ISO 9001 QMS Certification in Laboratory India

ISO 9001 QMS Certification in Laboratory

Follow all essentials of QMS in your Labs by implementation ISO 9001 Certification in India.

Quality Management System has been around for around 800 years. The ideas initially utilized in medieval European guilds have been hardened and refined throughout the hundreds of years into what is currently known as quality management systems. The quality Management Systems (QMS) model has been adjusted to the medical laboratory environment bringing about twelve fundamentals that structure the system for quality. 


The lab should be coordinated around proper quality management systems that uphold steady techniques. The supervisory group and quality unit assume a fundamental part in a quality-driven culture, alongside structures for monitoring continuous quality.  

2. Staff and Personnel

Capable staff individuals are the absolute most significant resource for a laboratory. Training, motivation, and engagement are key pieces of the quality management system.

3. Equipment

Each piece of hardware utilized in the lab should be kept up to date maintained to work securely.

4. Buying and Inventory

Appropriately dealing with the inventory network is basic to guarantee that crude sources of info and different supplies are reliably excellent. Stock exercises ought to check that materials and supplies are put away in a manner that protects integrity.

5. Process Control

Process Control Cycle incorporates QC measures for testing, including:

  • Collection
  • Handling
  • Method Verification
  • Process Validation 
6. Information Management

The laboratory produces many types of data and information, including QC test results, support reports, and other information. This information should be overseen in a manner that guarantees all data and information is precise, secure, classified, and open to people with the right privileges, such as lab managers and leadership.

7. Documentation and Records

Records are a comparative idea to information management, and there’s a huge cross-over between these classifications. Perhaps the most fundamental lab documents are standard operating techniques (SOPs) to make a standard for each cycle of the process. Records should be accessible at the place of work, keeping up with, precise, and secure.

8. Event Management

An “event” is any blunder or non-conformance. A QMS programming can assist you with distinguishing these issues and work with examinations to find the main cause and prevent reoccurrence.

9. Evaluation

Evaluation includes comparing laboratory performance execution with inside guidelines for quality or outer information sets, like industry benchmarks. Appraisals incorporate the exercises of lab or QC supervisors, interior evaluators, or outer monitors.

10. Process Cycle Improvement

A quality management system should uphold consistent improvement of lab measures. Parts of the QMS which support improvement can incorporate QC and CAPA (event management).

11. Client support

Client support is the objective of a laboratory. A laboratory’s QMS should support operations that reliably give a positive client experience through the creation of reliably excellent products or other missions. The laboratory needs to comprehend the clients and their requirements and use customer feedback for improvement.

12. Facilities and Safety 

Labs need a complete arrangement of methods and guidelines to guarantee a protected, secure, and clean environment. This incorporates genuinely getting the lab, control methodology for risks, laborer security, and ergonomics.

A lab QMS needs each of the 12 essentials to support consistently high-quality operations and frameworks to guarantee these components are working in a state of harmony. If your QMS is missing in few components, for example, document control or actual security, the whole management can easily crumble. Additionally, if your QMS hits all the basics yet you can’t arrange between the essentials by understanding the bigger picture of quality trends or root causes, you’re at risk of error.

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