How To Adapt Generic Templates To Specific Industries?

by Poorva Dange

Introduction

Generic ISO templates can save infinite amounts of time, offering a framework that meets the clause by clause requirements and good practice. Their wide applicability, however, is also a weakness, industry specific needs, compliance needs, realities of operations and risk environments are seldom taken care of on a canned basis. The bridging this gap lies in customization to not only assure compliance, but also excellent operations.

How To Adapt Generic Templates To Specific Industries?

How To Adapt Generic Templates To Specific Industries?

1. Begin With Gap Analysis: What has Missed?

Action steps:

  • Compare the templates with the standards in your industry, legal/regulatory requirements and important customer requirements.

  • Undertake a clause-by-clause and process-by-process analysis to find missing content, redundant sections or lack of specificity.

2. Connect with Internal and Industry Experts

Action steps:

  • Engage process owners, major personnel and industry compliance or regulatory authorities to review templates.

  • Use past lessons learned on the basis of past audits, incidents or industry benchmarking to make changes.

Why: The subject-matter experts are able to recognize the discrepancies between the generic controls in the template and the requirements or weaknesses of your industry.

3. Personalize Core Content and Terminology

Action steps:

  • Localize language to suit in-house or operational or regulatory language. Substitute general process names with terms that are applied on the production floor, in the laboratories or in IT processes.

  • Subtract, add or edit sections that are normative of real work culture, process or legal requirements.

4. Add Sector-Specific Controls, Risks and Records

Action steps:

  • Identify industry-specific risk and controls needed--merge them into risk registers, procedures, and forms.

  • Take any sector certification or best practice overlays (including GMP in the case of pharma, or DORA in the case of fintech/IT).

5. Combine Customer and Regulatory Requirements

Action steps:

  • Review all industry/jurisdictional regulatory standards. Discuss and describe them in your templates.

  • Adjust templates to customer requirements, supplier quality commitments or insurance requirements, where applicable.

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6. Name, Structure, and Design to be used

Action steps:

  • When it comes to industry structure, numbering and document codes, use familiar codes so that you are not confused.

  • Use visual aids, flowcharts or examples to simplify or make complex processes understandable to end users front-line or IT team members.

Why: Templates are just a value addition that is only realized when individuals use them. Customization of the industry enhances day-to-day adoption and functionality.

7. Pilot and Test with End Users

Action steps:

  • Deploy drafts in small teams. Request front-line users to test the new templates during live operations to document the problems, gaps, and areas of confusion.

  • Re-test and refine and then roll out before the final roll out depending on the areas that are most important to compliance and operational efficiency areas.

8. Create Change Control and Industry Surveillance

Action steps:

  • A document owner should be assigned to each critical procedure or template-preferably to an individual with experience in the industry development, enactment of new laws or the emergence of new risks.

  • Take periodic reviews, industry updates, regulatory changes and findings of audits.

Why: Industries evolve, so should you. The alive revision process maintains useful and compliant templates.

9. Audit Customization of Documents

Action steps:

  • Record all significant changes to templates, their justification, the person who made them and the industry/regulatory need met.

  • Trace customized parts to industry standards or regulations, so that auditor board can effortlessly and clearly see them by preparing a matrix or providing footnotes.

10. Use Technology and SMART Document Systems

  • Intelligent or AI-powered document management solutions should be used that can support role-based overlays, industry-specific templates and intelligent integration of regulatory updates.

  • Electronic solutions are useful to maintain changes with time, speed up review processes, and automation of reminders of necessary changes.

Conclusion

Only the compliance and operational improvement are the beginning lines with generic ISO templates. The difference between high-performing organizations is that they have fully tailored such templates to the specific needs, risks, controls, and terminology of their industry or business. This makes documentation a living compliance and management tool- making it much more usable, more likely to be a successful audit and more likely to drive business performance.

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