Conformance1

Tools for conforming to standards, goals and processes

Documented Information

  • What needs to be documented under ISO 9001:2015?
  • How do I document my organization’s information under ISO 9001:2015?
  • What are some common auditing questions about documented information?

What Needs to be Documented Under ISO 9001:2015?

Some degree of documentation is essential for an efficient quality management system, but too much documentation can be burdensome and a waste of resources. According to ISO, one objective for the ISO 9001 series of revisions is for the amount and detail of documentation required by the standard to be more relevant to the desired outcomes of each organization’s process activities. In order to serve this purpose, specific documentation procedures are not mentioned and organizations can determine the amount of documentation necessary to execute the QMS.

ISO 9001:2015 no longer uses the terms “documents” and “records”. Both are now referred to as “documented information”. According to the new standard, documented information refers to information that must be controlled and maintained. Records are documented information that is “retained” and documents are documented information that is “maintained”. A form is a document, but after the form is completed, it becomes a record. Documented information must include documents and records that are required by the standard and essential for your organization’s operational efficiency. According to ISO 9001:2015, organizations must maintain a quality policy, quality objectives and a QMS scope as documented information.

The definition of documented information is in Clause 3.8 of the ISO 9000:2105 standard. There is a lot of flexibility in how organizations document their quality management systems. For example, the size and complexity of organizations will influence the kinds and amounts of documentation that is maintained. ISO encourages organizations to determine how to document their management systems rather than focus on a set of documents they are required to provide. Each individual organization can determine the adequate amount of documented information necessary to illustrate the effective planning, implementation and control of its processes as well as QMS continual improvement.

Below are some common purposes for documenting information in your quality management system:

  • Communicating information
  • Demonstrating conformity/compliance
  • Maintain records of past achievements and processes from which to build on
  • Sharing knowledge/Collaboration

Clause 4.4 requires organizations 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.” Clause 7.5.1 explains a bit more about what kinds of documentation must be maintained in order to establish a quality management system, including:

  • The scope of the QMS (clause 4.3)
  • Any documentation necessary to support process operations (clause 4.4)
  • The quality policy (clause 5)
  • The quality objectives (clause 6.2)

How Do I Document My Organization’s Information Under ISO 9001:2015?

According to ISO 9001:2015 clause 7.5.3 Control of documented information

requirements, documents can take any form or medium. Examples given within the standard include:

  • Paper
  • Photos
  • Electronic files
  • Computer discs
  • Magnetic Media

But what exactly needs to be documented and in what ways? One primary purpose of documenting information is for internal and external communication. While the latest revision of the standard does not require any specific type of documentation, below is a list of example documents that can be used to add value to a QMS.

  • Charts
  • Process maps/flow charts or descriptions
  • Product specifications
  • Work instructions
  • Procedures
  • Production schedules
  • Quality manual
  • Strategic plans
  • Inspection plans
  • Supplier lists
  • Forms
  • Internal communication documents

Documented information is necessary to demonstrate evidence of achieved results and illustrate conformity/compliance. All organizations will need to document:

  • Scope of the QMS (4.3)
  • Quality policy (5.2)
  • Quality objectives (6.2)

Some additional examples of documentation that would fit this requirement and may apply to your organization include:

  • Calibration records from monitoring and measuring equipment (7.1.5.1)
  • Training records, experience and qualifications (7.2)
  • Contract requirements review records (8.2.3.2)
  • Design and development input records (8.3.3)
  • Design and development control records (8.3.4)
  • Design and development output records (8.3.5)
  • Design and development change records (8.3.6)
  • Criteria for selecting, managing, and assessing suppliers (clause 8.4.1)
  • Characteristics of products and services (8.5.1)
  • Customer property records (8.5.3)
  • Records of changes to production processes (8.5.6)
  • Records of product and service conformity (8.6)
  • Nonconforming output records (8.7.2)
  • Results of monitoring and measuring practices (9.1.1)
  • Internal audit records (9.2)
  • Management review results (9.3)
  • Corrective action records (10.1)

The above documents mostly refer to reactionary elements of the QMS that should be recorded. Additionally, there are plenty of non-required procedural documents organizations may find useful in implementing and ISO 9001 QMS. Some commonly-used procedures are listed below:

  • Identifying the context of the organization (4.1)
  • Identifying interested parties (4.2)
  • Identifying and addressing risks and opportunities (6.1)
  • Identifying, acquiring, and training competent personnel (7.1, 7.2, 7.3)
  • Maintaining and measuring equipment (7.1.5)
  • Document control (7.5)
  • Sales (8.2)
  • Production and service provision (8.5)
  • Warehousing (8.5.4)
  • Managing nonconformities (8.7 and 10.2)
  • Monitoring customer satisfaction (9.1.2)
  • Internal audits (9.2)

Common Auditing Questions About Documented Information

What Are Some Tools I Can Use to Control Documented Information and be Prepared for an Audit?

Process activity maps are a wonderful tool to help organizations control documented information. The map contains the item on the left side, and the respective information that needs to be controlled on the right. The activity connecting both sides is usually located in the center of the map. 

Source: https://www.iso-9001-checklist.co.uk/7.5.3-control-of-documented-information-explained.htm#requirements-for-documentation

What Else Can I Do to Control Documentation and Demonstrate Conformity?

It’s useful to have a familiarity with specific terms used in the new ISO 9000:2015 standard that are related to documented information. This will ensure you are adequately documenting your QMS as well as able to efficiently communicate and illustrate this to an auditor. For example, some terms you might want to become familiar with are:

  • Documented information (discussed in ISO 9001:2015, Clause 3.8.2)
  • Record (Clause 3.8.5)
  • Quality manual (Clause 3.8.7)
  • Specification (Clause 3.8.5)
  • Objective evidence (Clause 3.8.1)