When you read the different processes of implementing ISO 9001 Quality Management System (QMS), you’ll notice how they always end in requiring your organisation to work on documentation.
A good ISO 9001 documentation must be concise, making it easy to understand. To achieve this, QSE Academy has prepared a list of documentation requirements and how you can develop it in a comprehensive manner.
What Makes ISO 9001 Documentation Important
– Your organisation has to document its whole Quality Management System. The ISO 9001 standard includes both implicit and explicit requirements for different documents.
– Your organisation has to work on everything that is contained in your ISO 9001 documentation.
– Your organisation must have a comprehensive set of ISO 9001 documents to be able to conduct its business in accordance with ISO.
– Your organisation must secure that the documentation fulfils the requirements of ISO 9001:2015, while ensuring efficiency and the process doesn’t heighten bureaucracy.
QSE Academy reminds organisations not to put pressure on employees by adding work hours to come up with documentation. Some companies even tend to shell out excessive amounts of money to maintain a bureaucratic and complicated QMS.
ISO 9001:2015 Requirements to Prepare
Procedures are crucial in the ISO 9001 documentation because it principally details how organisations execute several processes, including those who are responsible for them.
ISO 9001:2015 establishes the requirements for the procedures and their content in many clauses, but the requirements are not always explicit. QSE Academy suggests organisations to outline the procedures that cover all applicable ISO 9001:2015 requirements.
- Quality objectives
ISO 9001:2015 requires organisations to maintain details about quality objectives as documented information.
- Quality policy
QSE Academy reminds organisations that ISO 9001 quality policy serves as an overall guiding principle. The quality policy describes the company’s position about quality and customer satisfaction. Note that the quality policy must fulfil the requirements of ISO 9001:2015 section 5.2.
- Scope statement
ISO 9001:2015 section 4.3 requires organisations to include a scope statement in the documentation. The scope statement identifies the Quality Management System’s boundaries and application within organisations.
- Process flowchart
ISO 9001:2015 section 4.4 obliges companies to have a process flowchart, which illustrates how the different processes of the ISO 9001 Quality Management System connect with each other.
- Work instructions
Required by ISO 9001:2015 section 8.5.1, work instructions are the most company-specific and intricate part of the documents. Work instructions precisely show how particular tasks must be executed. People who perform the actual work normally write the documents.
Yet, it is a misapprehension that all tasks in an organisation must be documented. QSE Academy reminds that ISO 9001 only needs necessary work instructions that add real value to organisations.
There’s a fine line between documents and records. Documents give directions on how to oversight an organisation. Meanwhile, records are evidence of how things and processes are done.
ISO 9001:2015 encompasses various explicit requirements on records, including requirements for undefined records.
Does ISO 9001 Requires a Quality Manual for Documentation?
Previous versions of ISO 9001 required a Quality Manual because it encloses the overall description of an organisation’s Quality Management System. However, ISO 9001:2015 no longer compels organisations to provide a Quality Manual.
Nevertheless, some organisations still decide to create a Quality Manual for marketing purposes and to provide external parties with general information about their QMS without unveiling their proprietary processes.
Are forms optional?
Here’s a little bit of breather– ISO 9001:2015 doesn’t have requirements on using forms. QSE Academy assures your organisation will not violate any ISO 9001:2015 requirements when you do not have any forms.
Nonetheless, using forms can be beneficial in terms of saving time and practising consistency. Forms can also aid in forming different records required by ISO 9001:2015. Similarly, forms can serve as instructions or guides through the process of providing the requested information.
Format and Content
The requirements mentioned above are critical to your organisation’s ISO 9001 documentation, yet there are also many things that are not needed.
-Your organisation doesn’t have to apply any particular format or layout.
-There’s no need to reference each form and every document to each other.
-There are no requirements regarding introductory paragraphs to procedures.
-There are no requirements that imply your organisation’s documentation must be complex and hard to understand.
How to Develop a Simple ISO 9001 Documentation
Keep in mind that the purpose of ISO 9001 documentation is to specify instructions about how your organisation implements ISO 9001 Quality Management System. Excellent documentation should be user-friendly, as well as easy to comprehend and follow.
QSE Academy warns organisations from developing several different documents and referencing all other documents in each of them. As a result, the documentation creates redundancies and leads to bureaucratic QMS.
Your organisation can develop a good ISO 9001 documentation by considering the different preferences of users. For instance, you can combine instructions through the use of flowcharts, long texts, and pictures.
If your organisation deems necessary, you can apply documentation templates. In addition, communicate with your ISO 9001 consultant about writing the documentation.
QSE Academy encourages organisations to keep their documentation as efficient and as simple as possible. Our team of expert consultants can help your organisation in implementing a Quality Management System that adheres to ISO 9001 standards, including your documentation.
Remember, simple documentation saves time in implementing a Quality Management System, which helps you attain operational efficiency and customer satisfaction.