ISO 9001:2015 Interpretation and Implementation (10/22/16)

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St Louis ASQ Quality Conference

Interpretation and Implementation


Preamble

• ISO 9001:2015 – Interpretation and Implementation. Addressing the key concerns and giving solutions

• Its one thing to understand what the requirements mean, its another to appreciate and optimize how they are applied. The new standard gives complete freedom to the user to determine how conformance is demonstrated. This has created a dilemma for many people. How much documentation do I need? How far should I go? What level of detail do I need? Do I need any records? Gray starts by clearly answering these questions and then applies these principles to solutions and options for some of the newer and bigger requirements in the standard. This is truly the answer to the question “how to do ISO well?”


Colin Gray & Cavendish Scott

• Cavendish Scott, Inc.– ISO 9001:2015 consulting packages– Training, auditing and gap analysis– 30+ Years Experience – Guaranteed Success– IRCA ISO 9001:2015 Lead Auditor Training– ISO 9001, AS, 14001, 17025, 13485

• Colin Gray - Presenter– 30 years auditing, training and consulting.– IRCA, EG, Lead Auditor– IRCA ISO 9001:2015 Lead Auditor instructor and training designer


Questions?

• Interrupt, challenge• Use the cards• Catch me after (use the cards)


Agenda

• Documentation (no requirement for documentation?)• Revisited: What we need to do• Project Management• Process based structure• Rewrite documentation• New Processes

– Risk, etc.• Top Leadership engagement• Certification transition• System Verification• Questions


Documentation

• Always for effectiveness…but also to be able to demonstrate it. (to customers to auditors and to ourselves)

• Make it easy to pass versus difficult to fail• 4.4.2 To the extent necessary, the organization shall:

– A) maintain documented information to support the operation of its processes;

– B) retain documented information to have confidence that the processes are being carried out as planned.

• 8.1 Operational planning and control– E) determining, maintaining and retaining documented information to the

extent necessary:• to have confidence that the processes have been carried out as planned;• to demonstrate the conformity of products and services to their requirements.


Documentation

• Definition• Communication• Training• Auditing• Improvement• Success

• Procedures• Flowcharts• Alternatives• None – you better be good


Records

• “Special type of document”• “shall consider”


What needs to be done?

• Gap Analysis– No not really – any comparison document– How solid is your current system

• Ensure a process based documentation structure• Rewrite documentation• Design and implement new processes (strategic, changes)• Ensure “engagement” of leadership

– Demonstrable “leadership and commitment”• Handle the transition certification• Adapt to your new “senior” role

– Assure consistency with good process control– Focus on tangible improvement


Project Management

• Do NOT take responsibility for other peoples processes – It is managements responsibility to get them on track

• Two goals– First and foremost, make this useful to your organization– Make it demonstrable – not just good but prove you are

good.• Get a Date - Fit the plan to it. Transition information

from your CB. Do not change it• You need Expertise, Resources, Time

– And if your new role is “senior” and “strategic” you don’t have/need these.


Quality’s Role

• QMS does have a strategic component (always did)– ISO now demands it

• Leaders are experts in the strategic elements of the QMS

• In-house expertise? Why?– Auditing?

• Periodic ISO expertise?• ISO does not require a Management Rep

– “to do ISO”• What is the purpose of Quality in the organization?


Process Based Structure

• Increase awareness of process theory– Management requirement– Training/awareness on processes/systems

• Restructure and rewrite some documents– (some will by nature be process based)

• “There is no requirement for a procedure”• Are they currently numbered/structured around the

standard! Reorganize around existing processes• Complete a document review/cross reference• Opportunity for seniority – strategic processes and

integration• Multiple standards, AS9100, 13485, 14001, 45001/18001


New Processes

• Likely these exist, to some extent– Likely quality personnel wasn’t involved– Likely quality wasn’t a topic– Likely informal

• How much to adopt and how much to adapt– Remember – add value, demonstrate conformance

• Integration into “business processes”• Context• Interested parties• Risk (and opportunity)• Communication• Knowledge• Change Management• Changes to existing processes – Corrective action and NC


Strategic

• Always a process. Always a procedure• Strategic.

– SWOT/PESTLE– Ensure quality content– Ensure integration – Brainstorming and Ranking– Plans and actions

• Ensure “maintenance”– Periodic – With change


5.1 Leadership & Commitment

• 5.1.1 General• Top management shall demonstrate leadership and commitment with respect to

the quality management system by:• a) taking accountability for the effectiveness of the quality management system;• b)ensuring that the quality policy and quality objectives are established for the quality management system and are

compatible with the context and strategic direction of the organization;

• c) ensuring the integration of the quality management system requirements into the organization’s business processes;

• d) promoting the use of the process approach and risk-based thinking;• e) ensuring that the resources needed for the quality management system are available;• f) communicating the importance of effective quality management and of conforming to the quality management system

requirements;• g) ensuring that the quality management system achieves its intended results;• h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

• i) promoting improvement;• j) supporting other relevant management roles to demonstrate their leadership

as it applies to their areas of responsibility.


Engage Leadership

• Leadership needs to be educated.– Are they going to participate in these new processes?– If not then who and how does top management “engage”– What degree of education/training will be appropriate– Necessary in order to get their commitment

• On a Peer to Peer basis– You must engage them on their level– QA on the Board?– Who is going to interface with leadership and design/define processes

• Direct responsibilities to demonstrate (leadership and commitment) – Tangible activities that create evidence (presentations, publications, lead

projects, meetings, mentoring)– Management will be audited


Rewrite Documentation

• Again – ISO doesn’t require any procedures….• Who?• How long to allow?• How to test it?

– Independent verification• Top Management level activities?

– Are you comfortable/capable to challenge management on their strategic processes

• Change terminology? Quality Manual?


Changes

• Objectives– Meaningful that drive success– Process

• Change Management– process

• Communication– plan


Certification Transition

• Get in touch with your CB ….now– Their process and costs– Likely timing issues– Get their documented interpretations

• They had to train their auditors…..• It’s a new standard – many additional requirements – losing 3 very minor

requirements – Its going to take more time• You have to maintain conformance to 2008 until you are 2015 certified• Best at recertification• Going forward may require more audit days (changes in MD5)• Deadlines

– Sept 1 2017 No new certifications to 2008– Sept 1 2018 standard withdrawn – certificates invalid


What to Do?

• Generate a “draft” project plan• Contact your CB• Meet with management

– Your involvement, strategic processes, engagement, project scope and resources• Preliminary Review

– How to address “new” processes, strategic/integration– Determine process nature of system– How to address management engagement– Update the plan

• Work on procedures – changes, new and structure – expect iteration – interdependency

• Management Training • Verify (independently?)

– Document review– Internal audit


Cavendish Scott, Inc.

• Standard ISO 9001:2015 training classes– Free Webinars– Custom leadership training– Awareness presentations– ISO standard review– IRCA Transition Training– IRCA ISO 9001:2015 Lead Auditor

• Standard ISO 9001:2016 transition consulting projects– Procedure development/change, leadership and management

support/training, document review, auditing• Auditing, document review and gap analysis/project

planning

ISO 9001:2015 Interpretation and Implementation (10/22/16)

Leadership & Management