Documentation and Compliance

If you work in an industry like healthcare or financial services, you know all about regulatory compliance. Regulatory compliance is an organization’s adherence to a set of laws, regulations and guidelines for their particular industry.

These regulations can be imposed by government or certification bodies. For example, Office of the Superintendent of Financial Institutions (OSFI) is a federal government agency that supervises and regulates banks, insurance, and trust companies. The International Organization for Standardization (ISO) is a certification body that certifies organizations to various standards, such as quality management, environmental management, or social responsibility.

If we use ISO 9001:2015 as an example, the standard requires documented information to show effectiveness of the quality management system and can be in a form deemed appropriate by the organization. So procedures, records or electronic forms like video are all options of documented information.

Procedures do seem to be the easiest way to communicate process information and remain complaint to the applicable regulation or standard. Procedures make it clear what the purpose is, who is responsible for the activities, what, when and how activities should be done, what tools or equipment is needed and what key performance indicators are monitored. And collecting and maintaining the procedures in a quality manual will keep it all organized.

ISO 9001 has a few mandatory documents, including:

• Scope of the quality management system – what is applicable and not applicable

• Quality Policy – statement aligning the company’s strategy, the quality objective and compliance with ISO 9001 standard

• Quality objectives – measurable goals for operations and customer satisfaction that are consistent with the quality policy

To show effectiveness of the quality management system, it may be useful to document such procedures as:

• Operations:

  • Competence and training

  • Sales

  • Design and development

  • Product / service delivery

  • Warehousing

• Control of documents

• Control of records

• Internal audit

• Control of nonconforming product

• Corrective action

• Preventive action

Not only are the procedures beneficial to prove compliance to the standard / regulations, but they are also used for training employees, preventing loss of knowledge and confirming consistency of the process.

Contact me if you need assistance with your process documentation or improvement.