Implementing ISO 9001? Make it Simpler. Easier.

2 out of every 3 firms report significant improvement to Business Performance when implementing a Certification Process like ISO. In many industries, implementation of a Certification process becomes mandatory when dealing with larger clients and government.
Yet, firms find the process difficult and cumbersome.

The problems of Difficult Understanding can be addressed by proper communication and keeping ISO Manual hosted on the Cloud for proper version control. But lack of resources, when you dig deeper tends to center around the uncertainty of how to make ISO processes central to daily work. Creating custom software is laborious and expensive. Add in the fact that carrying out Audits, and managing records can be difficult. This is precisely where we step in.

Software like Pronnel can aid implementation and working within the ISO Framework.

With ISO 9001: 2015 edition, documentation has become much easier. A software like Pronnel can help with implementation by three ways addressing issues like Lack of Resources and Difficulty Understanding:

• Organization wide Public Notice Board- List your ISO Manual on the Cloud with access Read-Only Access to all employees other than the Management Representative.
• Makes it easier to encode Procedures, Work Instructions and Record Keeping through Boards which cover processes not already covered explicitly in your ERP or CRM. Thus, the chances of errors or missing out records is reduced drastically. Team Members don’t have to refer offline documentation while doing their job.
• Internal Audits, Management Reviews and CAPA Task Tracking for continual improvement. Use Pronnel to run your Audit process with built-in Audit Forms, records, etc.

A closer look at ISO 9001:2015

Let’s find out how by taking ISO 9001:2015 as a test case. The same steps can be modified for implementing Environmental Standards like ISO 14001: 2015 (Environmental Management Systems -EMS) or ISO 45001: 2018 (Health and Safety Management Standard).
The ISO 9001:2018 Implementation Process and Key Components.
The typical ISO Implementation process follows the following steps:

• Preparatory Steps:
  1. Familiarize Yourself with ISO 9001
  2. Plan Everything out for Implementation
  3. Identify Responsibilities, Policies, and Objectives
• Launching ISO 9001
  1. Develop Your Documentation
  2. Launch Your Quality Management System
• Internal Audit: Review Your Performance
• Certification: Assess and Register for Certification
• Continual Improvement and Maintaining Compliance

Now, beginning with the Preparatory Steps, during which you will either be working with an external consultant, or, with your in-house implementation expert, you will layout the framework of your Implementation process. Let’s quickly map the different entities in ISO with how they will be executed in Pronnel. With that over we can look at how software like Pronnel will come into play in the implementation, execution of established SOP’s, record keeping and carrying out Internal Audits.

Record What You Do (in Pronnel). Do (through Pronnel) What You Record.

ISO Entity	Function	Mapped in Pronnel	Advantages
Management Representative (MR)	2.2	37	135,000
Remote work	Custodian of ISO. Can change processes post Top Management sign-off	Org level Admin+ Admin for each Process Board	Only MR can change process or revise ISO Documentation
Functional Representative	Draft specific documentation, flowcharts etc	Provides documentation and signs off on final process	Customized process updated in Pronnel
Quality Manual	Overall statement of ISO Policy Implementation	Posted as Document on Internal Notice Board	Read only access on Cloud for Org. Members. Only Management Representative can edit with complete Audit Trail
Procedures	Describes SOP	Individual boards where required can be crafted as per organization’s unique process	With process hardcoded minimize Non-Compliance (NC’s) due to non-Adherence.
Flowcharts	Describes inputs, outputs, flow, approval	Individual Boards with Workflow Diagrams	Customized to suit your firm. Only MR can modify the process.
Work Instruction	Detailed instruction in each work stage	Enter instructions at Bucket Level	Even new members know what to do, when to do.
Records	Each transaction needs to be recorded and stored	Create a ticket in a Board, move it through the process, record approvals, store documents	All Records are available at click of the mouse. Evaluation becomes so much easier.
Internal Audits	Periodic Assessment of Performance	Use Internal Audit Board and Forms to Audit each process	No more running around and scattered documents. Auditors read process in Pronnel, and Audit using forms, submit evidence attached to each ticket.
Management Review	Post Audit to evaluate Performance	Run meeting reviewing Tickets from Internal Audit Board. Use Notes Feature in Management Review Board to minute Meetings	All data is stored on cloud centrally, easy to access. Meeting Notes can be shared across the organization.
Continual Improvement (CAPA)	Based on Management Review generate Tasks for CAPA	Use the Board to create individual tickets for CAPA, or pass amendments to the Quality Policy	Everything documented. Easily available for MR and External Auditors.

Learn more about how you can use Pronnel as a support tool to support ISO Standards Implementation in your organization in our follow up Blog- Implementing ISO? Pronnel Can Help

FAQ’s

What are the advantages of using software for implementing ISO Processes?

If process standardization frameworks had a central tenet, it is “Record What You Do. Do What You Record.” This is where software comes in handy. By encoding your daily work processes as a workflow digitally, you enable automatic record keeping and adherence to processes. Whether it’s approvals, ensuring that correct steps are followed, everything is captured. What is more, by giving your team explicit process to follow, you enable even the newest recruit to follow the firm’s laid out SOP’s.

What are the advantages of using Pronnel as the software backbone?

Standardized process, User Role Control, Document Repository, Approvals, Record keeping, all the basics are in place. Where Pronnel stands head and shoulders apart from other offerings in the market are:

• Custom Configuration- You are the owner. With our Click-And-Drag menus customize the process as you need exactly
• Deployment Speed- An intermediate user can create up to 20 Process Boards a Day. So even if you must implement 60 processes, with review by MR, you can finish the activity in less than a week’s work with our readymade building blocks. Compare that to paying thousands of dollars to a software consultant who will take months to design your workflows.
• Iterations and Revisions- Compared to going back to your software vendor every time your Process changes for an amendment Pronnel, allows you to make the changes based on Management Review. A MR can make changes in less than a day. All backed by an Audit Trail.
• Cost- While a solution in the market like Intelex, has a setup fee, a fixed contract for three years and an monthly license cost of USD 12.5/ user, Pronnel comes in at a monthly cost of USD 5/ user approximately, no setup fee and no fixed contract. And there is no restriction to the standards you can implement. If you want to implement ISO 9001, ISO 14001, ISO 45001, you still pay the same amount.
• Additional Uses- Once you start using Pronnel, not only can you cover the ISO Processes, but also any additional non-Mandatory processes on Pronnel. No extra charges.

Does Pronnel Implement ISO Certification?

No, Pronnel is not an ISO Registrar or a Certification Body. Only ISO Registrar or a Certification Body (CB) can certify organizations. You must employ an authorized CB who complies with the relevant CASCO Standards to get an ISO Certification. To find an accredited certification body, contact the national accreditation body in your country or visit International Accreditation Forum CertSearch.

Which ISO Standards can you implement through this software?

To date, ISO has published over 22,000 standards and related documents. Use Pronnel to implement all of their documentation and workflows. While we may not be able to write or consult your firm for ISO implementation, we would be happy to help you bring the system to life on Pronnel. The typical ISO Standards we work on are:

• ISO 9001- For general organizational quality management systems (QMS), including vendor management. ISO comprises QMS standards for specific industries, too.
• ISO 14001- For Environmental Management Systems
• OHSAS 18000- assists organizations in managing and controlling their health and safety risks
• ISO 45001- for Occupational Health & Safety Management Systems
• ISO 27001- For Information Security Management Systems (ISMS)
• ISO 26000- For businesses and organizations committed to operating in a socially responsible way
• ISO/TS 16949- in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production, and, when relevant, installation and service of automotive-related products
• AS9100- For quality and safety within aviation, space, and defense.
• ISO 17025- (Testing/ FDA) for laboratories to demonstrate that they operate competently and generate valid results. It identifies the technical competence and management system requirements that guarantee consistently accurate test results and calibrations.
• ISO 13485- (Medical Devices), QMS for producing medical devices and equipment.
• ISO 29001- (Oil / Gas) for all oil and gas supply chain organizations.
• ISO 22000- (Food Safety), QMS for developing and implementing a food safety management system can help any organization in the food chain.

Other than ISO, what standards can you use through this software?

Pronnel supports a Process-Centric style of working. You can build the processes you define following any of the following standards on Pronnel:

• APQC (American Productivity and Quality Centre)
• JCI (Joint Commission International)/ NABH (National Accreditation Board for Hospitals & Healthcare Providers)/ ISQua (International Society for Quality in Health Care) for healthcare.
• NEBOSH National General Certificate in Occupational Health and Safety.
• HACCP management system in which food safety
• Forest Stewardship Council (FSC) for sustainable forestry or the Rainforest Alliance
• BS EN 15713 framework to manage and control the destruction of any confidential material destruction
• SEI- CMM (Software Engineering Institute- Capability Maturity Model) documentation and process implementation. Or other AGILE frameworks.

If you do not implement ISO Certification, who will configure our processes?

Pronnel can:

• Functioning as an Organizational Digital Notice Board for version control and communicating ISO Documentation to the team.
• Form the backbone for encoding processes which are not captured in your ERP, CRM, etc
• Carrying out Internal Audits through ISO Templates with NC recording, Management Review and Task Tracking for CAPA.

All these can be done by the Internal Team, or, a ISO Implementation Consultant. When you sign up to Pronnel with more than 4 user licenses, you are eligible for 40 hrs free training during which we can work with your nominated User Champion to train and provide guidance. Ultimately, Pronnel is just a vehicle and the core of the ISO implementation, Procedures, Workflows will come from you.
Should you need additional help, the Pronnel Team can help implement the ISO process based on your documentation for an additional fee. Drop us a mail at sales@pronnel.com to see if you really need any help.