This complete Internal Audit Checklist & Tools Package provides everything you need to establish your Internal ISO Audit Process. The documented procedure is a process that has been used and proven in ISO 9001:2015 trained and registered companies across the globe.
• • • • Version 2015 of the standard has brought some changes, so it’s important to know which documents are mandatory in this revision. How many documents are required? So, here is the list of ISO 9001 documentation requirements – below you will see not only mandatory documents, but also the most commonly used documents for ISO 9001 implementation. Mandatory documents and records required by ISO 9001:2015 Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.): • Scope of the QMS (clause 4.3) • Quality policy (clause 5.2) • Quality objectives (clause 6.2) • Criteria for evaluation and selection of suppliers (clause 8.4.1).
Records of training, skills, experience and qualifications refer to capability and competence to perform activities and processes and ultimately produce conforming products so the records should capture not only training regarding quality but any training the employees take while they are in the company. As far as the objectives are concerned, they should be related to the QMS (Quality Management System), example of such objective is to increase customer satisfaction by 10% compared to previous year. For more information, see: – How to Write Good Quality Objectives. Hi Mohammad, The standard does not require documented procedure for risk assessment. Identification of risks and opportunities should be conducted on the level of the QMS primarily, but it can consequently be applied in processes and projects as well. The standard doe not have explicit requirements in this regard, so the organization itself can determine to what level of details does it need to conduct risk assessment.
For more information, see: How to address risks and opportunities in ISO 9001 Best regards, Strahinja. Dear Tri, We haven’t developed any documents for organizational knowledge since the standard doesn’t requires this clause to be documented.
Basically, the organization knowledge is stored in procedures, work instructions and other documents that describe how the organization is performing its activities, so there is no need for additional documentation. If you like, you can write in the manual or some other document who is responsible for identification and preservation of the knowledge, as well as making it available where is is needed.
For more information, see: How to manage knowledge of the organization according to ISO 9001. Dear Mhammad, Requirements for quality policy are located in the clause 5.2. Zhurnal ucheta potrebleniya elektroenergii obrazec. Organogram and list of functions are not mandatory documents but defining the organogram would be part of determining context of the organization (cause 4.1) and list of functions can be considered as part of requirements regarding roles and responsibilities (clause 5.1) the same can be said for the job descriptions, although they can be part of requirements regarding people (clause 7.1.2) and competence (clause 7.2).