Oct 09, 2017

ISO 9001 is not all about documentation

ISO 9001 is not all about documentation

ISO 9001 is an international standard that defines the best practices for quality management. When many people think of ISO 9001, their perception is that it’s about documentation only.

The Standard does indeed require a number of documents and mandates that a QMS (quality management system) should include documents that the organization has determined as being necessary for the quality management system to be effective.

Many auditors and even implementers interpret this to mean that the organization has to write everything down. The ideal number of documents, however, depends on the organization and how much the controls that it implements need to be documented.

Is this document required?

A number of factors will define the amount of documentation you need in the QMS system. These factors include the competence of the people involved and the level of automation in place.  It will be easier to determine whether a document is required, or not, once all of the factors that give assurance that requirements are met methodically have been considered. Documenting a process often helps to ensure that it is communicated and understood properly. It also allows the process to be executed in such a way that it is effective in achieving its intended objective. Records should also be captured to ensure appropriate evidence and traceability where required.

The QMS is a living system, not a dusty manual on a shelf

Creating the right amount of documentation and designing it in a regular and usable way is a fundamental aspect to make sure it is used to deliver the objectives of the QMS. The documentation should ultimately form an integral part of your everyday processes and activities, or maintaining documents will be perceived a chore to be done in addition the normal work. When this happens, documentation updates will only be done when an audit is looming on the horizon.

When development of QMS documentation is embarked on for the first time, one of the biggest challenges is to determine where to begin.  How many documents are required, what should they look like, what fields should be in the documentation to cater for authorization, version control, etc.  Using the MyEasyISO system takes the guesswork and design out of the equation. It provides templates for all the required documentation with an authorization field where required. There is no need to worry about version control, as this built in feature happens in the background. Once the first challenge has been met, the next problem is providing the content. To develop even the most simple and easy process can cause writer’s block – what detail needs to be included in the document? How do I phrase it so that it will make sense to the people that have to work with it every day? MyEasyISO’s context sensitive help makes this a breeze with explanations and suggestions for every field.

When organizations are certified to any ISO standard, they are expected to implement and maintain a management system that meets the requirements of the standard involved. This is however not the only requirement. The system must also improve business processes.

Implementing more than one ISO standard can cause complexities such as duplication of content and conflicting objectives.

Integrate your management system into your processes

Using an integrated management system (IMS) has a number of benefits:

  • Helps to avoid duplication
  • Reduces overall risks
  • Uncovers conflicting objectives
  • Creates a formalized system out of informal processes
  • Enables the organization to focus on achieving its goals

MyEasyISO’s integrated management system reduces duplication and costs significantly, by providing you with the content that you need to start or expand your existing QMS / EMS or OHSAS system.

MyEasyISO combines many business components into one rational system, streamlining process operations and management, business objectives, auditing and continual improvement initiatives. This enables organizations to use a modular approach developing the content at your own pace and relevant to your resource availability.

Sree Vidhya

CRM Specialist At Effivity
Sree has over 7+ years of experience. She excels in building strong client relationships and ensuring customer satisfaction. Sree's expertise and dedication help drive Effivity's commitment to exceptional customer service.

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