ISO 9001 - Understanding ISO 9001 Requirements

5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management must provide evidence of its commitment to develop and implement the QMS and continually improve its effectiveness. To achieve this, they must:

a)Communicate to the organization the importance of meeting requirements (customer, statutory and regulatory)

b)Establish the quality policy

c)Ensure that quality objectives are established

d)Conduct management reviews

e) Ensure the availability of resources

Key Explanation Points and Tips:
ÞManagement commitment - relates to the responsibility of top management to provide leadership and direction for quality management within the organization. They must establish strategic quality management policies, directives and objectives consistent with the purpose and capabilities of the organization. They must establish the organizational structure and internal environment that motivates personnel to achieve the organization's quality management goals and objectives. They must provide adequate resources to develop, implement, maintain and improve the QMS. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness.

ÞThe above activities are all requirements of clause 5. Each sub-clause of clause 5 starts with the phrase “top management”. Top management is now clearly accountable and auditable for their role and responsibilities for the activities listed in the paragraph above.

ÞThe phrase “provide evidence” is very important here. Auditors are expected to review documents and records showing top managements role in planning and implementing the processes that apply clause 5 requirements.

ÞYou must begin with identifying the processes within your organization that perform these activities. These processes would typically include - business planning; quality planning; management review; internal communication; organization structure; etc. Business planning would address 5.1b and 5.1c, and so on for the other sub-clauses. Top management would be the process owner of all these processes.

ÞClause 5.1a - may be viewed in combination with clause 5.2 customer f
ocus, and clause 5.5.3 internal communication. Top management must communicate regularly to the organization on the importance of meeting customer and regulatory requirements. The communication process should define what needs to be communicated; to whom; the methods used; the frequency; and the means for determining communication effectiveness. (See clause 4.1a- 4.1f for guidance in developing such a process.). Top management may communicate in any number of ways including meetings; documented policies; memos; directives; email; etc,

ÞNote: effectiveness may be measured by asking - how much of the planned activities did we get done? Or to what extent did we achieve planned results?

ÞClause 5.1 does not require a ‘documented’ procedure. However, you must identify and document (e.g. process map; process flow diagram; etc.) the processes for business planning; quality planning; management review; internal communication; organization structure; etc. as part of your QMS (see clause 4.1). You must also identify what specific documents are needed for effective planning, operation and control of these processes (see clause 4.2.1d). These documents may include - a documented procedure; business plan; statement of policies and objectives; etc.

ÞLook at the risks related to your business, products, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes) for this clause.

ÞWhere some of clause 5 activities are performed off-site (e.g. at head-office), your QMS must identify the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of compliance may include - a copy of their ISO 9001 certification; ISO 9001 internal audit results (of these processes) for the off-site facility; auditing these processes at the off-site facility. The expectation is to flow down to the off-site facility, the relevant ISO 9001requirements that you would have to implement, had you carried out the process at your own facility.

Þ The specific requirements for clause 5.1b through 5.1d will be discussed in the upcoming sub-clauses.