ISO 9001:2015 & Documentation

ISO 9001:2015 & Documentation

ISO 9001:2015 and documentation

To most organizations, documentation is perhaps the most mind-numbingprocess. It is easy to get overwhelmed with endless requirements. However, implementing ISO 9001:2015 does not require comprehensive documentation for every function. The latest revision made documentation much more liberal. Let’s explore further;

Documentation required by ISO 9001:2015

From the text it is normally evident when “documented information” relates to “records” as evidence of performed activity/process and when “documents information” relates to how to perform an activity/ process. Normally the standard refers to “shall maintain documented information” when the meaning is how to perform an activity/process and “shall retain documented information” when the meaning is to keep evidence of performed activity/process.

How many mandatory documents come with the 2015 revision? How many are required? The 2015 revision brings its share of changes. Recognizing and implementing these changes will determine whether your organization can earn its certification. Here is a list of ISO 9001 documentation that details what is mandatory and the most commonly used. The applicable clause is in brackets.

Mandatory documentation (Records and Documents)

These are documents that you are required have in order to be ISO 9001:2015 compliant. Please note that records marked with an asterisk (*) are required where the relevant clause is included.

  • Scope of the QMS (4.3)
  • Quality policy (5.2)
  • Quality objectives (6.2)
  • Criteria for selection and evaluation of suppliers (8.4.1)
  • Measuring and monitoring equipment calibration records* (7.1.5.1)
  • Records of training, experience, skills and qualification. (7.2)
  • Service/product requirements review records (8.2.3.2)
  • Records about design and development output review* (8.3.2)
  • Records on development and design inputs* (8.3.3)
  • Records on development and design controls* (8.3.4)
  • Records of development and design outputs*(8.3.5)
  • Design and development changes record* (8.3.6)
  • Characteristics of products produced and services provided (8.5.1)
  • Records about customer property (8.5.3)
  • Service/production provision change control records (8.5.6)
  • Record of conformity of service/product with acceptance criteria (8.6)
  • Record of nonconforming outputs (8.7.2)
  • Measuring and monitoring results (9.1.1)
  • Internal audit program (9.2)
  • Internal audit results (9.2)
  • Results of the management review (9.3)
  • Results of corrective action (10.1)

Non –mandatory documents

The document vault for ISO 9001 is immense. Here are the most commonly used non-mandatory documents.

  • Procedures for determining interested parties in an organization (4.1, 4.2)
  • Procedure for addressing opportunity and risk (6.1)
  • Procedure for training competency and awareness (7.1.2, 7.2, 7.3)
  • Procedure for measuring equipment and equipment maintenance (7.1.5)
  • Procedure for record and document control (7.5)
  • Sales procedure (8.2)
  • Procedure for development and design (8.3)
  • Procedure for service provision and production (8.5)
  • Warehousing procedure (8.5.4)
  • Procedure for management of corrective action and nonconformities (8.7, 10.2)
  • Procedure for monitoring customer satisfaction (9.1.2)
  • Procedure for internal audits (9.2)
  • Procedure for management reviews (9.3)

ISO 9001 has no requirement that you document all of the procedures; however, there are several processes an organization must implement to generate the mandatory records outlined in the first few paragraphs. Documentation for these processes and procedures isn’t necessary, but many organizations do so anyway. Why? Because they want these procedures to be implemented correctly. They understand the implication of processes that are not implemented well.

Maintaining and keeping the correct documentation is a great way to support the integrity of the system.

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