ways to document evidence iso 9001:2015

WAYS TO DOCUMENT EVIDENCE ISO 9001:2015

25.01.2021

Judith Hargreaves LLB Hons

AMERICA’S

No.1

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body in aerospace

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OUR

IS TO HELP CUSTOMERS

DELIVER PRODUCTS THE WORLD CAN

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PURPOSE

NQA is a world leading certification body with global operations. NQA specialises in certification in high technology and engineering sectors.

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ISO 9001 ISO 14001 ISO 45001 ISO 27001

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We promise to update you on industry changes

We promise our experience will add value to your audit schedule

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WEBINAR OBJECTIVES

• How to create a lean ISO 9001:2015 system without unnecessary paperwork

• Where does the Standard require documented information?

• “I want to help my work force be more efficient by reducing documented information – how do I evidence the requirements are still met to an auditor?”

• Where to start when considering reducing and updating your system; important planning.

REAL TIME EFFECTIVE SYSTEMS

“Whether it's the best of times or the worst of times, it's the only time we've got”

Art Buchwald

WHAT DOES YOUR QUALITY MANAGEMENT SYSTEM LOOK LIKE?

It is likely (from what we see daily) that you have; • A quality manual – NOT REQUIRED • A written Policy within the manual and on a noticeboard –

WHO READS IT? • Folders of written procedures/flowcharts on walls – ARE

THESE EFFECTIVE? • Management review minutes – ARE THESE PUT IN A

FOLDER UNTIL NEXT YEAR? • A non-conformance register – HOW IS IT MANAGED? • Internal Audits – ARE THEY UTILISED OR A BURDEN?

IMAGINE IT COULD ALL BE FUNCTIONAL TOOL IN ONE PLACE THAT ADDS VALUE

• A lot of us will now be working from home, how do we access the QMS documents and how do we know they are being used and adding value?

• What software are we using to communicate: Teams, Hang Outs, Zoom, email, Whatsapp – have you considered that your main mode of communication may now be best suited to house your QMS?

• What time can be saved by not having to search through arduous files?

• Total document control from one administrator

PRETTY DOCUMENTS AND TIME WASTERS

Most of your manual can be done effectively, visually, and communicated simply by reducing the duplication and waffle. What we see daily; • A manual which doesn’t provide much information such as an almost direct copy and paste of the Standard such as: We have established, implemented, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. We have determined the processes needed for the quality management system and their application throughout the organization, and have: a) determined the inputs required and the outputs expected from these processes; b) determined the sequence and interaction of these processes; c) determined and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determined the resources needed for these processes and ensure their availability; e) assigned the responsibilities and authorities for these processes; f) addressed the risks and opportunities g) evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results;

METHODS

• Posters – Created easily, visual, informative and do not take up lots of storage

• Dashboards – More and more popular, putting the system in one place with icons to click

• Websites – These provide the context of your company, what products you sell and it is communicated to anyone who clicks on it

• The mechanism you are using to communicate eg Teams, Google etc

WHERE DOES THE STANDARD REQUIRE DOCUMENTED INFORMATION

SECTION REQUIREMENT 4. CONTEXT OF THE ORGANISATION Scope, maintain support to operation of processes,

provide confidence processes work

5. LEADERSHIP Policy

6. PLANNING Objectives

7. SUPPORT Monitoring and measuring resources and fitness for purpose, calibration, evidence of competence, determine documented information as being necessary for effectiveness of QMS, version control when updating and creating, control of documented information

EXAMPLE COMING….

As everything we see is confidential, and we are impartial, for the purposes of this webinar, I

have created a company myself in an area we wouldn’t audit just to show you…

EXAMPLE

WHAT THE STANDARD REQUIRES PART 2

SECTION REQUIREMENT 8.1 Operation planning and control

1) to have confidence that the processes have been carried out as planned; 2) to demonstrate the conformity of products and services to their requirements.

8.2 Requirements for products and services 1) Review customer requirements 2) Ensure any new requirements for products and services

8.3 Design and development: planning, inputs, controls, outputs and changes

1) 9 requirements to consider, ensure documented information met such as: resources, verification and validation, customer involvement, level of control, design reviews, responsibilities 2) Document design inputs 3)Document controls 4) Document outputs 5)Document changes


8.4 control of externally provided processes and resources Document how you control external process and resource (purchased product and suppliers)

8.5 Production and service provision 1)What the job is, what should the result be, monitoring and measuring resources – stages to do so, competent persons, validation where calibration not used, post delivery activities 2) Traceability must be available through documented information 3) Property belonging to customers or external source must have documented information – repairing an item hire agreement etc 4) Control of changes must be documented

8.6 Release of products and services 1) evidence of conformity with the acceptance criteria; 2) traceability to the person(s) authorizing the release.

8.7 Control of non-conforming outputs 1) describes the nonconformity; 2) describes the actions taken; 3) describes any concessions obtained; 4) identifies the authority deciding the action in respect of the nonconformity.


SECTION REQUIREMENT 9. Performance Evaluation 1) what needs to be monitored and measured;

2) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; 3) when the monitoring and measuring shall be performed; 4) when the results from monitoring and measurement shall be analysed and evaluated.

9.2 Internal Audit 1) Audit plan 2) Scope of audit 3) Audit results and corrective action

9.3 Management Review Retain minutes to verify all inputs and outputs met

10.2 Non-conformity and corrective action 1) the nature of the nonconformities and any subsequent actions taken; 2) the results of any corrective action.

“I WANT TO HELP MY WORK FORCE BE MORE EFFICIENT BY REDUCING DOCUMENTED INFORMATION – HOW DO I EVIDENCE REQUIREMENTS TO MY AUDITOR?”

Processes

Training

Awareness

Non-conformance

reporting

Corrective action

Internal audit

Management review

Starts at a thorough induction and refreshers which we can evidence

Discussion, demonstration

By showing issues, or points for learning you are evidencing utilisation of the system and effectiveness of the processes.

Shows improvement, reflection and reduces chances of reoccurrence

An opportunity to assess the system and see what can be removed and or refined. You may find too many processes that do not talk to each other, inefficient use of technology

An opportunity to deep dive into the internal audit results, NC’s and action effectiveness. Solutions may come from KPI’s and benchmarks, communicate this back through training

WHERE TO START WHEN CONSIDERING REDUCING AND UPDATING THE SYSTEM; IMPORTANT PLANNING

Leadership – It starts with you. What do you want to know from internal audit

Analyse results from internal audit, communicate with process users Set objectives which are monitored regularly

ways to document evidence iso 9001:2015

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