What is the Role of ISO 9001:2008 in maintaining Quality in a Laboratory?

· Updated

so-9001Quality standards of a laboratory are achieved through upkeep of high quality of products, manpower skills and standards of laboratory practices or systems. The benefits offered by quality are:

  • Business growth
  • Reputation amongst clients
  • Edge over competition through increase in sales and services both in domestic and international markets
  • Less disputes over flawed results

ISO 9000 Family of Standards

ISO 9000 series of standards relate to quality management and are widely accepted across the world. ISO 9000 evolved from the British Standard BS 5750 in 1979 which was adopted by ISO in 1988. It underwent revisions in 1995, 2000, 2005 and 2008.

ISO 9001:2008

ISO 9001 is the only standard in ISO family that can serve to assess conformity. It provides guidelines on:

  • Quality manual
  • Mandatory procedures
  • Standard operating procedures (SOPs)
  • Process definition documents
  • Work instructions
  • Miscellaneous documents
  • Format and records

Quality Manual

The Quality Manual explains how the requirements of standards are to be fulfilled. It is periodically reviewed by top management and contains the following information about the organization:

  • Year of establishment and evolution of organization
  • Quality Policy
  • Organizational Chart
  • Roles and Responsibilities of personnel
  • Documentation Structure
  • Statutory and Regulatory requirements

Mandatory Procedures

Essential procedures requiring maintenance:

  • Control of documents – approval of documents, re-approval, revision date, distribution and destruction
  • Control of records – identification of documents, storage, protection, retrieval, current version number with date, etc.
  • Internal audits – planning and conducting internal audits, deciding audit team, audit plan and maintenance of audit records
  • Control of non-conformity – handling and review of non-conformities
  • Corrective action – review and corrective action in case of non conformities, customer complaints, etc.
  • Preventive action – action requirements for preventing recurrences of non conformities, action implementation, recording and review of results

Standard Operating Procedures

SOPs are generally maintained on :

  • Training schedules
  • Calibration and maintenance of instruments and glassware
  • Working standards and reference materials
  • Handling of non conformities
  • Internal audits
  • Storage of raw material and finished products
  • Good documentation practices
  • Laboratory safety
  • Disposal of samples and laboratory waste

Process Definition Documents

  • Process no. and ID
  • Objectives
  • Process Owner
  • Input methods and outputs
  • Process tracking
  • Documents and records
  • Process effectiveness

Work Instructions

  • Guidance to operating personnel on activities mentioned in SOPs
  • Instructions should be in a language easily understood by the work force and be accessible in the work place
  • Pictorial representations are helpful to convey the instructions

Miscellaneous Documents

  • Statutory and regulatory requirements
  • Reference journals, books, standards, etc.
  • Quality policy
  • Technical brochures, operating manuals, IQ and OQ records
  • Standard test procedures and client specific test methods

Formats & Records

Records are maintained in formats prescribed in SOPs and serve as evidence for activities carried out :

  • Validation of analysts
  • Calibration records of balances, volumetric apparatus and instruments
  • Audit reports
  • Corrective and preventive action records
  • Training records of laboratory personnel
  • Preventive maintenance and service records of instruments
  • Document distribution records
  • Worksheets of tests conducted

As can be seen ISO 9001:2008 is a comprehensive standard which if adopted in right earnestness can contribute significantly in upkeep of your laboratory quality standards.

What is the role of ISO 9001:2008 in maintaining quality in a laboratory?

ISO 9001:2008 is a comprehensive standard that, if adopted with genuine commitment, can significantly contribute to upholding a laboratory's quality standards, covering documentation such as the quality manual, mandatory procedures, SOPs, process definition documents, work instructions, and records.

What benefits does quality bring to a laboratory?

Quality standards achieved through upkeep of products, manpower skills, and laboratory practices deliver business growth, reputation among clients, an edge over competition in domestic and international markets, and fewer disputes over flawed results.

How did the ISO 9000 family of standards evolve?

ISO 9000 evolved from the British Standard BS 5750 of 1979, which was adopted by ISO in 1988 and subsequently revised in 1995, 2000, 2005, and 2008.

What makes ISO 9001 different from other standards in the ISO 9000 family?

ISO 9001 is the only standard in the ISO 9000 family that can serve to assess conformity, and it provides guidelines covering the quality manual, mandatory procedures, SOPs, process definition documents, work instructions, and miscellaneous documents.

What information does a laboratory Quality Manual contain?

The Quality Manual explains how the requirements of the standard are fulfilled and is periodically reviewed by top management. It contains the year of establishment and evolution of the organization, the quality policy, the organizational chart, roles and responsibilities of personnel, the documentation structure, and statutory and regulatory requirements.

Which procedures are mandatory under ISO 9001:2008?

The mandatory procedures cover control of documents, control of records, internal audits, control of non-conformity, corrective action, and preventive action.