Mandatory documentation as per ISO 9001:2015 standard (2023)

Mandatory documentation as per ISO 9001:2015 standard (1)

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.

(Video) ISO 9001 2015 Mandatory Document List || Quality Management Complete Document List

Mandatory documents

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

Mandatory records

(Video) ISO 9001 2015 Documented Information

  • 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.

(Video) What Is Documented Information as per ISO 9001:2015

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.

(Video) What Documents are Required for ISO 9001?

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.

(Video) Documents Required for ISO 9001 : 2015 & Implementation

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).

FAQs

What are the mandatory required documents for ISO 9001:2015? ›

The mandatory records needed for ISO 9001 include:
  • Monitoring and measuring resources (7.1. ...
  • Monitoring and measuring equipment calibration records* (clause 7.1. ...
  • Records of competency in staff (clause 7.2)
  • Product/service requirements review records (clause 8.2. ...
  • Design and development inputs record (clause 8.3.
Aug 18, 2019

How many mandatory documents does ISO 9001:2015 require? ›

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.

Which of these documents are mandatory according to ISO 9001? ›

ISO 9001 Mandatory Requirements — Documents and Records
  • Monitoring and measuring equipment calibration records.
  • Records of training, skills, experience and qualifications.
  • Product/service requirements review records.
  • Record about design and development outputs review.
  • Record about design and development inputs.
Mar 3, 2022

What are the six mandatory procedures are required in ISO 9001:2015? ›

Six procedure are- Control of Documents, Control of Records, Internal Audit, Corrective Action, Preventive Action, Control of Non Conforming Products." Six procedure are- Control of Documents, Control of Records, Internal Audit, Corrective Action, Preventive Action, Control of Non Conforming Products.

What are mandatory documents? ›

Mandatory Documents means any requested document that may result in the disqualification of the supplier if not submitted; Sample 1Sample 2Sample 3.

Does the ISO 9001:2015 standard require any documented procedures? ›

The latest version of ISO 9001:2015 does not require mandatory procedures as such, but contains 7 clauses of requirements for documents and records.

What is the ISO standard for documentation? ›

ISO - ISO 19475:2021 - Document management — Minimum requirements for the storage of documents.

Is Quality Manual mandatory as per ISO 9001:2015? ›

A Quality Manual will no longer be a mandatory document, according to the available version of the DIS ISO 9001:2015 standard (to find out more about upcoming changes, read this article: 5 Main Changes Expected in ISO 9001:2015 from the 2014 Draft International Standard (DIS)).

What are all the documents required for ISO certification? ›

Documents Required for ISO Registration
  • Copy of PAN Card.
  • Copy of Aadhar Card or Voter Id.
  • Passport Size Photograph of the applicant.
  • Electricity Bill.
  • Copy of Sale deed in case of owned property.
  • Rent Agreement in case if the property is rented.
  • For an organization, Certificate of Incorporation and MOA &AOA is also required.
Aug 1, 2018

What does the ISO 9001 2015 document contain? ›

ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned ...

What are the five important components focused in ISO 9001 documents? ›

5 Essential Elements of the ISO 9001 Standard
  • Scope. The first three clauses of ISO 9001:2015 are scope, normative references and terms. ...
  • Terms and Definitions. The terms and definitions section outlines the rudimentary vocabulary and definitions from ISO 9001:2015. ...
  • Leadership. ...
  • Planning. ...
  • Enforcement.
Dec 17, 2020

What are documented information in ISO 9001 2015? ›

Documents and Records

Both are now called “documented information”. As per the ISO 9000:2015 definition, the term documented information refers to information that must be controlled and maintained. Therefore, it expects that you also maintain and control the medium as well as the information.

What are the six ISO 9001:2015 clauses that support evidence based decision making? ›

ISO 9001:2015 Clause Guidance
  • 4.1 Understanding Context.
  • 7.2 Competence.
  • 7.3 Awareness.
  • 7.5 Documented Information.
  • 9.1.1 Performance Evaluation.
  • 9.1.3 Analysis & Evaluation.
  • 9.2 Internal Audit.
  • 9.3 Management Review.

What are the 10 clauses of ISO 9001:2015? ›

Top 10 Clauses in ISO 9001:2015
  • Clause 0-3 – Introduction and scope of the standard.
  • Clause 4 – Context of the organization.
  • Clause 5 – Leadership.
  • Clause 6 – Planning.
  • Clause 7 – Support.
  • Clause 8 – Operation.
  • Clause 9 – Performance evaluation.
  • Clause 10 – Improvement.
Nov 14, 2016

What are three important documents? ›

The Declaration of Independence, the Constitution and the Bill of Rights are remarkable documents. The Declaration and the Bill of Rights were designed to set limitations on government.

What is the rule applies for documentation? ›

The most important rule of good documentation is for it to be as inviting as possible. This means that we should aim to write it in the clearest terms possible without skipping over any steps. We should avoid making assumptions about what our users may know.

Which of the following is a documentation requirement for the ISO 9000 quality system? ›

There are four tiers of documentation recommended for satisfying ISO 9000 requirements. These documents are: the Quality Policy Manual, Procedures, Work Instructions, and Records.

Is ISO compliance mandatory? ›

ISO compliance isn't mandatory; there is no “ISO regulation,” so no regulatory imperative to comply. But ISO compliance standards are trusted by organizations from across the world, making ISO compliance a boost to business reputation as well as to operations.

What are the standards of documentation? ›

Documentation Standard means the standard of quality and formatting of documents as stated in an Order. At a minimum all documentation created must meet or exceed applicable industry standards. Documentation Standard has the meaning assigned to such term in Section 3.04(2)(iii).

What are the 4 levels of documents in QMS? ›

Comprising 4 main tiers (quality manual, procedures, work instructions, and quality records) the QMS is a resource and documentation intensive effort.

What is minimum documentation? ›

The PCT minimum documentation is defined by WIPO as the minimum requirement for patent collections used to search for prior art documents for the purpose of assessing novelty and inventiveness.

What documented information must be retained by the organization as required by the ISO 9001:2015 standard? ›

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. The organization shall retain documented information on the release of products and services.

What are the three types of documents created for ISO 9001? ›

The mandatory records needed for ISO 9001 include: Monitoring and measuring resources (7.1. 5.1)
...
These include:
  • Scope of the Quality Management System (clause 4.3)
  • Quality policy (clause 5.2. ...
  • Quality objectives and how these will be achieved (clause 6.2)
Aug 18, 2019

What mandatory documented information is required to be maintained for the QMS of an organization? ›

Documented information to be maintained:

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.

What is a master list of documents? ›

A Master Document List (MDL), aka Master Document Register is a complete list of documents including their metadata to be delivered as part of an engineering capital project.

Why is documents and records control important ISO 9001? ›

Within ISO 9001:2015, control over documented information ensures that: the right people have access to a QMS when and where they need it. no unauthorized or unrecorded changes can be made to its required content.

What are the six types of documents used in a quality management system? ›

The QMS documentation can consist of different types of documents or manuals such as:
  • Quality policy.
  • Quality manual.
  • Procedures.
  • Work instructions.
  • Quality plans.
  • Records.
Feb 21, 2023

What is the difference between documents and records as per ISO? ›

Documents are created by planning what needs to be done and records are created when something is done and record the event. Documents can be revised and change, where as records don't (must not) change.

What is clause 10 of the ISO 9001:2015 and why is it important? ›

ISO 9001:2015 Clause 10 Improvement describes the requirements for continual improvement in the quality management system by identifying nonconformities and taking corrective actions to recur the nonconformity by eliminating the root cause of the non-conformance.

How many management principles are there as per ISO 9001:2015? ›

ISO 9001:2015 and the 8 Quality Management Principles to take you to the head of the class - IQVIA.

What is required in ISO 9001 quality policy? ›

The ISO quality policy requires the statement to be written, documented, communicated and enforced by top management, with the goals and direction gleaned from their high level of knowledge and rooted experience with the company's growth.

What are the 6 A's in evidence-based management? ›

The EBMgt process includes the following steps: 1) asking, 2) acquiring, 3) appraising, 4) aggregating, 5) applying and 6) assessing. We named them 6A that is an abbreviation of the words. Based on the problem or the population, managers should use the best sources of evidence.

What questions do ISO auditors ask? ›

ISO Auditor Questions
  • What is your quality (environmental, safety, information security) policy? ...
  • What are your objectives? ...
  • Where do you get your procedures from? ...
  • What do you do if you find a nonconformance or a potential improvement? ...
  • What are your responsibilities?
Mar 4, 2013

What are the 6 C's of decision making? ›

The 6 'C's-character, capacity, capital, collateral, conditions and credit score- are widely regarded as the most effective strategy currently available for assisting lenders in determining which financing opportunity offers the most potential benefits.

What many mandatory documents are there in ISO 9001:2015? ›

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.

What is the most significant addition to ISO 9001:2015 standard? ›

Risk-based thinking has a very important place in ISO 9001:2015. We use risk analysis in order to decide for ourselves which challenges we see in the management of our business processes. Formal risk analysis, familiar to many organizations via FMEA or HACCP techniques, is now standard for everyone.

What does the ISO 9001:2015 document contain? ›

ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned ...

Is ISO 9001:2015 records and documents are now called documented information? ›

The ISO 9001:2015 standard no longer uses the terms “documents” and “records”. Both are now called “documented information”. As per the ISO 9000:2015 definition, the term documented information refers to information that must be controlled and maintained.

What is the difference between a record and a document? ›

What is the difference between a record and a document? A document is a unit of recorded information. It becomes a record when it is used in pursuance of legal obligations or in the transaction of business.

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