ISO 13485:2016 – MANAGEMENT RESPONSIBILITY

Hi friends!!!

In our last
blog, we have seen about ISO 13485:2016, Clause 4. Please check out in the link
given below

ISO 13485:2016 – QMS REQUIREMENTS

https://biomedicalviews.blogspot.com/2020/06/iso-134852016-part-1.html?m=1

Our today’s
topic will be around Clause 5 of ISO 13485:2016.

Let’s get into
the topic with a small introduction about ISO 13485:2016

WHY ISO 13485:2016?

Clause 5 of ISO
13485:2016 gives out the requirements of top management as follows.

1. Implementation
and Maintenance of QMS.

2. Planning of QMS.

3. Ongoing review
of system to attain customer satisfaction and improvement.

CLAUSE
5 has some Sub Clauses. Let’s see in detail about each sub clauses.

CLAUSE 5.1 LEADERSHIP COMMITMENT REQUIREMENTS

1. Assist the
development of organization QMS.

2. Assist the
implementation of organization QMS.

3. Assist the maintenance
of organization QMS.

CLAUSE 5.2 CUSTOMER FOCUS

1. Ascertain to
determine the external requirements.

2. Ascertain that
external requirements are being met.

CLAUSE 5.3 POLICY REQUIREMENTS

1. Plan company’s
Quality Policy.

2. Draft company’s
Quality Policy.

3. Apply company’s
Quality Policy.

4. Review company’s
Quality Policy.

CLAUSE 5.4 PLANNING REQUIREMENTS

This is again
divided into following sub clauses.

CLAUSE 5.4.1 QUALITY OBJECTIVE

1. Develop quality
objectives throughout the organization.

2. Make objectives
needed to comply product requirements.

3. Make objectives
needed to comply regulatory requirements.

CLAUSE 5.4.2 QMS PLANNING

1. Plan how your organization
is going to develop QMS.

2. Plan how your organization
is going to document QMS.

3. Plan how your organization
is going to structure QMS.

4. Plan how your organization
is going to manage QMS.

5. Plan how your organization
is going to monitor QMS.

6. Plan how your organization
is going to control QMS.

7. Plan how your organization
is going to implement QMS.

8. Plan how your organization
is going to maintain QMS.

CLAUSE 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

This is again
divided into following sub clauses.

CLAUSE 5.5.1 CLARIFY RESPONSIBILITY AND AUTHORITY

1. Explicit QMS
responsibilities and authorities

2. Document QMS
responsibilities and authorities.

3. Document
interrelationship between QMS policies.

CLAUSE 5.5.2 APPOINT MANAGEMENT REPRESENTATIVE

1. Hire a member of
management to supervise organization QMS.

2. Offer management
representative with authority and responsibility.

3. Offer management
representative with authority and responsibility to document QMS.

4. Offer management
representative with authority and responsibility to report to top management

5. Offer management
representative with authority and responsibility to promote corporate
awareness.

CLAUSE 5.5.3 ESTABLISH INTERNAL COMMUNICATION

1. Develop relevant
internal communication process.

2. Boost
communication about the effectiveness of organizations QMS.

CLAUSE 5.6 MANAGEMENT REVIEW REQUIREMENTS

This is again
divided into following sub clauses.

CLAUSE 5.6.1 PERFORM REGULAR MANAGEMENT REVIEW

1. Develop
management review procedures.

2. Plan
organizations management reviews after fixed intervals.

3. Review
organizations QMS at fixed intervals.

4. Maintain records
of management reviews.

CLAUSE 5.6.2 STUDY MANAGEMENT REVIEW INPUT

1. Study
information about organizations QMS.

2. Review precedent
management reviews and the status of action items from those reviews.

3. Review results
of previous audits.

4. Review organization
complaint handling issues.

5. Review
organization monitoring & measurement activities.

6. Review new or
revised regulatory requirements that are relevant with your organization.

7. Review past
corrective and preventive actions.

8. Review
improvement activities and associated recommendation.

9. Review changes
that could influence QMS.

CLAUSE 5.6.3
GENERATE MANAGEMENT REVIEW OUTPUT

1. Develop
organizations management review output.

2. Make decisions
and actions to improve organizations QMS.

3. Make decisions
and actions to improve organizations medical products.

4. Make decisions
and actions to update QMS with regulatory changes.

5. Make decisions
and actions to fulfill applicable resource needs.

6. Develop a record
of organizations management review.