ISO 9001 requires an organization to create a Quality Management System to accurately direct and coordinate all organizational activities. The objective of a Quality Management System is to ensure effective procedures and associated documents are in place to meet customer and regulatory requirements and to improve customer satisfaction.
ISO 9001: 2015 defines a Procedure as “specified way to carry out an activity or a process”. A number of procedures may need to be written to develop an efficient Quality Management System. A well-written procedure helps bring greater consistency in the activities involved in the provision of products or services. Organization starting their ISO journeys often face problems when they start writing the procedures as they do not understand where to start and how to write a procedure. While ISO 9001 does not prescribe a standard template/method to write a procedure, some of the key requirements of the standard specify some of the areas that a procedure should handle.
A documented procedure is required for effective planning, operation and control of the processes and must include the documented information necessary to support the operation of the processes.
Key steps to write a procedure
Step 1: Align to business process
The first step to build a Quality Management System is to understand the context (internal and external issues) and the needs of the stakeholders. This is required to determine the risks involved in the process and determine steps that would be required in the procedures to mitigate these risks. Alignment of Quality Management System Procedures with the business context ensures efficient and leaner procedures. The procedures developed this way will work more in conjunction with the business objectives and help the Quality Management System meet its intended purpose.
Step 2: Define the scope of the procedure
Not all processes of an organization need to be documented, the organization can select the core processes for which procedures shall be written to ensure consistent and high-quality delivery to the customers. Once a list of procedures that need to be defined is decided, the first thing is to understand the limits of each procedure. The procedure should clearly define the scope of the procedure to ensure there is no ambiguity in the minds of the reader on the areas which are covered/not covered by the procedure.
Step 3: Gather process information
Each procedure needs a detailed description of all the activities required by the process. To write a procedure, you need to gather all the information which include inputs, output, activities, person responsible for each activity and measurements, if any. A flowchart or a process map can help you sequence the activities and gather all relevant details. Flowcharts help visualize what is going on and can be used to document the ‘As-is’ Process.
Another method that may be used to gather all the information is the Five Ws (also referred to as Five Ws and One How, 5W1H). This method includes questions whose answers are considered basic in information gathering or problem-solving. This method can help you define a procedure by answering all 5 W’s and 1 H’s.
- Why is this procedure important? – Define the purpose of the procedure
- Who is involved? – Define the person/s responsible
- What is the equipment/materials? -List of required material
- Where do the activities take place? – Specified sections for the activities
- When do the activities happen? – What are the pre-requisites for the procedure?
- How do activities take place? – All tasks/methods involved in a procedure
We will add 2 more questions to the list.
- How much do you get? – To define the measures
- How often do you want it? – To define the frequency
This method will help you gather all the information that is required and will ensure that you do not skip any useful information in the procedure.
Step 4: Create a standard structure for procedures
A standard document structure can be developed in the organization which will serve as a procedure template. This document is ideally built with the organization’s brand guidelines in mind. A typical procedure template will include:
- Scope & Purpose
- Definitions
- Responsibilities
- Procedure
- References (Checklists, templates, forms etc.)
- Version History (author, approvals, date, versions etc.)
Document control is an essential requirement of ISO 9001. A well-defined structure and version history should be maintained for all procedures. All steps necessary to control the changes to the procedures should be followed to ensure that the requirement of ISO 9001 is met.
Step 5: Document the procedure, Review and Approve
Once all the information is gathered and you understand the scope and purpose of the procedure, it is time to write the procedure. Ideally, a Subject matter expert should write a procedure. In case you are a consultant and are assigned to write a procedure, the best approach is to get all the inputs from SMEs or process owners and document each step, in detail. The procedure should include all the necessary steps required but at the same time should not be voluminous. It should have just enough details for the staff to understand. The procedure should be written without using jargons from the ISO standard and using the language which the employees use in their day to day interactions. It is necessary that the procedures are not complicated and any reader is able to understand the steps easily.
After a draft is written, it should be peer-reviewed by a colleague or manager. Once reviewed and all review comments are incorporated, it is required that the top Management approve the procedure before it is published for use in the organization.
Step 6: Communicate and provide training
The last and the final step is to communicate the approved procedure to all the relevant stakeholders. In case required, training should be provided to all stakeholders to make sure that the staff understand the procedure and implement the activities in the procedure. Changes to the procedure should also be communicated whenever these are done.
The above steps, if followed, can help you in the documentation of all the procedures. This will also ensure that you meet all the requirement of the ISO 9001 standard related to the Quality Management System and Document Control.
