per 3.8.1, data is fact about and object (entity, item) Example: Record, Specification, procedure document, drawings, report, standards. Record – Clause 3.8.10 Document (3.8.5 above) stating results achieved or providing evidence of activities performed. With above two we will see , Documented Information Clause 3.8.10 Information required to be controlled and maintained by an organization and the medium on which it is contained.

 Mandatory Documents

Determining the scope of the quality management system – 4.3 The scope shall state the types of products and services covered. Shall provide justification for any requirement Scope shall be available and be maintain as documented information. Operation of organization’s processes – 4.4.2 (a) Documented information to support operation of organization’s processes. Quality Policy – 5.2.2 Shall be available and be maintain as documented information. Quality Objective – 6.2.1 Shall maintain documented information on quality objective. Quality Objective shall be measurable, monitored, and communicated. Control of production and service provision – 8.5.1 The documented information that define , the characteristics of the products , the service or the activity to be perform for which results to be achieved.

Mandatory Records

Operation of organization’s processes for QMS( no such heading under this sub clause)  – 4.4.2 (b) Retain the documented information. Information that has confidence, that the processes are being carried out as planned. Monitoring and measuring resources – 7.1.5.1 Resources are suitable for the specific type of Monitoring and measuring activity. Resources are maintained to ensure their continuing fitness. Measurement traceability  — 7.1.5.2 Calibration to be traceable to international or national measurement standard. When measurement standard does not exist, the basis use for calibration or verification shall be retained as documented information. Competence  — 7.2 Necessary competence of person shall be determined. Competence on basis of education, training or experience. Action taken and evaluation of the effectiveness of the action taken Retain documented information as evidence of competence. Operational Planning and Control  — 8.1 Documented information to have confidence that the processes carried out as planned and conformity of product and services as per requirement. Review of the requirements for products and services — 8.2.3 The organization shall ensure that it has ability to meet the requirement for products and services to be offered to customers Retain documented information of the review and any new requirement. Design and Development Planning — 8.3.2 Documented information needed to demonstrate that design and development requirements met. Design and Development Inputs — 8.3.3 Determine the requirements essential for the specific type of products and services to be designed and development and retain documented information for these inputs. Design and Development Controls 8.3.4 The organization shall apply controls to the design and development process and activity such as reviews , verification , validation shall be carried out and for these activity documented information shall be retain. Design and Development  output — 8.3.5 Retain documented information for outputs. Design and Development Changes — 8.3.6 Retain documented information for design and development changes, results of review ,authorization changes and action taken to prevent adverse impacts on design and development. Control of externally Provided  processes, Products and Services — 8.4.1 Retain documented information for criteria of evaluation, selection, monitoring of performance etc. Control of production and service provision — 8.5.1 Documented information shall be available for the characteristics of the products to be produces, the service to be provided, or the activity to be perform and result to be achieved. Identification and traceability — 8.5.2 The organization shall control the unique identification of the output when traceability is a requirement, and shall retain documented information. Property belonging to customers or external providers — 8.5.3 Retain documented information for property of customer is lost , damaged or found to be unsuitable for use and  report to customer. Control of Changes — 8.5.6 Retain documented information related to changes. Release of Products and Services — 8.6 Retain documented information on release of products and services shall include acceptance criteria and traceability of person authorizing the release. Control of nonconforming outputs –8.7.2 Retain documented information about nonconformity, action taken concession obtained and authority deciding action. Monitoring, measurement, analysis and evaluation (General) — 9.1.1 Retain documented information as evidence of the result. Internal Audit — 9.2.2 Retain documented information as evidence of the implementation of the audit programme and the audit results. Management Review — 9.3.3 Retain documented information as evidence of the management review Nonconformity and Corrective Action — 10.2.2 Retain documented information as evidence of nature of non conformity action taken and result of action taken. Hope this article will be useful during implementation of QMS.