Transcript A LOOK AT EXPECTED AMENDMENTS TO ISO/IEC 17025 …

Preparing for Accreditation and the
Pre-Assessment Options
Background
A2LA is
non-profit
non-governmental
independent third party
2,700 Accreditations granted
Quick Review-Accreditation
Evaluation of a conformity assessment body to
determine technical competence
ISO/IEC 17025:2005 and ISO 15189:2012
Management system requirements
Technical requirements - competency
Used by labs to manage and operate systems
Used by accreditation bodies domestically
and internationally to evaluate labs
ISO Standards
 Uses general terms enabling it to be applied broadly
Adapts to specific program requirements (AOAC)
 Commercial, governmental and in-house laboratories
 Laboratories performing routine testing or R&D
 Large and small laboratories
 For accreditation purposes tied to a Scope of testing
ISO standard approach
 Empowers laboratory personnel
 Improves lab productivity and efficiency
 Reduces need for constant technical oversight
 Creates synergy between laboratory management and
technical staff
 Provides credibility to outside parties, and
international recognition if accredited
Accreditation Cycle
 2 Year Cycle
Optional pre-assessment
Full initial assessment (first year)
Surveillance assessment (second year)
Renewal assessment (third year)
Annual review (fourth year an off-site review)
Preparing for Accreditation
 Obtain relevant ISO Standard(s)
 Become familiar with Accreditation Body (AB)
website, requirements, policies and website tools
 Obtain relevant assessor checklists
 Identify the person in charge of the management
system (usually the quality manager)
 Conduct internal audits to determine gaps or
weaknesses and conduct a management review
Assessor proposals
 AB Staff reviews completed application and draft Scope of
Accreditation
 Identifies an assessor or assessment team based on
technologies, breadth of disciplines and number of personnel
 AB proposes assessor or team to the lab
 AB proposes assignment to the assessor/assessment team
 Target time is to have agreement within 2 weeks of receiving
the application.
Assessor preparations
 Conducts a prior document review of quality manual
and supporting procedures
This is to establish notes and questions
Determine readiness of the laboratory
It saves on valuable on-site time
On-site time can focus on record/data review,
interviews with staff, observing tests
Prior document review report goes to laboratory
Pre-assessment option
Planned Pre-Assessment
Lab applies for accreditation and requests a
pre-assessment
Lab applies and assessor conducts a prior
document review and determines that there
are significant gaps or errors in the quality
manual and SOPs
Planned Pre-Assessment
Features
 Both will involve one assessor
 Pre-Assessment typically is one day on-site
 Ideally occurs after the laboratory conducts a gap analysis and
internal audit during accreditation preparation
 Offers one last look or practice before the actual full, initial
assessment
Pre-Assessment Features cont.
 The assessor
Explains the requirements
Reviews the status of the lab’s preparations
Points out omissions
Responds to the organization’s suggestions on
bringing deficiencies cited into compliance
Does not assist in writing procedures or policies
Pre-Assessment-Technical
review
 A general review may be conducted of the
organization’s technical capability as part of the walk
through of the operations
 This may include testing accommodations,
environment, log books, etc.
 Focus of pre-assessment is heavily weighted to
management system requirements not technical
competence
Unplanned Pre-Assessment
 Assessor stops work on an initial assessment due to major findings
or a significant number of findings
 Assessor calls A2LA headquarters to inform/discuss
 Assessor recommends to laboratory that the initial assessment be
converted to pre-assessment
 Lab decides on path to take
 If laboratory opts for a pre-assessment, then the planned preassessment unfolds
Unplanned Pre-Assessment
cont.
 If laboratory opts not to convert the initial full assessment to a preassessment despite a looming disaster:
 Full, initial assessment continues
 Lab must respond and resolve all findings timely
 Follow up assessment may be required to determine
compliance
Pre-Assessment Deliverables
 Assessor leaves a list of issues and concerns
identified either as a short narrative report or
partially completed assessor checklist
It pays to prepare…and we have the tools to
help
Staff
Website
Training
Summary
 Pre-Assessment or Not?
 Preparations and support
 Conduct extensive internal audits
 Customer’s requirements
Resources
 Randy Querry contact info: [email protected] / 301-644-3221
 www.A2LA.org
 3 Sources to obtain the ISO standards:
 http://global.ihs.com/search_res.cfm?currency_code=USD&cust
omer_id=21254020200A&oshid=21254020200A&shopping_cart
_id=21254020200A&country_code=US&lang_code=ENGL
 http://webstore.ansi.org/?source=google&adgroup=ansi_standar
ds&gclid=CJKDn7_hjb0CFU4aOgodeQoA5g
 http://asq.org/index.aspx