What to Include in ISO/IEC 17025 Documents
The ISO 17025 documents for ISO/IEC 17025 certification can be easily implemented using 4 tier documentation structure. The lists of various types of documents are listed below.
- Laboratory Quality Manual
- Sampling instructions
- Work Instructions / Standard operating procedures
- Good work practices photographs, displays, drawings
- Product acceptance criteria specifications / Exhibits
- National Standards / Regulations / International Standards
- Formats / Records / Software
- Customer Data and external documents
Flexibility in ISO 17025 Documentation
ISO 17025 documentation should allow flexibility to the organization in developing Good laboratory practices and management system. ISO 17025 Documentation which may differ from one laboratory to other due to:
- Size of the laboratory and type of its activities
- Complexity of processes and their interactions,
- Training and competence of personnel
Developing ISO/IEC 17025 System Documentation
In a quality system, work activities are described in written documents and carried out in a planned way. The structure of documents under ISO 17025 standards are:
Description of quality system, how standards are applied and policy
Describe how processes which affect quality are carried out
Additional detail on how specific jobs are carried out
Forms to show evidence that system is followed
Tier 1. Contents of ISO 17025 Manual
ISO 17025 Quality manual should normally include the following though not necessarily in the same order:
- The document which communicates laboratory's quality policy and objectives to its staff and customers.
- Brief background of the company
- Scope of the management system as per ISO 17025 standard with justification for exclusions if any.
- Management system documentation containing list of documents such as procedures and other documents required to operate management system.
- Organizational structure and overview of processes followed
- As quality manual can also be used as promotional material, it should not contain anything that is confidential.
- Details for each applicable elements of iso 17025
Tier 2: ISO 17025 Procedures
ISO 17025 procedures are core of Documentation System:
- Methods of Meeting Requirements of Relevant Clauses of ISO/IEC 17025.
- Meant for Internal Use.
- Should Be protected from inadvertent exposure.
- To be Prepared by Functional Heads / Quality Manager / Technical Manager
- Below is the sample content of the procedures
Tier 3: Test procedures/ SOPs/ Work instructions
To achieve standard of workmanship -
- Required where their absence affects quality.
- Details of how the specific testing or calibration activities are to be undertaken to achieve the objectives / standards.
- Define the standards of acceptability.
- Contents to be simple and easy to follow standards, codes or practice, regulations
- If you are using any national or international standards like ASTM/BS or any other standards then you can take that also as a part of your test procedures.
Tier 4: Forms and records
Supporting document to record and distribute information.
- Forms of all kinds: test report, raw data sheet, audit, calibration, customer satisfaction and listed below
- These help to prove that the quality system is operating effectively.
Records Required by ISO/IEC 17025
List of Records:
- Record of qualification of operators / testing personnel.
- Inspection and testing reports
- Record of rework and rejection and retesting done for any laboratory incoming and in process products.
- Calibration record of measuring devices.
- Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.
- Results of corrective actions
- Results of preventive actions
- Document updating records
- Control of quality records and master list of records
- Management reviews
- Record of training and skill and competency of personnel
- Instrument Maintenance record
- Laboratory assistant’s raw data sheet and calculation records for results
- Record of product non conformities and products accepted on concession.
- Laboratory Data analysis and activities for continual improvement.
- Result of internal audits and follow up action.
- Data on customer feedback/satisfaction measurement and action taken on customer complaints.
- Vendor evaluation and purchase orders and actions arising from the evaluations
- Customer property that is lost, damaged or otherwise found to be unsuitable for use during testing