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20, February 2018

Updating Your ISO 9001:2015 Manual — What do you need to know?

ISO compass.pngWith the new ISO 9001:2015 standard there is no longer the requirement for a documented quality manual. I have seen different reactions to this change: “Great, we will drop it all!”, “I am going to keep the one I have - just in case”, “We will copy the new standard and call it our manual. Like in the good old times.” Whatever your initial reaction, it is now your responsibility to answer the question: to keep or not to keep the quality manual?

I would like to share thoughts regarding the value of having a quality manual and what information to include.

Although in the ISO 9001:2015 standard the requirement for a documented manual and procedures was dropped, there are still requirements to maintain documentation on:

  • The scope of the quality management system (4.3)
  • Some documented information to support the operation of the processes and evidence that the processes have been carried out as planned (4.4.2)
  • Quality policy (5.2.2)Quality objectives (6.2.1)
  • Fitness of resources used for monitoring and measurement (7.1.5.1)
  • Calibration documentation (7.1.5.2)
  • Competence of personnel (7.2)
  • Evidence of product or process conformity to established requirements (8.1)
  • Results of the review of customer requirements (8.2.3.2)
  • Changes to the requirements of products and services (8.2.4)
  • Evidence of met design and development requirements (8.3.2)
  • Design and development inputs (8.3.3)
  • Design and development review, verification, and validation activities (8.3.4)
  • Design and development outputs (8.3.5)
  • Design and development changes (8.3.6)
  • Results of the evaluation of external providers (8.4.1)
  • Documented information that controls production and service provision (8.5.1)
  • Documented information to enable traceability when required (8.5.2)
  • Damage to the customer or external provider property (8.5.3)
  • Changes for production and service provision (8.5.6)
  • Documented information on the release of products and services (8.6)
  • Nonconformities (8.7.2)
  • Monitoring and measuring results (9.1.1)
  • Internal audit reports (9.2.2)
  • Management reviews (9.3.3)
  • Corrective actions (10.2.2)

Some of these items can be combined which will decrease this list of 26 items. The list includes some fundamental documented information which you will not change very often:

  • The scope of the quality management system (4.3)
  • Quality Policy (5.2.2)

For those of you who decide not to keep the quality manual, these are two documents you still have to control and maintain. If you choose to add these two items to your Quality Manual you actually reduce the paperwork.

Furthermore, ISO 9001:2015 has certain requirements for determined information applicable to whole Quality Management System with no strict requirement to document it:

  • Internal and external issues (4.1)
  • Interested parties and their requirements (4.2)
  • Processes of the QMS, their sequence and interaction (4.4.1)
  • Processes inputs and outputs (4.4.1)
  • Processes criteria and methods for evaluation (4.4.1)
  • Resource needed for the processes (4.4.1)
  • Processes responsibilities and authorities (4.4.1)

You will not need to change the last five of these requirements often and it is valuable for any organization to have them documented for training and orientation purposes, as well as for a better internal communication.

Those organizations who choose not to keep the quality manual, often end up with a business or operational manual, which contains all relevant process descriptions, interactions, and organizational charts. Therefore, no matter whether you call it a business manual, process manual, or quality manual, the following information is valuable enough to have it summarized in a single document:

  • The scope of the quality management system (4.3)
  • Quality policy (5.2.2)
  • Processes of the QMS, their sequence and interaction (4.4.1)
  • Processes inputs and outputs (4.4.1)
  • Processes criteria and methods for evaluation (4.4.1)
  • Resource needed for the processes (4.4.1)
  • Processes responsibilities and authorities (4.4.1)

Depending on the purpose of the manual you may want to add some additional information, such as:

  • The brief history of your organization 
  • Established polices and rules
  • Emergency contacts
  • Communication plan (section 7.4 of ISO 9001:2015)
  • Etc.

Keeping the quality manual or any other type of top level document will in fact reduce the number of documents to control, will provide an overview of the systems/processes used in the organization, and will assist you in maintaining the integrity of the management systems and processes. In summary, document the manual to support your business and quality management systems and to consolidate into one controlled document high level information which you do not need to change on the regular basis.

It’s your choice.

Yulia Khayde
Alma, LLC
Julia.Khayde@almallc.com

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