ISO 9001-Clause 5.1,5.2,5.3

Clause 5 Management responsibility

ISO 9001-Clause 5.1,5.2,5.3

5.1 Management commitment

ISO 9001 requirement:

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

  1. communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
  2. establishing the quality policy,
  3. ensuring that quality objectives are established,
  4. conducting management reviews, and
  5. ensuring the availability of resources.

Explanation:

It is 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.. Auditors are expected to review documents and records showing top managements  role in planning and implementing the processes that apply clause 5 requirements. The processes within your organization that perform these activities must be identified. These processes would typically include – business planning, quality planning, management review, internal communication, organization structure etc.  Top management would be the process owner of all these processes. 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. Top management may communicate in any number of ways including meetings,documented policies, memos, directives, email etc. 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? Clause 5.1 does not require a ‘documented’ procedure. However, you must identify and document for 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. You must also identify what specific documents are needed for effective planning, operation and control of these processes. These documents may include a documented procedure, business plan, statement of policies and objectives etc. Look at the risks related to your business, products, processes and resources in determining the nature and extent of documented controls you need to have for this clause.  Where 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.   The expectation is to flow down to the off-site facility, the relevant ISO 9001 requirements that you would have to implement, had you carried out the process at your own facility.

5.2 Customer focus

ISO 9001 requirement:

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

Explanation:

Organizations depend on their customers. So it is important that customer relationships be effectively managed. Accordingly, you must understand current and future needs of customers; you must meet their requirements and strive to exceed their expectations. To ensure this you must understand your customer’s specific needs and requirements in terms of products, price, delivery communication, service and support. You must have an effective communication process between your customer and your organization, for discussion, review, timing, action and responsibility on the above issues. You must have an effective process for communication and review of the above requirements to relevant personnel or departments within your own organization.It is top management role to provide the leadership and commitment of time and resources to ensure this happens. Auditors will look for evidence of this. Clause 7.2.1 gets further into the details of understanding and processing customer requirements. Clause 8.2.1 sets requirements for monitoring and measuring customer satisfaction. Clause 5.2 provides the top management’s overall responsibility for customer relationship management, while clause 7.2.1 provides the front end and clause 8.2.1 provides the back end, of the underlying and detailed activities of customer relationship management. The requirements of clause 5.2 – customer focus can be included the following processes – business planning; communications; sales and marketing; and customer satisfaction feedback; etc. You must also identify what specific documents may be needed for effective planning, operation and control of these processes. Examples of such documents may include a business plan, statement of customer related policies and objectives etc

5.3 Quality policy

ISO 9001 requirement:

Top management shall ensure that the quality policy

  1. is appropriate to the purpose of the organization,
  2. includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
  3. provides a framework for establishing and reviewing quality objectives,
  4. is communicated and understood within the organization, and e) is reviewed for continuing suitability.

Explanation:

Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, starting with establishing the quality policy and objectives. Your quality policy provides top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management. Your quality policy must be consistent with the scope of your QMS and other business, management and organizational strategies within the organization. Clause 4.1.a requires that you document your quality policy and clause 5.3.c requires that you specify your commitment to ‘meet requirements’ and ‘continually improve the effectiveness of your QMS’. Clause 1 specifies requirements for the scope of your QMS. The wording of the quality policy should preferably specify what requirements are being complied with customer, regulatory, ISO 9001, etc. It must also clearly state your commitment to continually improve the effectiveness of the QMS. it may also include other complementary and important policies for business growth, product or manufacturing technology, workforce competence, business flexibility, etc. What you state in your quality policy must lead to establishing quality objectives, e.g. if you state in your quality policy that you will “meet customer requirements”, then from this, you might derive customer focused objectives for – product defects; customer complaints and returns; on time delivery, etc. Similarly, for the phrase -“meet ISO 9001 requirements”; from this you might derive process objectives for effectively using ISO 9001 requirements to manage, control and improve all of your QMS processes. Check out the process performance indicators suggested in our coverage of clause 4.2.3 and 4.2.4. Stating that you will continually improve the effectiveness of your QMS  in your quality policy – can lead to a number of objectives, as your QMS is comprised of many processes and you could have one or more objectives for each process. Therefore, each statement in your quality policy may result in one or more quality objectives. These quality objectives do not need to be stated in your quality policy, but top management must clearly be involved in providing direction, establishing and reviewing these objectives. Your internal communication process should cover how the quality policy is communicated throughout the organization. There are many ways of doing this. Personnel must understand the importance and impact of the quality policy on the work they do. Your quality policy may be documented in your quality manual or as an independent document or both. The quality policy is not written in stone. It must be reviewed  periodically by top management, for significant changes in your organization, e.g. management, ownership, relocation, product, shift in customer base, etc. Such changes may result in changes to the quality policy. The establishment of the quality policy should be part of the business planning or QMS planning processes. A review of the quality policy for continuing suitability should be part of your management review process. As a quality document, the quality policy is also controlled by 4.2.3 control of documents.

Audit Checklist

An audit checklist should cover these areas:

  • Check for evidence of  how top management shows its commitment to:
    1. communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
    2. establishing the quality policy,
    3. ensuring that quality objectives are established,
    4. conducting management reviews, and
    5. ensuring the availability of resources.
  • Look for how its made clear how a Customer requirement is translated into action, how the Quality Policy is communicated regularly, how Quality Objectives are established and by whom, that reviews are held regularly on the status of business operations, finally how resources are allocated to the functional areas.
  • For Clause 5.2, review Customer Satisfaction data that is being collected. Is the data showing that satisfaction levels are increasing? Have any actions been taken to improve how Customers perceive you?
  • For Clause 5.3, check the Quality Policy to see if it satisfies Clause 5.3 a, b and c? Through interviews with personnel, determine if they can tell you what the Quality Policy means in their words? Who reviews the Quality Policy, how is it done, and how often does this review occur?

When was the last time the Quality Policy was revised and how were the revisions communicated to all personnel?

Mandatory Procedure :

Clause 5.1: Not applicable
Clause 5.2: Not applicable
Clause 5.3: Not applicable

Mandatory record:

Clause 5.1:Not applicable
Clause 5.2:Not applicable
Clause 5.3: Not applicable

Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement):

Clause 5.1:

  • Role in planning and implementing the processes- business planning, quality planning, management review, internal communication, organization structure
  • Documents for the processes: process map, process flow diagram, a documented procedure, business plan, statement of policies and objectives
  • communicate- meetings, documented policies, memos, directives, email

Clause 5.2:

  • Process for customer focus: business planning, communications, sales and marketing, and customer satisfaction feedback
  • Documents needed for effective planning, operation and control of these processes: – a documented procedure, business plan, statement of customer related policies and objectives
pdf Sample business plan template

Clause 5.3:
Documented statement of Quality Policy

pdf Samples of documented statements of Quality policy

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