2016-12-12 Era: Auditing Tips and Tricks ISO 17025C

©2016 Waters Corporation 1

ERA is Pleased to Present:

Best Practices for Internal Audits

Presented by Matt Leiphartof

December 13, 2016

Copies of slides will be sent to registered participants after the webinar has concluded

ISO Auditing Best PracticesISO 17025

Welcome and Thanks for Attending

Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 2


What We Will Cover

• Why 17025 is Different• Key Auditing Issues

– Comprehensive Planning– Energetic Auditing– Accurate findings

• Update on new version of 17025• Questions

Cavendish Scott

• Cavendish Scott, Inc.– ISO 9001:2015 consulting packages– Focus area - ISO 17025– Training, auditing and gap analysis– 30+ Years Experience – Guaranteed Success

• Matt Leiphart - Presenter– Experienced Mgmt Rep, VP of Registrar/CB, CB auditor, consultant– IRCA certificated Lead Auditor– IRCA ISO Lead Auditor instructor and training designer

– www.CavendishScott.com– www.training.cavendishscott.com– [email protected]– [email protected]


http://www.cavendishscott.com/

http://www.training.cavendishscott.com/

mailto:[email protected]


ISO 17025 is different

• Its an accreditation system• This means – it’s not ISO 9001• Customers need to be able to rely on your output• “The public” needs to be able to rely on your output

(interested parties)• The system is expected to be mistake proof • The system is expected to be effective all of the time• Its going to be a more bureaucratic system, its going to be

more demonstrable• Not only be good but prove it.


Planning and Preparation

• Planning– Pick the best auditors– Provide refresher training– Allow time for preparation– Ensure a schedule clearly describes everything (scope, criteria, objective)– Plan to audit in different ways,

• full process, samples, just documents, backwards, forwards, specific requirements, etc.– Audit in teams (if possible)

• Preparation– Revisit goals of audit, what outcomes are desired – Read documents, make notes, discuss research, raise questions– Research, research, research– Challenge the process– Record questions and audit trails (checklist)


Use of checklists

• Can create any form of checklist• Pros

– Keeps you on track– Can ensure thoroughness – Tool to record evidence– Record of conformance and nonconformance

• Cons– Does not encourage exploration and curiosity– Can blind auditor to other issues– Too rigid

• Good checklist questions versus “canned” questions


Energetic Auditing

• Bring your personality to the audit• Audit the process, not the requirements

– Make sure the requirements are covered during preparation

• Focus on finding objective evidence – Auditing without objective evidence is wasted effort

• Be thorough (enough for a conclusion)– As planned - Entire process, many people, many

records, many observations, records, statements– Be positive, (you are on their side)

• Look for opportunities


Accurate Findings

• Reporting takes time (more than you think)• Detailed citation of the requirement• Detailed identification of all pertinent evidence • Finding must be clear and easily understood by those

who are not management system experts• Poorly written nonconformances

– Won’t lead to effective corrective action• Noteworthy objective evidence but no requirement

violated? – Observation, opportunity, OFI


Summary

• Don't skip planning. Trying to shortcut planning and preparation will waste your time and the auditees' time

• Audit like you mean it. Test the process, make them prove it works, don't be nit picky but don't be a pushover either

• Writing good findings takes time and dedication - and is imperative if the audit is going to provide valuable input to the corrective action process and benefit the organization by promoting continual improvement.


ISO 17025 Update

• DIS published 27 Oct 2016• Not the new Annex SL approach• Says in intro "Laboratories that conform to this

International Standard will also operate in accordance with the principles of ISO 9001."

• FDIS probably within a year – For ISO 9001 DIS – FDIS, May – August

• Transition (probably 2-3 years) after publication

12

Contents Organization Differences

ISO 17025:20054 – Management

Requirements5 – Technical Requirements

ISO 17025 DIS4 – General Requirements5 – Structural Requirements6 – Resource Requirements7 – Process Requirements8 – Management

Requirements

© Cavendish Scott, Inc.www.CavendishScott.com


More in 2017

• February 7 Webinar on New Version of ISO 17025• training.cavendishscott.com• Register to create a user name• “Free Webinar Series” link• “Take the Course” at the bottom of the page to enroll

and receive automated emails announcing classes• Watch recordings of previous webinars

Cavendish Scott, Inc.

• Consulting to ISO 17025, 9001, AS9100, 13485, 14001• ISO training – in house and public,

– Lead auditor, internal auditor, advanced auditing– ISO implementation, standard review, leadership

• Informational Webinars – Note February – review of the changes of ISO 17025

• Outsourced internal auditing– Guaranteed effective– Highly Professional– Comprehensive SOW, Planning, Reporting

• Document review and gap analysis/planning projects


2016-12-12 Era: Auditing Tips and Tricks ISO 17025C

Leadership & Management

Transcript of 2016-12-12 Era: Auditing Tips and Tricks ISO 17025C