Jan 07, 2018

Mandatory documentation as per ISO 9001:2015 standard

The 2015 revision of the ISO 9001 standard only lists 4 mandatory documents as opposed to the six mandatory procedures required in the 2008 version. ISO 9001 does however also require many records that have to be maintained. These records are generated by the QMS processes. The lists below indicate which documents and records are mandatory.

Mandatory documents

  • Scope of the Quality Management System.
  • Quality Policy.
  • Quality Objectives.
  • Procedure for the control of outsourced processes.

Mandatory records

  • Records of calibration and maintenance of monitoring and measuring equipment.
  • Competence records.
  • Products and services requirement review records.
  • Records of new requirements for products or services.
  • Design and development inputs records.
  • Records of design and development controls.
  • Design and developments outputs records.
  • Records of design and development changes.
  • Records of evaluation of external suppliers.
  • Records of characteristics of products and services.
  • Records of changes on customer’s property.
  • Records of changes in products or services provided.
  • Evidence of the conformity of products and services.
  • Nonconformity records.
  • Information on performance monitoring.
  • Internal audits programs and results.
  • Results of management reviews.
  • Records of corrective action taken.

Apart from the mandatory documents and records required by the 2015 version of the standard, there are a number of documents that are commonly used, although they are not mandatory. These include:

  • Determining the context of the organization and interested parties.
  • Procedure for identifying and addressing risks and opportunities.
  • Procedure for competence, training, and awareness.
  • Procedure for the control of documents and records.
  • Sales procedure.
  • Design and development procedure.
  • Production and service provisioning procedure.
  • Warehousing procedure.
  • Measuring customer satisfaction procedure.
  • Internal audit procedure.
  • Management review procedure.
  • Nonconformity and corrective action procedure.

Although ISO 9001 does not require that the procedures listed above should be documented, many of these procedures will be required in order to generate the records that are mandatory. It is for this reason that many companies prefer to document these procedures in any event. When deciding whether to document a process or not, it’s handy to look at the probability of a process not being carried out as planned if it is not documented. If the probability is high, it’s probably better to document it as this is the best way to ensure that your QMS is implemented reliably.

When you use the MyEasyISO software to implement your QMS as per the requirements of ISO 9001:2015, thing become a lot easier than trying to keep track of which documents and records are mandatory, and which are not but would be better to document.

As MyEasyISO complies fully with all the requirements of ISO 9001:2015, it becomes as simple as implementing all the various software modules for your company to ensure that your QMS is reliable and ready to be certified.

In cases where there is not a specific module for a clause, e.g. there is no separate module for the control of documents and records, this requirement is, however, being met seamlessly in the background without the user necessarily being aware of it. MyEasyISO has been written in such a way that this requirement is being taken care of in all the documents and records that are generated by the system.

Especially in the case of non-mandatory procedures where records need to be kept, the software module that is used to generate the records becomes the de-facto procedure that has been designed for you. There is no need to reinvent the wheel – simply use the module to capture your company’s details and the required records become available automatically.

ISO 9001 quality management systems (QMS) are implemented using MyEasyISO software in Taipei (Taiwan ), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with MyEasyISO in Tallinn (Estonia).

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