managing for an iso/iec 17025 laboratory
TRANSCRIPT
Managing for an ISO/IEC Managing for an ISO/IEC 17025 Laboratory17025 Laboratory
Presented by Dave HopePresented by Dave Hope
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ISO/IEC 17025 – A Brief Overview
• Global Bodies
• Specialist Regional Bodies
• Accreditation Bodies
• Proficiency Testing Suppliers
• Accredited Laboratories
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A Brief Overview - Global Bodies
• ISO International Organization for Standardization
• IEC International Electrotechnical Commission
• ILAC International Laboratory Accreditation Cooperation
• ISO
• The International Organization for Standardization widely known as ISO, is an
international standard-setting body composed of representatives from various
national standards organizations. Founded on February 23, 1947, the
organization promulgates worldwide proprietary industrial and commercial
standards. It has its headquarters in Geneva, Switzerland. While ISO defines itself
as a non-governmental organization, its ability to set standards that often
become law, either through treaties or national standards, makes it more
powerful than most non-governmental organizations. In practice, ISO acts as a
consortium with strong links to governments.
• ISO oversees the publication and updating of ISO/IEC 17025 and other
supporting standards.
• IEC International Electrotechnical Commission• is the organization that promotes International Standards and conformity
assessment for government, business and society for all electrical, electronic and
related technologies.
• is the original developer of the standard that became ISO/IEC 17025:2005
General requirements for the competence of testing and calibration
laboratories
• ILAC
• The International Laboratory Accreditation Cooperation or ILAC started as a
conference in 1977 with the aim of developing international cooperation for
facilitating trade by promotion of the acceptance of accredited test and
calibration results. In 1996, ILAC became a formal cooperation with a charter to
establish a network of mutual recognition agreements among accreditation
bodies that would fulfil this aim.
• The ultimate aim of the ILAC is increased use and acceptance by industry as well
as government of the results from accredited laboratories, including results from 3
A Brief Overview - Specialist Regional Bodies
• IAAC InterAmerican Accreditation Cooperation
• EA European co-operation for Accreditation
• APLAC Asia Pacific Laboratory Accreditation Cooperation
• Specialist Regional Bodies are associations of regional/national accreditation bodies
interested in conformity assessment (ISO/IEC 17011 Conformity assessment -- General
requirements for accreditation bodies accrediting conformity assessment bodies)
• These are the organizations who bind the accreditation bodies together through Mutual
(or Multilateral) Recognition Arrangements (or Agreements)
• The IAAC InterAmerican Accreditation Cooperation
• Is the organization in South America tasked with accomplishing this…
• The IAAC Multilateral Recognition Arrangement (MLA) is a an agreement among
accreditation bodies by which they recognize the accreditations issued by each
other. Such system of mutual recognition of accreditations is based on the
proper operation of the accreditation systems of the bodies that join the
arrangement. In order to establish and maintain an MLA, a program to establish
and maintain mutual confidence among the bodies that are signatories to the
IAAC MLA is required. The principal elements of that program are:
• Participation in programs of peer evaluation and re-evaluation;
• Exchange of information on the development and operation of
accreditation systems;
• Participation of personnel from IAAC MLA members in assessment, re-
assessment or surveillance visits to conformity assessment bodies
performed by other IAAC MLA member bodies.
• Two other examples of Specialist Regional Bodies are the EA (European co-operation for
Accreditation) and APLAC (Asia Pacific Laboratory Accreditation Cooperation)… there are
others… and there can be overlap geographically…
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A Brief Overview - Accreditation Bodies
• OUA Organismo Uruguayo de Acreditación, Uruguay
• SCC Standards Council of Canada, Canada
• CALA Canadian Association for Laboratory Accreditation, Canada
• A2LA American Association for Laboratory Accreditation, USA
• AIHA American Industrial Hygiene Association, USA
• NATA National Association of Testing Authorities, Australia
• Many to choose from…
• Their Accreditation Systems conform to ISO/IEC 17011 Conformity assessment --
General requirements for accreditation bodies accrediting conformity assessment
bodies.
• Some only accredit for specific specialty areas
• Some provide accreditations to all sectors
• Some are geographically/nationally specific
• The OUA Organismo Uruguayo de Acreditación is
• Your national accreditation body
• They are full members of IAAC
• They are signatory to ILAC MRA and IAAC MLA
• They provide accreditation within Uruguay to all sectors
• The SCC & CALA are
• Two of our national accrediting bodies
• They provide accreditation Globally to all sectors
• A2LA The American Association for Laboratory Accreditation (A2LA) is
• a nonprofit, non-governmental, public service, membership society. The mission
of A2LA is to provide comprehensive services in accreditation and accreditation-
related training. A2LA also offers programs for the accreditation of testing
laboratories, calibration laboratories (ISO/IEC 17011), inspection bodies,
proficiency testing providers (ISO/IEC 17043) , medical testing laboratories,
reference material producers and product certification bodies.
• They provide accreditation Globally to all sectors
• The AIHA Laboratory Accreditation Programs, LLC
• offers a group of highly acclaimed accreditation programs that have been relied
on in the global scientific community for more than thirty years. The legacy
industrial hygiene programs, developed by and for the IH community, received 5
A Brief Overview - Accredited Laboratories
• Accredited for specific tests
• Participate in ongoing Proficiency Testing
• Are audited (site assessment) biennially by their Accrediting Bodies
• Must conform to the requirements of ISO/IEC 17025
• Failure to conform to ISO/IEC 17025 results in loss of Accreditation
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ISO/IEC 17025 – What is Quality
• ISO’s definition Quality as: “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”
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What is Quality
• Good quality is defined as: “Meeting (or exceeding) the expectation and requirements, both stated and un-stated, of the customer.”
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What is Quality – Commodities
• Fast delivery
• Good product quality
• Competitive price
• Follow-up service
• Value added
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What is Quality – Laboratory Testing
• Rapid turnaround
• Precise & accurate
• Best sensitivity
• Best price (value)
• Value added service
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What is Quality – Key Points
• Establish your quality objectives– Price
– Accuracy & Precision
– Sensitivity
– Full service versus niche service
– Value added services
– Turnaround of results
– Other aspects
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What is Quality – Key Points
• Established Quality Objectives– Make them measurable
– Clearly define how they will be measured
– Establish how often they will be assessed
– Establish how often they will be adjusted
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ISO/IEC 17025 – Managing Quality
• Establish the vision
• Set operational parameters
• Provide the resources
• Provide the oversight
• Adjust when issues arise
• Upper management must first establish the vision for the organization which in part may
be dictated by external forces especially of the laboratory is a public sector facility
• Once the vision has been established specific operational parameters must be establish
through inputs from various internal and external sources… i.e.
•
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Managing Quality – Operational Parameters
• Level of effort required
• Quality of facility required
• Quality of equipment req’d
• Quality of personnel req’d
• Quality of training req’d
• Quality of methods req’d
• Accuracy & Precision req’d
• Sensitivity required
• Speed required (turnaround)
• Other requirements
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Managing Quality - Resources
• Personnel
• Training
• Facility
• Equipment
• Maintenance
• Upgrade & replace
• Consumables
• Support services
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Managing Quality - Oversight
• Ongoing assessments– Performance Monitoring
– Quality Control
– Quality Assurance
• Periodic audits– First party (Internal)
– Third party (External)
• Management Reviews
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Managing Quality – Adjust
• Revise vision
• Adjust operational parameters
• Apply more resources
• Add more capacity
• Add more capability
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ISO/IEC 17025 – Key Components
• Management Requirements
• Technical Requirements
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Key Components - Management Requirements
• Organization (clause 4.1)
• Management system (clause 4.2)
• Document control (clause 4.3)
• Review of requests, tenders and contracts (clause 4.4)
• Subcontracting of tests (clause 4.5)
• Purchasing services and supplies (clause 4.6)
• Service to the customer (clause 4.7)
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Key Components - Management Requirements
• Complaints (clause 4.8)• Control of nonconforming testing work (clause 4.9)• Improvement (clause 4.10)• Corrective action (clause 4.11)• Preventive action (clause 4.12)• Control of records (clause 4.13)• Internal audits (clause 4.14)• Management reviews (clause 4.15)
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Key Components – Technical Requirements
• General (clause 5.1)
• Personnel (clause 5.2)
• Accommodation & environmental conditions (clause 5.3)
• Test methods and method validation (clause 5.4)
• Equipment (clause 5.5)
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Key Components – Technical Requirements
• Measurement traceability (clause 5.6)
• Sampling (clause 5.7)
• Handling of test items (clause 5.8)
• Assuring the quality of test results (clause 5.9)
• Reporting the results (clause 5.10)
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ISO/IEC 17025 – What is Required Operationally
• Human Factors
• Facility & Environmental Conditions
• Method & Method Validation
• Equipment
• Measurement Traceability
• Handling of Samples
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Operationally – Human Factor
• Higher & retain competent personnel
• Job descriptions
• Duties & responsibilities
• Training program
• Professional development
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Operationally - Facility & Environmental Conditions
• Facilitation of correct test performance– Energy source
– Lighting
– Environmental conditions
– Etc.
• Monitor, control & record– Relevant conditions only
• Control access
• Good house keeping practices
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Operationally - Method & Method Validation
• Standard Methods– Verified prior to use
• Lab-developed Methods– Full validation prior to use
• Non-Standard Methods– Full validation prior to use
Full validation is outlined in the next slide… just stress that verification is a sub-set of Full
validation
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Operationally - Method & Method Validation
• Method Validation– Calibration using reference materials
– Comparison of results achieved with other methods
– Inter-laboratory comparisons
– Systematic assessment
– Estimation of measurement uncertainty
I have quoted what ISO 17025 outlines but you can go into more of the detail here…
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Operationally – Equipment (including software)
• Appropriate for correct performance of testing
• Validated before being put into routine use
• Operated by trained authorized personnel
• Inventoried
• Properly maintained
• Removal from service when deemed defective
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Operationally - Measurement Traceability
• International System of Units (SI)
• Physical Metrology– Temperatures
– Volumes
– Weights
• Chemical Metrology– Traceable standards
– Certified Reference Materials
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Operationally - Handling of Samples
• Sampling supplies
• Sampling
• Sample receipt
• Sample labeling
• Sample storage
• Sample disposal
Mention sampling supplies if it is applicable
The main point here is that the lab must manage the samples from point of receipt to pint
of disposal
Emphasis on proper disposal of samples as well as extracts….
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ISO/IEC 17025 – What is Required Administratively
• Record Control
• Document Control
• Equipment Inventory Control
• Consumable Inventory Control
• Assessment, Audit & Review Record Control
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Administration - Control
Control: is the practice of maintaining an item from the time it is created or acquired until the time it is disposal of
It is important to stress that control here focuses on ensuring the right information is in the
hand of the right people… control does not mean records, documents, equipment,
consumables, etc. are locked away… no it means rather that access is straight forward and
simple and that the information or item that the person needs is correct and/or the the
right thing…
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Administration - Record Control
Records: are accumulations of data & information which result from carrying out tests and which indicate whether specified quality or process parameters have been achieved
Record control or Record Management is the practice of maintaining the records of an
organization from the time they are created up to their eventual disposal. This may include
classifying, storing, securing, and destruction (or in some cases, archival preservation) of
records.
A record can be either a tangible object or digital information: for example, certificates of
analysis, raw data on a computer work station, office documents, databases, application
data, and e-mail. Records management is primarily concerned with the evidence of an
organization's activities, and is usually applied according to the value of the records rather
than their physical format.
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Administration - Document Control
Documents: can be policy statements, procedures, specifications, tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc.
The distinction between documents and records can be a times difficult to grasp… to clarify
records describe what was done and documents describe what is planned to be done… it
follows then that when a document is retired and archived it becomes a record of what
was done…
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Administration - Equipment Inventory Control
Equipment: records shall be maintained (i.e. controlled) of each item of equipment & its software significant to the tests performed.
These records must include:
a) the identity of the item of equipment and its software;
b) the manufacturer's name, type identification, and serial number or other unique
identification;
c) checks that equipment complies with the specification (see 5.5.2);
d) the current location, where appropriate;
e) the manufacturer's instructions, if available, or reference to their location;
f) dates, results and copies of reports and certificates of all calibrations, adjustments,
acceptance criteria,
and the due date of next calibration;
g) the maintenance plan, where appropriate, and maintenance carried out to date;
h) any damage, malfunction, modification or repair to the equipment.
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Administration - Consumable Inventory Control
Consumable: are purchased supplies, reagents and other materials that affect the quality of test results.
The consumable inventory may include where appropriate the type, class, grade, quantity
maintained, identification, specification, inspection instructions, the quality required, date
received, date opened lot number, etc.
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Administration - Assessment, Audit & Review Record Control
• These are defined as Quality Records
• They include reports from internal audits & management reviews as well as records of corrective & preventive actions arising from ongoing assessments of QA/QC data
Access to these records as with everything else must be straight forward and clear such
that events can be reconstructed after the fact…
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ISO/IEC 17025 – Managing the System
• Organization
• Management System
• Contracting
• Subcontracting Tests
• Purchasing
• Service to Customer
• Improvements, Corrective & Preventative Actions
• Management Reviews
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Managing - Organization
• Legal responsibility
• Meeting requirements of International Standards (including ISO/IEC 17025)
• Satisfy needs of the customer, regulators and organizations providing recognition (including the Accreditor)
• Conflict of interest
• Confidentiality
• Clear separation between operations and quality
• Identify and define authority and responsibilities
• Appointment of deputies for key managerial positions
• Top management’s commitment to quality & the quality system
• Communication of this commitment to all personnel
• Document
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Managing - Management System
• Mission/Vision
• Policies
• Procedures & Methods
• Work Instructions
• Records
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Managing - Contracting
• Review of requests for testing, tenders for testing & testing contracts:
• Ensure there is a documented systematic approach which incudes:– Methods to be used are adequately defined documented &
understood;
– There are adequate capacity & resources to meet the customers requirements;
– The appropriate test methods are selected and they are capable of meeting the customers requirements.
• Document procedure
• Keep records
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Managing - Subcontracting Tests• Ensure the competency of the sub-contract laboratory
1. Use an accredited laboratory
2. Audit the sub-contract laboratory
• Advice the customer that tests will be sub-contracted
• Laboratory is responsible to the customer
• Document procedure
• Keep records
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Managing - Purchasing
• Develop & document procedures for the:
– Purchase;
– Receipt;
– Storage.
• Ensure upon receipt that the purchased items comply with specifications
• Where an item could affect the quality of the laboratory’s output, purchasing documents are reviewed & approved prior to purchase of the item
• Keep records
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Managing - Service to Customer
• Provide access
• Address complaints
• Seek feedback
• Document
• Keep records
Provide access to laboratory & information for clarificationSatisfactorily address any complaintsPeriodically seek feedback both negative and positive
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Managing - Improvements, Corrective & Preventative Actions
• Control (& recall where appropriate) nonconforming test results
• Take appropriate corrective actions where non-conforming tests have occurred
• Take appropriate preventative actions where non-conformances may occur
• Take a pro-active approach to improvements
• Document procedure
• Keep records
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Managing - Management Reviews
• Carry out annually
• Focus on areas for improvement
• Document procedure
• Keep records
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Managing - Management Reviews• Include:
– Review of policies & procedures
– Managerial and supervisory reports
– Outputs from internal audits
– Corrective & preventative actions
– Assessments by external bodies
– Results of proficiency testing
– Changes in workload
– Customer feedback
– Complaints
– Improvements
– Etc.
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ISO/IEC 17025 – Benefits of Accreditation
• Scientific approach to improvements
• Working more efficiently
• Proven performance improvements
• Benchmarking performance
• Satisfying regulatory requirements
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Managing for an ISO/IEC 17025 Managing for an ISO/IEC 17025 LaboratoryLaboratory
¿Questions?
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