Documented Information

Management systems meeting international standards for quality have in the past been very document-intensive. This discouraged many organizations from implementing the international standard. Now with the advent of electronic technology and software programs to manage business systems, the need for documented procedures is becoming irrelevant.

The new ISO 9001:2015 supports these changes in business by making reference to the term “documented information,” which includes documents and records instead of documented procedures. Management standards now will be following the generic format for management systems, Annex SL, outlined earlier, which will make it easier for integrating information in a business management system manual. An organization needs to have a procedure for creating, updating and controlling its documented information.

Day-to-Day Business Management – Tell Your Story

An Integrated Management System (IMS) manual or-Business Management System (BMS) manual provides an overview of your organization's approach to business, your commitments (to quality, environment, health, and safety), identification of company's risks, referencing processes/procedures/records, responsibilities, and key systems for managing operations, and where to locate information.

This manual can be used in orientation training to introduce the company's operations to new employees or contractors, instead of duplicating time and costs in preparing new documents. It will also provide ongoing reference information for personnel. Upkeep of one centralized document (manual) helps personnel to know where to look and keep track of changes within the organization. Improved system operations will result as employees will know where to look for applicable information or procedures and records.

Not only will new employees have a road map to the company, but also it will benefit external stakeholders, such as boards of directors, government inspectors, insurance personnel, ISO auditors, etc., who will be able to understand day-to-day management of the organization.

The manual will provide a document that can provide due diligence in the case of a legal issue tied to the management of your business. Many organizations that have had compliance issues were required by judges to put in place management systems meeting international standards. Your manual will show a judge that the company has taken reasonable steps to identify and manage its risks tied to legal requirements, which provides a good start for a defense for due diligence, outlining your commitment to manage and monitor compliance issues.

Your manual will also be used by registrars/auditors who are conducting internal or third-party assessments of the organization. Does your manual tell the story of how you manage your business?

BMS or IMS Documented Information

Your BMS manual or IMS manual, whatever you wish to call it, should include the sections outlined in the following “Business Management System Manual Content Example" (Refer to Figure 13.1.)

Note: This is a manual template that would outline the core requirements for integrated management systems meeting international standards. Your company needs to adapt this template to your particular organization.

Consider the following: What is the purpose of your manual? Who will use it and why? The manual needs to be a living document, not one that just sits on the shelf or online and is never utilized.

The manual can be written by your management system coordinator or representative, or you may hire a subject matter expert on international standards for quality, environment, and health and safety or integrated management systems. His or her knowledge and advice would assist you greatly, regardless of whether you wish to register your system. This way your manual will meet the ISO criteria that have been developed by industry experts around the world and supported by more than 190 countries. The standards were developed to help companies manage their business operations in an effective and efficient manner through continual improvement.

There are many templates of manuals available online, and your management system coordinator can research these for other approaches.

The outline in this book provides the table of contents, which will address the requirements for the new generic management system for quality management, which will be released in 2015. Whichever template you utilize, ensure that all areas listed in the table of contents in the following pages are addressed.

When outlining your management system(s) in each of these categories, specify who is responsible for the overall area and the applicable documents (procedures/records) or software programs, and databases where information is kept. It is important to describe the interaction of your processes, which can be outlined in diagrams or process flow charts.

The numbering system is important in a manual, especially if you decide to register your management system. The new management system outline was described earlier, and this template follows the numbering system for the quality management system (ISO 9001-2015).

Do a draft manual, have all management review it for accuracy and clarity, and adjust as needed before it is approved and released. As changes occur, reference them in the manual, showing the revision history and status of the document and keeping it updated and current.

It is your organization, and regardless of whether you choose to go for ISO registration, you want your information to be complete and applicable to your unique operation. This way, the structure of what you have in place for managing your business will be understood around the world.

Business Management System Manual

BMS Manual Content Example

1 Introduction

a. Purpose of the manual (company developed and implemented the manual to outline its integrated MS so that the organization could provide products/services that meet customer and applicable legal requirements and be effective and efficient enough to manage its business risks for quality, environment, and health and safety)

b. Scope (What your management system includes: all locations, one division/department, or the whole organization)

c. Exclusions (e.g., design and development – outline justification for its exclusion)

d. Outsourcing (what is outsourced?)

e. Pictures of your goods and services

f. Site diagram – locations

g. Diagram of management system processes

h. Process flow charts – outlining interaction of processes of operation

(Note: You may wish to provide the foregoing information for (d) through (g) in this section or under #4, context of the organization.)

2 Normative references

This would outline what specific standards your management system is set up to, such as ISO 9001, ISO 14001, OHSAS 18001, etc.

3 Terms, definitions, and abbreviations

Every company has specific key terms and abbreviations; it is helpful for those working with the company to understand what they mean.

The following are excerpts from ISO standard definitions. Adjust according to your needs.

Management system: A set of interrelated or interacting elements used to establish policy and objectives, and to achieve those objectives; a process approach to managing and controlling inputs and outputs from its processes. A management system includes organizational structure, planning activities, responsibilities, practices, procedures, processes, and resources.

Quality: Degree to which a set of inherent characteristics fulfills requirements. Quality management includes planning, control, assurance (QA), and improvement.

Environment: Surroundings in which your organization operates, including air, land, water, natural resources, flora, fauna, humans, and their interrelation. Note that surroundings in this context extend from within an organization to the global system.

Occupational health and safety: Conditions and factors that affect or could affect the health and safety of employees, or other workers (including temporary workers and contract personnel), visitors, or any other person in the workplace.

Hazard: Source, situation, or act with a potential to harm in terms of human injury or ill health or combination of two. Table 13.1 outlines common hazards.

TABLE 13.1

4 Context of the organization

a. Understanding the organization and its context (e.g., management system process diagram)

b. Understanding needs and expectations of interested parties

Outline the values of the company and its mission – what standards (are you registered to any, when) or what best management practices does your organization follow?

Note: you can put the “Scope” here instead of introduction and the listing of the organization's processes.

5 Leadership

a. Commitment

What commitments have you made, as the president or CEO, for your organization?

When you have an integrated management system you are making many commitments, from providing a management system structure that will meet international standards to providing customer satisfaction, prevention of pollution, prevention of injury or illness, etc.

Your commitment is outlined in your policy statement, and is communicated to your people so that they will understand and meet the organization's plans, objectives for improvement, and statutory and regulatory requirements.

By providing the resources required to manage the company and support the organization's structure, you are committing to the implementation and ongoing management of the business operations.

Your ongoing management reviews show the continual monitoring of the company's operations and the commitment you have made as the leader of the organization to ensure the effectiveness and improvement of the company's business.

Keeping abreast of line managers and employees about changing circumstances, nonconformances, corrective actions, and project status is necessary to lead on the necessary action items that come out of meetings. Having a documented agenda for these reviews and a system in place to track and manage action plans improves performance. b. Policy statement(s)

If you have separate policy statements for quality, environment, and health and safety, I would recommend integration of these into one policy statement, which will reduce documentation and the time you are spending on these documents. Your time is valuable and needs to be focused and fine-tuned (see Figure 13.1).

i. As president, CEO, or top management, what commitments are you making in your signed and dated policy statement?

ii. How do you communicate this policy statement(s)? Outline the policy statement in the manual (or hyperlink to a stand-alone policy statement).

iii. Is your policy statement current?

iv. I have seen many companies who utilize the same policy statement for years with no updates, not even a date change to indicate that they have reviewed the document and still support it. A policy statement dated back three years or more shows that the organization is not up to date.

v. Many organizations have their policy statements posted on their website. What does this convey to viewers or customers?

c. Organizational Roles, Responsibilities, and Authorities

6 Planning

a. Risk management (quality, environment, health & safety) legal, emergency

b. Reference to objectives/targets

c. Management of change

7 Support

a. Resource management (Put organizational chart here or under leadership or put in appendix. Outline overall responsibilities for maintaining management system requirements, from top management to management representative, committees, supervisors, general responsibilities for employees. Contractors are also key resources.)

b. Human resources – competence

c. Infrastructure

d. Documented information

e. Awareness

f. Communication

8 Operation

a. Operational planning and control

b. Determining and reviewing requirements for products and services (customer communications, risks, legal and other emergencies)

c. Design and development of products and services (this may be an exemption)

d. Control of external provision of goods and services

e. Production and service provision (controls, identification and traceability, external property, preservation, post-delivery, control of changes)

f. Release of products and services

g. Control on Nonconforming process outputs, products and services

h. Maintenance

9 Performance evaluation

a. Monitoring, measurement, analysis, and evaluation (customer satisfaction, quality, environment, health & safety, finance)

b. Internal audit

c. Management review

10 Improvement

a. Nonconformity

b. Corrective action

c. Continual improvement

11 Manual revision history and change record

12 Documentation correspondence matrix

Note: The matrix outlines the manual's section numbers (applicable to ISO clauses) cross-referenced to key documents/data used by the organization (e.g., procedures, standard operating procedures [SOPs], database or software programs utilized for the each area – training, nonconforming products, corrective action, inspection database).

13 Appendix

a. Organizational chart (example)