A partnership project of Ministry of Health & Family Welfare and U.S. Centers for Disease Control

FAQs: Documentation

Laboratories perform several activities in several places in an institution starting with registration of the patient, collection, testing, discarding of biomedical wastes, archiving of reports and so on. So in order to standardize each step, it is very important to follow some internationally accepted standard or guideline. 2 most important such standards are ISO 15189 and CLSI. In India, mostly the ISO standard is followed. NABL accredits for ISO 15189
As the QMS of ISO 15189 is based ISO 9001, the documentation hierarchy suggested in this document is what a lab has to follow to establish, implement and maintain a QMS.

Documents are a reflection of the laboratory’s organization and its quality management. A well-managed laboratory will always have a strong set of documents to guide and show evidence of its work. Therefore, laboratories are required to maintain documentation.

A document is defined as ‘information (meaningful data) and its supporting medium. In simple terms, a document provides guidance and/or direction for performing work, making a decision or rendering judgment.
Record states results achieved providing evidence of activities performed. Thus records are types of documents on which data has been documented.

The documentation process has an order of authority as per ISO 9001. The Level 1 documents dictate the policy of the lab’s management regarding how the lab’s Quality Management System should be run. Level 2 documents follow these policy guidelines dictated by Level 1 and define the procedures to be followed, elaborating the steps of each activity. Level 3 documents follow the procedures defined by Level 2 and make provision to capture the data elicited by those activities.

Level 1 includes Strategic Documents used for establishing a documented QMS. These include Policies; comprising of the apex or Quality Policy and the policy or apex manual; the Quality Manual.

Level 2 are Tactical Documents for implementing a QMS that includes; Processes and Procedures; comprising of Quality System Procedures, Standard Operating Procedures, and Job Aids/ Bench-aids/ work desk instructions.

Level 3 are Operative Documents for maintaining a QMS; which include the Formats and Records.

Quality Policy is the “definition of the intent of the Quality Management system” as per clause of ISO 15189:2012 and is a list of statements by the laboratory management. The points to consider while writing a Quality Policy as mandated by the ISO are defined in the clause. The quality policy should be defined by the top management and should express commitment to the quality management system (QMS). It should be based on ISO’s quality management principles and should be compatible with your organization’s vision and mission.
All the activities undertaken by the laboratory should be consistent with the stated Quality Policy. The Quality Policy should be made aware to all lab staff and should be made available in the local language for better understanding.

The Quality Objectives are generally set by the top management in discussion with the staff involved in the daily activities and planning of the lab, say, the Lab Directors and HODs A few points to be kept in mind while defining Quality Objectives are:

  1. These should be consistent with the Quality Policy
  2. These should be measurable
  3. Further planning of the Quality Management System should be based on these objectives
  4. Should engage all the relevant functions of the lab
  5. Should engage all the levels of the lab
  6. Should meet the requirements of the users
  7. Objectives for improvement activities are to be directed at areas of highest priority based on risk assessments

It is very important point that people in the organization must be aware of how they contribute to the achievement of the quality objectives and therefore must know and understand the specific quality objectives that have been set up for their functions and how they can achieve them.
For awareness of quality objectives, specific training sessions may be organized. The quality objectives should be very simple and direct. Think carefully about the quality objectives set for the organization and the timeframe allowed for them to be achieved. Keep in mind that quality objectives must be measurable.

As described above, the bottlenecks are chosen to improve the quality. Assume that the turnaround time (TAT) is chosen. There could be many reasons for TAT violations which can include equipment breakdown, staff shortage, inventory shortage, power outages to name a few. There are many management tools available for improvement. An FMEA can indicate the places where you need improvement. Set each of these as a Quality Indicator. Capture the % Defect or violations as defined by the ISO. Alternatively, capture DPMO/ Sigma to assess progress. Labs for Life Monitoring tool can be used for this purpose.

Quality Manual is the apex document of a lab. All activities of the lab are dictated by the Quality Manual. While preparing the manual, each facility should carefully consider involving all the stakeholders. It is essential to involve the management and policy makers, technical and quality managers, Heads of departments and relevant technical staff in the drafting, as different clauses will require inputs from different personnel.
One can either follow the ISO standard to develop a Quality Manual or the CLSI guidelines. NABL 160, a downloadable document gives the guidelines for preparation of the Quality Manual based on ISO guidelines

A process is a set of inter-related procedures that convert an input into an output. A policy flows into a procedure through a process. So technically processes reside between policy and procedures (Levels 1and 2) and are generally depicted as flowcharts, tables etc.

The process approach considers the interaction between different processes, and the inputs and outputs that tie these processes together. The output of one process becomes the input of another.

SOPs are generally for testing procedures with step by step instructions and details as defined in the Question 6 above. QSPs (also known as Mandatory Procedures) are written down for non-testing activities of the Quality Management System which are complex and contains details that need to be read and understood by the lab personnel. QSPs or Mandatory Procedures are written for those clauses that ISO says “there shall be a documented procedure”.

As per ISO: 15189, 5.5.3(Documentation of examination procedure), 20 elements are to be addressed within an SOP (sub-clauses a-t) and are as follows

  1. Purpose of examination
  2. Principle and method of the procedure for examination
  3. Performance characteristics
  4. Type of sample
  5. Patient Preparation
  6. Type of container and additive
  7. Required equipment and reagent
  8. Environment and safety controls
  9. Calibration
  10. Procedural steps
  11. Quality Control Process
  12. Interferences (Lipemia, Icterus, Hemolysis, Drugs) and cross-reactions
  13. Principle and procedure where relevant measurement uncertainty of the measured quantity
  14. Biological reference intervals or clinical decision values
  15. Reportable interval of examination
  16. Instructions for determining quantitative results, when result is not within measurement interval
  17. Alert/ critical value
  18. Clinical Interpretation
  19. Potential sources of variation
  20. References

If a lab writes its SOPs by following these clauses, it can surely and comprehensively address all the information pertaining to a test

Job aids are shortened versions of SOPs that can be posted at the bench for easy reference on performing a procedure.

  • They are meant to supplement, not replace, the SOPs
  • It should be placed in a visible location, and serves as a reminder of the steps that need to be completed.
  • The job aid and the SOP must include the same instructions, though all the information in the SOP will not be available in the Job Aid.

Job aids are also called: Bench Aid/ Work Desk Instructions/ work instructions

The following procedures are mandatory to be recorded in a lab as per ISO 15189

  • Document Control
  • Establishment of service agreements
  • Selection and evaluation of referral labs
  • External Services and Supplies
  • Resolution of complaints
  • Identification and control of nonconformities
  • Control of Records
  • Personnel Management
  • Selection, purchase and management of equipment
  • Calibration of Equipment
  • Preventive maintenance of Equipment
  • Reagents and consumables: Reception, storage, acceptance testing, inventory management
  • Pre-examination activities
  • Collection and Handling of samples
  • Inter Laboratory Comparisons (PT/ EQAS)
  • Storage, retention and disposal of clinical samples
  • Release of results

The lab should identify the activities that need formatting. These activities are those which need documentary evidence. A few examples will be preventive maintenance schedule of machines, breakdown and downtime information and so on. A comprehensive list of mandatory records can be found in ISO 15189, clause 4.13. The format should be designed so as to capture all the requisite elements of the activity. All formats should be under document control and show the traceability to a second level document which refers to the activity. Should a format require reformatting to capture additional information than originally envisaged, it should show the revision number and date of issue. The reason for revision must be noted, all obsolete formats must be removed from circulation to prevent inadvertent use. One obsolete stamped format should be saved for future reference. A file of all in-use (controlled stamped) and obsolete (obsolete stamped) formats should be available in the lab

Controlled Documentation is a system for maintaining and ensuring the proper use of time or version sensitive documents. Basically the document control system is an inventory of the documents and records in a lab that allows for indexing, collection, identification and proper use. A document control system provides a method for formatting documents so that they are easily managed, and sets up processes for maintaining the inventory of documents. Documents, by definition, require updating. A system must be established for managing them so that current versions are always available.

Example of controlled documents: Documents that should be considered for document control are those which may vary based on changes in versions.

  • Standard Operating Procedures (SOP)—it is essential to have all SOPs up-to-date, showing the procedures that are in current use. Also, when work instructions or job aids are used, they must exactly match the SOPs for the tasks described.
  • Texts, articles, and books that are part of the documents referenced in a laboratory;
  • Documents of external origin, such as instrument service manuals, regulations and standards, and new references (that may change over time).
  • Other examples include, policy statements, instructions for use, flowcharts, procedures, specifications, forms, calibration tables, biological reference intervals, charts, posters etc. (ISO 15189:2012 Clause 4.3 - Note).

Audit trail is a record showing who has accessed a computer system and what operations s/he has performed during a particular period. It is useful for maintaining integrity of data, system security and encouragement of personal accountability.

Some of the common problems found in laboratories that do not have document control systems or that do not manage their document control systems include the following:

  1. Out-dated documents in circulation.
  2. Distribution problems: If multiple copies of documents are dispersed throughout different areas of the laboratory, it will be cumbersome to gather all copies when it is time to update them, and some could be overlooked. Out-dated copies end up in use
  3. Failure to account for documents of external origin: These documents may be forgotten in the management process, but it is important to remember that they may also become outdated and need to be updated.
  4. Not logging kit inserts: The instruction may change over time and may go unnoticed especially while using the same brand.
  5. Forms are inadequately designed to meet laboratory and client needs
  6. Standardized forms prepared by others may not be suitable for all laboratories
  7. Inability to retrieve data due to poor archiving processes or insufficient back-up of computerized information

Contact Persons

Dr. Naresh Goel
Deputy Director General - NACO & Project Coordinator,
Labs For Life Project

Dr. Anu George
Technical Manager, Labs for Life Project

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